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])

On October 22, 2025 Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, reported that it will present new data from its proprietary Targeted Protein Degradation (TPD) and Proximity Inducer Platform (A-PROX) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held at the Hynes Convention Center in Boston, MA, from October 22–26, 2025.

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Aurigene’s A-PROX platform integrates library screening, direct-to-biology chemistries, proprietary ternary complex assays, modelling algorithms, and structure-based design to accelerate the discovery and optimization of both protein degraders, molecular glues and proximity inducers.

Through this integrated approach, Aurigene has advanced a strong pre-clinical portfolio of next-generation degraders, including a SMARCA2-selective degrader, which recently received Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA); a pan-KRAS degrader; a SMARCA4-selective degrader; and a p300 degrader.

"Our A-PROX platform represents a significant step forward in the rational discovery of targeted protein degraders and molecular glues," said Dr. Murali Ramachandra, CEO of Aurigene Oncology Ltd. "We are excited to share our progress at the AACR (Free AACR Whitepaper)-NCI-EORTC conference and continue advancing differentiated therapies that have the potential to transform cancer treatment."

These programmes underscore Aurigene’s capability to deliver potent, paralogue-selective, and mutant-agnostic degraders, enabling the targeting of previously undruggable oncology pathways. Aurigene’s proprietary long-acting injectable (LAI) formulation has enabled infrequent intravenous dosing, just once every three weeks for most molecules, while maintaining excellent efficacy.

Poster Presentations

Title: Identification of an orally bio-available SMARCA2 selective degrader for treatment of SMARCA4 mutant cancers
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C025

This presentation describes the identification and characterization of an orally bioavailable SMARCA2 degrader with good potency and selectivity over SMARCA4. SMARCA2 and SMARCA4 regulate chromatin architecture by mobilizing and repositioning nucleosomes on DNA, which is critical for various genomic functions, including transcriptional regulation, DNA recombination and repair, and mitotic chromosome segregation. Loss-of-function mutations or silencing of SMARCA4 are frequently observed in multiple cancer types, where tumorigenesis becomes dependent on the residual SMARCA2 degrader with good potency and selectivity over SMARCA4. In this study, the lead SMARCA2 degrader demonstrated potent antitumor activity, driven by efficient SMARCA2 degradation, in multiple SMARCA4-deficient cell line-derived xenograft (CDX) models at well-tolerated dose levels. Additionally, with the use of Aurigene’s proprietary long-acting injectable (LAI) formulation, AUR110, a candidate with US-FDA clearance for first-in-human studies, has shown potent and comparable anti-tumor activity following once every three week intravenous dosing.

Aurigene will also be showcasing other pipeline programmes in poster presentations at the conference, including:

Title: Discovery and development of a highly differentiated, efficacious, first-in-class anti-SIRPα/β dual antibody with single agent phagocytosis activity
Presenting Author: Subhra Chakrabarty
Presentation Date/Time: Oct 24 12:30-4PM ET
Abstract Number: B077

Title: Discovery and preclinical characterization of novel macrocyclic KIF18A inhibitors for treatment of chromosomally instable tumors
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 23 12:30-4PM ET
Abstract Number: A030

Title: Development of a Differentiated, Best-in-Class oral Cbl-b inhibitor with Robust Immune Activation and Favourable Safety for Cancer Immunotherapy
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C059

(Press release, Aurigene Discovery Technologies, OCT 22, 2025, View Source [SID1234656910])

On October 22, 2025 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, production, and commercialization of novel cell therapies, reported that the Blood published the latest results of its independently developed fully human anti-GPRC5D CAR-T cell therapy, RD118, for the treatment of relapsed/refractory multiple myeloma (R/R MM). The study demonstrates that RD118 exhibited significant efficacy and a manageable safety profile in heavily pretreated R/R MM patients, offering new therapeutic hope for the patients with a poor prognosis.

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The study entitled ‘Fully Human anti-GPRC5D CAR T-Cell Therapy RD118 Induces Durable Remissions in Relapsed/Refractory Multiple Myeloma’ has been published in Blood. Full text available at: View Source This is an open-label, phase 1 dose-escalation and expansion study to evaluate the efficacy and safety of RD118 in the treatment of R/R MM, which was conducted at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (registered as NCT05759793 and NCT05219721).

A total of eighteen patients received RD118 infusion in this study, including 17 with R/R MM and 1 with a history of primary plasma cell leukemia (pPCL) who had relapsed after achieving complete remission. Among the 18 patients, the median age was 59.5 years, and the median line of prior therapies was 5. High-risk features included double-hit cytogenetics (50%), triple-class refractoriness (50%), penta-class refractoriness (22.2%), and prior anti-BCMA CAR-T therapy (38.9%). Following lymphodepletion with fludarabine and cyclophosphamide, patients received a single infusion of RD118 at one of three dose levels (1.0, 2.0, or 3.0×106 cells/kg) during the dose-escalation phase or 2.0×106 cells/kg in the expansion cohort. At a median follow-up of 17.0 months, results show that:

Efficacy: The overall response rate (ORR) was 94.4%, with 72.2% of patients achieving complete response or stringent complete responses (CR/sCR). Among the seven patients who had received prior BCMA-directed CAR T-cell therapy, the ORR was 85.7%, with 5 patients (71.4%) achieving CR/sCR. All three patients with extramedullary disease and the patient with pPCL achieved sCR and remained in remission at last follow-up. The median progression-free survival (PFS) was 18.2 months, with 12-month PFS and overall survival (OS) rates of 82.1% and 93.3%, respectively.

Safety: Cytokine release syndrome (CRS) occurred in 88.9% of patients, primarily grade 1-2. Only one patient developed grade 3 or higher CRS, which rapidly recovered with intensive management. One patient developed grade 3 immune effector cell–associated neurotoxicity (ICANS) which resolved within 72 hours. No cerebellar toxicities or treatment-related deaths were reported

Conclusion ：Fully human anti-GPRC5D CAR-T therapy RD118 demonstrated a 94.4% ORR and a median PFS of 18.2 months with a manageable safety profile in heavily over pretreated R/R MM, including patients who relapsed after prior anti-BCMA CAR-T therapy.

Professor Mi Jianqing from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, commented: "Multiple myeloma remains an incurable malignant plasma cell disorder. While anti-BCMA CAR-T therapy has greatly transformed the treatment for relapsed/refractory patients, challenges such as antigen escape often leads to relapse, highlighting the need for novel targets to overcome these limitations. GPRC5D has attracted significant attention due to its high expression, specificity, and independence from BCMA. The current study results have validated its potential: among patients previously treated with anti-BCMA CAR-T therapy, RD118 achieved an 85.7% overall response rate, with 71.4% of patients reaching complete response, demonstrating that GPRC5D is a highly promising novel therapeutic target."

Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, commented: "The innovative design of RD118 is the foundation of its outstanding clinical performance. RD118 is a novel GPRC5D-directed CAR-T that incorporates a fully human nanobody (VHH) as its antigen-binding domain. This design provides distinct advantages over conventional scFv, it is expected to lower immunogenicity, and potentially enhanced persistence, offering a new approach to overcome the safety limitations of existing comparable therapies. Meanwhile, the construct also includes a 4-1BB and a CD3ζsignal domains, which support expansion and sustained anti-tumor activity. Together, these features position RD118 as a highly competitive next-generation CAR-T product."

Ms. Jinhua Zhang, Founder, Chairwoman and CEO of IASO Bio, remarked: "We are delighted that the remarkable research results of IASO Bio’s independently developed anti-GPRC5D CAR-T product, RD118, for the treatment of R/R MM have been published in the prestigious international journal Blood. This achievement marks another significant milestone for the product following the IND approval from China’s NMPA in June 2024. The treatment landscape for multiple myeloma requires continuous innovation, and GPRC5D, alongside BCMA, are represents a crucial therapeutic target in this field. Developed based on our fully human antibody platform, RD118 is designed to provide a new treatment option for patients. It offers renewed hope particularly for those who have relapsed after prior anti-BCMA CAR-T therapy. This publication will further motivate us to advance the clinical development of RD118, with the goal of delivering this innovative therapy to more patients worldwide."

About RD118

RD118 is an autologous T-cell immunotherapy product targeting G protein-coupled receptor class C group 5 member D (GPRC5D). It can identify and eliminate malignant tumor cells expressing GPRC5D. GPRC5D is highly expressed on multiple myeloma cells. However, in normal tissues, its expression is limited to plasma cells and hair follicle cells. Such a feature has made GPRC5D a promising safe and effective target for the treatment of multiple myeloma.

The antigen recognition domain of RD118 is developed from IASO Bio’s proprietary fully human single-domain antibody library. It has advantages of high affinity, high specificity, and low immunogenicity. The intracellular domain is a fusion of 4-1BB (CD137) and CD3ζ signaling domains. RD118 has been subjected to extensive development and optimization in terms of antibody screening and structure design. The candidate molecule has demonstrated excellent in vitro cytotoxic activity and in vivo tumor suppression ability. Additionally, it has good expansion capability and persistence in vivo, indicating high development potential.

(Press release, IASO Biotherapeutics, OCT 22, 2025, View Source [SID1234656909])

On October 22, 2025 ACM Biolabs, a clinical-stage biotechnology company developing next-generation nanoparticle-based immunotherapies, reported encouraging early clinical findings from its ongoing Phase 1 study of ACM-CpG, a TLR9 agonist formulated with ACM’s proprietary polymersome platform through a strategic collaboration with the National Cancer Centre Singapore (NCCS).

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Preclinical experiments show that the ACM nanoparticle formulation fundamentally alters CpG’s mechanism of action, enabling myeloid modulation through comprehensive TLR9 engagement in immunologically "cold" tumors. The ongoing Phase 1 trial (NCT06587295)[i] is enrolling patients with advanced solid tumors at NCCS to assess the safety, tolerability, and pharmacodynamic effects of ACM-CpG.

Early clinical data indicate that these preclinical findings are translating into humans. In patients with advanced solid tumors, intramuscular administration of ACM-CpG – at weekly or biweekly doses as low as 0.25mg CpG – has demonstrated robust systemic immune activation as evidenced through immune biomarker data. The therapy shows a highly favorable safety and tolerability profile and to date, no dose-limiting toxicities have been observed.

"TLR9 has long been recognized as a validated immunologic target, but its therapeutic potential has been limited by delivery and safety limitations," said Dr. Madhavan Nallani, CEO of ACM Biolabs. "Our intramuscular nanoparticle delivery enables systemic immune activation with an excellent safety profile, creating opportunities not only for combination approaches but also for targeted monotherapy in patient populations with few treatment options. Over time, this platform can also support additional routes of administration allowing us to tailor treatment strategies to diverse tumor settings and address significant unmet medical needs."

"The safety profile and clear pharmacodynamic activity we have observed so far are very encouraging, with two out of the three patients enrolled at the 0.25mg dose level having ongoing disease control for eight months with monotherapy alone." said Dr. Amit Jain, Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore. "We look forward to exploring ways to optimize its delivery and maximize its therapeutic potential for patients with advanced cancers."

The collaboration is supported in part by funding from Singapore’s Industry Alignment Fund – Pre-Positioning (IAF-PP), which fosters strategic collaborations between industry and research institutes. This study is evaluating ACM-CpG in patients with advanced head and neck, lung, bladder, and kidney cancers and is designed to establish proof of mechanism to support global clinical development.

(Press release, ACM Biolabs, OCT 22, 2025, View Source [SID1234656908])