Eisai and Nuvation Bio Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside the U.S., China and Japan

On January 13, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported an exclusive license and collaboration agreement that significantly expands the long-term global footprint of taletrectinib (generic name, marketed as IBTROZI in the U.S. and Japan). Taletrectinib is a highly selective, next-generation oral treatment currently approved for patients living with advanced ROS1- positive (ROS1+) non-small cell lung cancer (NSCLC) in the U.S., China, and Japan.

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Eisai will now have exclusive development, registration and commercialization rights for taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India. Nuvation Bio will continue to lead global development and retain full U.S. commercial rights, maintaining its strong focus on U.S. launch activities and ongoing pivotal studies of taletrectinib across early- and late-stage ROS1+ NSCLC.

"Our partnership with Eisai represents a major global expansion milestone for taletrectinib, strengthening the long-term potential of this clinically meaningful treatment option for even more patients living with ROS1+ NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "With Eisai’s world-class infrastructure and track record of bringing innovative medicines to market in major regions, we believe the expanse of this collaboration illustrates the commercial potential of taletrectinib while accelerating the opportunity for providers and patients around the world to access this important treatment option."

Under the terms of the exclusive license and collaboration agreement, Eisai will pay EUR 50 million (approx. USD 60 million) upfront and up to EUR 145 million (approx. USD 170 million) in regulatory and commercial milestone payments, as well as double-digit tiered royalties up to the high-teens as a percentage of future net sales in the licensed territories. Following the upfront payment, Eisai will pay the first milestone payment of EUR 25 million (approx. USD 30 million) from this transaction upon achievement of EU regulatory approval (conditional or full) of taletrectinib. The USD amounts are approximated based on an exchange rate of EUR1= USD1.2. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2026.

"With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care for patients with ROS1+ NSCLC in the EU and beyond, as it is already becoming the standard of care in the U.S. just six months from approval," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "We are thrilled to partner with Nuvation Bio and prioritize taletrectinib as our flagship oncology product in NSCLC, bringing this innovative medicine to patients as quickly as possible."

A Marketing Authorization Application (MAA) for the treatment of advanced ROS1+ NSCLC is expected to be filed in Europe in the first half of 2026. Additional filings are then planned for Canada and other regions.

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

(Press release, Eisai, JAN 13, 2026, View Source [SID1234661947])

BriaCell Therapeutics Announces Pricing of $30 million Public Offering

On January 13, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the pricing of a best-efforts public offering of 5,366,726 units. Each unit consists of one common share (or pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit is being sold to the public at a price of $5.59 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $30 million, before deducting placement agent fees and offering expenses. The Warrants included in the units have been approved for listing on the Nasdaq Capital Market and are expected to commence trading under the symbol "BCTXL" on January 14, 2026. Each Warrant is immediately exercisable, will entitle the holder to purchase one common share at an exercise price of $6.93 per share and will expire five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants can only be purchased together in the offering but will be issued separately.

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The offering is expected to close on January 15, 2026, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering to fund working capital requirements, general corporate purposes and the advancement of the Company’s business objectives.

ThinkEquity is acting as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-292388) relating to the securities was filed with the Securities and Exchange Commission ("SEC") on December 23, 2025, and became effective on January 13, 2026, and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, on January 13, 2026. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

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

(Press release, BriaCell Therapeutics, JAN 13, 2026, View Source [SID1234662206])

Coherus Oncology value proposition

On January 13, 2026 Coherus oncology presented its corporate presentation.

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(Presentation, Coherus Oncology, JAN 13, 2026, View Source [SID1234662010])

Immunofoco Presents Phase I/IIa Data of IMC002 at ASCO GI 2026, Highlighting a Durable Complete Response Beyond One Year and a 66.7% ORR in Advanced GC/GEJ

On January 13, 2026 Immunofoco, a clinical-stage biotechnology company advancing innovative CAR-T cell therapies for solid tumors, reported clinical data from its Phase I/IIa study of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, in patients with advanced gastric cancer and gastroesophageal junction cancer (GC/GEJ). The data were presented as a poster (Abstract No. 398) at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2026).

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The study is a multicenter, open-label, dose-escalation Phase I/IIa trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ who had failed at least two prior lines of systemic therapy. The results presented at ASCO (Free ASCO Whitepaper) GI 2026 focus on the GC/GEJ cohort.

As of the data cutoff on August 8, 2025, 16 patients had received a single infusion of IMC002 and were included in the safety analysis, with 15 patients evaluable for efficacy. IMC002 demonstrated a favorable and manageable safety profile, with no dose-limiting toxicities observed during the dose-escalation phase. Cytokine release syndrome (CRS) occurred in all patients but was limited to Grade 1 or 2, and no Grade ≥3 CRS, ICANS, or treatment-related deaths were reported.

In evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7% (10/15). Survival data were immature at the time of analysis, with a median progression-free survival (mPFS) of 7.0 months (95% CI: 3.9, NA) and a median overall survival (OS) of 10.3 months (95% CI: 6.1, NA).

Notably, one patient in the 2.5×10⁸ CAR-T cell dose cohort achieved a complete response (CR) and has remained tumor-free for 60 weeks, demonstrating antitumor activity following IMC002 treatment in a heavily pretreated setting.

Further analyses indicated that IMC002 provided clinically meaningful PFS benefits in third-line and later-line GC/GEJ patients, comparing favorably with historical outcomes reported for this population. Together with its well-tolerated safety profile, these findings support the continued clinical development of IMC002 and its potential evaluation in earlier-line treatment settings.

"IMC002 demonstrated a controllable safety profile and encouraging antitumor activity in patients with advanced gastric and gastroesophageal junction cancers, including those who had failed multiple prior lines of therapy," said Professor Jianming Xu, corresponding author of the study and Professor at the First Medical Center of the Chinese PLA General Hospital. "Of particular clinical significance, one patient achieved a complete response lasting for more than one year. These findings provide important clinical evidence supporting the application of CLDN18.2-targeted CAR-T therapy in solid tumors, and the favorable safety profile also opens the possibility for future exploration in earlier-line settings and strategies aimed at long-term clinical benefit."

IMC002 is a novel CLDN18.2-targeted CAR-T cell therapy incorporating a highly specific VHH domain, designed to enhance tumor targeting while maintaining a favorable safety profile in solid tumors. Based on the encouraging results from this Phase I/IIa study, a Phase III randomized controlled trial of IMC002 in late-line GC/GEJ patients has been initiated.

The presentation at ASCO (Free ASCO Whitepaper) GI 2026 highlights Immunofoco’s continued progress in advancing CAR-T cell therapies for solid tumors and underscores the therapeutic potential of CLDN18.2-targeted approaches in addressing significant unmet medical needs in advanced gastrointestinal cancers.

(Press release, Immunofoco, JAN 13, 2026, View Source;highlighting-a-durable-complete-response-beyond-one-year-and-a-66-7-orr-in-advanced-gcgej-302659498.html [SID1234662026])

Evaxion expands AI-Immunology™ platform into autoimmune diseases

On January 13, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will expand the use of its proprietary AI-Immunology platform to also discover and develop new treatments for autoimmune diseases. Thus, Evaxion will in the future work within cancers, infectious and autoimmune diseases as its core disease areas.

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The expansion leverages the unique scalability of AI-Immunology and will increase the pool of diseases for which we can decode the immune system and potentially discover and develop new treatments. In turn, this will improve the quantity and quality of new programs within our pipeline, potentially available for partnership. Autoimmune diseases are characterized by high unmet medical need and offer significant partnership potential across all stages of drug development.

"Autoimmune diseases can be severely debilitating and even lethal, placing a substantial burden on patients, their families and on society across all stages of life. With AI-Immunology we have a unique technology and a platform that we know can deliver new treatment opportunities. By expanding the platform into autoimmune diseases, we have the potential to meaningfully improve the outcome for patients and unlock significant partnership value from the platform," says Helen Tayton-Martin, CEO at Evaxion.

We plan to expand and train AI-Immunology to be applicable to autoimmune diseases during the second half of 2026. Specifically, the AI-Immunology platform potentially allows for development of precision treatments targeting underlying disease mechanisms, in contrast to current treatment approaches that primarily address symptoms. The related work on the autoimmune disease application development is already included in Evaxion’s cashflow outlook and does not impact our cash runway, which still extends to the second half of 2027.

2026 company milestones
The expansion to autoimmune diseases represents a new strategic milestone for Evaxion in addition to other milestones for 2026 as outlined below. These reflect continued execution of our strategy of creating value from both our platform and pipeline assets through partnerships.

Milestone Target
EVX-01 Additional biomarker and immunogenicity data H1
AI-Immunology New application for autoimmune diseases H2
EVX-01 Three-year phase 2 clinical efficacy data H2
EVX-04 Regulatory filing for phase 1 trial H2
EVX-B4 Design and preclinical validation of antigens H2

(Press release, Evaxion, JAN 13, 2026, View Source [SID1234662011])