CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [5]

Active Indication

Immunoglobulin Light-Chain AmyloidosisMultiple MyelomaSmoldering Multiple Myeloma+ [20]

Inactive Indication

Adult Lymphoblastic LymphomaExtranodal NK-T-Cell LymphomaFollicular Lymphoma+ [11]

Originator Organization

Janssen Global Services LLC

Active Organization

Xian-Janssen Pharmaceutical Ltd.Janssen Research & Development LLC

Genentech, Inc.

+ [16]

Inactive Organization

Janssen-Cilag GmbH

Drug Highest PhaseApproved

First Approval Date

United States (16 Nov 2015),

Multiple Myeloma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (Japan), Orphan Drug (United Kingdom), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 9075449L

Source: *****

Sequence Code 9946743H

Source: *****

314

Clinical Trials associated with Daratumumab

NCT06892522

/ Not yet recruitingPhase 1

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date02 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06348147

/ Not yet recruitingPhase 2IIT

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

Start Date01 May 2025

Sponsor / Collaborator

UNC Lineberger Comprehensive Cancer Center

NCT06287944

/ RecruitingPhase 1IIT

Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.

Start Date18 Apr 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Daratumumab

100 Translational Medicine associated with Daratumumab

100 Patents (Medical) associated with Daratumumab

1,973

Literatures (Medical) associated with Daratumumab

31 Dec 2025·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

Author: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

01 Apr 2025·Clinical Lymphoma Myeloma & Leukemia

Presence of 1q21 Gain and Amplification May be Associated With Poorer Outcomes in Daratumumab-treated Multiple Myeloma Patients

Author: Kim, Kihyun ; Moore, Elizabeth ; McQuilten, Zoe K ; Spencer, Andrew ; Dun, Karen ; Wellard, Cameron ; Hocking, Jay ; Quach, Hang ; Chng, Wee Joo ; Mollee, Peter ; Ho, Phoebe Joy ; McCaughan, Georgia ; Lim, Kenneth J C ; Chen, Fiona ; Janowski, Wojt ; Ninkovic, Slavisa

01 Apr 2025·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Efficacy and safety of daratumumab for the treatment of refractory/relapsed multiple myeloma. A systematic review of meta-analyses

Review

Author: Abushanab, Dina ; Algarabli, Yousef ; Yassin, Mohamed A ; Sulaiman, Ruba ; Moustafa, Diala Alhaj ; Shafei, Laila ; Al-Badriyeh, Daoud

Introduction:

Several meta-analyses (MAs) of the efficacy and safety of daratumumab in refractory/relapsed multiple myeloma (RRMM) exist. They include different types of populations, Daratumumab regimens, and outcomes. Moreover, there is a wide variation in methodological quality and risk of bias.

Objective:

This study aimed to conduct a systematic review of MAs to summarize the literature on the efficacy and safety profile of daratumumab use in RRMM, and also provide an assessment of the quality and risk of bias of the MAs if sufficient data is available.

Methods:

The literature databases Pubmed, Embase, Web of Science, and Cochrane were searched since inception. The quality of methodology was assessed by the AMSTAR-2 tool, and the risk of bias was assessed by the ROBIS tool.

Results:

Eight MAs were included in the SR. Most studies reported ORR and CR improvement by adding daratumumab to the chemotherapy regimen. Five MAs reported improvement in PFS in daratumumab-based regimens compared to non- daratumumab-based regimens. Only two MAs reported molecular response, favoring daratumumab. Dara was associated with adverse drug events (ADEs), including pneumonia and diarrhea. Conflicting evidence regarding hematological ADEs association with daratumumab exists. The overall quality of the studies is poor, but the MAs had a low risk of bias overall.

Conclusion:

Despite including low-quality MAs, this SR provides a summary that simplifies clinicians’ access to efficacy and safety outcomes of daratumumab in RRMM patients. Future studies are required to reduce the uncertainty and produce higher-quality Mas, particularly regarding daratumumab's safety.

498

News (Medical) associated with Daratumumab

26 Mar 2025

·www.prnewswire.com

Keymed Biosciences Announces Annual Results of 2024

CHENGDU, China, March 26, 2025 /PRNewswire/ -- March. 25, 2025, Keymed Biosciences Inc. (HKEX: 02162) announced its annual results of 2024, along with a corporate update. Rapid development of our pipeline products Stapokibart (CM310) (IL-4Rα antibody) Three new drug applications of Stapokibart for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyposis (CRSwNP) and seasonal allergic rhinitis have been approved by the NMPA. By the end of 2024, Stapokibart resisted strong sales and recorded revenue of approximately RMB40 million within three and a half months. In September 2024, the new drug application of Stapokibart injection for the treatment of moderate-to-severe atopic dermatitis in adults was approved by the NMPA. The phase III clinical study results indicated that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Additionally, the rates of achieving a weekly average reduction of ≥ 4 points from baseline in the daily PP-NRS score were 67.3% and 60.5%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In December 2024, the new drug application of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps was approved by the NMPA. The study results showed that the data from the Phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P < 0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. In February 2025, the new drug application of Stapokibart injection for the treatment of seasonal allergic rhinitis was approved by the NMPA. We advanced and completed the data unblinding and statistical analysis for the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR). The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing. The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits. Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety. In February 2024, we launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in adolescent subjects with moderate-to-severe AD. In May 2024, we initiated a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in subjects with nodular prurigo. As of the date of this announcement, the patient enrollment for this clinical study is in progress. In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart injection for the treatment of moderate-to-severe AD were presented by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. In October 2024, the full text of the 52-week efficacy and safety data of the Phase III clinical study was published in the《Allergy》, the top international journal in allergy and immunology field. CMG901/AZD0901 (Claudin 18.2 ADC) AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the indications of gastric cancer, pancreatic cancer and biliary tract cancer, including the Phase III clinical trial for 2L+ gastric cancer, Phase II clinical trial for 1L gastric cancer, Phase II clinical trial for 1L pancreatic cancer, and Phase II clinical trial for 2L+ biliary tract cancer. In June 2024, the data from the Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. On 6 January 2025, the data from the Phase I clinical study was released on the international authoritative oncology journal, The Lancet Oncology. The clinical data indicated that the median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months. CM313 (CD38 antibody) In 2024, we initiated and advanced a multi-center, open-label Phase I/II clinical study. In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. 95.5% of patients achieved a platelet count of ≥50 × 109/L within 8 weeks upon the first acceptance of CM313 infusion, and the durable platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6%. In July 2024, we completed Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with SLE. We plan to initiate a Phase II clinical study in the first half of 2025. In 2024, we initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313(SC) injection in subjects with primary immune thrombocytopenia. The first patient was enrolled and dosed in November 2024. We initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313(SC) injection in subjects with IgA nephropathy in early 2025. As of the date of this announcement, preparations for patient enrollment are underway for this study. CM512 (TSLP x IL-13 bispecific antibody) We have initiated a randomized, double-blinded, single/multiple dose-escalation, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics and immunogenicity of CM512 in healthy subjects and patients with moderate-to-severe atopic dermatitis, with enrollment of the first subject completed in September 2024. The overseas Phase I clinical trial evaluating CM512 for the treatment of asthma was initiated in the first quarter of 2025. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a multi-center, open-label Phase I/II clinical study to assess CM336 injection in treating patients with relapsed or refractory multiple myeloma. As of the date of this announcement, the product is currently in the dose-expansion phase of Phase I/II clinical study. In December 2024, the latest data of the phase I/II clinical study of CM336 for relapsed or refractory multiple myeloma was presented as a poster at the 66th American Society of Hematology (ASH) Annual Meeting. CM383 (Aβ protofibrils antibody) As of the date of this announcement, the enrollment of all subjects in the Phase Ia clinical study of CM383 in healthy subjects was completed; In November 2024, the enrollment of the first subject in Phase Ib clinical study of CM383 in patients with mild cognitive dysfunction of Alzheimer's disease origin and mild Alzheimer's disease was completed. CM518D1 (CDH17 ADC) We submitted IND application to CDE, and planned to conduct a multi-center, open-label Phase I/II clinical trial for evaluation of CM518D1 in treatment of patients with advanced solid tumors. CM355/ICP-B02 (CD20 x CD3 bispecific antibody) We are conducting a Phase I/II clinical trial in China to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in r/r NHL. Dose escalation of the intravenous infusion formulation ("IV") was completed and the subcutaneous formulation ("SC") is being evaluated. Our preliminary data of both IV and SC formulations have shown good efficacy of CM355 in patients with follicular lymphoma ("FL") and DLBCL. CM350 (GPC3 x CD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study in 2024 to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. As of the date of this announcement, the product is currently in the dose-escalation of Phase I/II clinical study. CM369/ICP-B05 (CCR8 antibody) We are conducting a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed/refractory NHL. Dose escalation of CM369 has been escalated up to 450 mg in solid tumor and 600 mg in NHL, CM369 was well tolerated with no DLTs nor ≥grade3 TRAEs observed. The preliminary results demonstrated a favorable PK profile with sufficient exposure for target coverage and regulatory T-cell depletion. CM380 (GPRC5D×CD3 bispecific antibody) Preclinical studies indicated that CM380 had favorable antitumor effects and was well tolerated. As of the date of this announcement, we are planning to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively explore diversified BD models to maximize the global value of the pipeline. In July 2024, Chengdu Keymed entered into a license agreement with Belenos Biosciences,Inc. The license agreement grants Belenos the exclusive rights to develop, manufacture,and commercialize the Group's drug candidates CM512 and CM536 globally (excluding the Greater China region). In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments up to US$170 million. As of the date of this announcement, Belenos is planning to initiate a Phase I clinical trial evaluating CM512 for the treatment of asthma. In November 2024, Chengdu Keymed and Platina Medicines Ltd ("PML") entered into an exclusive license agreement. The license agreement grants PML the exclusive right to develop, manufacture and commercialize CM336 globally excluding Mainland China, Hong Kong, Macau and Taiwan. In return, the Group shall receive an upfront and near-term payment of US$16 million and a minority equity interest in Ouro Medicines, LLC ("Ouro Medicines") as part of the consideration. Ouro Medicines is the parent company of PML and owns 100% of the equity interest in PML. The Group may also receive additional payments of up to US$610 million subject to achievement of certain clinical, regulatory and commercial milestones and is also entitled to receive tiered royalties on net sales of CM336 and related products from PML. In January 2025, Chengdu Keymed entered into an exclusive out-license agreement with Timberlyne Therapeutics, Inc. The license agreement grants the target company the exclusive right to develop, manufacture and commercialize CM313 globally (excluding Mainland China, Hong Kong, Macau and Taiwan). In return, the Group shall receive an upfront and near-term payment of US$30 million and equity interest of the target company, being the largest shareholder of this company. The Group may also receive additional payments up to US$337.5 million subject to achievement of certain sales and development milestones. The Group is also entitled to receive tiered royalties on net sales from the target company. In January 2025, Chengdu Keymed, Beijing InnoCare and the Joint Venture have entered into the Agreement with Prolium for the development and commercialization of CM355. Under the terms of the Agreement, Prolium will have the exclusive right to develop, register, manufacture, and commercialize CM355 globally in non-oncology indications and in oncology indications outside of Asia. Rapid expansion of workforce and production facilities As of December 31, 2024, we had 1,300 full-time employees in total, including over 240 employees engaging in commercialization and nearly 400 employees engaging in drug discovery and clinical operations. We will continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. As of the date of this announcement, the production capacity of our production base has reached 20,000 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Financial highlights As of December 31, 2024, the Company generated a total annual revenue of RMB 430 million, representing a 21% year-on-year increase. This includes about RMB 40 million in sales revenue from Stapokibart over three and a half months and RMB 390 million in licensing revenue from BD agreements. Throughout 2024, the company continued advancing its differentiated pipeline development and clinical research, with R&D expenditures reaching approximately RMB 730 million, a 23% year-on-year increase. The company maintained a strong cash position with total cash on hand of approximately RMB 2.1 billion. Moving forward, Keymed will continue to establish, and refine its technology platforms, rapidly advancing the development of pipeline candidates in China and globally. The company will comprehensively drive the commercialization of approved product and indications. Concurrently, Keymed will proactively explore strategic partnerships worldwide to accelerate global patient access to its drug candidates through diversified BD models. The company plans to further recruit talent in commercial sales, clinical development, and manufacturing, expand cGMP-compliant production capacity, reduce costs, enhance operational efficiency, and remain committed to developing, producing, and commercializing innovative therapies that are globally competitive, high-quality, and affordable for patients worldwide. SOURCE Keymed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultPhase 3License out/inPhase 2

11 Mar 2025

·pipelinereview.com

2seventy bio Enters into Definitive Agreement to be Acquired by Bristol Myers Squibb

$5.00 per share, all-cash transaction Expected to close in the second quarter of 2025, subject to customary closing conditions CAMBRIDGE, MA, USA I March 10, 2025 I 2seventy bio, Inc. (Nasdaq: TSVT), today announced a definitive merger agreement under which Bristol Myers Squibb (NYSE: BMY) (“BMS”) will acquire all of the outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction for a total equity value of approximately $286 million, or $102 million net of estimated cash. The deal represents an 88% premium to the closing price of $2.66 on March 7, 2025. “A year ago, 2seventy decided to exclusively focus on unlocking the value of Abecma , with the goal of delivering more time for people living with multiple myeloma and maximizing value for all stakeholders,” said Chip Baird, chief executive officer, 2seventy bio. “The strategic rationale for this acquisition is clear and today’s announcement represents the culmination of the journey for 2seventy bio. We believe that Abecma will continue to benefit from BMS’ experience and resources to ensure this important therapy is delivered to patients who need it. I would like to express my deep gratitude for current and past 2seventy team members and more broadly the dedicated community of patients, scientists, providers and partners that helped take cell and gene therapy from a complicated idea to reality for patients.” Transaction Details and Path to Completion Under the terms of the agreement, BMS will promptly commence a tender offer to acquire all outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction. 2seventy bio’s Board of Directors unanimously recommends that 2seventy bio stockholders tender their shares in the tender offer. The closing of the transaction is expected to occur in the second quarter of 2025 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of 2seventy bio’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, BMS will acquire all remaining shares of 2seventy bio common stock that are not tendered in the tender offer through a second-step merger at the same price in the tender offer of $5.00 per share. Following the completion of this transaction, 2seventy bio’s common stock will no longer be listed for trading on Nasdaq. In connection with the execution of the merger agreement, certain stockholders of 2seventy bio owning approximately 5.3% of the outstanding shares of 2seventy bio’s common stock have entered into tender and support agreements pursuant to which they have agreed to tender all of their owned shares in the offer. Advisors Goldman Sachs & Co. LLC is serving as exclusive financial advisor to 2seventy bio, and Goodwin Procter LLP is serving as legal counsel. ABECMA U.S. INDICATION ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Please see full Prescribing Information , including Boxed WARNINGS and Medication Guide . About Bristol Myers Squibb and 2seventy bio Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S. The companies’ clinical development program for Abecma includes ongoing clinical studies (KarMMa-2, KarMMa-3) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov . About 2seventy bio Our name, 2seventy bio, reflects why we do what we do – TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR T cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit www.2seventybio.com . Follow 2seventy bio on social media: X (Twitter) and LinkedIn . SOURCE: 2seventy

ImmunotherapyAcquisitionCell Therapy

11 Mar 2025

·tuhurabio.com

TuHURA Biosciences, Inc Appoints Craig L. Tendler M.D., Former Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs, Johnson & Johnson Innovative Medicine Research & Development, to its Board of Directors

Dr. Tendler oversaw 30 Major Drug Approvals, including worldwide approvals for J&J’s transformational treatments in hematologic malignancies, prostate, lung and bladder cancers Dr. Tendler also oversaw 13 FDA Breakthrough Designations accelerating the early development of promising investigational medicines intended for treatment of serious oncology indications TAMPA, FL / ACCESS Newswire / March 11, 2025 / TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA”), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced it has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. “We are honored and thrilled to have Craig join our Board of Directors. His extensive experience in creating and overseeing development plans, including integration of biomarkers and diagnostics and overseeing comprehensive data-generation activities for all products in the oncology portfolio while at J&J, from proof of concept through registration and lifecycle management, will be a valuable asset to TuHURA as we advance IFx-2.0 through its registrational Phase 3 clinical trial planned to begin in second quarter 2025 and while we pursue optimal positioning of our pipeline of novel therapeutics focused on overcoming resistance to cancer immunotherapy,” commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. “His experience in overseeing major oncology business development opportunities, culminating in the acquisition/co-development of practice-changing oncology products, will be valuable in assisting the Company in evaluating potential corporate collaborations and potential acquisitions of other novel therapeutics to add to the Company’s pipeline.” “His impressive track record achieving worldwide approvals for transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA), will supplement the Board’s broad expertise with proven results across all aspects of oncology drug development at a critical juncture in TuHURA’s development programs,” noted James Manuso, Ph.D., Chairman of TuHURA’s Board of Directors. Dr. Tendler added, “TuHURA has established a science-based portfolio of novel complementary technologies and late-stage drug candidates that I believe has the potential to make a significant impact on the immuno-oncology treatment landscape. The data demonstrated to date are promising and underscore the ability of one of their potential therapeutics, IFx-2.0, to overcome resistance to immune checkpoint inhibitor therapy, a much-needed advance to further the patient benefit of this important class of cancer immuno-therapeutics. With their recent agreement with Kineta to acquire its VISTA inhibiting antibody, leveraging their novel discovery of the critical role the delta opioid receptor may play in controlling the immune suppressing capabilities of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages, I feel this is an optimal time to bring my experience in oncology drug development to the Board and to management. I look forward to contributing to the continued growth and future success of the Company.” Dr. Tendler previously served as Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development (Retired). In this position, he was responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio, from proof of concept through registration and lifecycle management. He worked closely with teams in early development and the disease areas of focus to implement a seamless end-to-end oncology clinical research strategy that incorporated compelling science, broad clinical trial access to diverse populations, and addressed areas of high unmet medical need. During his tenure at Johnson & Johnson, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA). He has played an instrumental role in achieving 13 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions. Prior to joining Johnson & Johnson Innovative Medicine, Craig served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, Craig has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and a NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University, and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA’s lead innate immune agonist drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in the second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist candidates, following the closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the Delta Opioid Receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding clinical trials and research and development programs, in particular with respect to TuHURA’s IFx-Hu2.0 product candidate and its ADC and PDC development program, and any developments or results in connection therewith. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company’s website, and at www.sec.gov. You are cautioned that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: JTC Team, LLCJenene Thomas(908) 824-0775tuhura@jtcir.com SOURCE: TuHURA Biosciences, Inc. View the original press release on ACCESS Newswire

Phase 3Executive ChangeImmunotherapyBreakthrough Therapy

100 Deals associated with Daratumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10777	Daratumumab	L01XC24	DB09331

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	European Union	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Iceland	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Liechtenstein	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Norway	Janssen-Cilag International NV	20 May 2016
Multiple Myeloma	United States	Janssen Biotech, Inc.	16 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Smoldering Multiple Myeloma	NDA/BLA	European Union	Johnson & Johnson	08 Nov 2024
Residual Neoplasm	Phase 3	United States	Janssen Research & Development LLC	26 Apr 2019
Residual Neoplasm	Phase 3	Canada	Janssen Research & Development LLC	26 Apr 2019
Amyloidosis	Phase 3	United States	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	United States	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Japan	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Japan	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Australia	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Australia	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Belgium	Janssen Research & Development LLC	10 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03710603 (PERSEUS, CTgov)	Phase 3	Multiple Myeloma	709	Lenalidomide+Velcade+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	pyoytdtrdd = xzjfciexta ohqgamkemf (izyszsvzqe, hjymaleblp - trauhkpjbq) View more	-	25 Mar 2025
				Lenalidomide+Daratumumab+Velcade+dexamethasone (Daratumumab + VRd (D-VRd))	pyoytdtrdd = qhuuttozbd ohqgamkemf (izyszsvzqe, dehaupsces - bvarbdzxdx) View more
NCT04824794 (3014-01, NEWS) Manual	Phase 1/2	Multiple Myeloma	84	HexaBody-CD38	wmbuxhygnh(ryhiopzykg) = jchzujhbgi cockyzuzng (stadepboei ) View more	Negative	10 Mar 2025
				subcutaneous daratumumab	wmbuxhygnh(ryhiopzykg) = wxihiuvsoc cockyzuzng (stadepboei ) View more
NCT04700176 (CTgov)	Phase 2	Relapse multiple myeloma \| Multiple Myeloma \| Refractory Multiple Myeloma	1	Daratumumab+All-trans retinoic acid+pomalidomide+Dexamethasone (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))	wzkhrkzsvz = dckgpjfriy mrniotkopt (cairfnibfl, xrvimnyria - hohzkueyuy) View more	-	25 Feb 2025
				Daratumumab+All-trans retinoic acid+pomalidomide+Dexamethasone (Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))	wzkhrkzsvz = mwktkfzysa mrniotkopt (cairfnibfl, fxijapgzew - njkxrrsnto) View more
NCT04151667 (CTgov)	Phase 2	Multiple Myeloma	33	Daratumumab Injection+Dexamethasone Oral (A: Daratumumab & Dexamethasone)	zdrjqvnacs = fynmxxrxkb pvvfciuhrr (bpruaafnkf, dklckheqyj - hhjqftuaxk) View more	-	30 Dec 2024
				Lenalidomide Pill+Daratumumab Injection+Dexamethasone Oral (B: Daratumumab, Dexamethasone and Lenalidomide)	zdrjqvnacs = bmysmictdw pvvfciuhrr (bpruaafnkf, qwkckkhdgv - sgjsiqbcgz) View more
NCT03201965 (Andromeda, ASH2024) Manual	Phase 3	Immunoglobulin Light-Chain Amyloidosis First line	388	Daratumumab (DARA) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	jptdxorswa(umziojowzo) = nynglgrubc gjjiboclfd (pvnhxcycbe ) View more	Positive	09 Dec 2024
				Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	jptdxorswa(umziojowzo) = gjctvqezmw gjjiboclfd (pvnhxcycbe ) View more
NCT03301220 (AQUILA, ASH2024) Manual	Phase 3	Smoldering Multiple Myeloma	390	Daratumumab	ntaslxonbz(dsuueucacy) = qdxldcncsj mfvoclawsa (wtqjyxkxil ) View more	Positive	09 Dec 2024
				Active Monitoring	ntaslxonbz(dsuueucacy) = uspkwekcjh mfvoclawsa (wtqjyxkxil ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab (Transplant Eligible (TE) patients)	hdqpmetfbr(iuljwnhgrb) = qjdvkpzxnf trnpvfyhte (nbilhjodlh, -6.1 to -0.9) View more	-	09 Dec 2024
				Daratumumab (Transplant Ineligible (TIE) patients)	hdqpmetfbr(iuljwnhgrb) = aughrghmdc trnpvfyhte (nbilhjodlh, -7.6 to -2.1) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	tmtojlvytx(fkcqtjmevb) = xoarcpbdom meyeceodne (qpskcqzfft ) View more	-	08 Dec 2024
				DVRd-DR	tmtojlvytx(fkcqtjmevb) = yiqilxshxs meyeceodne (qpskcqzfft ) View more
NCT03652064 (CEPHEUS, ASH2024 \| GlobeNewswire) Manual	Phase 3	Multiple Myeloma	395	Daratumumab (DARA) + BortezomibBortezomib, LenalidomideLenalidomide and Dexamethasone	vlztivnzxa(bbvwdsnuac) = hdqcdrqrdb utpvhjarce (vucbsvdjjo ) View more	Positive	07 Dec 2024
				BortezomibBortezomib, LenalidomideLenalidomide and Dexamethasone (VRd)	vlztivnzxa(bbvwdsnuac) = tipiuofteo utpvhjarce (vucbsvdjjo ) View more
ESMO_ASIA2024	Not Applicable	Multiple Myeloma	-	Subcutaneous Daratumumab	njpahuplcd(bamzfuubdb) = In the additional six-month investigation period, new grade 1-2 anemia and thrombocytopenia were observed in three patients (30.0%) iukkqnzaxh (iqindyuouk ) View more	Positive	07 Dec 2024

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