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])

On February 9, 2026 IN8bio (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ ) T cell therapies and T cell engagers for cancer and autoimmune diseases, reported the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer, effective immediately.

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Dr. Rochlin has served as IN8bio’s Chief Operating Officer since December 2021, following her tenure as Vice President and Associate Vice President of Operations and Innovation beginning in August 2020. In her expanded role, she will continue to oversee company operations as IN8bio advances its clinical and preclinical pipeline and prepares for its next phase of growth.

"Kate has been instrumental in translating IN8bio’s strategy into disciplined execution," said William Ho, Chief Executive Officer and Co-Founder of IN8bio. "Through her leadership and ability to align teams across operations, manufacturing, clinical, and research, she has played a central role in advancing our clinical programs, and T cell engager platform and delivering critical milestones on schedule. I am confident that her promotion to President will further strengthen the organization."

Dr. Rochlin brings more than 17 years of experience across biotechnology company development, including scientific research, intellectual property, business development, clinical manufacturing and operations spanning corporate strategy, partnering, and team buildout. Prior to joining IN8bio, she was Chief Business Officer at Curadigm, a biotech developing precision-targeted drug delivery technologies, where she helped lead the company’s spin-out from Nanobiotix.

Since joining IN8bio, Dr. Rochlin has played a key role in advancing the company’s programs, including INB-619, a potential first-in-class, pan-γδ T cell engager for deep B cell depletion in autoimmune disease. IN8bio recently presented preclinical data showing that INB-619 achieved complete B cell depletion comparable to approved T cell engagers, with minimal adverse cytokine release and robust expansion of γδ T cells. These results validate the differentiation of IN8bio’s T cell engager platform and support continued regulatory engagement and advancement toward the clinic. Dr. Rochlin has also been instrumental in developing and expanding IN8bio’s clinical manufacturing program, leading analytical, quality, regulatory and GMP manufacturing teams across multiple Phase 1 and 2 clinical programs in glioblastoma and hematological cancers.

"I’m honored to take on this expanded role and broader leadership responsibilities at such an important time for IN8bio," said Dr. Rochlin. "With encouraging clinical data emerging from our γδ T cell therapy programs and novel gamma-delta T cell engager technology, we are well positioned to build on this momentum. I look forward to continuing to work closely with our team to execute on our corporate priorities and position IN8bio for long-term success."

Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College, conducted research at Sloan Kettering Institute, and earned a BA in Biology from the University of Pennsylvania.

(Press release, In8bio, FEB 9, 2026, View Source [SID1234662545])