On April 14, 2025 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that it will have an oral presentation in collaboration with medical centers at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting entitled "Safety and efficacy of BAT8006, a Folate Receptor α (FRα) antibody drug conjugate (ADC), in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial" (Press release, BioThera Solutions, APR 14, 2025, View Source [SID1234651918]). Three posters will be also presented in the poster session, covering TROP2-ADC BAT8008, HER2-ADC BAT8010, BAT1006 (an ADCC-enhanced anti-HER2 mAb with a different epitope from BAT8010) , and a novel PD-1 mAb BAT1308 in various solid tumors.

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Presentation details are as follows:

Oral presentation:

Abstract Title: Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial.
Abstract ID: 5517
Type: Rapid Oral Abstract-Gynecologic Cancer
Time: 6/3/2025, 8:00 AM-9:30 AM CDT
Poster 1:

Abstract Title: BAT8008, a TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1 study.
Abstract ID: 3024
Type: Poster Session
Time: 06/02/2025 1:30 PM-4:30 PM CDT
Poster 2:

Abstract Title: A phase Ⅰb/Ⅱa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors.
Abstract ID: 1027
Type: Poster Session
Time: 6/2/2025 9:00 AM-12:00 PM CDT
Poster 3:

Abstract Title: Primary efficacy and safety results of BAT1308, a PD-1 inhibitor, + chemotherapy ± bevacizumab in phase 2 trial for persistent, recurrent, or metastatic cervical cancer.
Abstract ID: 2611
Type: Poster Session
Time: 6/2/2025 1:30 PM-4:30 PM CDT

On April 14, 2025 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a successful FDA Type D meeting on the Phase 3 registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma (UM) (Press release, Ideaya Biosciences, APR 14, 2025, View Source [SID1234651919]).

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"The successful FDA Type D meeting provides darovasertib a registrational path as neoadjuvant therapy for UM, using primary clinical endpoints of eye preservation and proportion of patients with vision loss, with no detriment to EFS as a secondary endpoint required for both cohorts. Based on the promising clinical efficacy and safety observed with darovasertib in the neoadjuvant setting in over 90 patients and the recent Breakthrough Therapy Designation by the US FDA, we are excited to advance the darovasertib program into our second registrational trial," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM (MUM). Darovasertib has received U.S. FDA Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic uveal melanoma (MUM), where a Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM is ongoing. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in MUM.

FDA Guidance from the Type D Meeting on the Phase 3 Neoadjuvant Darovasertib Registrational Trial Design for Potential Regulatory Approval in Primary UM

IDEAYA is targeting to initiate the Phase 3 randomized clinical trial evaluating neoadjuvant darovasertib in primary UM in the first half of 2025. The randomized Phase 3 clinical trial design incorporates guidance and feedback from the U.S. FDA following a recent Type D meeting.

In the Phase 3 clinical trial, we currently project approximately 520 patients will be randomized 2:1 to the darovasertib treatment versus control arm. There will be 2 cohorts enrolled: 1) 120 enucleation eligible UM patients, 2) 400 PB eligible UM patients. For the enucleation cohort, the randomization will be with or without darovasertib as neoadjuvant therapy. For the PB cohort, the randomization will be darovasertib followed by PB versus PB alone.

Key highlights of the Phase 3 registrational trial design in neoadjuvant UM, based on FDA guidance:

Eye preservation rate (exceed lower bound of 10% eye preservation rate with a 95% confidence interval) is the primary endpoint for the enucleation UM cohort
Proportion of patients with vision loss from the time of randomization and time of completion of PB is the primary endpoint for the plaque brachytherapy cohort. Vision detriment will be measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) of >15-letters lost
No detriment to Event-Free-Survival (EFS) is a secondary endpoint for both cohorts and is required for approval. No detriment is defined as overlapping confidence intervals
Additional secondary endpoints: Overall Response Rate (>20% ocular tumor shrinkage by product of diameters), proportion of patients with clinically significant macular edema, proportion of subjects with 20/200 vision loss or worse (legal blindness), proportion of subjects with reduction of radiation dose of >20% delivered to key eye structures
Potential to submit the enucleation cohort data for regulatory review earlier than the PB cohort pending the EFS data maturity in both cohorts
300mg BID darovasertib will be the move-forward dose for the registrational trial

On April 14, 2025 Pheast Therapeutics, a private biotechnology company developing novel therapies to unleash the power of macrophages on aggressive, difficult-to-treat cancers, reported that the first patient has been treated in its Phase 1 clinical trial evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, in patients with advanced solid tumors (Press release, Pheast Therapeutics, APR 14, 2025, View Source [SID1234651920]).

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"The start of this Phase 1 trial is an important milestone for Pheast and for the advancement of next generation macrophage checkpoint therapies," said Roy Maute, Ph.D., Cofounder and CEO, Pheast Therapeutics. "We believe PHST001 has the potential to provide new treatment options for patients, particularly in cancers where other immunotherapies have not been effective."

The multicenter, open-label Phase 1 study will enroll up to 80 patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: NCT06840886). The study’s primary objectives include evaluating safety and tolerability of PHST001 and establishing the recommended Phase 2 dose, with secondary endpoints assessing pharmacokinetics and early signs of anti-tumor activity.

Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer, Pheast Therapeutics, said, "PHST001 has demonstrated robust activity across tumor types and a favorable safety profile in preclinical studies. Furthermore, these data suggest that PHST001 may overcome tumor immune evasion through a differentiated approach to macrophage activation. We are pleased to have initiated this study as a first step in understanding the clinical potential of PHST001 to improve patient outcomes across multiple cancer types."

Irving Weissman, M.D., scientific co-founder of Pheast Therapeutics added, "CD24 is a key mechanism that tumors use to evade macrophage-mediated immune responses. PHST001 was developed based on foundational research into this pathway, and I’m encouraged to see this science progressing into the clinic. It’s a meaningful step toward harnessing the full potential of the innate immune system in cancer."

Preclinical data presented at SITC (Free SITC Whitepaper) 2024 highlight PHST001’s potential across multiple cancer types, and its differentiation as a novel macrophage checkpoint inhibitor uniquely designed to target all glyco-variants of CD24. By binding CD24 with high affinity and specificity, PHST001 promotes macrophage-induced phagocytosis in a variety of cancer cell types and significantly shrinks tumors in in vivo models. Additionally, PHST001 has a favorable pharmacokinetic profile in non-human primates and does not induce immune-mediated toxicity in in vitro studies.

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, including ovarian and triple negative breast cancer (TNBC), and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a best in class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response.

On April 14, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application covering its chimeric antigen receptor-T cell (CAR-T) technology (Press release, Anixa Biosciences, APR 14, 2025, View Source [SID1234651904]).

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The allowed claims in this patent encompass core methods and compositions that are fundamental to Anixa’s innovative CAR-T approach. Anixa’s CAR-T platform is specifically designed to address the long-standing challenges of applying CAR-T therapies to solid tumors, positioning the program as a potential breakthrough in immuno-oncology. This patent, along with others, was granted to The Wistar Institute and exclusively licensed to Anixa Biosciences. Anixa’s CAR-T technology is currently in a clinical trial at Moffitt Cancer Center, treating recurrent ovarian cancer patients.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "This Notice of Allowance further strengthens our growing intellectual property portfolio and reinforces the potential of our robust CAR-T program. Securing foundational patent protection is a vital step in supporting the program’s future success and in driving the development of next-generation immunotherapies with the potential to deliver transformative outcomes for patients."

On April 14, 2025 REVEAL GENOMICS and Ona Therapeutics reported a strategic collaboration aimed at accelerating the clinical development of ONA-255, a next-generation ADC designed to enhance the precision and efficacy of cancer treatment across multiple tumor types (Press release, Ona Therapeutics, APR 14, 2025, View Source [SID1234651921]).

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ONA-255 is positioned to be a first-in-class molecule against a novel ADC target present in multiple, prevalent solid tumor types. Ona has privileged insight of the target as a hallmark of molecular adaptation in advanced diseases and its unique function as a universal driver of resistance to various therapies. ONA-255 is an ADC tailor-made to match the design of the molecule to the extraordinary biology of the target to deliver exceptionally potent drug against recalcitrant tumors, especially resistant clones for deeper and more durable responses.

At the heart of this collaboration is Dr. Aleix Prat, Co-Founder and Chief Scientific Officer of REVEAL GENOMICS. A globally recognized expert in precision oncology and drug development, Dr. Prat played a key role in identifying the ONA-255 drug target and generating, in collaboration with Ona Therapeutics and Dr. Roger Gomis, the critical preclinical data necessary for its clinical advancement. He also serves as the head of Ona Therapeutics’ advisory board.

As a leader in genomic innovation, REVEAL GENOMICS will conduct a comprehensive molecular analysis of tumor and blood samples from the ONA-255 phase 1-2 clinical trial as part of this strategic collaboration. Leveraging proprietary technologies and advanced computational algorithms, the company will decode key molecular and genomic biomarkers to reveal insights into tumor biology, the immune microenvironment, and response mechanisms to ONA-255. This pioneering work will help define patient populations, identify predictive biomarkers, and deepen the understanding of ONA-255’s mechanism of action—accelerating its clinical development and opening new therapeutic avenues.

To advance this partnership, Ona Therapeutics—working in collaboration with the U.S. subsidiary of REVEAL GENOMICS—has been awarded a grant from CDTI (Centro para el Desarrollo Tecnológico y la Innovación), a public entity under the Spanish Ministry of Science, Innovation, and Universities that promotes technological innovation and development. The grant is funded by the Plan de Recuperación, Transformación y Resiliencia – Funded by the European Union NextGenerationEU.

Valerie Vanhooren, Co-Founder and CEO of Ona Therapeutics, added, "ADCs have transformed cancer treatment; however, the technology has been applied to a limited number of tumor targets. These limitations restrict the number of patients who can benefit from treatments and highlight the critical need to identify new broadly expressed tumor targets. Ona’s tailor-designed ADCs have the potential to define new treatment paradigms and patient populations, resulting in a clear benefit for patients with cancer. This partnership with REVEAL GENOMICS combines Ona’s ADC experience with cutting-edge diagnostics with the goal to transform the treatment landscape for aggressive solid tumors."

Patricia Villagrasa, Co-Founder and CEO of REVEAL GENOMICS, stated, "Ona Therapeutics is at the forefront of developing next-generation cancer therapies. This collaboration marks a key milestone in combining advanced diagnostics with innovative treatments, reinforcing the strategic value of integrating biomarker science early in drug development. It also underscores REVEAL GENOMICS’s leadership in driving biomarker strategy and our commitment to shaping new business models that bring precision oncology closer to patients."

Dr. Aleix Prat commented, "I am thrilled about this collaboration, which bridges groundbreaking therapies with precision medicine. By leveraging our combined expertise, we can gain deeper insights into ONA-255’s efficacy, paving the way for more targeted and impactful cancer treatments."