On May 21, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients (Press release, Alligator Bioscience, MAY 21, 2024, View Source [SID1234643480]).

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Gastric/gastroesophageal junction (G/GEJ) cancer is one of the most common cancers and approximately 20% of these patients show HER2 amplification or overexpression. Despite the approval of Herceptin (trastuzumab) in the US in 2010, the median overall survival of patients suffering from HER2+ gastric cancer remains limited.

HLX22 (AC101) is an innovative monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius Biotech.

In January 2024, Henlius Biotech presented promising Phase 2 results at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), which were also published in the Journal of Clinical Oncology. The data demonstrated that the addition of HLX22 (AC101) to HLX02 (a biosimilar of trastuzumab) and XELOX (Oxaliplatin and capecitabin) in 1st line treatment of HER2-positive locally advanced or metastatic G/GEJ cancer led to a dose-dependent increase in Progression Free Survival, meeting the study’s main efficacy endpoint.

"We are very pleased to see the highly encouraging progress Henlius Biotech are making with the development of HLX22 in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "The Phase 2 results presented at ASCO (Free ASCO Whitepaper) earlier this year followed by this Phase 3 IND clearance demonstrate our ability to deliver an asset like HLX22 with a highly differentiated profile and a great deal of potential to improve treatment outcomes for patients suffering from a devastating disease like gastric cancer."

On May 21, 2024 Sanofi, Formation Bio and OpenAI reported that they are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently (Press release, Sanofi, MAY 21, 2024, View Source [SID1234643497]). The three teams will bring together data, software and tuned models to develop custom, purpose-built solutions across the drug development lifecycle. This represents a first collaboration of its kind within the pharma and life sciences industries.

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Sanofi will leverage this partnership to provide access to proprietary data to develop AI models as it continues on its path to becoming the first biopharma company powered by AI at scale.

Paul Hudson
CEO, Sanofi
"This unique collaboration is the next significant step in our journey to becoming a pharmaceutical company substantially powered by AI. Next generation, first-of-its kind AI model customizations will be an important foundation in our efforts to shape the future of drug development for pharma and for the many patients waiting for innovative treatments."

OpenAI, the world leader in AI technology, will contribute access to cutting-edge AI capabilities, including the ability to fine-tune models, deep AI expertise and dedicated thought partnership and resources.

Brad Lightcap
COO, OpenAI
"There is massive potential for AI to accelerate drug development. We are excited to collaborate with Sanofi and Formation Bio to help patients and their families by bringing new medicines to market."

Formation Bio, an AI and tech-driven drug developer with its own pipeline of drug assets, will provide extensive engineering resources, experience operating at the intersection of pharma and AI, and its tech-driven development platform to design, develop and deploy AI technologies across all aspects of the pharma lifecycle.

Benjamine Liu
Co-Founder & CEO, Formation Bio
"I firmly believe that by combining our strengths, Sanofi, OpenAI and Formation Bio can reimagine drug development in the pharma industry. By creating and implementing customized AI agents and models designed for our industry, companies like Sanofi and Formation Bio can begin to scale with unprecedented productivity and transform the pace at which we bring new medicines to patients."

The potential positive impact of AI for patients waiting for new treatments is tremendous and Sanofi, Formation Bio and OpenAI plan to lead the way for drug developers.

On May 21, 2024 U.S. Precision Medicine, Inc. (USPM), a biopharma company developing novel cancer therapeutics, reported it will use state-of-the-art artificial intelligence (AI) technology to bolster independent research that has proven the company’s small molecule candidate is highly effective in killing breast cancer (Press release, US Precision Medicine, MAY 21, 2024, View Source [SID1234643517]).

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U.S. Precision Medicine’s new cancer drug candidate has demonstrated the ability to reduce tumor weight and volume by 85% in just 30 days of treatment with no toxicity. The findings were corroborated in the independent Investigational New Drug (IND) research with small animal studies required by the FDA. The company’s contract research organization currently is developing the dosing plan and expanding the research to include an additional 100 cancer types, for which patents or patents pending are held.

"Now that the validity of AI in pharmaceutical drug development is gaining traction, we plan to conduct a comparative study leveraging AI platforms in parallel with our ongoing IND research to prepare for human clinical trials," said Frederick Fey, co-founder and CEO of USPM.

"The drug candidate shows great promise as a treatment for most, if not all, solid tumor cancers, which account for approximately 90 percent of adult cancers and 30 percent of all pediatric cancers."

The worldwide incidence of cancer continues to rise, with the American Cancer Society projecting a 77% increase in new cases by 2050 versus 2022 levels. Last year, there were approximately 20 million new cancer diagnoses and 9.7 million cancer deaths globally.

"Cancer represents a tremendous unmet medical need that is projected to reach $200 billion by 2025 for cancer drugs alone," said Christopher Fey, co-founder and COO of USPM. "My brother and I are passionate about turning cancer victims into survivors because our father passed away from colon cancer at age 29 when we were toddlers. We hope others will join us in improving outcomes for patients across all cancer types."

On May 21, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, MAY 21, 2024, View Source [SID1234643481]). The study is being conducted through a research partnership with Moffitt Cancer Center.

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Anixa’s first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who were unresponsive to at least two prior therapies. Safety was confirmed in the first three-patient cohort. The patients in the second cohort, including patient #5, receive triple the dose of engineered T-cells compared with the first cohort of three patients. The study will identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), found only on ovarian cells

"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," said Dr. Amit Kumar, Chairman and CEO of Anixa. "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."

Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On May 21, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported that management will participate in the following upcoming investor conferences (Press release, Tempest Therapeutics, MAY 21, 2024, View Source [SID1234643498]):

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TD Cowen’s 5th Annual Oncology Innovation Summit – Fireside chat on Wednesday, May 29, 2024 at 2:00 p.m. ET

Jefferies Global Healthcare Conference – Presentation on Wednesday, June 5, 2024 at 4:00 p.m. ET
To access the live or archived recording of the discussions, please visit the investor section of the Tempest website at View Source