On April 28, 2025 EpiBiologics, a leader in tissue-selective extracellular protein degradation, reported the first preclinical data on its EpiTAC bispecific antibody degrader of c-Met, a potential first-in-class therapy for a range of cancers driven by mutated, amplified, or overexpressed c-Met signaling (Press release, EpiBiologics, APR 28, 2025, View Source [SID1234652281]). The data, which were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, show that c-Met degrading EpiTACs demonstrate strong anti-tumor activity in vivo and as ADCs, combining c-Met degradation with payload-dependent cell killing to broaden the clinical opportunity into tumors that are not solely dependent on c-Met signaling for survival.

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c-Met is a receptor tyrosine kinase that acts as both a pathogenic driver and disease marker in multiple tumor types, including non-small cell lung cancer (NSCLC), gastric cancer, colorectal cancer and renal cancer. While tyrosine kinase inhibitors are approved for tumors with c-Met mutations, targeted therapies for c-Met-amplified or -overexpressed tumors are lacking, hampered by the need for high levels of c-Met expression and variable dependency on c-Met for tumor cell survival and proliferation.

Key highlights of EpiBiologics’ data include:

c-Met EpiTACs degraded oncogenic mutant and wildtype forms of c-Met on tumor cells and demonstrated sustained tumor growth suppression in a patient-derived mouse model of NSCLC.
Degradation of c-Met resulted in deep anti-tumor activity, driven by the ability of EpiTACs to remove the oncogenic protein and associated scaffolding.
Combining targeted protein degradation of c-Met with a cytotoxic ADC payload suppressed tumor growth in c-Met-mutant, c-Met-amplified, and c-Met-overexpressed tumors, potentially broadening the clinical opportunity into tumors that have low c-Met expression and are not solely dependent on c-Met signaling for survival.
"We’re pleased to share data from our c-Met EpiTAC program, confirming our platform’s ability to drive deep and durable degradation with therapeutically relevant impact. These data underscore how we can flexibly tune EpiTACs to have specific characteristics that solve the limitations of current clinical therapies," said Shyra Gardai, Ph.D., Chief Scientific Officer of EpiBiologics. "Additionally, this dataset showed that there is exciting potential, in certain therapeutic settings, for augmenting our bispecific antibodies with a cytotoxic payload to drive even broader patient benefit."

"c-Met represents one of several important targets in our pipeline of EpiTAC bispecific antibodies," said Ann Lee-Karlon, Ph.D., Chief Executive Officer of EpiBiologics. "As our lead tissue-selective EGFR degrader moves rapidly toward the clinic, we are also advancing EpiTACs for membrane, soluble, and GPCR targets. We have demonstrated strong single-agent activity and can successfully combine with current standards-of-care, paving the way for future therapies."

The poster, entitled "Discovery of c-MET degrading bispecific antibodies (EpiTACs) for NSCLC and other c-MET driven tumors," will be available on the company’s website here when presentation concludes.

On April 28, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL (Press release, BriaCell Therapeutics, APR 28, 2025, View Source [SID1234652433]). In addition, Phase 3 early biomarker data will be presented as a late breaking abstract.

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The posters are summarized below and linked here: View Source

Title: Survival outcomes in a randomized phase 2 of Bria-IMT : An allogeneic whole cell cancer vaccine
Session Title: Phase II and Phase III Clinical Trials
Session Start: 4/28/2025 2:00 PM – 5:00 PM CST
Location: Poster Section 50
Poster Board Number: 18
Abstract Presentation Number: CT100

"The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study," stated Dr. William V. Williams, BriaCell’s President & CEO.

Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612 ). Patients have been heavily pre-treated a median of 6 prior treatments — including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs).

Clinical benefit rates [CR, PR, SD] ranged from 45% to 100% based on subtype
Decrease in size or no change in all tumors noted in 83% of patients receiving Phase 3 formulation
Overall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC)
Overall response rate (ORR) for patients with intracranial metastases was 50% with a 75% clinical benefit rate
Safety profile: No unexpected adverse events, no treatment related discontinuation of therapy
Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity
Session Category: Immunology
Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations
Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST
Location: Poster Section 39
Poster Board Number: 29
Published Abstract Number: 3553

Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, "We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer."

"This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs," stated Dr. William V. Williams, BriaCell’s President and CEO.

Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025 . Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies.

On April 28, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that the first patients have been dosed in KOMET-015, a Phase 1 clinical trial of ziftomenib, the Company’s potent and selective, oral investigational menin inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure (Press release, Kura Oncology, APR 28, 2025, View Source [SID1234652234]).

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"Building on compelling clinical activity of ziftomenib in patients with NPM1-mutant and KMT2A-rearranged AML, we are committed to evaluating the full therapeutic potential of menin inhibitors for the treatment of cancer," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Approximately 4,000 to 6,000 new cases of GIST are diagnosed each year in the U.S., and advanced GIST patients have limited treatment options. Our preclinical data demonstrate the combination of ziftomenib and imatinib provides robust and durable antitumor activity in both imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models, and we look forward to seeing whether the combination offers potential to transform the treatment paradigm."

In preclinical studies, the data demonstrates the combination exerts antitumor activity via a synthetic lethal mechanism through which ziftomenib epigenetically targets a vulnerability of GIST tumors actively induced by even ineffective tyrosine kinase inhibitor (TKI) treatments. Sixty percent of patients develop resistance to imatinib, the frontline standard of care for GIST, within two years, and ziftomenib has the potential to delay the onset of or overcome that resistance in these patients.

"This study is an important step in developing new combination treatments to potentially improve outcomes for patients with advanced gastrointestinal stromal tumors, a disease indication for which new therapeutic options are needed," said Mrinal Gounder, M.D., Sarcoma Oncologist & Early Phase Drug Development Specialist at Memorial Sloan Kettering Cancer Center. "KOMET-015 builds upon the promising preclinical data observed with ziftomenib in combination with imatinib in GIST models and we look forward to evaluating the investigational drug candidate and its potential to transform the treatment landscape."

"Until now, most approaches to treating gastrointestinal stromal tumors rely on targeted KIT inhibition via tyrosine kinase inhibitors such as imatinib, however most patients eventually progress due to acquired secondary KIT mutations highlighting the need for new treatment options," said Shreyaskumar Patel, M.D., Center Medical Director, Sarcoma Center, at The University of Texas MD Anderson Cancer Center. "We are highly encouraged by the substantial preclinical data generated to date supporting the combination for ziftomenib in combination with KIT inhibitors in advanced GIST, and the dosing of the first patients marks an important milestone to address the meaningful unmet need for these patients."

The KOMET-015 Phase 1a/1b, open-label, dose-escalation trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib in adults with GIST who have documented disease progression while currently on or previously treated with imatinib. Upon completion of the dose-escalation portion of the trial, expansion cohorts are planned to further assess the safety, tolerability, and clinical activity of ziftomenib. The primary objectives include evaluation of safety and tolerability and determination of the recommended Phase 2 dose, and key secondary endpoints include clinical benefit, overall response rate (ORR), progression free survival (PFS), duration of response, and overall survival (OS).

Currently, there are no other clinical trials evaluating the combination of a menin inhibitor with standards of care for the treatment of GIST. For more information regarding the KOMET-015 trial, please visit www.clinicaltrials.gov (identifier: NCT06655246).

About GIST

Gastrointestinal stromal tumors (GIST) are the most common form of sarcoma, and are characterized as KIT-dependent solid tumors, with an estimated 4,000 to 6,000 new cases diagnosed in the U.S. each year. Despite the successful disease control achieved with imatinib in advanced GIST patients, most patients eventually progress due to acquired secondary KIT mutations. TKIs such as sunitinib target imatinib-resistant genotypes and are approved in later lines, but response rates and long-term outcomes are modest, so new therapeutic options are needed.

About Ziftomenib

Ziftomenib is a once daily, oral investigational menin inhibitor currently in development for the treatment of genetically defined AML and GIST patients with high unmet need. In April 2024, ziftomenib received Breakthrough Therapy Designation (BTD) from the FDA for the treatment of relapsed/refractory (R/R) NPM1-mutant (NPM1-m) AML based on data from Kura’s KOMET-001 clinical trial. Additional information about clinical trials for ziftomenib can be found at www.kuraoncology.com/clinical-trials/#ziftomenib.

On April 28, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported on poster presentations of Kineta Inc.’s ("Kineta") KVA12123 novel anti-VISTA antibody and TuHURA’s IFx-Hu2.0 in advanced melanoma and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL (Press release, TuHURA Biosciences, APR 28, 2025, View Source [SID1234652249]).

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In the first poster presentation, (CT041/20) TuHURA and Kineta provided updated results from VISTA-101, a Phase I-II first-in-human study of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors (NCT05708950). The poster, was presented by Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. KVA12123 was found to be generally safe and well tolerated in all monotherapy and combination arms, with no dose-limiting toxicities observed. Additionally, KVA12123 demonstrated a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels, including:

At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose.
No dose limiting toxicities were observed in the study, including at the 1,000mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms
"We are pleased to have Thierry present the latest data from the KVA12123 program, a valuable drug candidate that TuHURA will acquire following the closure of the proposed merger with Kineta which is currently targeted for the end of Q2 2025. TuHURA’s exclusivity payment last July allowed Kineta the ability to restart and complete the Phase I study providing important data regarding receptor occupancy and other PK, PD and translational biomarker data at the previously unstudied 1,000mg dose level. The study demonstrated in excess of 90% VISTA receptor occupancy over the entire Q2W dosing interval where PK simulations would predict similar receptor occupancy even at 750mg Q2W dosing, which we believe will be the recommended Phase 2 dose and schedule", stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.

Dr. Bianco continued, "Our primary interest in VISTA is its potential in immunologic tolerance in a variety of blood related cancers. Recent scientific data demonstrates that NPM1 mutation, present in 30% to 35% of patients with acute myeloid leukemia (AML) results in the high expression of VISTA on leukemic blasts. This is believed to be the mechanism by which leukemia escapes immune recognition and attack and is responsible for high rate of treatment failures in AML. We look forward to evaluating the VISTA inhibiting antibody in a Phase 2 randomized study in relapsed AML, which we expect to initiate in the fourth quarter of 2025 based on the anticipated closing of the proposed merger with Kineta."

TuHURA also announced that the Markowitz Lab at Moffitt Cancer Center also presented a poster of TuHURA’s IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who, like patients in TuHURA’s Phase 1b Merkel cell carcinoma trial, progressed while on CPI therapy. The data demonstrated that, among heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD-1-based therapy, following IFx-Hu2.0, three of four patients achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI.

"Demonstration of the development of antibody specific response to the Emm55 bacterial protein expressed on the surface of the tumor cell following IFx-Hu2.0 in the phase 1 study and an abscopal effect in murine model of melanoma is consistent with the data generated in patients with advanced cutaneous malignancies like melanoma or Merkel cell carcinoma," noted Dr. Bianco. "We look forward to that anticipated initiation of our Phase 3 accelerated approval trial in first line treatment of patients with advanced or metastatic Merkel cell carcinoma targeted for later this quarter."

In the second poster presentation relating to IFx-Hu2.0 entitled: "Mechanistic Insights into IFx- Hu2.0 Responses in the First Human Trial After Prior Anti-PD-1 Therapy Failure," (3428/23) IFx-Hu2.0’s first-in-human study demonstrated stimulation of an innate immune response, with increased T cell and B cell production in peripheral blood compared to tumor tissue. This innate immune activation underscores the potential of IFx-Hu2.0 to generate tumor specific activate T and B cells for patients who are resistant to anti-PD-1 CPIs. Additionally, IFx-Hu2.0 was generally safe and well tolerated, with only mild Grade 1 and Grade 2 adverse events, largely injection site reactions.

As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) ("Kineta"), in which TuHURA agreed to acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions and subject to the conditions set forth in TuHURA’s Form 8-K filed on December 12, 2024. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain closing conditions.

On April 28, 2025 PredxBio, a pioneer in AI-powered spatial biomarker discovery, reported a strategic collaboration with Hamamatsu Photonics K.K., a global leader in imaging technologies (Press release, Hamamatsu Photonics KK, APR 28, 2025, View Source [SID1234652266]). The partnership unites Hamamatsu’s advanced MoxiePlex multiplex immunofluorescence imaging system with PredxBio’s SpaceIQ spatial analytics platform to deliver an integrated workflow tailored to basic and translational research tailored to immuno-oncology.

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Launched in late 2024, Hamamatsu’s MoxiePlex is a research use only platform that captures up to 10 fluorescent markers simultaneously, enabling precise spatial mapping of proteins on cancer and immune cells within the tumor microenvironment. Designed to support the complex needs of spatial proteomics research while maintaining workflow simplicity, MoxiePlex may in the future be developed for clinical applications, especially in areas like immunotherapy response profiling.

"This partnership reflects a shared vision to unlock the true potential of spatial proteomics through innovation and accessibility," said James Butler, VP of Marketing at Hamamatsu Corporation (the US subsidiary of Hamamatsu Photonics). "With MoxiePlex and SpaceIQ combined, we’re delivering a solution that meets the demands of advanced cancer research today, while paving the way for future development of clinical integrations."

By combining the high-resolution imaging capabilities of MoxiePlex with the explainable, multi-modal analytics of SpaceIQ, the joint offering creates a streamlined, plug-and-play ecosystem. Researchers can move from image capture to actionable insights—such as spatial immune cell profiling, pathway activation analysis, and biomarker stratification—with unprecedented speed, clarity, and scalability.

"We’re excited to partner with Hamamatsu to bridge the gap between image generation and spatial intelligence," said Dr. Dusty Majumdar, CEO of PredxBio. "Our joint solution makes it possible to explore not only what proteins are expressed, but where and how they drive disease biology—empowering researchers and drug developers with insights that matter."

PredxBio and Hamamatsu are jointly committed to simplifying spatial workflows while enhancing biological resolution. The integration supports spatially resolved proteomic data in support of translational research, biomarker validation, and clinical trial optimization.