On September 24, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that data from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be featured as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) which takes place from October 17–21, 2025, in Berlin, Germany (Press release, Summit Therapeutics, SEP 24, 2025, View Source [SID1234656211]). The presentation will take place on Sunday, October 19 during the Presidential Symposium from 4:30pm – 6:30pm CET (10:30am – 12:30pm EDT).

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HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.

On April 23, 2025, Akeso announced, via a press release, topline results from HARMONi-6. At a prespecified interim analysis conducted by an Independent Data Monitoring Committee, ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent central radiology review committee (BICR) compared to tislelizumab plus chemotherapy. The PFS benefit was demonstrated in patients with either PD-L1-positive or PD-L1-negative tumors. Akeso noted that no new safety signals were identified in this Phase III study. Prior to HARMONi-6, there were no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting.

The trial results will be presented by Dr. Shun Lu, MD, PhD, Chief of Shanghai Lung Cancer Center at Shanghai Chest Hospital, Professor of Medicine at Shanghai Jiaotong University, and associate editor for Journal of Thoracic Oncology, Lung Cancer, and editor for The Oncologist.

Summit is currently enrolling patients in the HARMONi-3 study. HARMONi-3 is a multiregional Phase III clinical trial sponsored by Summit which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab, an anti-PD-1 antibody, combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-3 is currently enrolling patients globally and is conducted with registrational intent for the United States and other regions within Summit’s license territories.

About the ESMO (Free ESMO Whitepaper) 2025 Presidential Symposium Presentation

Presidential Symposium Presentation
Presentation Title: Phase III Study of Ivonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as First-line Treatment for advanced squamous non-small cell lung cancer (HARMONi-6)
Presenter: Dr. Shun Lu, MD, PhD, Chief of Shanghai Lung Cancer Center at Shanghai Chest Hospital
ESMO Presentation No.: Presidential Symposium 2, #3035
Session Date & Time: Sunday, October 19, 2025, 4:30pm – 6:30pm CET (10:30am – 12:30pm ET)

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 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), 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 2,800 patients have been treated with ivonescimab in clinical studies globally.

Summit began its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. Additionally, in early 2025, the Company began enrolling patients in the United States for HARMONi-7.

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 have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

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.

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.

On September 24, 2025 Pi Health, a global health technology and clinical research company, reported it will provide fully outsourced clinical research services in a GSK clinical trial with the aim of significantly improving the time and efficiency of the clinical trial process (Press release, GlaxoSmithKline, SEP 24, 2025, View Source [SID1234656210]). Pi Health and GSK have executed a Master Clinical Services Outsourcing Agreement for the collaboration and have begun initial activities for a global Phase 2 oncology clinical trial.

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Pi Health will manage all aspects of this GSK clinical trial through a technology-driven service model, including site selection and activation, patient enrollment, study conduct, real-time monitoring and regulatory submissions.

Pi Health will leverage its Front-end Interoperable Capture System (FICS) platform — integrated with an international network of clinical trial sites across the globe — for the clinical trial. FICS is an end-to-end clinical trial software platform with artificial intelligence capabilities that enriches current systems by using a unified solution that connects sites and sponsors to accelerate trials, enhances compliance, streamlines data flow and automates manual processes.

The FICS platform can make study conduct 50% faster while maintaining audit-ready data quality. Pi Health’s technology and operational workflows are built to achieve regulatory-grade data capture throughout the lifecycle of trials, enabling perpetual, real-time readiness for regulatory reviews and eliminating the need for manual reconciliation and expensive third-party processing.

"By applying Pi Health’s technology and international reach to GSK’s global scale and expertise, we believe we can accelerate the development of vital treatments for patients in need of new therapies by making clinical trials faster and more efficient," said Pi Health CEO and co-founder Geoffrey Kim, M.D., former Deputy Director of the Oncology Center of Excellence at the Food and Drug Administration (FDA). "This collaboration validates our commitment to fundamentally reimagining how trials should be run. Our technology provides the transparency and efficiency that senior leadership demands while delivering the data quality that regulators require."

"We are thrilled about what this agreement represents for global drug development," said Bobby Reddy, M.D., Chief Operating Officer and co-founder of Pi Health. "We are optimistic about collaborating with GSK to support its efforts in streamlining clinical trial delivery, with our shared goal of developing medicines more efficiently for patients."

"Pi Health’s integrated approach to clinical trial management, and its team’s strong background in drug development and regulation, made them a natural choice," said Zeshaan Rasheed, M.D., Ph.D., Senior Vice President, Head of Oncology Clinical Development at GSK. "By removing inefficiencies that can slow progress in clinical trials, Pi Health is well positioned to help us focus on our main priority: getting innovative medicines to people with cancer as quickly and as safely as possible."

Pi Health was founded by physicians and has assembled a multidisciplinary team that includes highly experienced clinicians, principal investigators, former industry leaders with deep experience in pharma and biotech clinical development and operations, and former FDA leaders with extensive approval track records (>100 NDAs, BLAs, PMAs reviewed; >1000 INDs reviewed) — giving the company a unique window into the challenges and solutions needed in clinical research.

On September 24, 2025 Faeth Therapeutics, a clinical-stage biotechnology company developing therapies that target tumor metabolism, reported that results from the investigator-initiated Phase 2 DICE trial (NCT03648489) will be presented as a late-breaking oral session at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin (Press release, Faeth Therapeutics, SEP 24, 2025, View Source [SID1234656209]).

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Title: Mini Oral session: Gynaecological cancers
Location: Cologne Auditorium – CityCube A
Date: Sunday, October 19, 2025
Time: 11:01 am CEST
Presenter: Dr. Jonathan Krell, MD, Ovarian Cancer Action Research Centre at Imperial College London

On September 24, 2025 ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX) reported that it has reached an agreement to amend its previously announced Business Combination Agreement (the "Amended Agreement") with XenoTherapeutics Inc. ("Xeno"), a non-profit biotechnology company (Press release, ESSA, SEP 24, 2025, View Source [SID1234656208]). XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA) continues to act as structuring agent and intends to provide financing for the transaction (the "Transaction").

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the Amended Agreement, ESSA shareholders are now expected to receive approximately US$0.12, exclusive of future non-transferable contingent value right ("CVR") payments and exclusive of the approximately US$1.69 of cash previously distributed to ESSA shareholders, per Common Share at closing (as compared to the approximately US$1.91 that was originally estimated as the aggregate distribution, as described in greater detail below), plus one CVR per Common Share, which CVR now represents the right to receive up to approximately US$0.14 per CVR and payable within specified periods following the close of the Transaction. The potential CVR payments of US$0.14 per Common Share represents up to US$6.7 million in the aggregate that may be distributed to CVR holders depending on the outcome of certain contingent liabilities. ESSA and Xeno are making this change in light of potential liabilities, associated expenses and the latest estimates of the Company’s expected cash balance at closing. ESSA will be filing the Amended Agreement on a Current Report on Form 8-K.

As previously disclosed on July 14, 2025, ESSA shareholders were expected to receive a cash payment per Common Share determined based on ESSA’s cash balance at closing, plus one CVR per Common Share. At that time, ESSA estimated that shareholders would receive approximately US$1.91 per Common Share, exclusive of any CVR payments. On August 22, 2025, ESSA distributed approximately US$1.69 per Common Share to its shareholders as an initial cash distribution.

ESSA intends to apply to the Supreme Court of British Columbia (the "Court") to amend the interim order obtained from the Court on August 5, 2025 (the "Interim Order") following the adjournment of the Meeting. The amended Interim Order would provide for a new Meeting date of October 3, 2025, a new deadline to deliver notices of dissent of October 1, 2025, a new Court hearing date for approval of the Arrangement of October 7, 2025 and a deadline of October 3, 2025 for responses for persons intending to attend the October 7th hearing.

Special Meeting to Reconvene on October 3, 2025

In connection with the Amended Agreement, ESSA also announced today that it has further adjourned its special meeting of the holders of common shares of the Company ("Common Shares" and the holders of such Common Shares, the "Shareholders"), optionholders and warrantholders (the "Special Meeting") scheduled to occur on September 29, 2025.

The Special Meeting will now reconvene at 2:00 p.m. (Pacific Time) on October 3, 2025. The Special Meeting will still be held online via a live interactive webcast on the internet at View Source

The additional adjournment will allow time for shareholders to consider and approve the Amended Agreement. Shareholders who have already voted on the transaction and do not wish to change their vote do not need to take any further action.

ESSA will file supplemental proxy materials reflecting the revised terms in due course.

Advisors

Leerink Partners is serving as the exclusive financial advisor to ESSA and Blake, Cassels & Graydon LLP and Skadden, Arps, Slate, Meagher & Flom LLP are serving as ESSA’s Canadian legal counsel and U.S. legal counsel, respectively.

Stikeman Elliott LLP and Gibson, Dunn & Crutcher LLP are serving as XOMA Royalty’s Canadian legal counsel and U.S. legal counsel, respectively.

On September 24, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported the presentation of data on iza-bren (izalontamab brengitecan) and BL-M07D1, two distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany (Press release, SystImmune, SEP 24, 2025, View Source [SID1234656207]). Iza-bren, a potentially first-in-class EGFRxHER3 bispecific ADC, is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

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"The breadth of data we are presenting at ESMO (Free ESMO Whitepaper) this year reflects not only the strength of our ADC platform but also the speed and depth with which we are advancing our clinical pipeline across tumor types," said Dr. Jie D’Elia, Ph.D., Chief Executive Officer of SystImmune. "From our late-stage pivotal trials to our earlier proof-of-concept studies, these achievements demonstrate SystImmune’s ability to translate our differentiated ADC platform into potential medicines that have the power to change treatment paradigms for cancer patients worldwide."

Key data to be presented at ESMO (Free ESMO Whitepaper) include:

Highlighting the continued clinical advancement of iza-bren:

Late-breaking data from the first randomized, open-label, multicenter, Phase III study evaluating iza-bren versus physician’s choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma in China
Results from the first Phase 1 study of iza-bren in a global patient population (BL-B01D1-LUNG-101) with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors
Safety and efficacy results of iza-bren as a monotherapy in patients with advanced stages of ovarian cancer in China
Safety and efficacy results of iza-bren in combination with serplulimab, an anti-PD-1 monoclonal antibody, in patients with extensive-stage small cell lung cancer in China
Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1

Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented.
"We are excited to present the first randomized data of iza-bren compared to systemic chemotherapy in advanced nasopharyngeal carcinoma demonstrating the clinical benefit of iza-bren for these patients. In addition, the breadth of data being presented at ESMO (Free ESMO Whitepaper) underscores the potential versatility of iza-bren across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are strongly encouraged by the single-agent activity seen in ovarian cancer and EGFR-mutated NSCLC, as well as the potential for rational combinations observed in small cell lung cancer. These results reinforce our commitment to advancing iza-bren as a therapy that could meaningfully expand treatment options for patients with difficult-to-treat cancers."

Details of the presentations at ESMO (Free ESMO Whitepaper) are below:

Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician’s Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study
Trial Reference: BL-B01D1-303 (NCT06118333), China
Session Title: Proffered paper session: Development therapeutics
Presentation Number: LBA35
Speaker: Huaqiang Zhou (Guangzhou, China)
Session Date & Time: Sunday, October 19th, 2025, 2:45 PM-4:15 PM CEST

Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Trial Reference: BL-B01D1-LUNG-101 (NCT05983432), Global
Session Title: Mini oral session: Developmental therapeutics
Presentation Number: 921MO
Speaker: Helena A. Yu (New York, USA)
Session Date & Time: Friday, October 17th, 2025, 4:00 PM-5:30 PM CEST

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC)
Trial Reference: BL-B01D1-204-01 (NCT06437509), China
Session Title: Developmental therapeutics
Presentation Number: 934P
Speaker: Fei Zhou (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC)
Trial Reference: BL-B01D1-202 (NCT05803018, NCT05990803), China
Session Title: Developmental therapeutics
Presentation Number: 933P
Speaker: Wu Yong (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors
Trial Reference: CA244-0001 (NCT06618287), Global
Session Title: NSCLC, metastatic
Presentation Number: 2080eTIP
Speaker: Marie Florescu (Montreal, Canada)

BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase 1 study
Trial Reference: BL-M07D1-101 (NCT05461768), China
Session Title: Developmental therapeutics
Presentation Number: 935P
Speaker: Hong Zong (Zhengzhou, China, Henan)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ)
Trial Reference: BL-M07D1-101, 102, 202 (NCT05461768, NCT05631964, NCT06031584), China
Session Title: Developmental therapeutics
Presentation Number: 937P
Speaker: Shuqin Ni (Jinan, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

About BL-M07D1
SystImmune is developing BL-M07D1, an ADC comprising a monoclonal antibody component binding HER2 and a linker-payload component composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. HER2 is highly expressed in multiple solid tumors. BL-M07D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to HER2 on cancer cells. In addition, the binding to HER2 causes its internalization followed by the release of the payload, which then kills the tumor cell.