On May 9, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT7104, a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors (Press release, BioThera Solutions, MAY 9, 2022, View Source [SID1234613960]).

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BAT7104 was designed to inhibit the PD-1/PD-L1 and CD47/SIRP-α pathways. By an "imbalanced" design with finely tuned binding affinity to CD47 and high affinity to PD-L1, BAT7104 is expected to avoid RBC depletion and block CD47 on CD47+/PD-L1+ tumors in a more selective and tumor-enriched manner. BAT7104 was shown to effectively inhibit both pathways in vitro and demonstrated synergistic activity in inducing complete tumor regression in vivo. In non-human primates (NHP) study, BAT7104 was well tolerated with no adverse effects, suggesting a favorable therapeutic index in future clinical development. "BAT7104 has demonstrated higher anti-tumor activity with better safety profile in preclinical studies". Commented Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "As the first bispecific antibody of Bio-Thera, we are pleased to see BAT7104 enter clinical development in Australia, and we will continue bringing more innovative anti-tumor drugs to cancer patients." Dr. Shengfeng Li continued.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT7104 is designed to assess the safety and tolerability of BAT7104. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Another early stage Phase 1 clinical study evaluating BAT7104 is being conducted in China in patients with solid tumors and lymphoma. In addition, Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early stage clinical studies.

Verastem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 8, 2022 AskGene Limited ("AskGene"), a clinical-stage biopharmaceutical company focusing on discovery and development of innovative biological drugs, reported the completion of USD 20 million in Series A financing (Press release, AskGene Pharmaceuticals, MAY 8, 2022, View Source [SID1234613849]). The financing was led by Qiming Venture Partners and TF Capital. Proceeds from the financing will be used to advance clinical development of AskGene’s robust pipeline of innovative therapeutic candidates and development of SmartKine cytokine prodrug platform.

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Cytokines are well validated co-stimulators and hold great promise in immunotherapy, however, they have short half-lives, severe systemic toxicity and narrow therapeutic windows. SmartKine is a transformational cytokine technology platform developed by AskGene with global intellectual property rights. The technology overcomes the limitations of current cytokine therapeutics, brings next-generation cytokine therapies to patients with unmet medical needs. SmartKine molecules are designed to selectively activate a subset of immune cells preferentially at a disease site to enhance the function selectivity, developability and therapeutic indexes of cytokines.

"We are very pleased to have support from first-class investors who share our vision to modulate immune system at disease sites with precision," said Jeff Lu, Chief Executive Officer of AskGene Limited. "This is an exciting time for our company. We are advancing several potentially first-in-class or best-in-class molecules from our SmartKine platform to preclinical development and clinical development later this year. In addition, our clinical programs ASKB589 and ASKG712 are progressing smoothly. We look forward to promising results from multiple clinical programs later this year and next year."

"Cancer is still one of the major disease burdens for patients and IO has demonstrated its effectiveness", stated William Hu, Managing Partner of Qiming Venture Partners, "AskGene’s team shows deep understanding in IO and protein engineering. We believe their proprietary platform continues to generate more pipelines to clinic and market."

Allan Liu, Director at TF Capital commented: "Application of immunostimulatory cytokines has become a promising approach in cancer immunotherapy, however unfavorable PK and safety profile limit their further clinical development and application. AskGene’s proprietary SmartKine platform can overcome limitations of first-generation recombinant cytokines by achieving conditional activation of cytokines in the tumor microenvironment to unleash the full therapeutic potential. We are thrilled to partner with AskGene’s exceptional leadership team as they advance SmartKine molecules into the clinic with the ultimate goal of providing better outcomes to cancer patients."

On May 8, 2022 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that it will present the latest clinical study data for Carteyva via poster presentations and online publication at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, JW Pharmaceutical, MAY 8, 2022, View Source [SID1234613850]).

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Title: Two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of relmacabtagene autoleucel (Carteyva) in Chinese patients with relapsed/refractory large B-cell lymphoma
Format: Poster Presentation
Abstract number: 7529
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Presenter: Dr. Zhitao Ying

Title: Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL): Results from an open-label, multicenter, single-arm phase I study
Format: Online publication
Abstract number: e19509
First author: Dr. Zixun Yan

Title: Relma-cel (JWCAR029) in relapsed and refractory B-cell non-Hodgkin lymphoma: A two-year survival update of a phase I study
Format: Online publication
First author: Dr. Zhitao Ying

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

On May 8, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicated to developing innovative therapies targeting stroma microenvironment and drug resistance for hard-to-treat solid tumors, reported that it had completed $15 million in Series B+ Financing (Press release, InxMed, MAY 8, 2022, View Source [SID1234614002]). The Series B+ was funded by Hyfinity Investments.

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InxMed will use the funds to accelerate ongoing clinical trials of IN10018 for multiple cancer types in both US and China, including the initiation of pivotal trials in the second half year, and advance more stroma targeting pipelines into clinics in both US and China this year, and strengthen the R&D capabilities in Nanjing.

IN10018 is a potent and highly selective adenosine triphosphate competitive FAK inhibitor, and InxMed has its exclusive global development and commercial operation rights. InxMed Nanjing Translational Medicine Center has conducted extensive original exploratory research on IN10018 and FAK targets and has published research results in renowned academic journals. Early clinical data on IN10018 showed its safety and efficacy in multiple tumor types, and the latest research results and preclinical data demonstrated that IN10018 can also be effective in combination therapies. It is expected to overcome the tumor-associated fibrosis barrier and improve local immunity, and therefore has the potential to act as an important anchor molecule in synergy with different therapeutic modalities including immunotherapy, chemotherapy, and targeted therapy.

IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) for the treatment of patients with platinum-resistant ovarian cancer. The company plans to disclose more data on IN10018 at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2022.

"InxMed is focused on the development of innovative treatments to address the true global unmet medical needs. Our strategy is targeting the ecosystem fostered by tumor cells including tumor microenvironment to develop effective therapeutic regimens to combat or even cure cancer. We have built robust pipelines with different, yet complementary Mechanism of Actions, and promising preliminary efficacy data. Building partnership is also our important strategy to maximize the value of our assets, and we are actively exploring global partnership opportunities to accelerate more value inflections of IN10018 and other programs," said Dr. Zaiqi Wang, Founder and Chief Executive Officer of InxMed.

Dr. Xin He, managing partner of Hyfinity Investments, added, "InxMed’s vision and pipeline strategy aligns with the purpose of our fund. In past three years, InxMed has proven its value and potential through its capability of global innovation, strong execution, highly synergistic pipeline and encouraging clinical efficacy of IN10018. We think InxMed is well positioned to become the first-tier China-based biotechnology innovator with a global impact and we are pleased to partner with InxMed and provide our unreserved support all along."