On January 12, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported it has entered into a clinical trial collaboration with GSK plc ("GSK", LSE/NYSE: GSK) to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with risvutatug rezetecan (also known as GSK’227), GSK’s novel investigational B7-H3 targeting antibody drug conjugate (ADC), across multiple solid tumor settings, including small cell lung cancer (SCLC).

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"We believe exploring new mechanisms and combinations with the potential to surpass current options for patients and physicians will have the most profound impact on those battling the toughest cancer challenges today," stated Robert W. Duggan and Dr. Maky Zanganeh, Co-Chief Executive Officers of Summit. "With the goal of accelerating development of ivonescimab in multiple solid tumors, this collaboration enables us to swiftly advance ivonescimab and expand Summit’s combination strategy."

The intent of this agreement is to investigate the combination potential of ivonescimab and risvutatug rezetecan in multiple solid tumor environments to determine the safety profile and potential anti-tumor effects.

Under the terms of the agreement, Summit will supply ivonescimab for the planned study, while GSK will manage the day-to-day clinical operations of the study. Each party will maintain rights to their respective products, and the agreement is mutually non-exclusive. The study is expected to begin dosing patients in mid-2026.

About risvutatug rezetecan

Risvutatug rezetecan, also known as GSK’227, is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of risvutatug rezetecan. GSK’s global phase III trial for risvutatug rezetecan in relapsed ES-SCLC began in August 2025.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC (Free SITC Whitepaper), 2023) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization in the fourth quarter of 2025.

HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, JAN 12, 2026, View Source [SID1234661975])

On January 12, 2026 Tahoe Therapeutics and Alloy Therapeutics reported that they are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers.

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The joint venture will advance two ADC programs directed at novel tumor targets discovered by Tahoe using its proprietary Mosaic platform and large-scale, perturbative single-cell datasets. The collaboration reflects a strong strategic fit between Tahoe’s ability to identify high-confidence, tumor-selective targets using its AI-powered virtual cell models and Alloy’s end-to-end capabilities in biologic drug engineering, ADC design, and company creation through its venture studio 82VS.

Over the past year, Tahoe analyzed a subset of its proprietary multi-million-cell datasets and identified tens of tumor-specific surface antigens, many of which had taken decades to discover previously, and most of which are novel. Tahoe subsequently validated the most promising targets across multiple independent assays and clinical samples. After rigorous evaluation, Alloy recognized the exceptional therapeutic potential of these targets, catalyzing the decision to jointly spin out a dedicated ADC development company around two of them.

"We are excited to partner with Tahoe and were immediately impressed by the depth and quality of biological insight generated by the Mosaic platform," said Errik Anderson, Founder and CEO of Alloy Therapeutics. "With our track record of 20 clinical programs discovered with Alloy platforms and services, including multiple drugs in Phase III, we are well positioned to translate the cutting-edge biology from world-class target rich companies like Tahoe into optimized therapeutics."

Under the structure of the joint venture, Tahoe and Alloy will co-invest, co-build, and co-lead the new company. Tahoe will contribute its novel targets and biomarker insights, while Alloy will provide its ADC engineering platforms, translational development expertise, and 82VS company creation infrastructure. Together, the team aims to efficiently advance both ADC programs to key value-inflection points suitable for independent financing or pharma partnerships.

Our datasets and AI models are enabling the discovery of novel targets," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Alloy, which has had a strong track record in developing first-in-class biologics, shares this excitement with us, and that is a strong validation of the biology discovered by our platform. This joint venture is also a preview of the business model our platform enables: building new companies alongside partners with complementary capabilities."

Combining Tahoe’s AI-powered approach to understanding novel tumor biology with Alloy’s fully integrated drug discovery, development, and company creation capabilities creates a highly efficient path to translate novel biologic insights into first-in-class drugs for patients in need.

(Press release, Alloy Therapeutics, JAN 12, 2026, View Source [SID1234661974])

On January 12, 2026 Xoma corporation presented its corporate presentation.

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(Presentation, Xoma, JAN 12, 2026, View Source [SID1234661973])

On January 12, 2026 Tscan therapeutics presented its corporate presentation.

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(Presentation, TScan Therapeutics, JAN 12, 2026, View Source [SID1234661972])

On January 12, 2026 Ferring Pharmaceuticals and Theralase Technologies Inc. (TSXV:TLT) (OTCQB:TLTFF) reported that they have entered into a collaborative clinical development agreement ("Agreement"), on January 9, 2026. The Agreement builds on Theralase’s existing clinical program (NCT03945162) with a new cohort investigating Theralase’s investigational light-activated small molecule Ruvidar (TLD-1433) in combination with Ferring’s intravesical non-replicating gene therapy ADSTILADRIN(nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin ("BCG")-unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") with or without papillary tumors (±Ta/T1).

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Under the terms of the Agreement, Theralase will remain the sponsor of the study, with both parties providing clinical overview of the new cohort through a joint development committee. The new cohort will be enrolled and treated in the United States and then subject to written agreement may expand into Canada or other countries.

"The introduction of ADSTILADRIN, as the first intravesical gene therapy, filled a critical unmet need for patients with BCG-unresponsive NMIBC who faced limited treatment options and needed an alternative to invasive bladder removal surgery," said Ashish Kamat, MD, MBBS, Endowed Professor of Urologic Oncology (Surgery) and Cancer Research at University of Texas MD Anderson Cancer Center, Houston, Texas and President of the International Bladder Cancer Group. "As the BCG-unresponsive treatment paradigm continues to evolve, the combination of complementary therapies may offer additional treatment options to definitive therapy. This new study offers an opportunity to explore the possibility of enhancing efficacy and durability of response with a combination of a promising, investigational light-activated small molecule with the leading gene therapy in NMIBC."

The collaboration between Ferring and Theralase underscores their shared commitment to advancing innovative therapies for patients with BCG-unresponsive bladder cancer. The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action. ADSTILADRIN is the first and only intravesical gene therapy approved by the U.S. Food and Drug Administration ("FDA") for high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors (±Ta/T1) that delivers the human interferon alpha-2b gene directly to bladder cells, prompting local secretion of interferon that exert multiple anticancer and immunomodulatory effects. Ruvidar is an investigational small molecule that penetrates cancer cell walls and, upon light activation, delivers targeted cytotoxic effects to destroy cancer cells, while inducing immunogenic cell death, stimulating both innate and adaptive immune responses.

"Underscoring our ambition to establish ADSTILADRIN as the backbone therapy in NMIBC, this collaborative clinical study with Theralase aims to explore whether combination approaches can further enhance patient outcomes, building on the strong foundation ADSTILADRIN has established in treating this challenging disease." said Daniel Shoskes, M.D., M.Sc, FRCS (C), Vice President and Global Medical Director for Uro-Oncology, Ferring Pharmaceuticals.

Roger DuMoulin-White, B.Sc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase, added, "We are honored to collaborate with Ferring, a worldwide leader in uro-oncology with deep expertise in bladder cancer treatment. As we approach completion of our clinical study and regulatory submissions for Ruvidar, this partnership provides the perfect opportunity to investigate whether we can deliver even greater benefits to patients through innovative combinational approaches."

Study Details

In Study II NCT03945162, Theralase is clinically investigating light-activated Ruvidar in the treatment of patients diagnosed with BCG-unresponsive NMIBC CIS (Study II). Theralase has enrolled and successfully treated 88 out of a planned 90 patients in Study II and plans to complete enrollment and treatment of the remaining 2 patients by 1Q2026 with follow-up completed by 2Q2027.

In the Collaborative Clinical Study, Theralasewill apply to the FDA to add a new cohort to Study II. This cohort will be treated with Theralase’s lead small molecule, light-activated Ruvidar, followed by treatment with Ferring’s FDA-approved ADSTILADRIN.

About NMIBC

NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.1 In the United States, bladder cancer is the sixth most common cancer,2 fourth among men,3 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.3 Historically, 75% of bladder cancer presents as NMIBC.4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network ("NCCN") guidelines recommend cystectomy (partial or complete removal of the bladder).6

About Ruvidar

Ruvidar (TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses.

About ADSTILADRIN

ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors (±Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).7-8

INDICATION

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit View Source or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

(Press release, Theralase, JAN 12, 2026, View Source [SID1234661971])