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TuHURA Biosciences, Inc. and Kineta, Inc. Stockholders Approve Proposed Merger and All Related Proposals

On June 23, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the Company’s Special Meeting of Stockholders held today, June 23, 2025 (the "TuHURA Special Meeting") (Press release, TuHURA Biosciences, JUN 23, 2025, View Source [SID1234654061]). The proposals included an increase of the Company’s authorized shares to 200 million shares and a proposal to reincorporate the Company in Delaware.

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Additionally, Kineta stockholders approved the proposed merger (the "Merger") with TuHURA at Kineta’s Special Meeting of Stockholders held today, June 23, 2025 (the "Kineta Special Meeting"). The parties anticipate that the Merger will close as soon as possible following the satisfaction or waiver of any remaining closing conditions.

The final voting results of the TuHURA Special Meeting and the Kineta Special Meeting will be reported in Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission.

Revolution Medicines Announces FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations

On June 23, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations (Press release, Revolution Medicines, JUN 23, 2025, View Source [SID1234654060]).

The Breakthrough Therapy Designation is based on encouraging data from the Phase 1 RMC-6236-001 clinical trial evaluating daraxonrasib in patients with previously treated metastatic PDAC.

"This Breakthrough Therapy Designation underscores the enormous need for new treatments for patients with pancreatic cancer and highlights the potentially important role the investigational drug, daraxonrasib, may have in helping patients living with this disease," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We look forward to substantially completing enrollment of the RASolute 302 study this year to enable an expected readout in 2026, and should the results support it, working closely with the FDA and other regulatory agencies around the world to bring daraxonrasib to patients as quickly as possible."

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

More than 90% of patients living with PDAC have tumors carrying a RAS cancer driver mutation with ~85% carrying a KRAS G12 mutation. Revolution Medicines is currently enrolling patients in RASolute 302, a global Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC. The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation. The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases2. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations3. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%4.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Purple Biotech Highlights Significant Advantages of the Novel CAPTN-3 Tri-Specific Antibody Platform at the EACR 2025 Annual Congress

On June 23, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported the presentation of new preclinical data on its novel CAPTN-3 tri-specific antibody platform in a poster presentation at the 2025 Annual Congress of the European Association for Cancer Research (EACR 2025), that was held in Lisbon, Portugal from June 16-19, 2025 (Press release, Purple Biotech, JUN 23, 2025, View Source [SID1234654059]).

"Purple’s proprietary CAPTN-3 platform of T-cell engagers enables the creation of a large number of antibodies to different targets, and by capping the anti-CD3 arm for conditional activation and adding an NK cell antibody arm, we are creating tri-specific antibodies that safely activate both the innate and adaptive immune systems," said Gil Efron, Purple Biotech CEO. "Our poster at EACR 2025 highlights the flexibility and efficiency of the platform."

The design of the CAPTN-3 lead product and other candidates in this platform includes an anti-NKG2A arm, which acts both as an NK cell antigen and as an immune checkpoint on both T cells and NK cells through its interaction with HLA-E, which is often upregulated in tumors to evade immune detection.

NKG2A expression identifies a subset of human gamma delta 2 T cells exerting the highest antitumor effector functions. Anti-NKG2A function is required to unleash the NKG2A+ gamma delta 2 T cell anti-cancer activity. Our data demonstrate that the NKG2A arm in CAPTN-3 TCE synergizes with the anti-CD3 arm to induce significant cytotoxic effects against solid tumor cells.

NKG2A is an immune checkpoint that plays an important role in the exhaustion of cytotoxic T cells in the tumor microenvironment (TME). The preclinical data demonstrate the potential of CAPTN-3 to re-invigorate exhausted T cells and efficiently kill solid tumor cells, largely attributed to the significant contribution of the unique anti-NKG2A arm.

These activities are further supported by the in-vivo data demonstrating that both the NKG2A and CD3 arms contribute to the sustained tumor regression observed in mice models. These results underscore the innovative design of CAPTN-3, highlighting the impact of the novel anti-NKG2A arm and its synergistic effect with the anti-CD3 arm.

The CAPTN-3 platform creates a tri-specific scaffold with three binding arms. In the variable region, one arm conditionally binds to CD3, only after the cap has been cleaved by proteases in the TME. The other variable region engages natural killer (NK) cells, activating the innate immune system to join activated T cells in the killing of tumor cells. The constant region of the tri-specific antibody targets tumor associated antigens (TAA) to recruit both NK and T cells to the tumor. Through activation of both the innate and adaptive immune systems, the CAPTN-3 platform can generate synergistic responses within the TME, without the risk of off-target cytokine release.

Key Highlights from the Poster Presentation:

● Robust In Vivo Anti-Tumor Activity: The lead CAPTN-3 tribody, IM1240 (capped-CD3×5T4×NKG2A), induced sustained tumor regression in a triple negative breast cancer (TNBC) xenograft model.

● Conditional, Tumor-Restricted Activation: The ‘capped’ CD3 arm remained inactive in serum samples of advanced cancer patients and healthy donors and is selectively unmasked by TME proteases, expanding the therapeutic window and reducing potential systemic NKG2A+NK cell depletion.

● Dual Innate and Adaptive Engagement: IM1240’s NKG2A checkpoint blockade arm synergizes with the CD3 engager to activate both innate and adaptive immune subsets, translating to potent cytotoxicity in vitro and in vivo. The poster demonstrates:

o Activation of the extremely high antitumor NKG2A+ gamma delta 2 T effector cells

o Reinvigoration of exhausted T cells against solid tumor cells

o The added value of IM1240 NKG2A arm to the in-vivo tumor suppression

● Plug & Play Flexibility: Additional CAPTN-3 tribodies, such as IM1060 (CD3×5T4×NKG2D) and IM1065 (CD3×EGFR×NKG2A), demonstrated significant tumor regression, underscoring the platform’s modularity and customizable capabilities.

● Superior efficacy versus combination of individual antibodies was demonstrated.

EACR 2025 poster details are as follows:

Abstract #: EACR25-1964

Title: "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers"

Session Title: Immunotherapy

The poster is available in the Publications section on Purple Biotech’s website.

Abstracts related to the EACR meeting will be published online following the presentation. For more information, please visit the EACR 2025 website.

Oxcia enters a research collaboration with LEO Pharma to explore OXC-101 in medical dermatology

On June 23, 2025 Oxcia reported that it has entered into an early research collaboration with LEO Pharma to explore OXC-101 in topical formulations for medical dermatology indications including psoriasis (Press release, Oxcia, JUN 23, 2025, View Source;utm_medium=rss&utm_campaign=oxcia-enters-a-research-collaboration-with-leo-pharma-to-explore-oxc-101-in-medical-dermatology [SID1234654058]).

Oxcia is developing an oral product, OXC-101, mainly for treatments of cancer. In one of Oxcia’s clinical trials, a cancer patient with plaque psoriasis experienced significant improvement in the disease during OXC-101 treatment, indicating that OXC-101 might also have potential in skin diseases, as previously seen in pre-clinical models. OXC-101 is a mitotic MTH1 inhibitor with biological rationale also to treat skin diseases.

This collaboration, aimed at exploring OXC-101 for medical dermatology, aligns with Oxcia’s vision of extending the application of its technology platform beyond cancer. LEO Pharma’s proven expertise and long-standing success in developing dermatology treatments that deliver significant therapeutic advancements make them the ideal partner to help explore the potential of Oxcia’s OXC-101.

"We are very happy about the collaboration with LEO Pharma, a leading global dermatology company. Cancer cells and activated T cells have many similarities, i.e. increased oxidative stress and heightened levels of the enzyme MTH1, meaning that OXC-101 has potential also in auto-immune diseases. Together with Professor Helleday and Professor Enerbäck’s research groups, Oxcia have shown that OXC-101 has good effects in disease models for psoriasis and it is exciting that this is now further investigated. The patient that responded well on OXC-101 treatment is encouraging and we are looking forward to seeing the results of the continued development. At Oxcia, we also see the psoriasis project as a confirmation of the potential and versatility of the O2-DDR platform" says Ulrika Warpman Berglund, CEO of Oxcia.

Lyell Immunopharma to Participate in the H.C. Wainwright “HCW@Home” Series

On June 23, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, reported that members of its senior management team will participate in the H.C. Wainwright "HCW@Home" Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET (Press release, Lyell Immunopharma, JUN 23, 2025, View Source [SID1234654057]).

The discussion will highlight the positive new clinical data recently presented in an oral session at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on LYL314, Lyell’s lead product candidate, and the emerging landscape of next-generation dual targeting chimeric antigen receptor (CAR) T-cell therapy for patients with large B-cell lymphoma (LBCL). LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) that is in pivotal-stage development for patients with relapsed and/or refractory LBCL. LYL314 is designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL.

Fireside chat details are as follows:

Lyell Speakers: Lynn Seely, MD, President and Chief Executive Officer and Charlie Newton, Chief Financial Officer
Date and Time: Wednesday, June 25, 2025, 12:00 PM to 1:00 PM ET
Webcast Link: Register here

A live webcast of the presentation can be accessed through the Investors section of the Company’s website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company’s website.