On October 3, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported to gather clinical evidence for the steady improvement of its AI-Immunology platform (Press release, Evaxion Biotech, OCT 3, 2024, View Source [SID1234647026]).

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The platform’s precision has significantly improved between the two clinical trials with Evaxion’s personalized cancer vaccine EVX-01. In the ongoing phase 2 trial, 81 out of 103 (79%) vaccine targets assessed to date triggered a tumor-specific immune response, a notable increase from the 58% observed in the phase 1 trial completed last year.

The high number of immune-active vaccine targets is observed across all patients. The ability to trigger a broad and consistent tumor-specific immune response is pivotal for a vaccine’s clinical efficacy and, thereby, critical for the vaccine’s commercial potential and ability to address unmet medical needs.

"As a truly AI-first TechBio company, Evaxion rests on our leading AI-Immunology platform and its continued improvement remains a top priority for us. It is, of course, very pleasing to see that we are successful in that work, reaching 79% of identified vaccine targets triggering an immune response in the ongoing EVX-01 phase 2 trial. This compares very favorably to data reported from other personalized cancer neoantigen trials. We are further pleased that the clinical outcome data are also very strong, providing us with a compelling AI-Immunology derived investigational vaccine candidate." says Christian Kanstrup, CEO of Evaxion.

The improvement of the AI-Immunology platform’s predictive capabilities results from iterative learning loops, optimization based on clinical data and the integration of novel bioinformatic and machine learning methodologies.

About AI-Immunology
AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modeling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

On October 3, 2024 Onconetix, Inc. (Nasdaq: ONCO) ("Onconetix" or "the Company") (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, reported the signing and closing of a private placement of (i) 3,499 shares of the Company’s Series C Convertible Preferred Stock, $0.00001 par value (the "Series C Preferred Stock"), and (ii) warrants (the "Warrants") to acquire up to an aggregate of 591,856 additional shares of the Company’s common stock, $0.00001 par value per share (the "Common Stock"), for aggregate gross proceeds of approximately $2.0 million (Press release, Onconetix, OCT 3, 2024, View Source [SID1234647012]). The Series C Preferred Stock are initially convertible into an aggregate of 776,590 shares of Common Stock, subject to certain anti-dilution adjustments. The Warrants will have an exercise price of $4.38 per share, subject to customary adjustments, and are exercisable beginning six months and one day after the issuance date (the "Initial Exercisability Date") and expiring on the third anniversary of the Initial Exercisability Date. The Company has filed a Current Report on Form 8-K with the Securities and Exchange Commission on October 3, 2024, with additional details of the transaction. The Company agreed to seek stockholder approval for the issuance of all of the shares of Common Stock issuable upon conversion of the Series C Preferred Stock and exercise of the Warrants in accordance with the rules and regulations of the Nasdaq Stock Market. The Company intends to use the gross proceeds from the private placement for working capital and general corporate purposes.

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Additionally, on October 2, 2024, Onconetix entered into a Common Stock Purchase Agreement with an equity line institutional investor (the "Purchaser"), whereby the Company has the right, but not the obligation, to sell to the Purchaser, and, subject to limited exceptions, the Purchaser is obligated to purchase, up to $25 million of newly issued shares of the Company’s common stock. The Company’s right to commence sales of Common Stock to the Purchaser are subject to certain conditions, including that a registration statement covering the resale of such shares is declared effective by the SEC. Actual sales of shares of Common Stock to the Purchaser under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding and the Company’s operations.

"We are pleased to announce this private placement and the equity line of credit," said Ralph Schiess, Interim CEO. "The Company expects to use the proceeds from the financing to fund operations and potential growth opportunities."

Tungsten Advisors served as the financial advisor to Onconetix.

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 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 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.