On October 22, 2025 GemPharmatech, a global leader in preclinical research solutions and genetically-engineered mouse models, reported a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the discovery of new therapeutic antibodies.

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Through the non-exclusive agreement, researchers at Memorial Sloan Kettering will have access to GemPharmatech’s extensive preclinical service capabilities and resources, utilizing the NeoMab platform — a next-generation transgenic mouse model designed for rapid, efficient discovery of fully human therapeutic antibodies. The collaboration will help scientists at Memorial Sloan Kettering who are already tapping a wide range of leading-edge preclinical resources to further accelerate the development of fully human therapeutic antibodies against high-value targets and address urgent, unmet needs in cancer treatment.

"Our mission has always been to enable transformative biomedical research through innovative mouse models and technologies," said Dr. Xiang Gao, founder of GemPharmatech. "Collaborating with MSK on antibody discovery represents a powerful opportunity to combine scientific excellence with cutting-edge mouse models such as NeoMab. Together, we can accelerate the development of novel therapeutics that address some of the most urgent challenges in cancer treatment."

Part of the world’s largest library of genetically engineered mouse models (GEMMs), the immunoglobulin gene-humanized mouse model- NeoMab, carries the full variable gene repertoire of human heavy and kappa light chains, and regulatory elements, in a BALB/c background. This innovative design enables the rapid generation of diverse, high-affinity fully human antibodies without the need for time-consuming sequence humanization steps. By skipping this process, the collaboration aims to shorten antibody development timelines and reduce immunogenicity risks.

"This collaboration underscores our mission to provide the global research community with advanced platforms to accelerate innovations in drug discovery," said Dr. Brandy Wilkinson, Chief Executive Officer of GemPharmatech. "We are excited to be supporting MSK’s pioneering work in oncology research with the NeoMab platform. It is an honor to contribute to their scientific mission and to help advance antibody programs with the potential to transform therapies and improve patient outcomes worldwide."

(Press release, Memorial Sloan-Kettering Cancer Center, OCT 22, 2025, View Source [SID1234656915])

On October 22, 2025 Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, and the University Hospitals Birmingham NHS Foundation Trust, reported new overall survival (OS) insights from the PROCLIPI (PROgnostic Cutaneous Lymphoma International Prognostic Index) Study aligning with previous findings that suggest mogamulizumab may offer meaningful OS benefit for patients living with mycosis fungoides (MF) and Sézary syndrome (SS), two rare conditions and subtypes of cutaneous T-cell lymphoma (CTCL).

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Key findings2:

For patients with advanced-stage MF and SS (n=371), the median overall survival from the onset of treatment was higher for patients treated with mogamulizumab (n=72) at 64 months compared with those not receiving mogamulizumab (n=175) at 54 months (p<0.01).
Patients treated with mogamulizumab showed a trend toward improved OS compared to those not receiving mogamulizumab across risk-stratified groups according to the new Cutaneous Lymphoma International Prognostic Index (CLIPI).
For a subset of patients with SS (n=96), the median OS is around 6.5 years for patients treated with mogamulizumab (n=46) compared with around 3 years for systemic treatment but not mogamulizumab (n=50) (p<0.01).
This research was presented as part of the Scientific Proceedings at this year’s European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting in Athens, Greece.2 The data contributes to a growing body of evidence suggesting potential OS benefits with mogamulizumab, 4,5 highlighting the importance of collaboration across the CTCL community in advancing understanding of survival outcomes and helping to shape the future of patient care.

"The PROCLIPI Study demonstrates the power of global collaboration in rare diseases. By bringing together data from across the world, we can generate insights that simply wouldn’t be possible in isolation," says Professor Julia Scarisbrick, Chief Investigator of the PROCLIPI Study and Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. "We are proud to coordinate this initiative as we’re working to build rigorous scientific evidence while giving patients and their families a better understanding of what long-term survival looks like."

The PROCLIPI Study, now in its tenth year, aims to develop prognostic indices for MF and SS. The study collects comprehensive data, including clinical, haematological, pathological, imaging, treatment with responses, quality of life and survival data.1 Recently, a new prognostic index (CLIPI) for advanced CTCL was published to enable precise patient risk stratification.6

"For those of us in the CTCL community, survival isn’t just about numbers on a chart – it’s about being able to spend more time with our families, plan for the future, and live life with dignity", says Susan Thornton, CEO, Cutaneous Lymphoma Foundation. "That’s why initiatives like PROCLIPI are important, as the data collected reflects real lived experiences and can help inform future improvements in care for patients."

The independent international PROCLIPI Study aligns with Kyowa Kirin International’s commitment to generating real-world insights that advance the understanding of CTCL and turn these clinical insights into meaningful improvements in access, policy, and patient care.

Cutaneous T-cell lymphoma is a rare disease7, and innovation in this environment can be challenging due to the rarity of this disease.8 Yet despite these challenges, mounting evidence continues to emerge4,5 to help strengthen our collective understanding of potential treatment benefits.

"These insights into improved overall survival for patients living with CTCL mark an important step forward, providing a stronger clinical evidence base and reinforcing the value of international networks in rare disease research," says Dr Nick Kronfeld, Head of Medical Affairs, Kyowa Kirin International. "By working alongside scientific and patient communities in CTCL, we can gain a better understanding of real-world outcomes, enabling us to bring life-changing value to patients and families, not just today but over the long term."

Note to editors

The OS data from the PROCLIPI Study was presented as an oral presentation during the EORTC CTCL Annual Group Meeting 2025.2 KKI did not sponsor the PROCLIPI study or OS analysis.
The median OS for patients (n=72) receiving mogamulizumab compared to those not receiving mogamulizumab (n=175) was 64 months versus 54 months.2
Median OS data amongst risk stratifications according to CLIPI: 2,6
Low-risk: 67 months vs. ‘not reached’ for mogamulizumab versus those who had not received mogamulizumab
Medium-risk: 64 vs. 48 months for mogamulizumab versus those who had not received mogamulizumab
High-risk: 26 vs. 13 months for mogamulizumab and for those who had not received mogamulizumab

(Press release, Kyowa Hakko Kirin, OCT 22, 2025, View Source [SID1234656914])

On October 22, 2025 Charles River Laboratories International, Inc. (NYSE: CRL) and The Francis Crick Institute (Crick) reported a new collaboration around Antibody-Drug Conjugate (ADC) drug discovery and development, leveraging combined strengths to accelerate the development and delivery of next-generation targeted therapies.

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This agreement leverages an integrated approach to streamline discovery and characterization—bringing promising ADC candidates to the clinic faster and more efficiently. This end-to-end approach—spanning antibody discovery, conjugation, in vitro profiling, and preclinical studies—will be fully integrated and managed jointly by Charles River and the Crick to minimize timelines and maximize efficiency.

"This integrated ADC development agreement represents a powerful synergy between cutting-edge antibody discovery and rigorous safety profiling," said Justin Bryans, PhD, Chief Scientific Officer, Charles River. "Together, we’re enabling the development of smarter, safer therapeutics that are more likely to succeed in the clinic—ultimately supporting the mission of delivering life-changing therapies to patients."

This collaboration will feature antibody generation leveraging phage display libraries, ensuring high-affinity, target-specific antibodies as the foundation for ADC development. It will also utilize Charles River’s advanced Retrogenix platform, an in vitro profiling technology designed to evaluate off-target interactions and enhance safety and therapeutic index early in the development process.

David Allen, Director of Translation at the Crick, added, "This collaboration marks a powerful convergence of innovation and execution. Working together will allow us to translate our research discoveries into new treatments at a scale and speed that simply wouldn’t be possible alone."

(Press release, Charles River Laboratories, OCT 22, 2025, View Source [SID1234656913])

On October 22, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the Company has accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 26.68 million shares of the Company’s common stock at $18.74 per share, the closing price on Tuesday, October 21, 2025, for aggregate gross and net proceeds to the Company of approximately $500 million.

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Robert W. Duggan, the Company’s Co-Chief Executive Officer, Executive Chairman of the Board of Directors (the "Board") and majority stockholder, Dr. Mahkam Zanganeh, Co-Chief Executive Officer, President and member of the Board, Manmeet Soni, Chief Operating Officer, Chief Financial Officer and member of the Board, Bhaskar Anand, Chief Accounting Officer and certain non-executive employees each participated as Investors in the Private Placement, investing an aggregate of $272 million. Additionally, Akeso, Inc. ("Akeso"), participated as an Investor in the Private Placement, investing $10 million. Dr. Yu (Michelle) Xia, a member of the Board, is the Chief Executive Officer and Chairwoman of Akeso.

Summit’s insiders including Akeso invested a total of $282 million. The remaining funds of $218 million were raised with multiple leading biopharma institutional investors and other individual investors.

Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, in addition to working capital needs and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement.

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

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 in China and Australia, 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. 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 could 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. 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 these 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 early 2025, the Company began enrolling patients in the United States for HARMONi-7. Summit intends to open clinical trial sites in the United States for the Phase III study in CRC by the end of 2025.

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 planned 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 for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6.

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, OCT 22, 2025, View Source [SID1234656912])

On October 22, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that it has entered into a collaboration agreement with Shanghai Henlius Biotech, Inc., (2696.HK) ("Henlius") to develop innovative cancer immunotherapy with an engineered cytokine.

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Under the terms of the agreement, Forlong will fuse a monoclonal antibody against a specific target selected by Henlius in a site-specific manner, with an engineered cytokine. In exchange, Forlong will receive an undisclosed upfront sponsor fee and research milestone payments, and upon reaching a predetermined development milestone, further licensing fee payments.

Forlong has developed a portfolio of engineered cytokines aiming to activate specific subpopulations of the immune system. FL115 is an interleukin-15 (IL-15) superagonist to stimulate natural killer (NK) cells and memory T cells, showing favorable safety profile and preliminary clinical responses in multiple Phase I studies in China and US, and is currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with advanced solid tumors and combo therapy with Bacillus Calmette-Guérin (BCG) in Phase II for patients with nonmuscle invasive bladder cancer (NMIBC). FL116 is a human anti-programmed cell death protein 1 (PD-1) antibody site-specifically fused to an interleukin-18 (IL-18) variant with minimal binding affinity to the IL-18 binding protein (IL-18BP), to preferentially activate T cells expressing both PD-1 and IL-18 receptors, and is in Preclinical Development Candidate Stage. Early research programs include cytokine-fusion proteins to activate naïve T cells and others being developed with proprietary Syntokine Synthetic Cytokine Platform and AI-driven Intelligent Biomolecular Discovery Platform.

"Recent progress in cancer immunotherapy has shown tremendous advancement in harnessing power of engineered cytokines through fusion with target proteins to activate desired segments of the immune system with precision," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "we are very excited by this collaboration, and will continue to further develop cytokine fusion proteins for target-specific immunostimulatory activity to significantly improve therapeutic outcome, through our internal programs such as FL115 and FL116 as well as additional partnership in the future".

"We are pleased to collaborate with Forlong Biotech to explore new frontiers in cancer immunotherapy," said Jijun Yuan, Ph.D., Chief Scientific Officer of Henlius. "By leveraging Forlong’s synthetic cytokine platform for engineered cytokines and Henlius’ profound expertise in the ​full-cycle​development of biologics, we will join forces to accelerate the development of novel therapies that can bring clinical benefits to cancer patients."

(Press release, Forlong Biotechnology, OCT 22, 2025, View Source [SID1234656911])