On October 2, 2024 Kineta, Inc., a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that TuHURA Biosciences Inc (TuHURA) is exercising its right to extend their exclusivity and right of first offer agreement (the "Agreement") for Kineta’s VISTA blocking antibody KVA12123 (Press release, Kineta, OCT 2, 2024, View Source;utm_medium=rss&utm_campaign=kineta-announces-the-extension-of-the-tuhura-biosciences-exclusivity-and-right-of-first-offer-agreement-for-kva12123-kinetas-vista-blocking-antibody-currently-in-phase-1 [SID1234647000]). Under the terms of the Agreement entered in July 2024 between Kineta and TuHURA, TuHURA has the right to extend their rights for up to two 10-day periods. Kineta is entitled to receive $150,000 for each 10-day extension.

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"In February, Kineta announced that it would be exploring strategic alternatives for the company to maximize shareholder value. This priority continues, and I look forward to providing additional information on this front later this year," said Craig W. Philips, President, Kineta. "Through the exclusivity and right of first offer agreement with TuHURA for KVA12123, we reopened the Phase 1 clinical study in August 2024 and are currently enrolling patients into this study in advanced solid tumor cancers. Kineta is focused on completing the enrollment of the Phase 1 trial by year end 2024."

"KVA12123 is a novel, differentiated new treatment alternative for patients with cancer. The progress being made in the clinical trial is encouraging. As TuHURA continues our diligence, I have been pleased with the enthusiasm for KVA12123 that I have seen in the medical community. VISTA expression is broadly observed in patients with a number of solid and hematologic cancers. KVA12123 may provide a valuable therapeutic alternative to improving the treatment of patients with cancer," said Dr. James A. Bianco, Chief Executive Officer of TuHURA.

On July 8, 2024, Kineta announced that it had entered into the Agreement with TuHURA, a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA in July 2024. Under the terms of the Agreement, any payment made by TuHURA in consideration for Kineta’s compliance with its obligations set forth in the Agreement will be credited to the upfront payment from TuHURA if a transaction between the parties is completed. In August, Kineta announced that in collaboration with TuHURA, it reopened enrollment in the VISTA-101 clinical trial. Kineta and TuHURA continue to collaborate on the ongoing Phase 1 clinical program for patients with advanced solid tumor cancer.

KVA12123, through the combination of unique epitope binding and an optimized IgG1 Fc region, has demonstrated strong tumor growth inhibition as both a monotherapy or in combination with other checkpoint inhibitors in preclinical models. KVA12123 provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer. Significant VISTA expression is observed in patients with a variety of cancer types including gynecologic tumors such as ovarian, cervical, and endometrial cancer.

On October 2, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported the presentation of data from a Phase I study (NCT04192981) evaluating concurrent paxalisib and radiation therapy (RT) in patients for the treatment of solid tumor brain metastases (BM) or leptomeningeal metastases (LM) harboring PI3K pathway mutations at the American Society for Radiation Oncology 66th Annual Meeting (ASTRO 2024), which is taking place from September 29 – October 2, 2024, in Washington, D.C (Press release, Kazia Therapeutics, OCT 2, 2024, View Source [SID1234646999]).

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"The encouraging response rates observed from this Phase 1 study suggests that the concurrent administration of the investigational brain penetrant PI3K inhibitor, paxalisib, in combination radiation therapy appears to be a viable treatment approach for addressing the tumor radioresistance in patients harboring PI3K pathway mutations," said John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "Additional data, including circulating tumor DNA (ctDNA) from this study will be presented at an upcoming 2024 scientific congress and discussions for a potential pivotal registration study to evaluate this unique combination therapy for patients with PI3K mutant brain metastases are ongoing."

Presentation details:

Title:    Multi-Center Phase I Study of Concurrent Paxalisib and Radiation Therapy in Patients with Solid Tumor Brain Metastases (BM) or Leptomeningeal Metastases (LM) Harboring PI3K Pathway Mutations
Presenter: Brandon S. Imber, M.D., M.A., Memorial Sloan Kettering Cancer Center
Abstract 1094
Scientific Session Title: CNS 4: Brain Mets and LMD
Session Date/Time: October 1, 5:15-6:15 PM ET
Summary Results from Part II of Phase 1 Study

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Concurrent daily administration of paxalisib with brain radiotherapy was generally well-tolerated at a maximum dose of 45 mg per day in advanced solid tumor patients with brain metastases and PI3K pathway mutations;

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The most commonly reported adverse events in the study were nausea, vomiting and hyperglycemia;

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Established proof-of-principle for molecularly-selected, rational combination studies in radiation oncology to assess safety and ultimately efficacy;

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Treatment with 45mg paxalisib and radiotherapy demonstrated a 67% PR; and

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Over two-thirds of the patients at MTD achieved intracranial response which compares favorably to historical response rates for WBRT alone.

The Phase 1 study (n=17 evaluable) was a two-part, investigator-initiated trial evaluating the use of paxalisib with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors. Part I of the study established the MTD of paxalisib in combination with radiation therapy, while also demonstrating promising signs of clinical activity in all nine evaluable patients. Part II was a follow-on expansion cohort to further evaluate safety and efficacy of the MTD (45mg daily) combined with radiation therapy in up to 12 additional patients.

Approximately 200,000 cancer patients develop brain metastases in the United States each year. Radiotherapy is the mainstay of treatment for brain metastases, and generally consists of either stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) or some combination thereof. The efficacy in patients who receive WBRT differs according to the type of tumor and the number and volume of brain metastases, but several recent publications cite overall response rates of 20-45%. The increasing incidence of brain metastasis and the low response rates to existing treatments underscores the need for new treatment options.

On October 2, 2024 ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, and Biotheus Inc. (Biotheus), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, reported that the two parties have entered into a Material Transfer and Evaluation Agreement (MTEA) pertaining to a Talem therapeutic antibody asset for the development of a bispecific therapy against solid tumors (Press release, ImmunoPrecise Antibodies, OCT 2, 2024, View Source [SID1234646998]). Under this MTEA, Biotheus will obtain the rights to further evaluate the suitability of Talem’s Artificial Intelligence (AI)-enhanced TATX-20 lead candidate for the development of novel bispecific antibodies for the treatment of hypoxic solid tumors.

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Under this agreement, Biotheus will receive a specialized antibody asset from Talem Therapeutics, a subsidiary of ImmunoPrecise Antibodies. Biotheus plans to use this asset in conjunction with its own proprietary technology and binders to develop a new class of cancer-fighting drugs. These innovative therapeutics, known as bispecific antibodies, are designed to simultaneously target two different targets on tumors, specifically those found in oxygen-deprived environments. This approach could potentially lead to breakthrough therapies that address the complex challenges of treating cancer, particularly in difficult-to-target tumor environments. The ultimate goal is to identify the most promising molecule for advancement into clinical trials, potentially accelerating the development of novel cancer treatments.

"We are happy to enter into a collaboration with ImmunoPrecise Antibodies, a leading AI-driven biotech with powerful multi-omics modelling expertise." stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus. "Biotheus’ broad expertise in antibody discovery and development is powered by our fully integrated capabilities. By virtue of the AI-informed molecules spawned by ImmunoPrecise’s platform, we aim to develop novel bispecific antibodies with first-in-class potential and bring forth breakthrough therapies to cancer patients in the world."

Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies, stated: "We’re excited to transfer our AI-enhanced therapeutic antibody asset to Biotheus for bispecific molecule development. This strategic move leverages our cutting-edge technology in antibody discovery and Biotheus’ expertise in bispecific engineering. Our collaboration aims to accelerate the creation of innovative cancer treatments, potentially leading to groundbreaking clinical outcomes. This agreement not only demonstrates the value of our AI-enhanced assets but also sets the stage for a long-term, mutually beneficial partnership that could transform the landscape of cancer therapeutics. We anticipate this collaboration will drive significant value for both companies and, most importantly, for patients in need of advanced treatment options."

The transfer of this therapeutic asset to Biotheus aims to accelerate the development of targeted therapies that could potentially improve outcomes for patients with solid tumors. Following the transfer, Biotheus will evaluate the TATX-20 lead candidate. If the evaluation proves successful, Biotheus intends to further develop the bispecific molecules, with the objective of creating a clinically successful product that addresses the challenges associated with treating hypoxic solid tumors resistant to current therapies.

On October 2, 2024 Etcembly reported a groundbreaking new research study aiming to uncover new targets for cancer therapies by analysing the immune cells of cancer survivors (Press release, Etcembly, OCT 2, 2024, View Source [SID1234646997]).

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The ETCh study is recruiting people aged 18-65 who are living with or have survived cancer to join the study, as well as healthy volunteers. Participants will be asked to donate a small amount of blood up to five times over the course of one year, and provide information about their health.

Unlocking the secret to surviving cancer

The ETCh study is rooted in the well-established concept that long-term survivors have beaten cancer due to their immune system’s ability to recognise and eliminate cancerous cells. However, a systematic search for the specific targets recognised within tumours has yet to be undertaken.

In this study, blood samples will be collected from people who are living with or have survived cancer as well as healthy individuals. The research team will conduct an extensive analysis of the immune repertoire at an unprecedented scale by sequencing millions of antibodies and T cell receptors (TCRs) from each participant.

Etcembly’s advanced AI platform, EMLyTM, will then perform an in-depth analysis to identify which of these are likely to play a role in recognising and destroying cancer cells, and determine the aberrant molecules in tumours that they target.

These molecules could become new targets for next-generation immunotherapies that harness the power of a patient’s own immune system to combat cancer. The team expects to identify new targets within 12 to 18 months, which will then enter Etcembly’s pipeline for developing novel TCR-based therapies.

Harnessing the power of TCRs

This approach will allow Etcembly to delve deep into the immune response of cancer survivors and find vital clues to future cures.

Nick Pumphrey, Chief Scientific Officer at Etcembly says, "There is an urgent need to discover new cancer targets that traditional approaches have largely failed to deliver. By approaching the problem from the opposite direction, we can identify TCRs and targets from cancer survivors that have proven their ability to beat cancer, allowing us to develop therapies that are more likely to work for others."

On October 2, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that the U.S. Food & Drug Administration (FDA) cleared an IND application for ALE.P02, an anti-CLDN1 ADC with a tubulin inhibitor payload (Press release, Alentis Therapeutics, OCT 2, 2024, View Source [SID1234646996]). A Phase 1/2 clinical trial in patients with CLDN1+ squamous tumors is expected to start during the first quarter of 2025.

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"ADCs have shown great potential in the treatment of cancer," Luigi Manenti, Chief Medical Officer of Alentis. "Squamous cancers originating in the head and neck, cervix, esophagus and lung are characterized by high CLDN1 expression, and ALE.P02 provides a first-in-class opportunity for these patients who need new therapies after first-line treatment fails."

"Anti-CLDN1 ADCs are exciting because they address the urgent need for novel targets in the ADC space," added Tony Mok, Professor of Clinical Oncology at the Chinese University of Hong Kong. "ALE.P02 is particularly promising for squamous cancers, including HNSCC and NSCLC, where CLDN1 is often overexpressed. The unmet medical need in these indications is significant, and I look forward to the results of the Phase 1/2 study."

Dr. Roberto Iacone, Chief Executive Officer of Alentis said, "ALE.P02, entering the clinic, marks a significant advancement in our oncology pipeline. We can maximize our development plan by leveraging insights from human clinical trials of lixudebart (ALE.F02), used as the backbone antibody for Alentis’ ADCs."

Dr. Iacone added, "For our second ADC program, ALE.P03, with its topoisomerase I inhibitor payload, we plan to initiate a first-in-human clinical trial in 2025."

About ALE.P02
ALE.P02 is a first-in-class ADC designed by linking a tubulin inhibitor, a potent cancer drug, to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination could be a powerful new tool to fight the many squamous cancers that overexpress CLDN1 with less toxicity than traditional cancer drugs.