On February 9, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519) of safusidenib that expands it to a Phase 3 trial. SIGMA is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-risk or high-grade IDH1-mutant astrocytoma following standard-of-care. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.

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The new protocol broadens patient eligibility in the registrational portion of the trial and includes those with grades 2 and 3 IDH1-mutant astrocytoma with high-risk features and grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. The primary endpoint is progression-free survival as assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0. To support regulatory submissions for patients with astrocytoma, the protocol amendment significantly increases trial enrollment from 100 to 300 patients in the U.S., Australia and China.

The trial will now also enroll a non-pivotal single-arm cohort to examine the efficacy and safety of safusidenib in chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma. The primary endpoint for this arm is objective response rate. This cohort is expected to enroll approximately 40 patients.

"These SIGMA protocol updates reflect alignment with U.S. regulators to support the potential approval of safusidenib as swiftly as possible for a patient population that is in dire need of options," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Following discussions with regulatory agencies, advocacy groups and physicians, we substantially expanded the study to include most patients with an IDH1-mutant glioma who currently have no approved targeted therapies available. We are encouraged by the promising results seen in the Phase 2 study, which included both astrocytoma and oligodendroglioma, and are eager to explore the potential of safusidenib across multiple settings through this registrational trial. We expect initial data for the separate oligodendroglioma cohort in 2027."

"Patients with IDH1-mutant gliomas face a lack of available therapies with proven ability to extend long-term survival while maintaining quality of life," said David Arons, President and Chief Executive Officer of the National Brain Tumor Society. "This is particularly true for patients with higher-risk or high-grade IDH1-mutant astrocytoma and oligodendroglioma, where available treatment options — including clinical trials specific to their tumor type — are historically few and far between. Including such patients in pivotal trials, we hope, could bring meaningful benefit for this area of high-unmet medical need."

About IDH1-Mutant Glioma

Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high grade tumors.

About Safusidenib

Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In Phase 1 and 2 clinical studies, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

(Press release, Nuvation Bio, FEB 9, 2026, View Source [SID1234662550])

On February 9, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC).

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"The FDA’s decision to grant RMAT designation to KB707 reflects both the urgent unmet need for new NSCLC therapies as well as the promising early clinical evidence of efficacy we have observed with inhaled KB707 in patients with advanced NSCLC," said Suma Krishnan, President of Research and Development at Krystal Biotech. "This is the second RMAT designation granted to a Krystal program and, as such, we know first-hand the benefits that this designation can provide to accelerate development and shorten the path to a potential approval. We are excited to work closely with the FDA to maximize the potential impact of our KB707 program for patients with NSCLC."

The FDA’s RMAT designation is intended to support and expedite the development of regenerative medicine therapies, including gene therapies. An investigational regenerative medicine therapy is eligible for the RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates potential to address unmet medical needs for that disease or condition. The designation provides all the benefits of the FDA’s Fast Track and Breakthrough Therapy designations, including potential for rolling review, intensive FDA guidance and interaction, and organizational commitment from senior managers at the FDA, as well as the ability to work more closely and frequently with the FDA to discuss innovative trial designs, surrogate or intermediate endpoints to support potential accelerated approval, and novel approaches to satisfy post-approval requirements.

Data to support the FDA’s RMAT designation included early clinical evidence from the Company’s ongoing KYANITE-1 study that demonstrated consistent and meaningful antitumor activity, including durable responses and clinically significant tumor reductions, in patients with heavily pre-treated advanced NSCLC receiving inhaled KB707. Enrollment in KYANITE-1 is ongoing, and further details will be presented at upcoming scientific conferences. Additional details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

(Press release, Krystal Biotech, FEB 9, 2026, View Source [SID1234662549])

On February 9, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program have been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)- Immuno-Oncology (AACR-IO) Conference, taking place in Los Angeles, CA on February 18–21, 2026.

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The abstract, titled "Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab," evaluates how systemic inflammatory markers, tumor microenvironment (TME) immune activity, and peripheral immune cell states are associated with clinical outcomes in patients treated with BOT alone or in combination with balstilimab (BAL).

Botensilimab is an Fc-enhanced multifunctional anti-CTLA-4 antibody designed to help prime and activate the immune system, while BAL is an anti-PD-1 antibody designed to help sustain immune activity against cancer. Together, BOT+BAL targets complementary immune pathways and is being evaluated across multiple solid tumors, including immunologically "cold" or treatment-refractory cancers.

Presentation Details:

Poster Presentation Title: Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab
Presenting Author:

Chloe Delepine PhD, Biomarker Operations, Agenus

Session Date:

Thursday, February 19, 2026

Session Time:

12:15-3:15PM PT / 3:15-6:15 PM ET

Location:

JW Marriott, Platinum Ballroom

Poster Session:

Poster Session B

(Press release, Agenus, FEB 9, 2026, View Source [SID1234662548])

On February 9, 2026 XOMA Royalty Corporation (NASDAQ: XOMA) ("XOMA Royalty" or the "Company"), a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health, reported the Company successfully completed its previously announced tender offer to acquire all outstanding shares of Generation Bio Co. (NASDAQ: GBIO) ("Generation Bio") common stock for a price per share of $4.2913 in cash (the "Cash Amount"), plus one non-tradeable contingent value right ("CVR") (together with the Cash Amount, the "Offer Price") and successfully completed its acquisition of Generation Bio.

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The tender offer and related withdrawal rights expired one minute after 11:59 p.m. Eastern Time on Friday, February 6, 2026 (the "Expiration Date"). As of the Expiration Date, a total of 4,722,533 shares of Generation Bio common stock were validly tendered, and not validly withdrawn, representing approximately 70% of the outstanding shares of Generation Bio common stock as of the Expiration Date. As of the Expiration Date, the number of shares validly tendered in accordance with the terms of the tender offer and not validly withdrawn satisfied the minimum tender condition, and all other conditions to the tender offer were satisfied or waived. After the Expiration Date, XOMA Royalty irrevocably accepted for payment all shares validly tendered and not validly withdrawn and expects to promptly pay for such shares.

Following the closing of the tender offer, a subsidiary of the Company, XRA 7 Corp., merged with and into Generation Bio (the "Merger"), and all shares of Generation Bio common stock that had not been validly tendered and irrevocably accepted for purchase were converted into the right to receive the Offer Price without interest. As a result of the Merger, Generation Bio became a wholly owned subsidiary of XOMA Royalty. Following the closing of trading on The Nasdaq Stock Market LLC ("Nasdaq") on February 6, all shares of Generation Bio common stock ceased trading on Nasdaq, and the Company and Generation Bio intend promptly to cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. TD Cowen served as financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to Generation Bio.

(Press release, Xoma, FEB 9, 2026, View Source [SID1234662547])

On February 9, 2026 Quince Therapeutics, Inc. (Nasdaq: QNCX), reported that it has engaged LifeSci Capital to serve as its exclusive financial advisor to assist in its restructuring and evaluation of strategic alternatives aimed at maximizing shareholder value.

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Strategic alternatives under consideration may include, but are not limited to, partnerships, joint ventures, mergers, acquisitions, licensing, or other strategic transactions. LifeSci Capital will also act as the company’s financial advisor in connection with any restructuring of the company’s liabilities. The company does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

(Press release, Quince Therapeutics, FEB 9, 2026, View Source [SID1234662546])