On May 29, 2025 As the global oncology community gathers for the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30–June 3), the Parker Institute for Cancer Immunotherapy (PICI) reported that it is demonstrating how bold science, accelerated through collaborative networks, can drive meaningful progress where patients need it most (Press release, Parker Institute for Cancer Immunotherapy, MAY 29, 2025, View Source [SID1234653500]). At a pivotal moment when scientific breakthroughs in immunotherapy are arriving alongside heightened pressure for faster, smarter impact, PICI’s integrated model shows how to compress timelines from discovery to patient care.

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PICI’s presence spans more than 50 presentations including 16 oral sessions, 30+ poster sessions, 10 e-papers and a featured clinical science symposium. This volume reflects not only the strength of the PICI network but also a unique ability to support promising work early and help carry it across the finish line, from foundational discoveries to practice-changing trials.

Glioblastoma Breakthroughs: New Hope for Cancer’s Most Formidable Challenge

After decades of limited progress in glioblastoma, where median survival has hovered around one year, multiple PICI-supported teams are reporting clinical responses that suggest the field may be turning a corner. These advances demonstrate how collaboration, persistence and innovation can converge on even the most intractable problems:

Stanford Medicine researchers achieved median overall survival of 14.6 months in recurrent glioblastoma patients using B7H3 CAR T cells delivered directly to the brain via dual Ommaya reservoirs. The Phase 1 study established a recommended Phase 2 dose and demonstrated manageable inflammation using IL-1 blockade, offering a tangible advance in a cancer where meaningful clinical progress has long remained elusive. (Crystal Mackall, MD, Director of the PICI Center at Stanford; Michelle Monje, MD, PhD — Abstract #2018)

University of Pennsylvania investigators reported tumor shrinkage in 85% of evaluable patients using bivalent CAR T-cell therapy targeting EGFR and IL13Rα2 in recurrent glioblastoma. Delivered into the cerebroventricular space without lymphodepletion, the engineered T cells persisted in cerebrospinal fluid and blood for up to one year, marking an encouraging step toward sustained response and long-term disease management. (Carl June, MD, Director of the PICI Center at Penn; Donald O’Rourke, MD — Abstract #102)

UCSF and Memorial Sloan Kettering researchers identified more than 700 glioma-specific, splice-derived neoantigens using the SNIPP antigen discovery platform. These targets elicited CD8+ T-cell responses in vitro and many were conserved across tumors, opening the door to scalable, potentially off-the-shelf TCR-based therapies. (Hideho Okada, MD, PhD, UCSF — Abstract #2519)

Leadership Recognition: PICI CEO Receives ASCO (Free ASCO Whitepaper)’s Highest Honor

Dr. Karen Knudsen, PICI’s CEO, will receive the Allen S. Lichter Visionary Leader Award during ASCO (Free ASCO Whitepaper)’s opening session, recognizing a career spent building bridges from bench to patient and helping reshape how academic institutions, nonprofits and companies move from insight to implementation. Saturday, May 31, 9:45 AM–12:00 PM CDT, Room N – Hall B1

Dr. Knudsen will also join Endpoints News for a live discussion on research acceleration, regulatory pace and how PICI’s model aligns research, policy and investment with the realities facing patients today. Wednesday, June 4, 10:35 AM CDT, Endpoints Stage

Network-Wide Impact: Where Discovery Meets Delivery

PICI-supported science appears across the ASCO (Free ASCO Whitepaper) agenda, tackling critical questions in high-burden cancers through studies connected by a framework that enables speed, coordination and clinical relevance. These presentations reflect a hallmark of the PICI approach: compressing the distance between new insight and patient impact, often turning early-stage ideas into clinical action within just a few years.

Melanoma Advances

DREAMseq Final Results: Optimal treatment sequencing in BRAF-mutant metastatic melanoma (Jedd Wolchok, MD, PhD, Weill Cornell; Antoni Ribas, MD, PhD, UCLA — Abstract #9506)
Quadruple Immunotherapy: IL-6 blockade combined with checkpoint inhibitors in advanced melanoma (F. Stephen Hodi, MD, Dana-Farber — Abstract #9510)
Neoadjuvant Strategy: Pembrolizumab in clinical stage IIB/C melanoma (Alexander Huang, MD, University of Pennsylvania — Abstract #9502)
Prostate Cancer Innovation

COMRADE Trial: Olaparib plus radium-223 in castration-resistant prostate cancer with bone metastases (Eliezer Van Allen, MD, Dana-Farber — Abstract #5007)
C3NIRA Trial: Triplet chemo-immunotherapy induction followed by PARP inhibitor maintenance (Padmanee Sharma, MD, PhD, MD Anderson — Abstract #5008)
Breast and Lung Cancer Precision Strategies

NeoSTAR Trial: Response-guided neoadjuvant sacituzumab govitecan plus pembrolizumab in early triple-negative breast cancer (Elizabeth Mittendorf, MD, PhD, Dana-Farber — Abstract #511)
ADRIATIC Correlatives: Genomic analysis of long-term responders in limited-stage small cell lung cancer (David Barbie, MD, Dana-Farber — Abstract #8014)
Translational Platforms

INCIPIENT Trial: CARv3-TEAM-E immunological correlates in recurrent glioblastoma (Marcela Maus, MD, PhD, Massachusetts General Hospital — Abstract #2008)
BRCA1/2 DNA Vaccines: Plasmid-based immunotherapy platform with and without IL-12 (Robert Vonderheide, MD, DPhil, University of Pennsylvania — Abstract #10505)

On May 29, 2025 RBL LLC, a pioneering biotech venture creation studio dedicated to rapidly building companies based on breakthrough medical technologies from Rice University, reported the launch of Sentinel BioTherapeutics at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Sentinel BioTherapeutics, MAY 29, 2025, View Source [SID1234653499]). Sentinel’s launch marks RBL’s first company spin-out since its formation in October 2024 and positions Sentinel to begin preparations ahead of the next phase of clinical development for its lead cancer immunotherapy program.

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Developed in the laboratory of bioengineering expert, Omid Veiseh Ph.D., at Rice, Sentinel’s platform enables sustained and local delivery of the cytokine interleukin-2 (IL-2) to activate the immune system and enhance the potency and effectiveness of checkpoint inhibitors against solid tumors. The allogeneic encapsulated cell-based system enables constitutive expression of human IL-2. This approach can offer a new paradigm for treating cancers that typically respond poorly to checkpoint inhibitors, such as ovarian cancer and mesothelioma.

"We believe this is a powerful, new approach that can increase the sensitivity of solid tumors to immunotherapy" said Rima Chakrabarti, M.D., the company’s Chief Executive Officer and managing partner at RBL. "Data from a Phase 1 study show the significant potential of our IL-2-producing cell-based platform to specifically stimulate immune checkpoint expression, supporting the rationale for using our agent in combination with immunotherapy. With the backing of RBL, we are moving forward with GMP manufacturing and clinical trial preparation plans in high unmet need solid tumor indications. We are proud to be part of the growing Houston biotech ecosystem that is supported by the Rice Biotech Launch Pad and RBL."

Sentinel’s Phase 1 data will be presented in a poster at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago. The presentation will highlight clinical biomarker data showing the ability of the company’s IL-2 immune priming therapy to induce dose-dependent increases in CTLA-4 expression on both CD8+ and CD4+ T cells, supporting its use as a priming agent for effective checkpoint inhibition. Full details of the abstract (#5562) can be viewed here.

Session Title: Gynecologic Cancer

Poster Title: Phase I Study of Sustained and Local Delivery of Intraperitoneal IL-2 using Encapsulated Cells in Patients with Platinum-Resistant High-Grade Serous Carcinoma

Date & Time: June 1, 2025, 9 – 12 p.m. CT

Location: Poster Bd #460

"The launch of Sentinel represents a major milestone in RBL’s mission to support companies that are transforming bold scientific ideas into therapeutic products with the potential for rapid patient impact," said Paul Wotton, Chief Executive Officer and Managing Partner of RBL and Chairman of Sentinel. "Sentinel’s cytokine factory platform is the breakthrough technology that we believe has the potential to define the next era of cancer treatment."

On May 29, 2025 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that the Company and Horizon Technology Finance Corporation ("Horizon") have executed a follow-on Amendment ("Amendment") to the Asset Purchase Agreement dated February 11th, 2024 ("APA") for acquiring the entire portfolio of assets and intellectual property based on the DPX immune educating platform technology developed by Canadian biotechnology company, IMV Inc (Press release, BioVaxys Technology, MAY 29, 2025, View Source [SID1234653498]).

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Section 12 of the February 11th, 2024 APA is a performance milestone provision for BioVaxys to demonstrate an aggregate capital raise of USD $10M by December 31, 2024. On December 9th, 2024, Horizon and BioVaxys initially amended the APA by agreeing to delete the reference to "December 31, 2024" found in Section 12 and replacing it with the date of "June 30, 2025."

This new Amendment of May 29th, 2025, supersedes and replaces the Section 12 terms of the APA so that the net performance milestone required to be raised in any form (including, but not limited to equity, grants, licensing fees, or loans) is now significantly lowered to USD $2,028,636. If BioVaxys is successful in meeting this milestone by September 30, 2025, Section 12 of the APA shall end and be of no further force or effect.

As consideration for Horizon amending the APA, BioVaxys agrees to issue to Horizon 2,800,000 share purchase warrants and 1,200,000 share purchase warrants to Powerscourt Investments XXV LP ("Powerscourt"), with each warrant entitling Horizon and Powercourt the purchase of one whole at a purchase price of $0.06 Canadian Dollars per share at any time on or before May 31, 2028. Horizon and Powerscourt are the members/owners of HIMV LLC (70%/30%), the party to the APA. All other terms and conditions of the APA to remain the same.

BioVaxys and Horizon have further agreed that Section 7(c)(i) of the APA "Licensing Earn-Out Payments Term" be amended from the original "Eighth anniversary of the Closing Date" found in the last line of Section 7(c)(i) to August 11, 2033. During the Licensing Non-Sales Earn-Out Term, BioVaxys shares a predetermined percentage of net licensing non-sales revenues with Horizon.

The "Licensing Non-Sales Earn-Out Term" refers to payments received from an existing licensee or preexisting potential licensee, ending upon the expiration of the last valid claim of a former IMV patent that is the subject of the license agreement to which such existing licensee or preexisting potential licensee is party, and any other payment received under a license agreement, ending on August 11, 2033.

On May 29, 2025 The National Medical Products Administration reported that it has recently granted approval for Trastuzumab rezetecan, China’s first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy (Press release, Hengrui Pharmaceuticals, MAY 29, 2025, View Source [SID1234653497]).

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The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study led by Professor Lu Shun at Shanghai Chest Hospital, which demonstrated groundbreaking efficacy in HER2-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months—thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan significantly reduced the toxicity risks typically associated with conventional ADCs. These results have redefined global benchmarks for ADC research and garnered significant attention from the international scientific community.

Trastuzumab rezetecan has achieved breakthroughs in both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by Hengrui Pharmaceuticals’ decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP enables end-to-end capabilities spanning molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over 10 differentiated ADC candidates into clinical development, including Trastuzumab rezetecan, its flagship HER2-targeted ADC therapy.

Shun Lu, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)，China, and principal investigator of Horizon-Lung, said, "the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2-mutant NSCLC, addressing a critical unmet need for advanced HER2-driven NSCLC patients in China. Grounded in epidemiological data that accurately reflect China’s NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China’s emergence as a pioneering force in shaping the global ADC landscape for precision oncology.

Beyond its established efficacy in lung cancer, Trastuzumab rezetecan has demonstrated significant clinical advances across multiple tumor types, with eight additional indications—including breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer—receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA).

On May 29, 2025 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that the Company will be presenting a Trials in Progress poster outlining its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for the treatment of metastatic soft tissue sarcomas (Press release, Intensity Therapeutics, MAY 29, 2025, View Source [SID1234653496]). The poster will be shown at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting held at McCormick Place in Chicago May 30-June 5, 2025.

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The poster, titled, "A Multicenter, Randomized, Global Phase 3 Study to Assess the Efficacy and Safety of Intratumoral (IT) INT230-6 (SHAO, VINblastine, Cisplatin) as Monotherapy Compared with Standard of Care Systemic Chemotherapy in Adults with Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (STS) (INVINCIBLE-3)," will be presented by Sant P. Chawla M.D., Director, Sarcoma Oncology Center of Southern California, during the "Sarcoma" session to be held on Saturday May 31, 2025 from 9:30 AM to 12 PM on panel 66a. An abstract of the poster, which outlines the Company’s Phase 3 study protocol, can be found here.

"The INVINCIBLE-3 trial is breaking new ground in metastatic sarcoma with a unique, new, investigational product, INT230-6. Following direct intratumoral injection, this drug product results in significant necrosis and the formation of cysts within tumors, with little residual cancer remaining in those injected tumors. A successful outcome of the INVICIBLE-3 study will require practicing physicians to think differently about setting dose and disease endpoints. INT230-6’s dose per tumor is set by the tumor size. In this protocol, survival advantage is the gold standard upon which the efficacy of a novel investigational agent such as INT230-6 would be ultimately based," said Dr. Chawla.

"We have designed a unique Phase 3 protocol comparing our local therapy to the best systemic standard of care based on our completed Phase 1/2 trial. In our first study, refractory, metastatic sarcoma patients whose disease continued to progress following a median of three prior lines of therapy received INT230-6 alone," said Lewis H. Bender, Intensity Therapeutics Founder, President, and CEO. "Those sarcoma patients showed immune engagement post-dose, uninjected tumors regressing, a disease control rate of 93%, and a median overall survival of 21.3 months with minimal treatment-associated adverse events. Eight regulatory agencies, including the U.S. FDA, have authorized the Phase 3 study. Until sufficient additional funding is obtained, new enrollment for the Phase 3 has been paused. We are continuing to treat the enrolled patients, maintain pharmacovigilance, monitor sites, and look forward to reinitiating recruitment as soon as sufficient resources are available."

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 is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which so often occurs with systemic chemotherapy.

About INVINCIBLE-3

INVINCIBLE-3 is a study to evaluate a novel, new drug product administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed second- or third-line US standard of care chemotherapy. Patients will be randomized 2 to 1 to INT230-6 or pazopanib, trabectedin, or eribulin (selection of SOC depends on the sarcoma subtype). As this is a survival study, there is no crossover allowed between US SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) Criteria in conjunction with evaluation of the post-treatment scans. Dosing beyond radiographic progression is allowed should tumors have low levels residual cancer on scans post baseline. Participants will be prospectively stratified into 1 of 3 histologically defined aSTS strata: leiomyosarcoma, liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic) and undifferentiated pleomorphic sarcoma

The participants will undergo in 4 phases: screening, treatment, maintenance, and follow-up in the study. Study visits, tumor and endpoint assessments will occur as indicated in the procedural outlines as part of a schedule of events. Important inclusion criteria include: histologically proven, unresectable, locally advanced, or metastatic STS only of the following Participant must have a pathology report indicating the diagnosis of their STS. Participants must have received at least 1 line of therapy for STS and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by the participant. A participant cannot have received more than 2 prior regimens for unresectable, locally advanced or metastatic STS. Participants must have measurable disease per RECIST 1.1 criteria. Participants must have at least 1 target tumor ≥ 2 cm suitable for injection using routine image guidance, measurable by CT or MRI.

Key exclusion criteria include: Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off steroid therapy for at least 2 months. History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients. Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example, excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years.