On September 2, 2025 Akeso (9926.HK) reported the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1) (Press release, Akeso Biopharma, SEP 2, 2025, View Source [SID1234655673]). This Phase III trial is being conducted in China.

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Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab’s strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation.

Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:

Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):

First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
First-line squamous NSCLC (versus tislelizumab + chemotherapy)
NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)
Phase III trials for core immuno-oncology indications (first-line therapy ):

First-line biliary tract cancer (versus durvalumab + chemotherapy)
First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab
Phase III trials for cold tumors and more:

First-line triple-negative breast cancer (TNBC)
First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
First-line pancreatic cancer
Additional global Phase III trials are in advanced stages of planning
An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide.

Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.

For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.

On September 2, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it will participate in the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Intensity Therapeutics, SEP 2, 2025, https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-to-participate-in-fireside-chat-at-the-hc-wainwright-27th-annual-global-investment-conference-302543127.html [SID1234655672]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

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Lewis H. Bender, President and CEO of Intensity Therapeutics will participate in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director, Senior Healthcare Analyst at H.C. Wainwright. The fireside chat will be available on demand beginning Friday, September 5 at 7:00am ET for registered investors of the conference. To request a one-on-one meeting with Mr. Bender, and to register for the conference, click below: View Source

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On September 2, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it will participate in the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Intensity Therapeutics, SEP 2, 2025, https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-to-participate-in-fireside-chat-at-the-hc-wainwright-27th-annual-global-investment-conference-302543127.html [SID1234655672]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Lewis H. Bender, President and CEO of Intensity Therapeutics will participate in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director, Senior Healthcare Analyst at H.C. Wainwright. The fireside chat will be available on demand beginning Friday, September 5 at 7:00am ET for registered investors of the conference. To request a one-on-one meeting with Mr. Bender, and to register for the conference, click below: View Source

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On September 2, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported that two abstracts for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented at the World Conference on Lung Cancer (WCLC) 2025 Annual Meeting taking place September 6 – 9 in Barcelona, Spain (Press release, SystImmune, SEP 2, 2025, View Source [SID1234655671]). Iza-bren 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 safety and efficacy results of iza-bren as a monotherapy and in combination with Osimertinib in patients with advanced stages of EGFR mutated Non-Small Cell Lung Cancer will be presented at WCLC. The data highlights the continued progress of iza-bren clinical development and builds upon the previously reported clinical activity in lung, breast, and bladder cancer patients at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), and SABCS in 2023, 2024 and 2025.

"These data further enhance our confidence in iza-bren’s clinical activity across a wide range of tumors," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are particularly excited by the potential of iza-bren in combination with osimertinib as a first-line treatment for EGFR-mutated NSCLC. This approach may offer the opportunity for deeper and more durable responses in newly diagnosed patients, and we remain committed to advancing its development to address unmet needs in lung cancer."

Details of the presentations at WCLC are below:
Phase I/II Study of iza-bren (BL-B01D1) as Monotherapy in Patients with pre-treated Locally Advanced or Metastatic EGFR Mutated NSCLC
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.03
Speaker: Wenfeng Fang (Guangzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 PM CEST

Phase II Study of iza-bren (BL-B01D1) Combo with Osimertinib in EGFR Mutated Locally Advanced or Metastatic NSCLC Patients
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.04
Speaker: Fei Zhou (Zhengzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 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 targets that 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 payload is released causing genotoxic stress that leads to cancer cell death.

On September 2, 2025 Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide (Press release, Servier, SEP 2, 2025, View Source [SID1234655670]). Under the agreement, Servier obtains the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA retains its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

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"At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide," said Arnaud Lallouette, Executive Vice-President Global Medical & Patient Affairs at Servier. "Today, there are limited treatment options and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network, and expertise in developing oncology targeted therapies, to make this groundbreaking treatment accessible to patients across the globe."

"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development for darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"We believe Servier’s global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the U.S. will ensure that this potentially life-changing treatment reaches as many patients as possible," said Daniel Simon, Chief Business Officer, IDEAYA Biosciences.

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial evaluating darovasertib in combination with crizotinib in first line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomized trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumor, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million, and be eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.