On January 6, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Monday, January 12, 2026 at 9:45 AM PT. Robert W. Duggan, Chairman and Co-Chief Executive Officer, and Dr. Maky Zanganeh, President and Co-Chief Executive Officer, will present a corporate overview and a new update on the progress of our organization, including the development of our innovative investigational bispecific antibody, ivonescimab. Our leadership team will also participate in investor meetings during the conference.

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The presentation will be available live from our website: www.smmttx.com. An archived version of the presentation will be available on our website following the presentation.

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, in addition to side effects and safety profiles associated with prior approved targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 3,000 patients have been treated with ivonescimab in clinical studies globally, and over 40,000 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). Enrollment in HARMONi was completed in the second half of 2024, and top-line results were announced in May of 2025, with detailed results provided in September 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.

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 6, 2026, View Source [SID1234661786])

On January 6, 2026 Instil Bio, Inc. (Nasdaq: TIL) ("Instil") reported that Axion Bio, Inc. ("Axion"), a wholly-owned subsidiary of Instil, has decided to discontinue clinical development of AXN-2510 and that Axion and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX: 1541.HK) ("ImmuneOnco") have entered into an agreement terminating their license and collaboration agreement for AXN-2510 and AXN-27M ("Termination Agreement").

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Under the terms of the Termination Agreement, all rights previously licensed to Axion, including global development and commercial rights outside Greater China, have reverted to ImmuneOnco, subject to a limited license to Axion to wind down its clinical development activities.

(Press release, Instil Bio, JAN 6, 2026, View Source [SID1234661755])

On January 6, 2026 Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, reported that Jin-Seok Seo, Chief Executive Officer and Hyuk-Jae Lee, Senior Executive Vice President at Celltrion, will present at the 44th Annual J.P. Morgan Healthcare Conference taking place in San Francisco, California on January 12–15, 2026.

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Celltrion’s presentation and fireside chat are scheduled for Tuesday, January 13, 2026, from 3:45 PM to 4:25 PM (PT) at the Grand Ballroom, The Westin St. Francis San Francisco Union Square.

(Press release, Celltrion, JAN 6, 2026, View Source [SID1234661771])

On January 6, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.

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"We are pleased with the NMPA’s approval of AUGTYRO for patients with NTRK-positive solid tumors. This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population," said Dr. Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "We believe this approval will help address the high unmet medical needs for patients across this treatment spectrum."

The NMPA’s decision is based on the results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust and durable efficacy and a manageable safety profile of repotrectinib in patients with NTRK fusion-positive solid tumors. Zai Lab contributed to the global pivotal TRIDENT-1 study and dosed the first patient in Greater China in May 2021.

In May 2024, the NMPA approved AUGTYRO (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Zai Lab has an exclusive license agreement with Bristol Myers Squibb Co., following their acquisition of Turning Point Therapeutics, Inc., to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively).

About AUGTYRO

AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to a shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and NTRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance.

In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It was approved by the FDA for this indication in November 2023.

About NTRK-Positive Solid Tumors

NTRK-positive advanced solid tumors are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations.1 In China, the NMPA’s approval is the first to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors.

(Press release, Zai Laboratory, JAN 6, 2026, View Source [SID1234661787])

On January 6, 2026 NanOlogy, LLC, a clinical-stage oncology company, reported the appointment of John M. Goldberg, MD as fractional Chief Medical Officer (CMO) to advance development of its Large Surface Area Microparticle (LSAM) drug portfolio including its development program targeting Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brain cancer with limited treatment options.

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John is a graduate of the University of Massachusetts Chan Medical School and is board-certified in Pediatric Hematology/Oncology, with more than 20 years of experience in all phases of drug development, from early research through late-phase clinical trials. His most recent roles as CMO included positions at Rafael Holding, Inc., a healthcare investment, family office, and biotechnology company, and at Oncorus, Inc., a biopharmaceutical company developing an intratumorally delivered viral immunotherapy for cancer. Earlier in his career, John served as Senior Medical Director at H3 Biomedicine Inc. (a research subsidiary of Eisai) and Medical Director at Agenus, Inc., and was also a Lecturer part-time at Harvard Medical School and Associate Professor at the University of Miami Miller School of Medicine.

"As we progress our DIPG program toward initiating a clinical trial in late 2026 and advance our clinical-stage investigational drugs into late-phase clinical trials, John will play a critical role in our development strategy and execution," said David Arthur, CEO of Nanology. "John’s broad expertise across both drug development and business strategy will strengthen our ability to rapidly advance these programs."
"I am impressed by NanOlogy’s progress and believe my experience, including development of intratumoral therapies, positions me well to contribute to NanOlogy’s future success," said John Goldberg, MD. "My initial priorities are to advance the DIPG program and select the best clinical pathway for our adult solid tumor investigational drugs. I am looking forward to our progress and the benefit it may hold for cancer patients."

(Press release, NanOlogy, JAN 6, 2026, View Source;utm_medium=rss&utm_campaign=nanology-appoints-john-m-goldberg-md-as-chief-medical-officer-to-further-its-preclinical-clinical-large-surface-area-microparticle-investigational-drug-portfolio [SID1234661756])