[Translation] A Phase II, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of TAK-079 in patients with persistent/chronic primary immune thrombocytopenia

主要目的主要目的是评价TAK-079在持续性/慢性原发性免疫性血小板减少症(ITP)患者中的安全性和耐受性次要目的：次要目的是评估TAK-079对持续性/慢性原发性ITP患者血小板计数的影响探索性目的： 1. 确定TAK-079的PK 2. 确定TAK-079的药效学特征 3. 探索血小板应答的持久性 4. 确定TAK-079对血小板相关抗体水平和亚型的影响 5. 需要补救治疗的患者频率和比例 6. 使用ITP出血评分进行出血评估 7. 确定治疗对健康相关生活质量的影响 8. 探索疫苗诱导的保护性抗体 9. 探索TAK-079重复给药对抗药物抗体（ADA）和疾病活动度的探索性生物标志物的影响

[Translation]

Primary Objectives The primary objective is to evaluate the safety and tolerability of TAK-079 in patients with persistent/chronic primary immune thrombocytopenia (ITP) Secondary Objectives: The secondary objective is to evaluate the effect of TAK-079 on platelet counts in patients with persistent/chronic primary ITP Exploratory Objectives: 1. Determine the PK of TAK-079 2. Determine the pharmacodynamic profile of TAK-079 3. Explore the durability of platelet responses 4. Determine the effect of TAK-079 on platelet-associated antibody levels and subtypes 5. Frequency and proportion of patients requiring rescue therapy 6. Bleeding assessment using the ITP Bleeding Score 7. Determine the effect of treatment on health-related quality of life 8. Explore vaccine-induced protective antibodies 9. Explore the effect of repeated dosing of TAK-079 on anti-drug antibodies (ADA) and exploratory biomarkers of disease activity

Start Date31 May 2023

Sponsor / Collaborator

Takeda (China) International Trading Co. Ltd.

[+2]

CTR20222215 / Active, not recruitingPhase 1

一项在原发性IgA 肾病患者中评价Mezagitamab（TAK-079）联合稳定背景治疗的安全性、耐受性、药代动力学和有效性的Ib 期、多中心、开放性研究

[Translation] A Phase Ib, multicenter, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of mezagitamab (TAK-079) in combination with stable background therapy in patients with primary IgA nephropathy

主要目的: 评价Mezagitamab 在接受稳定背景治疗的原发性IgAN 患者中的安全性和耐受性。次要目的：确定Mezagitamab 的PK， PD 特征，对蛋白尿的影响和免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of mezagitamab in patients with primary IgAN receiving stable background therapy. Secondary objectives: To determine the PK, PD characteristics, effect on proteinuria and immunogenicity of mezagitamab.

Start Date18 Dec 2022

Sponsor / Collaborator

Takeda (China) International Trading Co. Ltd.

[+2]

NCT05174221 / Active, not recruitingPhase 1

A Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy

This study will have two parts. The main aims are to:
check the side effects from mezagitamab.
check for long-term side effects from mezagitamab.
Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period.
Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.

Start Date09 Nov 2022

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Mezagitamab

100 Translational Medicine associated with Mezagitamab

100 Patents (Medical) associated with Mezagitamab

Literatures (Medical) associated with Mezagitamab

02 Dec 2023·Expert opinion on biological therapy

Antibody based therapeutics for autoimmune hemolytic anemia

Review

Author: Fattizzo, Bruno ; Cavallaro, Francesca ; Barcellini, Wilma

INTRODUCTION:

Autoimmune hemolytic anemia (AIHA) treatment has been revolutionized by the introduction of target therapies, mainly monoclonal antibodies (MoAbs).

AREAS COVERED:

The anti-CD20 rituximab, which targets Ab production by B-cells, induces 80% of response in warm-type AIHA (wAIHA) and 50-60% in cold agglutinin disease (CAD). Other B-cell targeting MoAbs including ianalumab, povetacicept, and obexelimab are under active study. The anti-CD38 MoAb daratumumab has been used in several reports to target long-lived plasma-cells responsible for AIHA relapse, being effective even in multi-refractory cases. Anti-complement MoAbs will soon change the treatment paradigm in CAD; the anti-C1s sutimlimab rapidly increased Hb in more than 80% of the cases. Finally, MoAbs inhibiting the neonatal Fc receptor (FcRn), such as nipocalimab, can reduce the half-life of the pathogenic autoAbs, representing a promising treatment for wAIHA.

EXPERT OPINION:

MoAbs offer the potential to improve efficacy by reducing toxicity. However, there is a huge need for clinical trials exploring response duration rather than short-term efficacy. Complement inhibitors and anti-FcRns do not abrogate autoAb production and are being developed as long-term therapies. Thus, the combination of B-cell/plasma cell targeting drugs deserves to be explored. On the other hand, their rapid efficacy should be exploited for the acute AIHA phase.

01 Nov 2023·Transfusion

Steady‐state versus chemotherapy‐based hematopoietic cell mobilization after anti‐CD38‐based induction therapy in newly diagnosed multiple myeloma

Article

Author: Egger-Heidrich, Katharina ; Franke, Georg-Nikolaus ; Bach, Enrica ; von Bonin, Malte ; Remane, Yvonne ; Jentzsch, Madlen ; Bornhäuser, Martin ; Vučinić, Vladan ; Hölig, Kristina ; Röllig, Christoph ; Klötzer, Christina ; Zimmer, Kristin ; Heyn, Simone ; Kretschmann, Theresa ; Merz, Maximilian ; Schwind, Sebastian ; Platzbecker, Uwe ; Brückner, Mandy ; Rathaj, Grit ; Rieprecht, Susanne ; Teipel, Raphael ; Wang, Song-Yau ; Trautmann-Grill, Karolin

Abstract:

Background:

The incorporation of anti‐CD38 monoclonal antibodies (mAb) in induction regimens of newly diagnosed transplant‐eligible multiple myeloma (MM) patients has been established as a new standard. However, the optimal strategy of stem cell mobilization in this context is not yet clear.

Study Design and Methods:

From May 2020 till September 2022, we retrospectively reviewed patients receiving anti‐CD38 mAb‐based induction therapy followed by stem cell mobilization either in a steady‐state protocol (SSM) using 10 μg/kg granulocyte colony‐stimulating factor (G‐CSF) for 5 days or in a chemotherapy‐based protocol (CM) using 1–4 g/m2 cyclophosphamide and G‐CSF.

Results:

Overall, 85 patients (median age 61 years) were included in the analysis. In total, 90 mobilization attempts were performed, 42 with SSM and 48 with CM. There was no significant difference in the median concentration of CD34+ cells in peripheral blood (PB) prior to apheresis between SSM and CM (61/μL vs. 55.4/μL; p = .60). Cumulative CD34+ yields did not differ between the groups with median of 6.68 and 6.75 × 106/kg body weight, respectively (p = .35). The target yield (≥4 × 106 CD34+ cells/kg body weight) was reached in 88% (CM) and 86% (SSM), with a high proportion even after a single apheresis session (76% vs. 75%).Plerixafor was found to be more frequently used in SSM (52%) than in CM (23%; p < .01). A total of 83 patients underwent autologous transplantation and all were engrafted.

Conclusions:

Stem cell collection in patients undergoing anti‐CD38‐based induction therapy is feasible with either CM or SSM, although SSM more frequently requires plerixafor.

01 Oct 2023·British journal of haematology

Novel therapeutics and future directions for refractory immune thrombocytopenia

Review

Author: Al-Samkari, Hanny ; Neufeld, Ellis J

Summary:

Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder affecting approximately 1 in 20 000 people. While most patients with ITP are successfully managed with the current set of standard and approved therapeutics, patients who cannot be adequately managed with these therapies, considered to have refractory ITP, are not uncommon. Therefore, there remains an ongoing need for novel therapeutics and drug development in ITP. Several agents exploiting novel targets and mechanisms in ITP are presently under clinical development, with trials primarily recruiting heavily pretreated patients and those with otherwise refractory disease. Such agents include the neonatal Fc receptor antagonist efgartigimod, the Bruton tyrosine kinase inhibitor rilzabrutinib, the complement inhibitors sutimlimab and iptacopan and anti‐CD38 monoclonal antibodies such as daratumumab and mezagitamab, among others. Each of these agents exploits therapeutic targets or other aspects of ITP pathophysiology currently not targeted by the existing approved agents (thrombopoietin receptor agonists and fostamatinib). This manuscript offers an in‐depth review of the current available data for novel therapeutics in ITP presently undergoing phase 2 or 3 studies in patients with heavily pretreated or refractory ITP. It additionally highlights the future directions for drug development in refractory ITP, including discussion of innovative clinical trial designs, health‐related quality of life as an indispensable clinical trial end‐point and balancing potential toxicities of drugs with their potential benefits in a bleeding disorder in which few patients suffer life‐threatening bleeding.

News (Medical) associated with Mezagitamab

09 May 2024

·www.globenewswire.com

XOMA Reports First Quarter 2024 Financial Results and Highlights Recent Activities

Earned $9 million milestone upon U.S. Food and Drug Administration’s approval of Day One’s OJEMDA™ (tovorafenib); XOMA is entitled to receive a mid-single digit royalty on OJEMDA™ sales Acquired Kinnate Pharmaceuticals, adding at least $9.5 million in non-dilutive capital to XOMA’s balance sheet Expanded the commercial royalty and milestone portfolio with the acquisitions of economic interests in DSUVIA® (sufentanil sublingual tablet) and XACIATO™ (clindamycin phosphate) vaginal gel 2%, as well as two Phase 3 assets Launched XOMA’s first stock repurchase program for up to $50 million EMERYVILLE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2024 financial results and highlighted recent activities. “We continue to build the foundation for accelerating value creation with a disciplined approach to capital deployment,” stated Owen Hughes, Chief Executive Officer of XOMA. “In recent months, we’ve completed the acquisition of Kinnate, acquired economic interests in two commercial assets, as well as in two first-in-class Phase 3 assets, and initiated our first share buyback program on the heels of securing the VABYSMO® royalty-backed loan with Blue Owl. Lastly, and most importantly, the FDA approved OJEMBA™ (tovorafenib), Day One Biopharmaceuticals’ type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement or BRAF V600 mutation, ushering in an important new treatment for children living with relapsed or refractory pLGG.” Key First Quarter Events PartnerEventTalpheraXOMA added another commercial asset to its royalty portfolio with an economic interest in DSUVIA®, which is marketed by Alora Pharmaceuticals. XOMA receives 100 percent of the DSUVIA® economics until a threshold is achieved; thereafter, XOMA retains the 15 percent royalty associated with DSUVIA® commercial sales. The 75 percent royalties from Department of Defense purchases and remaining milestone payments will be shared equally between XOMA and Talphera.Kinnate PharmaceuticalsXOMA initiated the acquisition of Kinnate Pharmaceuticals for $2.5879 in cash per share, plus a non-tradeable contingent value right (CVR) representing the right to receive 85 percent of the net proceeds from the out license or sale of Kinnate assets effected on or before April 2, 2025, and 100% of the net proceeds received from Pierre-Fabre.Zevra TherapeuticsU.S. Food and Drug Administration (FDA) accepted the arimoclomol NDA resubmission for review and set a Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024. XOMA paid a $1 million milestone to LadRx based upon the achievement of this milestone.MedexusFDA approved the pediatric label expansion application for IXINITY® [coagulation factor IX (recombinant)].TakedaReported positive topline results from Phase 2 study evaluating mezagitamab (TAK-079), a potential best-in-class anti-CD38 monoclonal antibody for primary immune thrombocytopenia (ITP).iLG Chem (AVEO Oncology)Dosed the first patient in the ficlatuzumab Phase 3 study, resulting in a $1 million milestone payment to XOMA.CompugenReceived a $1 million milestone payment from Compugen. Subsequent Events PartnerEventDay One BiopharmaceuticalsFDA approved Day One’s OJEMDA™ (tovorafenib) for use in pediatric patients with pediatric low-grade glioma (pLGG). XOMA earned a $9 million milestone upon the approval and is entitled to receive mid-single digit royalties from OJEMDA sales.Daré BioscienceXOMA added economic interests to three best- or first-in-category assets to its portfolio. XACIATO™ vaginal gel 2% is commercially available and marketed by Organon. Bayer holds the U.S. rights to commercialize Ovaprene®, a hormone-free monthly intravaginal contraceptive, currently in Phase 3 clinical trials. XOMA also acquired a synthetic royalty in Sildenafil Cream, 3.6%, a Phase 3-ready asset for female sexual arousal disorder.RezoluteDosed first patient in its Phase 3 trial of RZ358; XOMA earned a $5.0 million milestone associated with the event. Anticipated 2024 Events of Note PartnerEventZevra TherapeuticsSeptember 21, 2024 – FDA PDUFA action date for arimoclomol NDATakedaIn its press release dated March 13, 2024, Takeda announced plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.ii First Quarter 2024 Financial Results XOMA recorded total revenues of $1.5 million for the first quarter of 2024, which included a $1.0 million milestone payment received from AVEO Oncology, as compared with $0.4 million in the first quarter of 2023. Research and development (R&D) expenses were $33,000 and $54,000, respectively, for the first quarters of 2024 and 2023. Upon closing the Kinnate merger in the second quarter of 2024, XOMA assumed operations of Kinnate’s pipeline, as well as ongoing Phase 1 study, and will incur increased R&D costs until winddown activities are complete. General and administrative (“G&A”) expenses were $8.5 million for the first quarter of 2024, compared to $6.2 million for the first quarter of 2023. The increase of $2.3 million was primarily due to a $1.3 million increase in stock-based compensation and a $0.7 million increase in consulting and legal expenses. The increase in stock-based compensation expenses was largely due to the appointment of Mr. Hughes as our full-time Chief Executive Officer in January 2024. In the first quarter of 2024, G&A expenses included $2.9 million in non-cash stock-based compensation expense, compared with $1.6 million in the first quarter of 2023. The increase in stock-based compensation expenses was largely due to the PSU grant associated with the appointment of Mr. Hughes as our full-time Chief Executive Officer in January 2024 combined with PSUs granted in May 2023. Interest expense in the first quarter of 2024 was $3.6 million, representing interest related to the Blue Owl Loan established in December 2023. The Company reported total other income, net, of $2.0 million in the first quarter of 2024, as compared to total other income, net, of $0.4 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher cash balances and higher market interest rates on our investments, as well as the change in the market price of Rezolute’s common stock. Net loss for the first quarter of 2024 was $8.6 million, compared to a net loss of $9.8 million for the first quarter of 2023. On March 31, 2024, XOMA had cash and cash equivalents of $142.4 million (including $6.2 million in restricted cash). On December 31, 2023, XOMA had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the first quarter of 2024, XOMA received $9.8 million in cash from royalty and milestone payments and deployed $8 million to acquire new royalty and milestone economic interests. Net cash used in operating activities during the quarter was $4.9 million. On April 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO). About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), and arimoclomol; the potential occurrences of the events listed under “Anticipated 2024 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA’s portfolio; and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, the commercial assets in XOMA’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) March 31, December 31, 2024 2023 ASSETS(unaudited) Current assets: Cash and cash equivalents$136,225 $153,290 Short-term restricted cash 160 160 Short-term equity securities 413 161 Trade and other receivables, net 3 1,004 Short-term royalty and commercial payment receivables 9,819 14,215 Prepaid expenses and other current assets 270 483 Total current assets 146,890 169,313 Long-term restricted cash 6,016 6,100 Property and equipment, net 40 25 Operating lease right-of-use assets 364 378 Long-term royalty and commercial payment receivables 65,577 57,952 Other assets - long term 533 533 Total assets$219,420 $234,301 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$1,515 $653 Accrued and other liabilities 1,299 2,768 Contingent consideration under RPAs, AAAs and CPPAs 3,000 7,000 Operating lease liabilities 55 54 Unearned revenue recognized under units-of-revenue method 2,159 2,113 Preferred stock dividend accrual 1,368 1,368 Current portion of long-term debt 6,144 5,543 Total current liabilities 15,540 19,499 Unearned revenue recognized under units-of-revenue method – long-term 6,692 7,228 Long-term operating lease liabilities 319 335 Long-term debt 114,528 118,518 Total liabilities 137,079 145,580 Stockholders’ equity: Preferred Stock, $0.05 par value, 1,000,000 shares authorized: 8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at March 31, 2024 and December 31, 2023 49 49 8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at March 31, 2024 and December 31, 2023 — — Convertible preferred stock, 5,003 issued and outstanding at March 31, 2024 and December 31, 2023 — — Common stock, $0.0075 par value, 277,333,332 shares authorized, 11,636,355 and 11,495,492 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 87 86 Additional paid-in capital 1,314,036 1,311,809 Accumulated deficit (1,231,831) (1,223,223) Total stockholders’ equity 82,341 88,721 Total liabilities and stockholders’ equity$219,420 $234,301 XOMA CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 Revenues: Revenue from contracts with customers$1,000 $- Revenue recognized under units-of-revenue method 490 437 Total revenues 1,490 437 Operating expenses: Research and development 33 54 General and administrative 8,461 6,196 Arbitration settlement costs - 4,132 Amortization of intangible assets - 225 Total operating expenses 8,494 10,607 Loss from operations (7,004) (10,170) Other income (expense) Interest expense (3,551) - Other income (expense), net 1,960 357 Net loss and comprehensive loss$(8,595) $(9,813) Less: accumulated dividends on Series A and Series B preferred stock (1,368) (1,368) Net loss and comprehensive loss attributable to common stockholders, basic and diluted$(9,963) $(11,181) Basic and diluted net loss per share attributable to common stockholders$(0.86) $(0.98) Weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders 11,580 11,460 XOMA CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands) Three Months Ended March 31, 2024 2023 Cash flows from operating activities: Net loss$(8,595) $(9,813)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 2,856 1,570 Common stock contribution to 401(k) 118 123 Amortization of intangible assets — 225 Depreciation 2 1 Accretion of long-term debt discount and debt issuance costs 306 — Non-cash lease expense 14 47 Change in fair value of equity securities (252) 24 Changes in assets and liabilities: Trade and other receivables, net 1,001 (5)Prepaid expenses and other assets 213 269 Accounts payable and accrued liabilities (105) 3,122 Operating lease liabilities (15) (50)Unearned revenue recognized under units-of-revenue method (490) (437) Net cash used in operating activities (4,947) (4,924) Cash flows from investing activities: Payments of consideration under RPAs, AAAs and CPPAs (15,000) (9,600)Receipts under RPAs, AAAs and CPPAs 7,771 2,366 Purchase of property and equipment (17) — Net cash used in investing activities (7,246) (7,234) Cash flows from financing activities: Principal payments – debt (3,616) — Debt issuance costs and loan fees paid in connection with long-term debt (581) — Payment of preferred stock dividends (1,368) (1,368)Repurchases of common stock (13) — Proceeds from exercise of options and other share-based compensation 1,956 — Taxes paid related to net share settlement of equity awards (1,334) — Net cash used in financing activities (4,956) (1,368) Net decrease in cash, cash equivalents and restricted cash (17,149) (13,526)Cash, cash equivalents and restricted cash at the beginning of the period 159,550 57,826 Cash, cash equivalents and restricted cash at the end of the period$142,401 $44,300 Supplemental Cash Flow Information: Cash paid for interest$3,780 $— Non-cash investing and financing activities: Accrual of contingent consideration under the Affitech CPPA$3,000 $— Preferred stock dividend accrual$1,368 $1,368 Investor contact: Media contact:Juliane SnowdenKathy VincentXOMAKV Consulting & Management+1-646-438-9754+1-310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com i https://www.takeda.com/newsroom/newsreleases/2024/takeda-announces-positive-topline-results-from-phase-2-study-evaluating-mezagitamab-TAK-079-a-potential-best-in-class-anti-CD38-monoclonal-antibody-for-primary-immune-thrombocytopenia/

Phase 3Drug ApprovalFinancial StatementPhase 1Clinical Result

28 Mar 2024

·www.prnewswire.com

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023. CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022. The 2023 full-year revenue of $34 million reflects an 11% of decrease compared to 2022. Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, said "CASI's team has navigated our business through a challenging external environment. We have successfully brought the second commercial product FOLOTYN® to China market as a treatment for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). We will continue to strengthen the commercial franchise throughout 2024 and beyond. At the same time, our regulatory and development team made significant pipeline advancements." Dr. He continued, "Advancement, development, and commercialization of the pipelines remain our strategic focus. 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023. We continue the development for BI-1206 in China, with the early clinical data from the ongoing phase I trial in China demonstrating promising preliminary clinical results for patients with relapsed/refractory non-Hodgkin lymphoma. CB-5339 received Clinical Trial Application approval from the NMPA in January 2023. We are currently preparing for CID-103 clinical study application in relapsed or refractory multiple myeloma in China. We will continue to drive our portfolio forward by executing on several milestones in the quarters ahead." Key Highlights for 2023 EVOMELA® (melphalan for injection) Prior to EVOMELA's entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA's launch in August of 2019, CASI worked closely with therapeutic area experts to improve market awareness and expedite adoption in the Chinese market. In 2023, nearly 10,000 patients were treated with EVOMELA. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further the adoption of stem cell transplantation as a standard of care in the MM treatment setting and will continue working to address the persistent high unmet need in this patient population. FOLOTYN® (Pralatrexate) On July 31, 2023, CASI entered into a tripartite assignment agreement with Mundipharma International Corporation Limited ("MICL"), Mundipharma Medical Company (MMCo), and Acrotech Biopharma Inc. (Acrotech) for the commercialization of FOLOTYN® (Pralatrexate) in the People's Republic of China. FOLOTYN® (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This product was approved by both the FDA and China's NMPA for PTCL. CASI announced the first patient was dosed with FOLOTYN® in China on February 15, 2024. CASI will continue to spend time, resources, and efforts on the commercialization of FOLOTYN® in China. BI-1206 (Anti-FcyRIIB antibody) Along with CASI's partner, BioInvent, CASI continues to progress the development and regulatory framework for BI-1206 in China. The NMPA granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. EC approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated in two Phase 1/2 trials as combination agent with rituximab for the treatment of non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors. In 2022, the U.S. FDA granted orphan drug designation, for BI-1206, for the treatment of follicular lymphoma (FL), the most common form of slow-growing non-Hodgkin lymphoma (NHL). Inaticabtagene Autoleucel (CNCT-19) On November 8, 2023, The China National Medical Products Administration (NMPA) has granted market approval for Juventas' Inaticabtagene Autoleucel (CNCT-19) for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product comprised of a unique CD19 scFv（HI19a）structure and utilizes leading CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of efficacy, with durable remissions, and substantially improved safety profile with reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL. CASI is currently involved in arbitration proceedings against Juventas in relation to Juventas's purported termination of the CNCT-19 Agreements, between the Company and Juventas with respect to the commercialization of Juventas' cell therapy, Inaticabtagene Autoleucel (CNCT-19). On March 2, 2024, CASI received a notice from Juventas, which purported to terminate the CNCT-19 Agreements. CASI responded to Juventas's purported termination notice, noting that Juventas was not entitled to unilaterally terminate the CNCT-19 Agreements and further demanding that Juventas cease any conduct that may constitute further breach of the CNCT-19 Agreements and execute a written undertaking regarding compliance with the CNCT-19 Agreements by March 13, 2024. Juventas did not comply with CASI's demands. On March 20, 2024, CASI submitted a Notice of Arbitration at the Hong Kong International Arbitration Centre ("HKIAC") against Juventas pursuant to the CNCT-19 Agreements' dispute resolution clauses, claiming that Juventas's purported termination was invalid and that Juventas breached the CNCT-19 Agreements and seeking, among other things, damages and injunctive reliefs. Together with the Notice of Arbitration, CASI also submitted an application for the appointment of an emergency arbitrator, seeking emergency injunctive reliefs. On the same day, Juventas also submitted a Notice of Arbitration at the HKIAC against CASI, alleging, among other things, that the CNCT-19 Agreements were validly terminated and that CASI breached the CNCT-19 Agreements. The HKIAC has appointed an emergency arbitrator in accordance with CASI's application. The arbitration proceedings are ongoing. CB-5339 (VCP/p97 inhibitor) In March 2021, the Company entered into an exclusive license with Cleave Therapeutics, Inc. ("Cleave") for the development and commercialization of CB-5339, an oral novel VCP/p97 inhibitor, in both hematological malignancies and solid tumors, in Mainland China, Hong Kong, Macau and Taiwan. CB-5339 has been evaluated by Cleave in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Because CB-5339 has not yet reached technological feasibility and has no alternative future uses, the Company expensed the $5.5 million upfront payment as acquired in-process research and development in 2021. On July 18, 2023, the Company entered into an assignment agreement (the "Assignment Agreement") with Cleave, pursuant to which the Company obtained the global intellectual property rights related to CB-5339. Pursuant to the Assignment Agreement and partially in exchange for the transfer of the global intellectual property rights for CB-5339 as well as all remaining CB-5339 drug substance and drug product to CASI. CID-103 (Anti-CD38 Mab) CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is closed to further accrual in France and the UK. Future multiple myeloma development activities will be focused on China. CASI entered into a sublicense agreement with Precision Autoimmune Therapeutics, who will carry out the development activities for the autoimmune indications for CID-103. Full-Year 2023 Financial Results Revenues consist of product sales of EVOMELA®. Revenue was $34.0 million for the year ended December 31, 2023 compared to $38 million for the year ended December 31, 2022. The decrease was mainly attributable to the launch of an undifferentiated generic formulation of melphalan for injection product by a Chinese domestic manufacture. Costs of revenues were $13.8 million for the year ended December 31, 2023 compared to $15.8 million for the year ended December 31, 2022. Costs of revenues as a percentage of EVOMELA® sales for 2023 and 2022 were 41% and 42%, respectively. General and administrative expenses for the year ended December 31, 2023 were $25.4 million, compared with $23.4 million for the year ended December 31, 2022. The increase in general and administrative expenses was primarily attributable to incremental share-based compensation expense recognized due to the option modification in May 2023 amounted to US$2.2 million, and increased depreciation expense of US$1.2 million due to the full year depreciation expenses of CASI Wuxi's leasehold improvement that started to depreciate in August 2022, offset by decrease of land vacancy fee of US$1.3 million in relation to the return of the Wuxi land use right. Selling and marketing expenses for the year ended December 31, 2023, were $16.4 million, compared with $14.3 million for the year ended December 31, 2022. The increase was primarily due to increased travel and conference expenses incurred for our commercial activities after the Chinese health authority cancelled the stringent COVID-19 controlled measure in December 2022. Research and development expenses for the year ended December 31, 2023 were $9.9 million, compared with $16.0 million for the year ended December 31, 2022. The decrease in R&D expenses is primarily due to CID-103 as we incurred less laboratory tests and decrease in the research and development expenses of generic pharmaceuticals in Wuxi manufacturing facility. Net loss for the year ended December 31, 2023 was $26.3 million compared to $40.3 million for the year ended December 31, 2022. As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022. Further information regarding the Company, including its Annual Report on Form 20-F for the year ended December 31, 2023, can be found at . About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at . CASI Forward-Looking Statements: This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN® is proprietary to Acrotech Biopharma Inc and its affiliates. COMPANY CONTACT: Rui Zhang CASI Pharmaceuticals, Inc. 240.864.2643 [email protected] (Financial Table Follows) SOURCE CASI Pharmaceuticals

Phase 1License out/inCell TherapyDrug ApprovalOrphan Drug

13 Mar 2024

·www.biospace.com

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

− Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated − Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024 − Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024 OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP). Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high affinity for CD38 expressing cells (including plasmablasts, plasma cells, natural killer cells) resulting in their depletion. The TAK-079-1004 trial (NCT04278924) evaluated three different doses of subcutaneous mezagitamab vs placebo, given once weekly for eight weeks in patients with chronic (more than one year in duration) or persistent (3-12 months in duration) primary ITP. An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results. Mezagitamab has been generally safe and well tolerated across all three cohorts. All mezagitamab doses tested demonstrated a higher platelet response rate than placebo. The increases in platelet count were dose-dependent with the greatest platelet response observed at the highest dose tested. Platelet response in mezagitamab treated patients occurred rapidly and was maintained post-therapy. Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024. When mezagitamab advances to Phase 3 in ITP Takeda will have five new molecular entities in Phase 3 development in fiscal year 2024 including TAK-279 for the treatment of psoriasis and psoriatic arthritis, TAK-861 for the treatment of narcolepsy type 1, soticlestat for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and fazirsiran for the treatment of α1-antitrypsin associated liver disease. ITP is a rare, IgG mediated autoimmune disease caused, in part, by the development of autoantibodies to platelets (and/or megakaryocytes), which are blood cells responsible for preventing or stopping bleeding. ITP is characterized by the accelerated destruction of platelets (with or without impaired production), resulting in a decreased platelet count and an increased risk of bleeding, which can be debilitating (including fatigue and impaired quality of life), and in severe cases may be life-threatening. The precedent for approval of new drugs in this indication requires that platelet counts be maintained at 50,000/uL or more for a sustained period. Approximately 20 percent of patients with ITP do not achieve a platelet count above 50,000/uL following treatment with available first- and second-line therapies creating significant patient burden and unmet need for a disease modifying treatment that is also tolerable.1,2 “These Phase 2 results demonstrate mezagitamab’s compelling disease modifying mechanism of action, which has the potential to achieve disease remission for people with ITP. There remains considerable unmet need among ITP patients who may not respond or have inadequate response to prior treatment. In addition, some patients who do respond to available therapies struggle to manage side effects or relapse despite treatment,” said Chinwe Ukomadu, Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “We look forward to initiating the Phase 3 trial and presenting these data at an upcoming scientific congress.” Therapy with mezagitamab is designed to deliver rapid and sustained improvement in platelet response and generally rapidly restores platelet counts to functional levels. Mezagitamab previously received Orphan Drug Designation for the treatment of ITP from the U.S. Food and Drug Administration and the program recently received Fast Track Designation. Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023). About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. References Provan D, Donald A, et al. Blood Advances. 2019;26;3(22):3780-3817. Rodeghiero F. International Journal of Hematology. 2023;117:316–33.

Clinical ResultPhase 2Orphan DrugFast TrackPhase 3

100 Deals associated with Mezagitamab

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	CN	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	JP	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	BG	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	HR	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	DE	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	GR	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	IT	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	SI	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	ES	Takeda Pharmaceutical Co., Ltd.	09 Nov 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04278924 (TAK-079-1004, Biospace) Manual	Phase 2	Purpura, Thrombocytopenic, Idiopathic	-	Mezagitamab	yowyzxyjlh(aupnyyuutu) = Mezagitamab has been generally safe and well tolerated across all three cohorts. vxtmkhmqbn (mrqfmpvlsb ) View more	Positive	13 Mar 2024
NCT04278924 (TAK-079-1004, Biospace) Manual	Phase 2	Purpura, Thrombocytopenic, Idiopathic	-	Placebo		Positive	13 Mar 2024
NCT04159805 (CTgov)	Phase 2	Myasthenia Gravis	36	TAK-079 Placebo (TAK-079 Placebo-matching)	rtmiyvyjbc(lwuukxzwfd) = koyopknzea yezflhfywz (lkslcxxlwo, lyxaectmcr - taqggblreo) View more	-	02 Jun 2023
NCT04159805 (CTgov)	Phase 2	Myasthenia Gravis	36	TAK-079 (TAK-079 300 mg)	rtmiyvyjbc(lwuukxzwfd) = hhwqjpxmbs yezflhfywz (lkslcxxlwo, thvnkcobku - zybfkqchxg) View more	-	02 Jun 2023
NCT02219256 (Pubmed \| Br J Clin Pharmacol)	Phase 1	-	74	TAK-079	xgdujppdqn(itkksdjxkw) = nwvwvlwaon uaretmgvhk (tbfwlkmpwq, 52) View more	-	01 Jul 2020
NCT03439280 (ASCO2020)	Phase 1/2	Relapse multiple myeloma	34	TAK-079	tymvutgfzv(wbrjzcpwjd) = 18% ahfcjtvtgr (dionjhhplw ) View more	Positive	25 May 2020
NCT03439280 (EHA2020)	Phase 1	Relapse multiple myeloma	34	TAK-079	hvgiieojqx(xshcloowbk) = Drug related adverse events (AEs), any grade, occurring in at least 10% of patients were: fatigue (21%), anemia (18%), neutropenia (18%), leukopenia (15%). Neutropenia was the only drug related grade 3 AEs in 2 or more patients (n=2); only drug related SAE was 1 Grade 3 diverticulitis. No drug-related grade 4 AEs, AEs leading to study discontinuation, or on-study deaths reported ctecoqwspb (slwzmeqdoh ) View more	Positive	14 May 2020
ACR2016	Not Applicable	Systemic Lupus Erythematosus CD38 \| CD20 \| CD27 ... View more	-	TAK-079	bvebofkizw(tpllqnmlfq) = qcziehhrgj gdtuuqoepx (uujyzzdngh ) View more	Positive	14 Nov 2016

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