Lineage Takes Delivery of Gene-edited Hypoimmune Cell Line Under Partnership With Factor Bioscience

On January 6, 2026 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf," cell therapies for serious medical conditions, reported the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience Inc. ("Factor"). Generation of the line marks a successful milestone in the strategic collaboration between the two companies, under which Factor developed a proprietary, genetically engineered iPSC line that Lineage can utilize for differentiation into certain cell transplant product candidates. The novel cell line contains edits which are expected to support non-immune privileged and/or non-human leukocyte antigen (HLA) matched indications and includes an additional disease-specific edit with the potential to further differentiate this cell line from other cell therapies. Acceptance of the line triggered a success payment from Lineage to Factor as reimbursement for Factor’s development efforts to date. Factor remains eligible for an additional payment from Lineage subject to Lineage’s entry into an exclusive license to utilize the line. Lineage’s decision to proceed with the program will be based on further performance criteria and the outcome of additional testing, including the evaluation of the line for its ability to adapt to Lineage’s proprietary cell expansion manufacturing platform, the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform.

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"Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies," stated Brian M. Culley, Chief Executive Officer of Lineage. "This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen, for dry age-related macular degeneration with geographic atrophy. We look forward to leveraging the knowledge and expertise we have developed in retinal cell transplantation to additional cell therapy product candidates which may have the potential to transform the treatment of a wide range of diseases. We view the convergence of directed cell differentiation with modern gene editing technology as an exciting new branch of medicine, and we plan to continue to advance this emerging space."

"The cells we have delivered to Lineage embody the incredible potential of Factor’s gene-editing technology and represent a major milestone in the partnership between our companies," said Matt Angel, Ph.D., Chief Executive Officer and President of Factor. "We believe Factor’s state-of-the-art cell-engineering technologies have the potential to enable treatment of diseases in ways not previously possible. Factor and Lineage together are driving progress at the leading edge of engineered cell therapy development to benefit patients."

Lineage’s exclusive option and license agreement (the "Agreement") with Factor was announced in 2023. The novel hypoimmune iPSC line received by Lineage contains a set of specific edits selected in a development strategy vetted with subject matter experts in the U.S. and abroad, as well as under a broader competitive landscape analysis. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent adverse NK cell responses; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell line developed by Factor in a specific field for preclinical, clinical, and commercial purposes.

(Press release, Lineage Cell Therapeutics, JAN 6, 2026, View Source [SID1234661767])

Immunome to Present at 44th Annual J.P. Morgan Healthcare Conference

On January 6, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management reported it will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 10:30 a.m. PST.

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Interested parties can access a live audio webcast of the presentation via the Investor Relations section of Immunome’s website at www.immunome.com. A replay webcast will be available for approximately 30 days following the live presentation.

(Press release, Immunome, JAN 6, 2026, View Source [SID1234661783])

Brenus Pharma Reports Favorable Tolerability and Clinical Signals in Early Preliminary Results of First-In-Human Study for STC-1010 in Unresectable Metastatic Stage Colorectal Cancer (MSS CRC) Patients

On January 6, 2026 Brenus Pharma, a clinical stage biotechnology company unlocking the immune system in vivo to fight solid tumors, reported the successful completion of the first dose levels in its ongoing first-in-human study.

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The multi-center, open-label trial (NCT06934538) is a phase Ia/Ib study designed to evaluate safety, tolerability and preliminary clinical activity of STC-10101 in a first line setting. It will include in vivo analysis of immune and tumor dynamics during dose escalation of treatment and cohort extension to patients with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) MSS2 colorectal cancer (CRC).

Early findings indicate that the first dose levels have been successfully completed with good overall tolerance and no-dose-limiting toxicities observed to date.

"We are pleased to report that the safety profile observed to date is good and consistent with our expectations with no DLT," said Paul Bravetti, CEO of Brenus Pharma. "Moreover, preliminary clinical signals are very promising and support further evaluation of subsequent cohorts – we are observing trends in efficacy that are stronger than anything that has been previously reported in hard-to-treat solid tumors."

The trial is continuing to enroll patients at higher dose levels, and additional data on exploratory analyses (cytokine profiles, immunophenotyping, PBMC markers, ctDNA, HLA expression, tumor necrosis, immune infiltration, and TLS evolution) and efficacy will be communicated as the trial progresses.

Brenus’ next report is expected to be released in Q1 2026, as a key milestone in advancing STC-1010 for patients with advanced MSS "cold" colorectal cancer.

(Press release, Brenus Pharma, JAN 6, 2026, View Source [SID1234661752])

Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL® (obe-cel) on the Cellares Cell Shuttle™ Platform

On January 6, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, and Cellares Corp, the first Integrated Development and Manufacturing Organization (IDMO), reported that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in Stevenage, UK.

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Autolus commercializes AUCATZYL (obecabtagene autoleucel; obe-cel), an autologous CD19 CAR T cell therapy approved in the United States, UK, and Europe for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Obe-cel is also being studied in ongoing clinical trials to potentially expand its use in pediatric r/r B-ALL, and autoimmune diseases, such as lupus and multiple sclerosis.

Cellares’ Cell Shuttle platform integrates all unit operations for CAR T manufacturing into a single-use, closed, pre-sterilized cartridge operated on a fully automated platform capable of processing up to 16 patient batches in parallel.

This architecture enables a single IDMO Smart Factory to deliver up to 10-fold higher throughput than conventional cell therapy manufacturing facilities of similar footprint and headcount, while providing partners with more consistent batch quality, lower cost, and greater resilience in commercial supply. Cellares pairs the Cell Shuttle with Cell Q, a purpose-built quality control platform for cell therapy drug products that transforms analytical testing from manual, fragmented workflows into automated, high-throughput methods with fully digital, compliant batch records.

The Cellares Cell Shuttle platform was the first to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, which offers partners additional touchpoints and priority review mechanisms when referencing the platform in their INDs, BLAs, and post-approval supplements.

"We are evaluating obe-cel in a range of indications beyond acute leukemia, and if successful, expect future demand to exceed the manufacturing capacity at our Nucleus facility. Cellares’ Cell Shuttle platform may provide an attractive option for a capital-efficient expansion of our manufacturing footprint in the future," said Christian Itin, PhD, Chief Executive Officer of Autolus.

"If a commercial CAR T shows durable benefit, the next question is whether the industry can produce enough doses at a sustainable cost," said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "Autolus has already built a strong manufacturing foundation. Our role is to extend that foundation with a global infrastructure that can reduce cost and process failure rates, while meeting total patient demand."

(Press release, Autolus, JAN 6, 2026, View Source [SID1234661768])

DEM BioPharma Announces Poster Presentation Featuring DEM301 at the 2026 ASCO Gastrointestinal Cancers Symposium

On January 6, 2026 DEM BioPharma, Inc. (DEM Bio), a biopharmaceutical company dedicated to discovering novel targets for solid tumors and developing innovative, first-in-class, cancer medicines, reported that preclinical data for DEM301, a first-in-class bifunctional antibody drug conjugate (ADC), will be presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), taking place January 8-10, 2026, in San Francisco, CA.

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DEM301 targets a novel plasma membrane-associated glycoprotein protein, DEM-TXX, that is overexpressed in colorectal cancer and several other gastrointestinal malignancies. DEM-TXX plays roles in cell adhesion and myeloid cell suppression, and its expression is negatively correlated with disease progression, underscoring its potential significance in tumor biology.

"This ASCO (Free ASCO Whitepaper) GI presentation represents an important milestone for DEM BioPharma as we introduce DEM301 and its underlying biology to the oncology community for the first time," said Nenad Grmusa, CEO of DEM Bio. "DEM-TXX emerged from our scientific founders’ functional genomics screen and validated by DEM BioPharma as a target that appears to contribute to immune suppression in GI cancers. DEM301 was purpose-built to translate that biology into a differentiated ADC designed with a dual mechanism of action to directly kill tumor cells while engaging immune-mediated mechanisms."

DEM301 is a first-in-class bifunctional antibody drug conjugate composed of an afucosylated monoclonal antibody directed against DEM-TXX and conjugated to a clinically validated linker-payload. The molecule is designed to selectively target tumor cells expressing DEM-TXX while leveraging both direct cytotoxic delivery and immune-mediated mechanisms of action.

The preclinical data to be presented at ASCO (Free ASCO Whitepaper) GI will highlight potent and durable single-agent anti-tumor efficacy in preclinical models of colorectal and other GI tumors and a favorable safety profile in a humanized DEM-TXX mouse model, supporting advancement toward clinical development. DEM Bio is currently advancing DEM301 through preclinical pharmacology and toxicology studies and has initiated CMC process development and manufacturing development in preparation for a planned Phase 1a/1b clinical trial expected to begin in the second half of 2026.

ASCO GI Poster Presentation Details

Title: DEM301, a novel anti-DEM-TXX antibody-drug conjugate with potent anti-tumor activity for the treatment of gastrointestinal tumors
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract Number: 159; available on the ASCO (Free ASCO Whitepaper) GI website
Date & Time: January 10, 2026, 7:00 – 7:55 AM PST
Presenter: Sarah Carden, PhD, DEM BioPharma

(Press release, DEM BioPharma, JAN 6, 2026, View Source [SID1234661784])