On October 1, 2025 Ensem Therapeutics, Inc. (ENSEM) reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its clinical stage pan mutant-specific allosteric PI3Kα inhibitor and degrader, ETX-636, for the treatment of adult patients with PIK3CA-mutant, hormone receptor positive (HR+)/human epidermal growth factor negative (HER2-) advanced breast cancer (Press release, ENSEM Therapeutics, OCT 1, 2025, View Source [SID1234656387]).

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ETX-636 was designed using ENSEM’s unique Kinetic Ensemble platform to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα and can selectively inhibit multiple activating mutant forms of PI3Kα, while sparing wildtype PI3Kα. The selectivity of ETX-636 for mutant PI3Kα greatly reduces the risk for hyperglycemia and other wildtype PI3Kα-related adverse events compared to non-mutant selective PI3Kα inhibitors. In addition, ETX-636 also leads to proteasome-dependent degradation of mutant PI3Kα, while sparing wildtype protein (a feature not seen with other pan-mutant allosteric inhibitors).

Activating mutations or alterations of the PI3Kα pathway are known to promote cancer cell growth and survival in a variety of tumor types, including breast cancer. In HR+/HER2- breast cancer (approximately 70% of all breast cancers), PIK3CA mutations are particularly prevalent, occurring in up to 40% of the cases.

"Patients with advanced HR+/HER2- breast cancer harboring PIK3CA mutations have poor prognosis, and there is an unmet need for therapies targeting this population that are safer and more efficacious than the current FDA approved non-mutant selective treatments," said Dr. Shengfang Jin, CEO and Co-Founder of ENSEM. "We are appreciative that the FDA has recognized ETX-636 as a potentially important treatment for this indication and we remain laser-focused on demonstrating its benefit to patients in our current clinical trials."

ETX-636 is currently being studied in an initial first-in-human, Phase 1/2 study which is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation. ETX-636 will be administered alone or in combination with fulvestrant, a selective estrogen receptor degrader approved for the treatment of advanced hormone receptor HR+/HER2- breast cancer NCT06993844.

Fast Track designation is a program provided by the FDA to expedite the development and review of drugs and biologics that treat serious conditions with unmet medical needs. It provides the opportunity for frequent and early communication and collaboration with the FDA, as well as the potential for accelerated approval and priority review eligibility to allow faster access to promising treatment to patients.

On October 1, 2025 Humanetics Corporation, an advanced clinical-stage specialty pharmaceutical company pioneering novel approaches to tissue protection in oncology-related radiation exposure and mitigating the inflammatory response in pulmonary disease, reported that the Company will be hosting a virtual panel on October 08, 2025, 1:30 pm EDT, entitled "Mitigating Tissue Damage in Radiation Oncology and Inflammation in Pulmonary Disease: Targeting Pathways of Tissue Injury and Inflammatory Response (Press release, Humanetics, OCT 1, 2025, View Source [SID1234656386])."

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Panel members include:

Rany Condos, MD, Director, Interstitial Lung Disease Program and Post-COVID Program, NYU Langone
Pranshu Mohindra, MD, MMM, Professor and Vice Chair of Operations and Quality for the Department of Radiation Oncology and Director of the University Hospitals Proton Therapy Center, University Hospitals Cleveland Medical Center
Colin G. Chinn, MD, MHS, FACP, RADM MC USN (Ret), Chief Medical Officer, Humanetics
Michael D. Kaytor, PhD, Vice President, Research & Development, Humanetics
Hannah Olson, PhD, Research & Development Scientist, Humanetics
This panel will explore advances in addressing unmet medical needs related to oncology and radiation exposure, as well as pulmonary disease and inflammation. Leading oncology and pulmonary medicine clinicians, together with researchers, will share perspectives on emerging data, trial design, clinical practice challenges, and insights into potential therapeutic targets.

A live Q&A session will follow the panel discussion.

Humanetics convened an expert panel on August 12, 2025, that explored its Medical Countermeasure development program. As discussed, protecting Warfighters from tissue damage due to accidental or intentional ionizing radiation exposure remains a priority for the United States as well as its allies and partners. Likewise, safeguarding emergency medical personnel, first responders, and civilian populations is among the domestic imperatives for Strategic National Stockpile decision makers. Access to the video recording of the August 12 session is available on the Humanetics Corporation website under "News & Events."

On October 1, 2025 PhotonPharma , a cancer immunotherapy company developing a scalable autologous therapy platform, Innocell, reported that CEO and Chief Scientific Officer Raymond Goodrich, PhD, will present at the 2nd Annual Personalized Cancer Vaccine Summit taking place November 18-20, 2025, in Boston, Massachusetts (Press release, PhotonPharma, OCT 1, 2025, View Source [SID1234656385]).

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Dr. Goodrich will deliver two featured presentations showcasing PhotonPharma’s innovative approach to personalized cancer immunotherapies:

"Developing a Practical & Scalable Autologous Vaccine Manufacturing Platform Using Whole Tumor Cells to Enable Real-World Application of Personalized Immunotherapy" – This presentation will detail how PhotonPharma is adapting pathogen reduction technology to manufacture metabolically active, non-replicating tumor cells for autologous immunotherapy, significantly simplifying production while preserving immunogenic function.

"Activating the Immune System with Whole-Tumor Vaccines: Harnessing Shared & Neoantigens to Remodel the Tumor Microenvironment" – Dr. Goodrich will present preclinical data demonstrating how PhotonPharma’s whole tumor cell platform stimulates immune responses by combining shared tumor-associated antigens and patient-specific neoantigens in a single vaccine format.

"We’re excited to share our progress in developing a truly scalable manufacturing platform to potentially deliver personalized cancer immunotherapies" said Dr. Terry Opgenorth, Chairman of the Board. "Our approach addresses the key challenges facing the field – manufacturing speed, cost-effectiveness, and broad tumor coverage – while maintaining the personalized benefits that make these therapies so promising."

The presentations highlight PhotonPharma’s unique manufacturing workflow that streamlines the process from tumor resection to reinjection, reducing turnaround time and improving reproducibility. The technology platform’s initial indication targets patients with relapsed ovarian cancer.

About the Personalized Cancer Vaccine Summit

The 2nd Annual Personalized Cancer Vaccine Summit brings together 80+ senior executives from leading pharmaceutical and biotechnology companies to address critical challenges in personalized cancer vaccine development. The event features presentations from industry leaders including Moderna, Merck, BioNTech, and Genentech, alongside innovative companies developing next-generation platforms across mRNA, peptide, viral, and cellular modalities.

On October 1, 2025 Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) and QIAGEN K.K. (HQ: Chuo-ku, Tokyo, Japan; President and Representative Director: Xunlong Lin; "QIAGEN"), the Japanese subsidiary of QIAGEN N.V., reported that they entered into a strategic alliance agreement for clinical diagnostic products in the field of molecular diagnosis1 on September 30, 2025 (Press release, Sysmex, OCT 1, 2025, View Source [SID1234656384]).

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This agreement marks the enhancement of collaboration between the two companies in the field of clinical diagnostics based on the global alliance agreement signed in 2024. Sysmex and QIAGEN will now partner for distribution for QIAGEN’s clinical diagnostic instruments, reagents, and other products in the field of infectious diseases and oncology for Japan, and will promote their introduction into the Japanese medical institution and testing center markets.

Sysmex and QIAGEN N.V. have built a successful partnership over 10 years, based on collaboration utilizing the strengths of both parties. In 2024, the two companies signed a strategic alliance agreement for clinical diagnostic products, including those in the field of genetic testing, further deepening their collaboration.

The two companies have now concluded an exclusive agreement for the distribution and supply of QIAGEN’s clinical diagnostic instruments, reagents, and other products for infectious diseases and oncology in the Japanese market. With this agreement, in addition to the sale of existing cancer genetic companion diagnostic products2, they will establish a sales collaboration in the field of infectious diseases, which accounts for roughly half of the total genetic testing market in this country.3

They will initially begin by handling existing products for clinical testing, including cancer molecular diagnostics and tuberculosis testing involving the market-leading QuantiFERON-TB Gold Plus test4 in the Japanese market, and will subsequently consider expanding the product lineup. By distributing the products of QIAGEN, a leader in the field of infectious diseases based on a broad platform of molecular diagnostic technologies, through Sysmex, which has a robust sales network for clinical testing products, the two companies aim to deliver products tailored to customer needs as quickly as possible to customers and to deliver more appropriate services more effectively.

Under the global strategic alliance agreement, Sysmex and QIAGEN will continue to strengthen their partnership by expanding their collaborative framework for product sales and exploring joint R&D initiatives that leverage the technological foundation of both companies. The two companies will contribute to improving patients’ quality of life and realizing optimal healthcare by developing and promoting high-value products globally.

On October 1, 2025 OmniaBio Inc., a next generation contract development and manufacturing organization (CDMO) pioneering the manufacturing of cell and gene therapies (CGT) with robotics and artificial intelligence, and BrainChild Bio Inc, a clinical-stage biotechnology company developing Chimeric Antigen Receptor T-cell (CAR-T) therapies to treat solid tumors in the central nervous system, reported their collaboration aimed at manufacturing BrainChild Bio’s pivotal clinical trial therapeutic candidate BCB-276 (Press release, OmniaBio, OCT 1, 2025, View Source [SID1234656383]).

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BrainChild Bio is a kids-first biotechnology company, prioritizing treatments for pediatric brain tumors, with a pipeline that extends the technology platform to adult indications, including glioblastoma and brain metastases. BCB-276 represents a significant advance in the fight against pediatric diffuse intrinsic pontine glioma (DIPG), a rare, aggressive, and universally fatal brain cancer with limited treatment options and a median overall survival of less than 1 year according to the International DIPG/DMG Registry. This innovative autologous CAR-T therapy utilizes a patient’s own immune system by re-engineering their T-cells to recognize and kill cancer cells.

BrainChild Bio is preparing to advance BCB-276 in a Phase 2 multi-center, pivotal registration trial to support a potential Biologics License Application (BLA) to the U.S. FDA for the treatment of children and young adults with DIPG. Manufacturing for BCB-276 will take place at the OmniaBio CGT production facility based in Hamilton, Ontario.

"We’re proud to partner with BrainChild Bio, a company that exemplifies patient-centered innovation in pediatric oncology," said Michael May, President and CEO of OmniaBio. "While many CAR-T developers have solely prioritized clinical outcomes, often leaving manufacturing and supply considerations for later, BrainChild is redefining that approach—placing much needed emphasis on reliability, affordability, and thus patient access by working with OmniaBio."

Steven Brugger, CEO of BrainChild Bio added, "Establishing a scalable and reliable manufacturing pathway is critical for the success of our CAR-T therapy programs. OmniaBio’s deep expertise, commitment to our needs, and advanced facilities make them an ideal partner. This strategic collaboration will significantly augment our ability to scale production and provide reliable and efficient supply for clinical timelines, ultimately bringing hope to patients suffering from devastating brain tumors."

The collaboration will focus on the process development and GMP manufacturing of BrainChild Bio’s lead autologous CAR-T therapy candidate. Both companies anticipate expanding the scope of their collaboration to include additional programs as BrainChild Bio’s pipeline advances.