On September 16, 2026 Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and GenomeFrontier Therapeutics, a Taiwanese cell therapy company developing novel virus-free CAR-T therapies, reported a partnership to evaluate automated manufacturing for GF-CART01, GenomeFrontier’s investigational CAR-T cell therapy, on Cellares’ Cell Shuttle platform.

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The collaboration will evaluate the translation of GenomeFrontier’s virus-free manufacturing process to the Cell Shuttle, with a focus on supporting transfection unit operation using Cellares’ proprietary integrated electroporator. The partnership marks Cellares’ first development collaboration in Asia and is intended to support GenomeFrontier’s U.S. clinical initiative as it advances GF-CART01.

GenomeFrontier is developing GF-CART01 for B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal large B-cell lymphoma and high-grade B-cell lymphoma. The company has demonstrated promising clinical data in Taiwan and is actively recruiting for a Phase 1 clinical trial in the United States.

"As we advance GF-CART01, it is important that our manufacturing strategy can support both clinical development and future scale," said Sareina Wu, PhD, Founder, CEO and Chief Scientific Officer of GenomeFrontier. "Our virus-free approach is central to the development of GF-CART01, and this collaboration with Cellares allows us to evaluate how that process can be translated to an automated manufacturing platform as we expand our clinical development in the United States."

"GenomeFrontier’s virus-free approach reflects the increasing complexity of next-generation cell therapy manufacturing," said Fabian Gerlinghaus, Co-Founder and CEO of Cellares. "The Cell Shuttle is built to automate complex processes, including electroporation-based workflows, with the scalability and reliability needed as therapies advance through clinical development. This partnership brings that capability to GenomeFrontier as it expands its program in the United States."

Autologous CAR-T manufacturing remains labor-intensive, variable and difficult to scale, creating challenges for clinical development, manufacturing reliability, cost and ultimately patient access. The Cell Shuttle is an end-to-end automated cell therapy manufacturing platform designed to improve the scalability and reliability of autologous cell therapy manufacturing.

Through the collaboration, Cellares and GenomeFrontier will evaluate the potential to automate GenomeFrontier’s process on the Cell Shuttle while maintaining the flexibility required for its virus-free approach. The companies aim to establish a manufacturing strategy capable of improving reliability, driving down manufacturing costs and improving patient access as GenomeFrontier advances its program.

(Press release, GenomeFrontier Therapeutics, SEP 16, 2026, View Source [SID1234670909])

On September 16, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the previously announced strategic partnership with Sobi is now effective following the expiration of applicable antitrust waiting periods and completion of other conditions.

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As announced on August 10, 2026, Innate Pharma entered a strategic partnership with Sobi to license lacutamab in T-cell lymphoma. Transaction closing triggers the USD 75 million upfront payment and marks the initiation of the TELLOMAK-3 confirmatory Phase 3 study, with first patient expected in Q1 2027.

Under the agreement, Innate is conducting the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma. The TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results.

(Press release, Innate Pharma, SEP 16, 2026, View Source [SID1234670908])

On September 16, 2026 IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IASO208, the Company’s proprietary CD20-targeted in vivo CAR-T therapy developed using its InTelliCAR platform.

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IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance. Supported by early clinical data from an investigator-initiated trial (IIT) in China and informed by interactions with the FDA, IASO208 is expected to advance directly into a Phase Ib clinical study in the United States for the treatment of adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study in China to assess its safety, tolerability, and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. The treatment does not require leukapheresis or lymphodepleting chemotherapy and is administered as a single intravenous infusion. To date, 11 patients have been dosed, with early data demonstrating favorable tolerability and encouraging anti-tumor activity, providing a strong foundation for larger and more systematic clinical studies. IASO Bio will continue to advance the clinical development of IASO208 to further evaluate its safety and efficacy. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, said: "The FDA’s clearance of the IND application for IASO208 represents an important milestone for InTelliCAR, IASO Bio’s proprietary in vivo CAR-T platform, and marks the entry of China-originated cell therapy technologies into the global race in the in vivo CAR-T field. Leveraging the proprietary InTelliCAR platform, IASO Bio has established a pipeline of multiple in vivo CAR-T product candidates spanning hematologic malignancies, autoimmune diseases, and solid tumors, with several of these products already in the IND-enabling stage. The FDA’s clearance of IASO208 based on early IIT data from China reflects the regulator’s recognition of the high quality of China’s IIT clinical data, and lays a solid foundation for the international development of the platform’s pipeline. Going forward, we will continue to advance the clinical development of the InTelliCAR platform pipeline to accelerate global patient access to China-originated cell therapies."

About IASO208

IASO208 is a replication-incompetent, self-inactivating, third-generation lentiviral vector-based therapeutic. It is pseudotyped with an engineered COCV-G viral envelope and carries a second-generation humanized anti-CD20 chimeric antigen receptor (CAR) transgene. Through selective binding to and transduction of T cells in vivo, IASO208 enables the generation of anti-CD20 CAR-T cells directly within the patient’s body.

About Non-Hodgkin Lymphoma (NHL)

Non-Hodgkin lymphoma (NHL) is a group of malignant tumors originating in the lymphatic system. According to GLOBOCAN estimates, approximately 563,000 new cases of NHL were diagnosed globally in 2024, with approximately 1.721 million people living with NHL within five years of diagnosis. In the United States, approximately 74,000 new cases of NHL were estimated in 2024, with approximately 256,000 people living with NHL within five years of diagnosis.1 B-cell non-Hodgkin lymphoma (B-NHL) accounts for approximately 85% of all NHL cases, making it the largest disease category within NHL.

(Press release, IASO Biotherapeutics, SEP 16, 2026, View Source [SID1234670907])

On September 16, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported that the U.S. FDA has granted Fast Track Designation to its PD-1/VEGF bispecific antibody cesalatamig (also known as AI-081) for the treatment of patients with NSCLC whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

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"This designation reflects the clinical safety and efficacy signals we have seen in our global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications".

The global BiPAVE-001 Phase 1/2 trials are designed to evaluate the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancer. Part A is Phase 1 dose escalation and expansion study. Part B is the Phase 2 dose optimization studies consisting of multiple cohorts evaluating the safety and clinical activities of cesalatamig either as monotherapy or in combination therapy with standard of care or novel agents. The trials are being conducted at more than 50 clinical sites across the United States and China, with majority of the patients enrolled from the United States.

About cesalatamig

Cesalatamig is a differentiated PD-1/VEGF bispecific antibody with high affinity for PD-1 and more than 40-fold higher affinity for VEGF than bevacizumab-based bispecific PD-(L)1/VEGF inhibitors. As a result, cesalatamig shows best-in-class potential with a stronger cooperative interaction that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1 positive effector T cells.

(Press release, OncoC4, SEP 16, 2026, View Source [SID1234670906])

On September 16, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), reported that the U.S. Patent and Trademark Office (USPTO) has officially granted a patent (Patent No. US12,735,481) for its proprietary, core bispecific antibody technology platform, PACbody (PAC = Pairing of Alternative Cysteines). This patent grant marks a significant milestone for Phanes in its foundational bispecific technology and global intellectual property protection.

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PACbody is a proprietary bispecific antibody construction platform internally discovered and owned by Phanes. It enables the generation of bispecific antibodies that maintain native IgG structures with drug-like CMC characteristics. Bispecific antibodies built on this platform exhibit excellent manufacturability, including stability, high expression, and seamless compatibility with conventional monoclonal antibody commercial manufacturing processes, significantly reducing development, clinical, and manufacturing risks.

Innovative bispecific antibodies developed using the PACbody platform have demonstrated robust clinical potential. Most notably, Phanes’ core asset spevatamig (PT886) has advanced into Phase II clinical trials and showed positive results, as reported at the ASCO (Free ASCO Whitepaper) Annual Meeting in May 2026. Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted by the FDA orphan drug designation (ODD) for the treatment of pancreatic cancer in 2022, Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and recently, Fast Track designation for the treatment of advanced and metastatic biliary tract carcinoma. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

"We are thrilled that our PACbody platform has been granted this U.S. patent," said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. "PACbody is our core technology for overcoming the CMC challenges that typically hindered bispecific antibody development. This patent approval not only validates our top-tier innovative R&D capabilities but also significantly strengthens the protection of our core pipeline’s intellectual property. We will continue to leverage this platform to accelerate the delivery of safer and more effective breakthrough therapies to cancer patients worldwide."

(Press release, Phanes Therapeutics, SEP 16, 2026, View Source [SID1234670905])