[Translation] An open, multicenter phase II clinical study of A166 for injection for the treatment of HER2-positive unresectable or metastatic breast cancer that has previously received a topoisomerase inhibitor antibody-drug conjugate (ADC)

主要目的：采用RECIST v1.1评估的客观缓解率（ORR），评价注射用A166用于治疗既往接受过载荷为拓扑异构酶抑制剂HER2 ADC的HER2阳性不可切除或转移性乳腺癌患者的有效性。次要目的： 1) 采用RECIST v1.1评估的无进展生存期（PFS）、6个月PFS率、12个月PFS率、疾病控制率（DCR）及缓解持续时间（DOR）和临床获益率（CBR）、至缓解时间（TTR）；12个月总生存（OS）率、18个月OS率、24个月OS率、总生存期（OS）等进一步评价A166用于治疗既往接受过载荷为拓扑异构酶抑制剂HER2 ADC的HER2阳性不可切除或转移性乳腺癌患者的有效性； 2）评价注射用A166用于治疗既往接受过载荷为拓扑异构酶抑制剂HER2 ADC的HER2阳性不可切除或转移性乳腺癌患者的安全性。

[Translation]

Primary objective: The objective response rate (ORR) assessed by RECIST v1.1 was used to evaluate the efficacy of A166 for injection in the treatment of patients with HER2-positive unresectable or metastatic breast cancer who had previously received a topoisomerase inhibitor HER2 ADC. Secondary objectives: 1) Progression-free survival (PFS), 6-month PFS rate, 12-month PFS rate, disease control rate (DCR), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR) assessed by RECIST v1.1; 12-month overall survival (OS) rate, 18-month OS rate, 24-month OS rate, overall survival (OS), etc. were further evaluated for the efficacy of A166 for the treatment of patients with HER2-positive unresectable or metastatic breast cancer who had previously received a topoisomerase inhibitor HER2 ADC; 2) Evaluate the safety of A166 for injection in the treatment of patients with HER2-positive unresectable or metastatic breast cancer who had previously received a topoisomerase inhibitor HER2 ADC.

Start Date11 Sep 2024

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

CTR20231740 / RecruitingPhase 3

注射用A166对比注射用恩美曲妥珠单抗（T-DM1）在既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移性乳腺癌患者中的随机、开放、对照、多中心Ⅲ期临床试验

[Translation] A randomized, open-label, controlled, multicenter phase III clinical trial of A166 for injection versus trastuzumab emtansine for injection (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who had previously received trastuzumab and taxane treatment

主要目的：评估注射用A166相较于T-DM1在既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移性乳腺癌患者中的有效性。次要目的： 1) 评估注射用A166相较于T-DM1在HER2阳性不可切除或转移性乳腺癌患者中的有效性； 2) 评估注射用A166在HER2阳性不可切除或转移性乳腺癌患者中的安全性； 3) 评估注射用A166在HER2阳性不可切除或转移性乳腺癌患者中的免疫原性； 4) 评估注射用A166在HER2阳性不可切除或转移性乳腺癌患者中的药代动力学（PK）特征。

[Translation]

Primary objective: To evaluate the efficacy of A166 for injection compared with T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane treatment. Secondary objectives: 1) To evaluate the efficacy of A166 for injection compared with T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer; 2) To evaluate the safety of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer; 3) To evaluate the immunogenicity of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer; 4) To evaluate the pharmacokinetic (PK) characteristics of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer.

Start Date16 Jun 2023

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

NCT05346328 / Not yet recruitingPhase 2IIT

An Open-clinical Trial Phase Ⅱ, Injection of A166 for HER2-positive Patients With Refractory Unresectable Locally Advanced or Metastatic Breast Cancer；KL166-IIS-001

This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.

Start Date01 Jun 2022

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Trastuzumab botidotin

100 Translational Medicine associated with Trastuzumab botidotin

100 Patents (Medical) associated with Trastuzumab botidotin

Literatures (Medical) associated with Trastuzumab botidotin

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Apr 2022·Canadian journal of ophthalmology. Journal canadien d'ophtalmologieQ4 · MEDICINE

Reversible HER2 antibody-drug conjugate–induced ocular toxicity

Q4 · MEDICINE

Author: Ang, Qiuqing ; Patnaik, Amita ; Ulahannan, Susanna V ; Wang, Judy S ; Sharma, Anushree ; Bergonio, Gregory R ; Wirostko, Barbara M ; Riaz, Kamran M ; Cicic, Dragan ; Gill, Mohsain S ; Gombos, Dan S ; Zhang, Cong

PURPOSE:

To report 3 cases of reversible epitheliopathy induced by A166-a human epidermal growth factor receptor (HER2)-targeted antibody-drug conjugate (ADC) therapy for resistant HER2 tumours.

METHODS:

Advanced HER2 tumour patients were enrolled in A166 phase I/II clinical trial using Bayesian logistic regression model dose escalation. Key exclusion criteria were ≥grade 2 (G2) corneal pathology, severe organ disease, and other cancer therapy within 4 weeks. Eye exams were performed at baseline, regularly scheduled intervals, and additionally upon A166-induced ocular symptoms. Topical therapy with autologous serum tears (ASTs) was implemented based on visual acuity, symptoms, and slit lamp exam. A166 was withheld if ≥G2 ocular toxicity developed; if status improved to ≤G1, A166 therapy was resumed. Visual acuity, corneal exam, and subjective comfort were recorded.

RESULTS:

After ≥2 cycles of A166, 6 eyes of 3/23 enrolled patients developed whorl pattern epitheliopathy suggestive of limbal stem cell (LSC) dysfunction requiring cessation of A166 despite positive tumour response. Patients 1 and 3 received 3.6 mg/kg A166 dose, and patient 2 received 3.0 mg/kg. Topical steroids (2/4 eyes) failed to improve epitheliopathy. Adding ASTs improved vision, ocular comfort, and whorl pattern epitheliopathy in 6/6 eyes within 3 weeks. Patient 1 continues to improve on ASTs; patient 2 withdrew from the study; and patient 3 resumed A166 therapy.

CONCLUSION:

A166 precipitates LSC dysfunction-like epitheliopathy. Combination therapy including aggressive lubrication, withholding drug, and ASTs help reverse toxicity. Recognizing that ADC-induced epitheliopathy can respond to ocular management may enable cancer patients to continue lifesaving therapy.

01 Jan 1993·Biological & pharmaceutical bulletinQ4 · MEDICINE

Mitogenic Activity and Lethal Toxicity of Lipid A Analogs, Glucosamine-phosphate Carrying Aromatic Alkyl Groups, in Mice.

Q4 · MEDICINE

Article

Author: Yanagihara, Yasutake ; Iwamoto, Yoshihisa ; Nakamoto, Shinichi ; Achiwa, Kazuo ; Shimizu, Tadayori ; Itoh, Hajime

The mitogenicity and lethal toxicity of four synthetic lipid A analogs, glucosamine-4-phosphate with a 7-hydroxy-heptanoyl group (A-166), with a 7-phenyl-heptanoyl group (A-167), or with a 8-(1-phenyl-hexanoyl)-nonanoyl group (A-168), at the C-2 and C-3 positions, and glucosamine-6-phosphate with the same substituents as A-168 at C-2 and C-3 (A-169), were compared. The compound A-166 exhibited no mitogenic activity at various concentrations ranging from 3.13 to 50 micrograms/ml in the splenocytes of BALB/c mice, but A-167 exhibited weak mitogenic activity at concentrations of 12.5 and 25 micrograms/ml. A-168 and A-169, as well as A-103, glucosamine-4-phosphate carrying (R)-3-tetradecanoyl-oxytetradecanoyl groups, have remarkable mitogenic activity at concentrations ranging from 12.5 to 100 micrograms/ml; the activity of A-169 (6-phosphate) was stronger than that of A-168 (4-phosphate). Compound A-167 failed to cause death at doses of 25 and 50 micrograms/mouse in galactosamine-loaded C57BL/6 mice while A-166 and A-169 were toxic to 2 out of 6 mice at 50 micrograms/mouse; no deaths were observed at 25 micrograms/mouse. A-168 showed the highest toxicity of any of the compounds tested at 25 and 50 micrograms/mouse. The lethal effect of A-103 appeared to be somewhere between that of A-168 and A-169. These findings indicate that lipid A analogs, carrying an aromatic alkyl group as well as a hydroxyacyl group, are mitogenic and lethal when given to mice.

News (Medical) associated with Trastuzumab botidotin

23 Aug 2024

·www.echemi.com

Kelun Biotech's Net Profit Soars 1068% in H1, But Hidden Crisis?

In the first half of 2024, the Biotech company Kelun Biotech delivered a remarkable report card. The company has been able to achieve such remarkable results, mainly thanks to a number of partnerships with pharmaceutical giant Merck. These collaborations enabled Kelun Biotech to successfully turn a profit, with net income up 1,068% year-over-year. Specifically, Kelun Biotech's total revenue for the period amounted to $1.382 billion, an increase of 32.2% year-over-year. This significant increase was primarily driven by a number of milestone payments with Merck. At the same time, Kelun Biotech has also entered into a number of BD (Business Development) partnerships with companies such as Harbour Biomed and Ellipses Pharma, further enriching the company's cash flow. As of the end of June, the company's cash and financial assets reached 2.885 billion yuan, providing a solid financial foundation for the company's sustainable development. It is worth noting that Kelun Biotech has four products in the pipeline. These products include SKB264, the core product for the treatment of advanced solid tumors, and A166 for the treatment of advanced HER2-positive breast cancer of third line and above. Among them, SKB264 is expected to be approved for the treatment of triple-negative breast cancer within this year, becoming the first TROP2 ADC (Antibody Drug Conjugate) produced in China. This will fill the gap in this field of TROP2 ADCs produced in China, which has important clinical significance. In addition, SKB264 has also obtained the second indication application accepted by the National Medical Products Administration (NMPA). For the treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI and platinum-containing chemotherapy. If this indication can be approved, it will fill this clinical gap and bring new treatment options to patients. Currently, SKB264 has been initiated in 10 global Phase III clinical studies that will evaluate the efficacy of SKB264 as a monotherapy or in combination with other drugs for multiple indications. The development of these clinical studies has added more chips to the future commercialization of SKB264, and has also injected a strong impetus to the development of the company. With a rich product pipeline, strong research and development capabilities, and extensive cooperation with multinational pharmaceutical companies, Kelun Biotech is in a golden period of rapid development. In the future, with the continuous launch of the company's products and the approval of new indications, Kelun Biotech is sure to become a shining star in the Chinese biomedical industry, bringing more hope and choices to patients.

Phase 3Phase 1ADCFinancial StatementDrug Approval

23 Aug 2022

·www.prnewswire.com

Bladder Cancer Clinical Trial Pipeline Insights Featuring 100+ Companies | DelveInsight

DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. LAS VEGAS, Aug. 23, 2022 /PRNewswire/ -- DelveInsight's ' Bladder Cancer Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline bladder cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the bladder cancer pipeline domain. Key Takeaways from the Bladder Cancer Pipeline Report DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. Leading bladder cancer companies such as CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others are evaluating novel bladder cancer drugs candidate to improve the treatment landscape. Key bladder cancer pipeline therapies in various stages of development include CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. In July 2022, The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023. In June 2022, CG Oncology announced the interim data on two ongoing clinical studies to be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.The first poster presentation reports on efficacy and safety data from a global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second poster presentation centers on a Phase 1b/2 study (CORE2) of CG0070 in combination with OPDIVO®(nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. In May 2022, Asieris Pharmaceuticals announced that the ANTICIPATE Study will be presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 3-7, 2022, in Chicago. This is a study of taking oral APL-1202 in combination with BeiGene's tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC). In March 2022, Protara Therapeutics, Inc. announced that the Company had dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC). In January 2022, Vaxiion Therapeutics, announced the U.S. Food and Drug Administration had cleared the company's Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy. In December 2021, LintonPharm Co., Ltd., announced that the first patient had been dosed in the Company's Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Request a sample and discover the recent advances in bladder cancer treatment @ Bladder Cancer Pipeline Report The bladder cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage bladder cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the bladder cancer pipeline landscape. Bladder Cancer Overview Bladder cancer usually starts in the cells that line the inside of the bladder. It typically affects adults over the age of 70 and is more common in men. Bladder cancer is the fifth most prevalent type of cancer in the general population and the fourth most common in males. When detected early, bladder cancer usually responds well to bladder cancer treatment. Smoking is among the most common bladder cancer causes. Blood in the urine is usually the first sign of bladder cancer. Other bladder cancer symptoms may include urine pain or burning, as well as a change in urinary habits. This can include frequent urination or the need to urinate but being unable to do so. The tests used for bladder cancer diagnosis include biopsy, cystoscopy, urine cytology, imaging tests, and others. Find out more about bladder cancer drugs in development @ Bladder Cancer Drugs A snapshot of the Bladder Cancer Pipeline Drugs mentioned in the report: Learn more about the novel and emerging bladder cancer pipeline therapies @ Bladder Cancer Clinical Trials Bladder Cancer Therapeutics Assessment The bladder cancer pipeline report proffers an integral view of the bladder cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Bladder Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Parenteral, Oral, Intravenous, Subcutaneous, Intramuscular Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem cell, Vaccine Therapeutics Assessment By Mechanism of Action: Cell death stimulants, Granulocyte macrophage colony stimulating factor agonists, Interleukin-15 receptor agonists, DNA synthesis inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Gene transference, IFNA2B expression stimulants, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants Key Bladder Cancer Companies: CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co.,Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others Key Bladder Cancer Pipeline Therapies: CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. Dive deep into rich insights for bladder cancer drugs, visit @ Bladder Cancer Treatment Table of Contents For further information on the bladder cancer pipeline therapeutics, reach out @ New Drug for Bladder Cancer Treatment Related Reports Bladder Cancer Market Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies including RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others. Bladder Cancer Epidemiology Forecast Bladder Cancer Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted bladder cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Muscle Invasive Bladder Cancer Pipeline Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key muscle invasive bladder cancer companies, including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Muscle Invasive Bladder Cancer Market Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key muscle invasive bladder cancer companies including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Non Muscle Invasive Bladder Cancer Pipeline Non Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non muscle invasive bladder cancer companies, including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Non Muscle Invasive Bladder Cancer Market Non Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non muscle invasive bladder cancer companies including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. 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Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

CollaborateAntibodyGene TherapyBiosimilarFirst in Class

01 Jun 2022

·www.globenewswire.com

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Levena Biopharma, a Sorrento Company, are to Present Positive Clinical Progress of A166, an Anti-HER2 ADC, in Treating Locally Advanced or Metastatic HER2-Positive Breast Cancer Patients at the ASCO 2022 Annual Meeting

A166 is an antibody-drug conjugate (ADC) composed of an anti-HER2 antibody conjugated to Duostatin-5, a novel anti-microtubule Auristatin derivative, via a proprietary stable covalent linker.The ASCO meeting presentation (ASCO Poster# 415) includes A166 dose expansion data administered in 3-week cycles at doses of 4.8 mg/kg or 6.0 mg/kg in a total of 58 female patients with HER2-positive breast cancer.The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort, respectively.Median PFS was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort, respectively.Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months. CHENGDU, China, and SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) -- Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma (“Levena”), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO, the American Society of Clinical Oncology, to be held on June 3-7 in Chicago, IL. A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker. As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)]. At the upcoming 2022 ASCO meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles. The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO meeting. About Sichuan Kelun-Biotech Biopharmaceuticals, Co. Ltd.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., founded in 2016. Kelun-biotech is committed to developing, and commercializing innovative drugs for the treatment of cancer, autoimmune and other diseases with unmet medical needs. Kelun-Biotech has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), and clinical development capabilities. Leveraging the platform, the company has built a robust pipeline, 1 I/O monoclonal antibody asset in NMPA NDA stage, 3 assets (including 1 monoclonal antibody and 2 ADCs) in Phase 3 or pivotal clinical trials, and an additional 10 molecules in clinical studies. For more information, please contact: China: klbio_bd@kelun.com, US: bd@kluspharma.com About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic test solutions, including COVIMARK™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com Forward-Looking StatementsThis press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding A166, an anti-HER2 ADC; the therapeutic and clinical potential of A166; the potential safety and efficacy of A166, including A166’s potential efficacy against HER2-positive breast cancer; and the potential advantages of A166 over its competitors. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to safety and efficacy for A166; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law. Media and Investor RelationsContact: Brian CooleyEmail: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2022 Sorrento Therapeutics, Inc. All Rights Reserved.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	11 May 2023
HER2 Positive Cancer	Phase 2	-	Fudan University	01 Jun 2022
Advanced Head and Neck Carcinoma	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Bile Duct Neoplasms	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Bladder Cancer	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Breast cancer recurrent	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
HER2-positive gastric cancer	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Laryngeal Neoplasms	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Lip Neoplasms	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018
Liver Cancer	Phase 2	US	KLUS Pharma, Inc.Startup	16 Jul 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20181301 (ASCO2022)	Phase 1	HER2 Positive Solid Tumors	58	A166	amknhcvmmp(sdchgzprly) = uaawpvjkxn whlvqcjyai (fndqymrsik, 51.59 - 89.77) View more	-	02 Jun 2022
CTR20181301 (ASCO2021)	Phase 1	HER2 Positive Solid Tumors	57	A166	avtjtzczuz(ylohmhszih) = 19.3% gqlllfwvfm (goumrncqiv ) View more	Positive	28 May 2021
NCT03602079 (ASCO2020) Manual	Phase 1/2	Solid tumor	35	A-166	bgbqfttahg(wdcubpcxyg) = Keratitis, Decreased appetite, Dry eye, Vision blurred etc fpinwjouhx (nmfojcfioj ) View more	Positive	29 May 2020

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