On January 20, 2026 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. Sofetabart mipitecan is a novel folate receptor alpha (FRα) antibody-drug conjugate (ADC) that uses proprietary linker technology and an exatecan payload.

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Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

"Platinum-resistant ovarian cancer remains one of the most challenging settings in gynecologic oncology, with limited treatment options and poor outcomes for patients," said Bhavana Pothuri, M.D., professor of Obstetrics/Gynecology and Medicine at NYU Grossman School of Medicine, NYU Langone Health and director of Clinical Trials Office at the Perlmutter Cancer Center. "The Breakthrough Therapy designation and preliminary clinical data for sofetabart mipitecan across all levels of FRα expression are encouraging and point to its potential as a meaningful treatment option for patients."

"We are pleased the FDA has granted Breakthrough Therapy designation for sofetabart mipitecan, reflecting the significant unmet need in platinum-resistant ovarian cancer and the promising initial results shown in our Phase 1 study," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology and head of corporate business development. "Building on compelling results generated to date, we’ve initiated our Phase 3 FRAmework-01 trial with the goal of bringing a potential therapeutic option to patients with advanced ovarian cancer, across all levels of folate receptor expression."

The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the Phase 1a/b study. Lilly presented initial Phase 1 results at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June and updated data at the 2025 ESMO (Free ESMO Whitepaper) Congress in October, showing responses at all dose levels and across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. These initial data also indicate a promising tolerability profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity.

Sofetabart mipitecan recently advanced into the Phase 3 FRAmework-01 study (NCT07213804), a global trial investigating the treatment as a monotherapy in patients with platinum resistant ovarian cancer (PROC), and in combination with bevacizumab in patients with platinum-sensitive ovarian cancer (PSOC). Lilly is conducting the FRAmework-01 study in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT – lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

About Ovarian Cancer
Ovarian cancer is the fifth leading cause of cancer death among women in the United States. While most patients initially respond to platinum-based chemotherapy, approximately 70% will experience recurrence, leading to progressively shorter remission periods with each subsequent treatment. When cancer recurs during or within six months of platinum therapy, known as platinum-resistant disease, patients face limited treatment options.

About Sofetabart Mipitecan
Sofetabart mipitecan (LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). Sofetabart mipitecan was designed to target FRα across all expression levels with improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.1,2 FRα is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.1,3,4 Sofetabart mipitecan is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, NCT06400472 and NCT07213804.

(Press release, Eli Lilly, JAN 20, 2026, View Source [SID1234662092])

On January 20, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in the offering will be offered by Corvus. In addition, Corvus expects to grant the underwriters of the offering a 30-day option to purchase up to an additional $22,500,000 of shares of common stock at the public offering price less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Corvus currently expects to use the net proceeds from this offering for working capital and general corporate purposes, which may include capital expenditures and research and development, including for its Phase 3 T cell lymphoma, and Phase 2 atopic dermatitis, hidradenitis suppurativa and asthma clinical trials, sales and marketing and administrative expenses.

Jefferies and Goldman Sachs & Co. LLC are acting as lead book-running managers for the offering. Mizuho is acting as bookrunner for the offering. Ladenburg Thalmann is acting as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-281318) relating to the securities to be sold in this offering was declared effective by the Securities and Exchange Commission ("SEC") on August 15, 2024. The offering of these securities will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC on January 20, 2026 and will be available on the SEC’s website at www.sec.gov. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 1-877-821-7388, or by email at [email protected]; and Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526, or by email at [email protected].

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

(Press release, Corvus Pharmaceuticals, JAN 20, 2026, View Source [SID1234662091])

On January 20, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program.

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"This milestone reflects the FDA’s recognition of the significant unmet need facing patients with imatinib resistant GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "Based on positive results from the PEAK trial, the bezuclastinib combination has the potential to be the first new approval in this patient population in over 20 years. We look forward to the continued, close collaboration with the FDA as we advance bezuclastinib toward commercialization."

As announced in November 2025, the bezuclastinib combination in the PEAK trial demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented overall response rate (ORR) in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. At the time of this analysis, data for overall survival remains immature.

The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib.

The FDA’s RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Cogent is expected to initiate the RTOR process immediately with completion of the NDA submission expected in April 2026.

Full results from the PEAK trial will be presented at a major medical meeting during the first half of 2026. Additionally, Cogent expects to initiate in mid-2026 a Phase 2 trial investigating the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

(Press release, Cogent Biosciences, JAN 20, 2026, View Source [SID1234662090])

On January 20, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported that patient enrollment has been completed in its Phase 2a pancreatic cancer clinical trial of Namodenoson.

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The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.

"This achievement marks a significant step forward in the clinical development of Namodenoson in pancreatic cancer," said Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. "With enrollment now complete and safety continuing to be favorable, we believe we are well positioned to generate meaningful efficacy top-line data in Q3 2026."

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, JAN 20, 2026, View Source [SID1234662089])

On January 20, 2026 Bristol Myers Squibb (NYSE: BMY, "BMS"), a global leader in oncology, reported an agreement with Microsoft, a market leader in AI-powered radiology and clinical workflow technologies, aiming to accelerate early detection of lung cancer.

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Through this digital health collaboration, U.S. FDA-cleared radiology AI algorithms will be deployed via Microsoft’s Precision Imaging Network, part of Microsoft for Healthcare radiology solutions. Today, more than 80% of hospitals in the U.S. use Microsoft’s award-winning network to share medical imaging and access third-party imaging AI. AI capabilities available through Precision Imaging Network can automatically analyze X-ray and CT images to help identify lung disease, supporting radiologists in their daily workflow and helping reduce clinical workload. These advanced AI algorithms can help surface hard to detect lung nodules, potentially identify patients at earlier stages of lung cancer, and help triage them for appropriate care.

Lung cancer remains the leading cause of cancer-related deaths in the United States, with approximately 125,000 deaths and 227,000 new cases reported annually. Medically underserved populations experience even higher lung cancer mortality rates and are less likely to receive guideline-concordant screening. With more than half of the patients with incidental findings lost to follow-up, the collaboration leverages workflow management tools to track patients with lung nodules through care pathways and help ensure regular follow-up.

"By combining Microsoft’s highly scalable radiology solutions with BMS’ deep expertise in oncology and drug delivery, we’ve envisioned a unique AI-enabled workflow that helps clinicians quickly and accurately identify patients with Non-Small Cell Lung Cancer (NSCLC) and guide them to optimal care pathways and precision therapies," said Dr. Alexandra Goncalves, VP and Head of Digital Health, Bristol Myers Squibb. "An integrated, AI-powered platform that streamlines patient flow can significantly improve operational efficiency and patient outcomes."

A core objective of the collaboration is to expand access to early detection in medically underserved communities, including rural hospitals and community clinics across the United States. By harnessing advanced AI tools, especially in resource-limited settings, this initiative promotes earlier diagnosis and follow-up, enabling more equitable care for all patients.

"This new Microsoft collaboration reflects our commitment to breaking down barriers and addressing healthcare challenges," said Andrew Whitehead, VP and Head of Population Health, Bristol Myers Squibb. "At BMS, health equity is not a standalone initiative—it is embedded in everything we do. By deploying this solution and bringing advanced AI tools to the front lines, together we will help to address health disparities in lung cancer."

The early detection strategy for lung cancer directly supports BMS’ commitment to health equity and its focus on scalable, sustainable solutions to improve patient outcomes.

"With Microsoft’s AI-powered radiology technology platform widely deployed within healthcare delivery organizations across the country and operating behind the scenes, clinicians can more easily identify patients who may be showing early signs of cancer—often before they are aware of any symptoms—and help guide them into the appropriate care pathway sooner," said Peter Durlach, Corporate Vice President and Chief Strategy Officer, Microsoft Health and Life Sciences. "This is a clear win for both patients and providers and aligns with Microsoft’s goals to utilize technology to unlock insights, increase efficiencies, and improve patient care."

(Press release, Bristol-Myers Squibb, JAN 20, 2026, View Source [SID1234662088])