On January 20, 2026 Immunomic Therapeutics, Inc. ("ITI"), a privately held clinical-stage biotechnology company pioneering nucleic acid-based immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has cleared ITI’s Investigational New Drug (IND) application for ITI-5000. This clearance allows ITI to initiate the first-in-human clinical trial evaluating ITI-5000, a UNITE-based self-amplifying RNA vaccine, as monotherapy and in combination with pembrolizumab (Keytruda), in patients with Stage II–III Triple-Negative Breast Cancer (TNBC).

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The Phase 1, multicenter, open-label, two-part study—known as VITALITI (VITAL-TNBC Study of ITI-5000)—is designed to assess safety, tolerability, and preliminary immunologic activity of ITI-5000 alone and in combination with pembrolizumab. TNBC represents approximately 15%–20% of breast cancer diagnoses and remains associated with poorer outcomes and fewer targeted treatment options, underscoring a substantial unmet medical need. Breast cancer is the fifth leading cause of cancer mortality globally.

ITI-5000 utilizes nucleic acid vaccine constructs engineered to preferentially deliver tumor-associated antigens (TAAs) to the MHC II compartment via LAMP-1, potentially enhancing antigen presentation, antibody generation, and CD4+ T-cell responses.

Pembrolizumab (Keytruda), a humanized monoclonal antibody and PD-1 inhibitor, is widely used in cancer immunotherapy and has demonstrated benefit across numerous tumor types, including TNBC.

"Preclinical data have demonstrated enhanced efficacy in animal models without additional safety concerns. The FDA’s clearance of our IND application for ITI-5000 marks a significant milestone for us as we advance this program into its first clinical trial," said DG Kim, Chief Executive Officer of ITI. "This achievement reflects years of innovative research and the dedication of our scientific and technical teams, and it brings us another step closer to offering a potentially transformative therapy for patients with TNBC."

Dr. Teri Heiland, Chief Scientific Officer of ITI, added, "The ITI-5000 program represents an important evolution of our UNITE technology, leveraging LAMP-mediated antigen presentation to drive robust CD4+ T cell activation. Our preclinical findings provide strong scientific rationale for advancing ITI-5000 into human studies, particularly in a disease area where new therapeutic approaches are urgently needed. We are excited to translate this promising data into the clinic and further explore the potential of this platform in TNBC."

ITI expects to begin patient enrollment in the second quarter of 2026 across up to eight U.S. clinical sites.

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

(Press release, Immunomic Therapeutics, JAN 20, 2026, View Source [SID1234662095])

On January 20, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

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The Company presented an overview of the clinical status of its papillary disease program, including more than five years of follow-up data supporting the papillary indication. Highlights included durable disease-specific survival of approximately 96% at 36 months, with the median survival not yet reached even with five years of follow-up; high rates of cystectomy avoidance of 92% and 82% at one and three years, respectively; and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors. In addition, several thought-leading urologists who attended the meeting presented real-world treatment approaches for patients with BCG-unresponsive disease, where the remaining alternative is often radical cystectomy.

Based on these discussions, the FDA recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication. ImmunityBio has compiled the requested information and will submit it to the Agency within the next 30 days. This additional information does not contemplate the initiation or design of a new clinical trial.

This submission follows a productive face-to-face meeting with senior FDA officials, during which the regulatory path forward for ANKTIVA in papillary NMIBC was collaboratively defined. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the Company’s data. BCG-unresponsive disease remains a serious condition, with risks of progression to muscle-invasiveness disease, higher mortality, and limited bladder-sparing treatment options for patients.

"We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency’s review."

About the Papillary Indication: The proposed submission for the BCG-unresponsive NMBIC papillary indication is supported by long-term results from the QUILT-3.032 Phase 2/3 trial (Cohort B) in 80 patients with BCG-unresponsive high-grade papillary-only NMIBC. As recently published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%. Patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival (DSS) rate at 36 months, with the median DSS not yet reached. Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Notably, the therapy conferred a bladder-sparing benefit: cystectomy-free survival was 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These long-term outcomes, including ≥82% bladder preservation and ≥96% bladder cancer-specific survival at 36 months, are unprecedented in this high-risk population and underscore the potential of ANKTIVA to offer a curative-intent, chemo-free immunotherapy alternative to surgery. (Clinical reference: Chang et al., 2025, Journal of Urology)

"The 12- and 36-month survival rates observed with ANKTIVA plus BCG are higher than those reported for other investigational therapies in this patient population," said Dr. Patrick Soon-Shiong. "Together with the high rate of bladder preservation – with over 80% of patients remaining cystectomy-free at three years – these data demonstrate the effectiveness of ANKTIVA in enhancing the immune response against bladder cancer. We remain committed to bringing this important therapy to patients as quickly as possible. Patients with BCG-unresponsive papillary NMIBC currently have no approved treatment options aside from life-altering radical cystectomy, so our mission is to deliver a safe and effective bladder-sparing treatment to address this urgent unmet need."

Global Regulatory Status: ANKTIVA in combination with BCG is already approved in multiple regions for BCG-unresponsive NMIBC CIS. The product received FDA approval in April 2024 for patients with carcinoma in situ (CIS) with or without papillary tumors. It is also approved by the United Kingdom’s MHRA and has a positive opinion for Conditional Marketing Authorization in the European Union for NMIBC with CIS with or without papillary tumors. Most recently, the Saudi Food and Drug Authority (SFDA) granted approval to ANKTIVA for NMIBC CIS (with or without papillary disease) in January 2026. These approvals reflect ImmunityBio’s commitment to expanding patient access to ANKTIVA globally as a potentially bladder-sparing option. The Company is actively engaging with additional regulatory agencies, including the European Medicines Agency (EMA) and authorities in other regions, to extend the label to papillary-only disease pending U.S. approval.

Unmet Medical Need: High-grade papillary NMIBC that is unresponsive to BCG poses a serious treatment challenge, as no targeted therapies are currently approved for these patients. Standard of care for BCG-unresponsive, papillary-only disease has been radical cystectomy (complete removal of the bladder), an invasive surgery associated with significant morbidity and impact on quality of life. ImmunityBio’s pursuit of the papillary NMIBC indication is aimed at providing an alternative to cystectomy – a therapy that can eradicate disease while preserving the bladder. The long-term data from QUILT-3.032 suggest that ANKTIVA plus BCG can achieve durable remissions in papillary NMIBC, delaying or avoiding the need for radical surgery in the majority of responders. If approved, ANKTIVA would become the first immunotherapy option for BCG-unresponsive papillary NMIBC, expanding on its existing approved use in CIS and potentially transforming the treatment paradigm for these patients.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JAN 20, 2026, View Source [SID1234662094])

On January 20, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered a definitive agreement to acquire RAPT Therapeutics ("RAPT") (NASDAQ: RAPT), a California-based, clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients living with inflammatory and immunologic diseases. The acquisition includes ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody, currently in phase IIb clinical development for prophylactic protection against food allergens.

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IgE is a clinically validated target and is the only approved systemic therapy shown to protect patients from a harmful allergic and inflammatory immune response. Around 94% of severe food allergies are caused by IgE-mediated reactions.1

Current anti-IgE treatment for food allergy involves injections every 2 to 4 weeks, which can be a significant burden, particularly since most patients are children. Ozureprubart’s clinical profile offers the potential for less frequent dosing of every 12 weeks, supporting improved compliance and patient outcomes; as well as providing a new option to approximately 25% of patients currently ineligible for existing therapy. Ozureprubart complements GSK’s extensive commercial footprint and prescriber base in allergy.

Data from the phase IIb trial (prestIgE) assessing use of ozureprubart as monotherapy is expected in 2027, with phase III trials to be focused on both at-risk adult and paediatric populations. In the US, over 17 million people are diagnosed with food allergies, with more than 1.3 million people suffering severe reactions.2,3,4 This results in more than 3 million patient visits each year to hospital and emergency care.5

Tony Wood, Chief Scientific Officer, GSK said: "The addition of ozureprubart brings another promising new, potential best-in-class treatment to GSK’s pipeline. Food allergies cause severe health impacts to patients with existing treatment requiring injections as frequently as every 2 weeks. Ozureprubart offers the opportunity to bring sustained protection to patients with dosing every 12 weeks, and is consistent with our approach to acquire assets that address validated targets and where there is clear unmet medical need."

Brian Wong, President & Chief Executive Officer, RAPT Therapeutics, said: "We are excited to enter into this agreement with GSK, which offers an attractive path forward for our programs, particularly the opportunity we envision for ozureprubart in food allergy. This transaction has the potential to provide access to the global development and commercialisation capabilities, resources and infrastructure that GSK has to offer and ultimately bring added value to our pipeline, patients and stockholders."

Financial considerations
Under the terms of the agreement, GSK will pay RAPT Therapeutics shareholders $58.00 per share at closing for an estimated aggregate equity value of $2.2 billion. Net of cash acquired, GSK’s estimated upfront investment is $1.9 billion.

The transaction gives GSK the global rights to the ozureprubart programme, excluding mainland China, Macau, Taiwan and Hong Kong. GSK will also be responsible for success-based milestone and royalty payments for ozureprubart owed to RAPT’s partner, Shanghai Jeyou Pharmaceutical Co., Ltd.

Under the terms of the agreement, GSK’s subsidiary is obligated to commence a tender offer to acquire all outstanding shares of RAPT common stock for $58.00 per share in cash within 10 business days of signing. The transaction is subject to customary closing conditions, including the tender of a majority of RAPT’s outstanding shares of common stock in the tender offer and expiration or termination of the applicable waiting period under the under the Hart-Scott-Rodino Act in the US. Promptly following the closing of the tender offer, GSK will acquire any shares of RAPT that are not tendered in the tender offer through a second-step merger under Delaware law at the tender offer price. GSK will account for the transaction as a business combination.

The transaction is expected to close in the first quarter of 2026.

Advisors
Evercore is acting as exclusive financial advisor and A&O Shearman is serving as legal counsel to GSK in connection with the transaction. J.P. Morgan Securities LLC is acting as exclusive financial advisor and Cooley LLP is serving as legal counsel to RAPT Therapeutics.

Additional information
This press announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer or a recommendation to sell securities, nor is it a substitute for the tender offer materials that GSK,
GlaxoSmithKline LLC ("GSK LLC") and its wholly-owned subsidiary, Redrose Acquisition Co. will file with the Securities and Exchange Commission (the "SEC"). The tender offer for the outstanding shares of RAPT Therapeutics common stock described in this press announcement has not commenced. At the time the tender offer is commenced, GSK, GSK LLC and Redrose Acquisition Co. will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the SEC, and, thereafter, RAPT Therapeutics will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials (once they become available) will be made available to RAPT Therapeutics stockholders at no expense to them by the information agent for the tender offer, which will be announced. In addition, those materials and all other documents filed by or caused to be filed by RAPT Therapeutics or GSK with the SEC will be available at no charge on the SEC’s website at www.sec.gov. In addition to the Schedule 14D-9 Solicitation/Recommendation Statement and Schedule TO Offer Statement (once each becomes available), RAPT Therapeutics and GSK file or furnish, as applicable, annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by RAPT Therapeutics at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-0330 for further information on the public reference room. RAPT Therapeutics and GSK filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

About food allergies
In the US, over 17 million people are diagnosed with food allergies, with more than 1.3 million people suffering severe reactions.2,3,4 Notably, 65% of severe food allergy patients are children and adolescents.1 This results in more than 3 million patient visits each year to hospital and emergency care.5 Disease burden is amplified by the frequency and complexity of allergic reactions, which can escalate to anaphylaxis, emergency care and impact a patient’s wellbeing and participation in social activities. Collectively, food allergies cost US families an estimated $33 billion in 2024, underscoring the need for more effective and durable therapies.

(Press release, GlaxoSmithKline, JAN 20, 2026, View Source [SID1234662093])

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])