On January 9, 2026 Nona Biosciences ("Nona"), a global biotechnology company advancing biologics discovery through innovative technology platforms, reported that it has entered into a multi-target antibody discovery collaboration with Link Cell Therapies. This collaboration will leverage Nona’s proprietary fully human HCAb Harbour Mice platform and its innovative direct CAR-function-based HCAb library screening platform, NonaCarFx, to generate novel CAR-T cell therapy candidates.

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The fully human heavy chain-only antibodies (HCAbs) generated from Nona’s HCAb Harbour Mice platform provide an ideal modality for CAR-based cell therapies. Unlike traditional methods, fully human HCAbs have the potential to significantly reduce immunogenicity. Their compact size, simplified structure, and precisely calibrated binding properties offer enhanced versatility in CAR design. In the rapidly evolving field of cell therapy, fully human HCAbs present a promising approach to unlock the next wave of therapeutic innovation.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, commented, "We are pleased to collaborate with Link Cell Therapies to advance the next generation of CAR-T therapies. By combining Nona’s HCAb Harbour Mice and NonaCarFx platforms with Link Cell Therapies’ expertise in cell therapy, we aim to accelerate the discovery of differentiated candidates with the potential to address both solid and hematologic malignancies."

Dr. Mark Wallet, Chief Science Officer of Link Cell Therapies, commented, "At Link Cell Therapies, we are building a new generation of chimeric antigen receptor (CAR)-T cell therapies to treat solid tumors using a logic-gated approach that precisely discriminates between malignant and healthy cells. While the LINK CAR signaling technology is the backbone of our logic-gating strategy, a CAR molecule is only as good as its antibody domains. We are pleased to be working with Nona Biosciences to discover novel human HCAbs to pair with the LINK CARs."

(Press release, Nona Biosciences, JAN 9, 2026, View Source [SID1234661899])

On January 9, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the completion of a Series F financing round in December 2025 led by Lightspeed Venture Partners. With $250M in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100M in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline.

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The proceeds will be used to ensure commercial readiness as the company approaches the April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy. The funding will help strengthen the company’s infrastructure to support future commercial scale, including the addition of East Coast manufacturing capacity to complement its Sacramento, CA operations. The capital will also support the accelerated advancement of Orca Bio’s pipeline across multiple clinical programs designed to expand treatment to more patients in need.

"Our financial position is a powerful validation of Orca-T’s transformative potential and reflects our commitment to pioneering a new standard in cell therapy," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "With the resources and infrastructure now in place, we are uniquely positioned to bring our first high-precision therapy to leukemia patients in the U.S. This milestone not only solidifies our anticipated commercial launch but also provides the runway to advance our promising pipeline as we seek to redefine treatment across multiple life-threatening blood cancer and autoimmune diseases."

In parallel to commercialization efforts, Orca Bio remains focused on advancing its pipeline of high-precision cell therapies. The company progressed two clinical programs designed to evaluate Orca-T and Orca-Q in both the reduced intensity conditioning (RIC) and nonmyeloablative (NMA) settings for patients who may not be candidates to receive a traditional myeloablative conditioning (MAC) regimen.

"While myeloablative conditioning offers the best chance to eradicate disease with a traditional allogeneic stem cell transplant, the high toxicity levels carry significant risks, particularly for older patients or those with co-morbidities," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "Less intensive conditioning regimens are safer for patients who are not candidates for myeloablative conditioning. Through these new studies, we aim to evaluate if Orca-T and Orca-Q can bring safer, curative interventions to a broader population of blood cancer patients."

SERENE-T Phase 2 Study: SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing RIC or NMA. The overall survival (OS), another secondary endpoint, was 93.7% (95% CI: 86%, 97%) in the Orca-T arm and 83.2% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
Expanded Phase 1b Study of Orca-Q: The first patients have been treated in the expanded Phase 1b study (NCT03802695​) which now includes three additional cohorts of patients receiving RIC or NMA with either matched related or unrelated, 7/8 mismatched unrelated or haploidentical related donors. Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for patients with AML, MDS or mixed phenotype acute leukemia (MPAL). The cumulative incidence of non-relapse mortality (NRM) was 3.4% (95% CI: 0.9%, 8.8%) for Orca-T versus 13.2% (95% CI: 6.8%, 21.6%) for alloHSCT (HR 0.27 [95% CI: 0.08, 0.93]; p=0.03 in a post hoc analysis).

Both studies are now enrolling with plans to open at additional centers across the U.S. For more information, visit ClinicalTrials.gov.

(Press release, Orca Bio, JAN 9, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-250m-in-aggregate-financing-in-preparation-for-potential-commercialization [SID1234661900])

On January 9, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration ("FDA") for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.

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The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company’s VERSATILE-002 trial, which showed promising mOS and durable PFS.

"Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of VERSATILE-003. The amendment retains mOS and safety as requirements for full FDA approval, and based on the dialogue we had with the agency in December, we are confident that we have a pathway to potentially accelerate our regulatory submission."

(Press release, PDS Biotechnology, JAN 9, 2026, View Source [SID1234661901])

On January 9, 2026 AnaptysBio presented its corporate presentation.

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(Presentation, AnaptysBio, JAN 9, 2026, View Source [SID1234661887])

On January 9, 2026 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 44th Annual J.P. Morgan Healthcare Conference, January 12-14, 2026, in San Francisco.

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Valneva’s CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming catalysts from its clinical development pipeline, including the pivotal data readout for its Lyme disease vaccine in the first half of this year, as well as the Company’s commercial portfolio of vaccines.
To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can contact Valneva’s investor relations department at [email protected].

(Press release, Valneva, JAN 9, 2026, View Source [SID1234661904])