On June 4, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical") and SyntheticGestalt KK (hereinafter "SyntheticGestalt"） reported that they have entered into an agreement to initiate technology validation to utilize SyntheticGestalt’s world largest molecular foundation AI model, aiming towards the further expansion and evolvement of Taiho Pharmaceutical’s proprietary drug discovery platform technology, Cysteinomix (Press release, Taiho, JUN 4, 2025, View Source [SID1234653704]).

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SyntheticGestalt has developed an innovative foundation AI model (SG4D10B*) which is trained on 10 billion compound data points. This foundation AI model features the ability to improve the prediction accuracy of molecular profiles for new compounds by learning a large amount of complex 3D structure molecules. By using this model as an additional learning and inference target in compound libraries owned by companies, each company can easily build its own exploration platform.
*SG4D10B: The world’s largest molecule-specialized foundation AI model developed by SyntheticGestalt. It solves the challenges of conventional molecular AI technologies, specifically low prediction accuracy and poor generalization performance. It enabｌes high-precision model development even with small-scale data held by pharmaceutical companies and chemical manufacturers. It contributes to the efficiency of new drug and new material development through significant reduction in development time and research costs.This model was developed with support from GENIAC (Generative AI Accelerator Challenge) program implemented by Ministry of Economy, Trade and Industry (METI) and New Energy and Industrial Technology Development Organization (NEDO).

Taiho Pharmaceutical has established its unique drug discovery platform Cysteinomix, with its proprietary covalent compound library at its core. This platform has a track record of creating an agent already approved in Japan, the United States and Europe, and multiple agents currently in clinical development. In order to further strengthen and increase the competitive advantage of this drug discovery platform, the company is working to expand the application of Cysteinomix, including the discovery of covalent drugs targeting amino acids other than cysteine.

SyntheticGestalt’s CTO, Kotaro Kamiya commented, "By applying our 4D exploration technology, which incorporates spatial structures and charge information, to covalent drug libraries, we can contribute to the discovery of innovative covalent drugs."

Taiho Pharmaceutical’s Executive Director, Clinical Development and Medical Affairs, Discovery & Preclinical Research, Takeshi Sagara commented, "By applying SyntheticGestalt’s proprietary generative AI platform into our Cysteinomix drug discovery platform, we aim to increase the success rate of discovering covalent drugs for targets which have been considered as undruggable for a long time. We will continue to advance the discovery of innovative new drugs with Cysteinomix, and remain committed to provide cancer therapies which can support patients with cancer through their entire patient journey."

About Cysteinomix Drug Discovery
Cysteinomix is Taiho Pharmaceutical’s proprietary drug discovery platform to continuously generate covalent drugs in variety of cysteine-containing target proteins. Cysteinomix drug discovery platform consists of target protein database, covalent compound library, and various compound evaluation systems, and has a track record of creating multiple pipelines to date.
*Covalent drug: A drug which forms a covalent bond with a target protein to irreversibly control its function. It consists of a portion that binds to the pocket of the protein (ligand) and a portion that covalently binds to the specific amino acid (reactant group).

On June 4, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP) patient selection technology—reported a research collaboration with the Indiana Biosciences Research Institute (IBRI) (Press release, Allarity Therapeutics, JUN 4, 2025, View Source [SID1234653720]). The collaboration is aimed primarily at further deepening the Company’s mechanistic understanding of the dual mechanism of action of stenoparib.

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Stenoparib is a novel, orally available small-molecule inhibitor of PARP1/2 and tankyrase1/2. As such, stenoparib not only impairs DNA repair to selectively kill cancer cells but also inhibits the WNT signaling pathway—a cellular pathway commonly associated with chemoresistance and advanced-stage disease in multiple cancer types. This unique dual activity distinguishes stenoparib as a highly differentiated therapeutic candidate with the potential to address cancers that are resistant to standard-of-care therapies. Under the agreement, IBRI will conduct advanced molecular and cellular studies to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s observed anticancer effects.

"Understanding how stenoparib exerts its dual biological effects is central to our long-term clinical development strategy. It will enhance our ability to raise awareness of this molecule among leading oncologists and help us engage more effectively with sophisticated biotech investors," said Thomas Jensen, CEO of Allarity Therapeutics. "In addition to deepening our understanding of the foundational biology behind stenoparib’s differentiated profile, this research may further strengthen our DRP-based patient selection strategy and potentially open new opportunities for additional therapeutic combinations and indications, such as colorectal cancer, where WNT pathway activation is very common."

The collaboration is also expected to support Allarity in potential future efforts to pursue marketing approval for stenoparib, and to further clarify its mechanism of action in both the Company’s ongoing Phase 2 trial in advanced ovarian cancer and its recently announced combination trial evaluating stenoparib with temozolomide in recurrent small cell lung cancer (SCLC).

Furthermore, this collaboration underscores Allarity’s commitment to scientific excellence, translational research, and data-driven development, which form the foundation of its personalized oncology strategy.

On June 4, 2025 Niagen Bioscience, Inc. (NASDAQ: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Ozan Pamir, will participate in Oppenheimer’s 25th Annual Consumer Growth and E-Commerce Conference (Press release, ChromaDex, JUN 4, 2025, View Source [SID1234653705]).

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Mr. Fried is scheduled to participate in a fireside chat on Monday, Jun 9, from 2:15 p.m. to 2:50 p.m. Eastern Time (11:15 a.m. Pacific Time). To register for the Niagen Bioscience fireside chat webcast, please visit www.wsw.com.

Mr. Fried and Mr. Pamir will also hold one-on-one meetings with institutional investors throughout the day.

A replay of the webcast will be available following the event on the Niagen Bioscience Investor Relations website, www.investors.niagenbioscience.com. For additional information on Niagen Bioscience, visit www.niagenbioscience.com.

On June 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has approved the company’s first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab (Press release, Akeso Biopharma, JUN 4, 2025, View Source [SID1234653721]). The NMPA approval marks the third approved indication for cadonilimab.

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With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

The approval for cadonilimab’s use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer.

Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology.

Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide.

Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We’ve seen cadonilimab’s breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients."

Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso’s robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. "

Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer.

On June 4, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T cell engager. Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory (r/r) multiple myeloma (MM) (Press release, Cullinan Oncology, JUN 4, 2025, View Source [SID1234653706]). Cullinan will develop velinotamig in autoimmune diseases.

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"We believe T cell engagers represent the next wave of innovation in autoimmune diseases, and we are excited to build upon our core T cell engager expertise and extensive KOL relationships to develop another potential best-in-class, clinical-stage program. Accumulated data supports BCMA as a promising target in autoimmune diseases, offering a precise and potentially disease-modifying approach by eliminating the entirety of the self-reactive plasma cells that result in certain autoimmune diseases, especially those diseases driven by long-lived plasma cells," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "Adding a BCMAxCD3 bispecific T cell engager to our pipeline complements our rapid global clinical development of CLN-978, enabling us to address the needs of more patients across a broader range of autoimmune diseases than with either molecule alone."

Genrix plans to initiate a Phase 1 study in China by the end of this year in patients with autoimmune diseases. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.

"With our planned Phase 1 study of velinotamig in autoimmune diseases, we will be able to quickly leverage our experience in autoimmune diseases to complete the study in China expeditiously," said Dr. Liu Zhigang, Chairman, Chief Executive Officer, and Chief Science Officer of Genrix Biopharmaceutical "Cullinan is a proven leader in developing T cell engagers and we are confident in the company’s ability to carry the program forward to address the needs of patients with autoimmune diseases."

Under the agreement, Cullinan will pay Genrix Bio an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig in all disease areas globally outside of Greater China. In the future, Genrix will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400M in sales-based milestones, as well as tiered royalties from mid-single digits up to the mid- teens on potential ex-Greater China net sales.

Importantly, with refinement of the clinical oncology pipeline, Cullinan reiterates its existing guidance to have cash resources into 2028 based on its current operating plan.