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])

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])

On January 6, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) ("Crinetics"), a pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported the pricing of an underwritten public offering of 7,620,000 shares of its common stock at a price to the public of $45.95 per share. All of the shares to be sold in the offering are to be sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $350 million. In addition, Crinetics has granted the underwriters a 30-day option to purchase up to an additional 1,143,000 shares of common stock. The offering is expected to close on or about January 8, 2026, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the offering, together with its cash, cash equivalents and investment securities, to fund its commercial activities in connection with the launch of PALSONIFY, research and development of its product candidates, other research programs and other general corporate purposes, which may include, among other things, capital expenditures or working capital. Crinetics may also use a portion of the remaining net proceeds, together with its existing cash, cash equivalents and investment securities, to in-license, acquire, or invest in complementary businesses, technologies, products or assets; however, it has no current commitments or obligations to do so.

Leerink Partners, J.P. Morgan, Evercore ISI, Piper Sandler and Cantor are acting as joint bookrunning managers for the offering. Baird is acting as lead manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to this offering has been filed with the SEC, and a final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Crinetics Pharmaceuticals, JAN 6, 2026, View Source [SID1234661766])

On January 6, 2026 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported the publication of a manuscript detailing the discovery and optimization of VVD-214, the company’s covalent inhibitor of Werner helicase (WRN), on the cover of the Journal of Medicinal Chemistry. The article, "Identification of VVD-214/RO7589831, a Clinical-Stage, Covalent Allosteric Inhibitor of WRN Helicase for the Treatment of MSI-High Cancers" (Kikuchi et al., J. Med. Chem.,December 2025), validates Vividion’s covalent-first chemoproteomics approach to reach targets that have eluded traditional drug discovery.

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"The discovery of VVD-214 marks a significant milestone in the development of a new class of potential therapies for MSI-high solid tumors," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "Patients with malignancies with high microsatellite instability (MSI) — including colorectal, endometrial, ovarian, and gastric cancers — have limited treatment options, and many ultimately relapse or become resistant to available therapies. This program’s continued progress, as the first covalent inhibitor in clinical development, underscores our platform’s ability to generate differentiated investigational medicines that address some of the toughest challenges in cancer biology."

VVD-214 is designed to exploit the dependency of MSI-high cancer cells on WRN-mediated DNA repair, leading to selective tumor cell death while sparing healthy tissue. In the manuscript, researchers report utilizing Vividion’s chemoproteomics platform to identify molecular fragments that covalently bound an allosteric pocket of WRN to lock it into an inactive conformation. These molecules were then optimized through iterative structure-activity relationship testing, with particular focus on the cysteine-reactive electrophile (vinyl sulfone) and the molecule’s core aromatic rings. The resulting structure of VVD-214 was chosen for its balance of potency, selectivity, and drug-like ADME properties. In preclinical studies, VVD-214 was well tolerated and led to robust tumor regression in multiple patient-derived xenograft mouse models of MSI-high colorectal cancer.

The compound is now in a Phase I clinical trial (NCT06004245) as monotherapy and in combination with pembrolizumab for patients with MSI-high or mismatch repair deficient (dMMR) cancers.

"WRN is a high-value oncology target known to induce synthetic lethality in cancers with high MSI, but as a helicase it has been extremely difficult to drug," said Matt Patricelli, Ph.D., Chief Scientific Officer of Vividion. "This paper highlights the strength of Vividion’s chemoproteomics platform at identifying selective small molecules against even the most challenging protein classes, while our medicinal chemistry expertise in covalent drug design enables us to optimize those discoveries into potent and selective therapeutic candidates."

(Press release, Vividion Therapeutics, JAN 6, 2026, View Source [SID1234661765])

On January 6, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that its management team will meet institutional investors during the upcoming editions of:

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– LifeSci Partners Corporate Access Event (by LifeSci Partners), on January 12 and 13, 2026, in San Francisco (United States) in conjunction with the JP Morgan Healthcare Conference;
– Biomed Forum (by Allinvest Securities), on January 29, 2026, in Paris (France).

(Press release, Transgene, JAN 6, 2026, View Source [SID1234661763])