On September 18, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it will present at the Ovarian Cancer Research Alliance’s ("OCRA") International Gynecologic Cancer Conference taking place online September 25-27, 2024 (Press release, Anixa Biosciences, SEP 18, 2024, View Source [SID1234646717]).

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The presentation, entitled "Autologous T Cells Engineered to Target Follicle Stimulating Hormone (FSH) Receptor in Recurrent Ovarian Cancer, A Phase 1 Trial," will be presented by Dr. Pamela Garzone, Anixa’s Chief Development Officer, and will discuss the clinical development of Anixa’s novel chimeric antigen receptor T cell (CAR-T) therapy for ovarian cancer. The presentation will take place at 3:00PM ET on September 25.

The International Gynecologic Cancer Conference is organized by OCRA. OCRA is the leading organization in the world fighting ovarian cancer from all fronts while supporting women and their families.

More information about the event may be found at: International Gynecologic Cancer Conference – Ovarian Cancer Research Alliance (ocrahope.org).

About Anixa’s CAR-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor-T cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

On September 18, 2024 Brenus Pharma, a biotech company specializing in the development of cancer vaccines, reported the completion of a $25 million Series A financing round (Press release, Brenus Pharma, SEP 18, 2024, View Source [SID1234646715]).

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The round is led by Angelor, an investment fund bringing together a cluster of investors from the Auvergne-Rhône-Alpes (AURA) region, including UI Investissement for the Fonds régional Avenir industrie Auvergne-Rhône-Alpes, Crédit Agricole Centre-France and Crédit Agricole Centre-Est, with 2 family offices. Belgian funds Noshaq and Investsud complete this significant deal. Together, they join co-founder and lead investor Jacques Gardette (BIOJAG) and long-time investor Stéphane Legastelois (33 CALIFORNIE). In addition, Brenus Pharma has received non-dilutive funding from the French government and Bpifrance, as beneficiary of the France 2030 call for projects.

Jacques GARDETTE, BIOJAG Chairman commented: "Brenus Pharma has taken a major step forward. The arrival of investment professionals in our young company confirms the interest we are arousing. After the creation and sale of Biocorp to Novo Nordisk in 2023, Brenus Pharma now has our full attention to help the company achieve its ambitious goals. I’m convinced that the constant commitment and innovation of the Brenus team have built a solid foundation for tackling one of the world’s most complex therapeutic challenges. During it’s rapid development, Brenus has demonstrated boldness, achievement and resilience in the biotech field."

The proceeds will be used to fully fund the STC-1010 cancer vaccine’s first-in-human proof-of-concept, in first line settings for metastatical colorectal cancer patients. STC-1010 is the first vaccine candidate based on the STC ‘Stimulated-Tumor-(ghost)-Cells’ technology platform developed by Brenus Pharma. Adaptive and innovative, this platform uses an in-depth understanding of the complexity of cancer to offer a new type of precision treatment, enabling Brenus Pharma to give patients’ immune systems a head-start by anticipating the progression of their disease.

Marie CHAMBODUT, Partner, and Investment Director at Angelor, added: "We are proud to lead this strategic transaction for Brenus Pharma to support the clinical development of their cancer vaccines, including STC-1010, the first and most advanced program to emerge from the platform. We look forward to joining Paul and his exceptional team in transforming Brenus into a global player in precision immuno-oncology, bringing solutions to millions of patients experiencing treatment failure, and contributing to the development of the French biotherapeutics industry."

Hélène SABATEL, Investment Manager at Noshaq, said: "Together with our colleagues at InvestSud, we are delighted to support the Brenus Pharma team in the development of this cutting-edge technological platform, as we are convinced of its future impact for patients currently without concrete therapeutic solutions. We are also enthusiastic about the prospect of welcoming a Brenus R&D branch to the Liège region soon, and we hope that this new Franco-Belgian collaboration between two biotech ecosystems will provide the company with optimal support for its development."

The funds raised will enable the STC platform to be deployed in humans from the end of the year, starting with STC-1010, which will be administered as a first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC) resistant to immunotherapies (pMMR/MSS and dMMR/MSI-H). At the same time, STC-1010 will be extended to other types of gastric tumors, such as those of the pancreas and liver. Finally, Brenus Pharma intends to accelerate the development of its portfolio in other solid tumor indications, notably with STC-1020, our second candidate in development.

Paul BRAVETTI, Chief Executive Officer of Brenus Pharma, added: "We are delighted to welcome top-tier investors who have been part of recent French success stories (Mablink, Amolyt Pharma). This is an important milestone for Brenus Pharma, confirming the potential of the STC platform, and of STC-1010, which has already demonstrated solid proof of efficacy in various preclinical models. I would like to thank all our team for their motivation and their passionate work to rapidly bring a new therapeutic solution to patients. Our shared ambition is to position our platform at the forefront of the national and international scene, and to become a leader in next-generation cancer immunotherapies."

A PRESSING NEED FOR SOLUTION

This cutting-edge technology is based on proteomics-guided anti-cancer vaccines, and sparked from the ambition to produce, in France, an innovative biotherapy on an industrial scale capable of responding to a significant public health challenge: 90% of patients treated for solid tumors will suffer a relapse, while by 2022, 10 million of them will have reached a therapeutic dead-end leading to their death. This figure is set to rise by 70% by 2045 (Source: Cancer Tomorrow | IARC – View Source).

The technology developed by Brenus Pharma not only treats the immediate threat, but also defends the immune system against tumors that may appear later, thereby reducing the risk of relapse. To achieve this, STC reproduces in the laboratory the resistance and escape mechanisms of tumor cells, to educate the patient’s immune system to detect and destroy them, thanks to the widest panel of therapeutic targets currently available (over 200 tumor antigens).

With proven expertise in CMC and a standardized, ready-to-use production process, it ensures rapid availability to patients in need, with controlled costs and supply chain, outpacing personalized approaches and autologous vaccines in development.

THE "BREAK-CRC" STUDY IS DESIGNED TO CONFIRM THE THERAPEUTIC POTENTIAL OF STC-1010

STC-1010’s phase I/IIA "BreAK-CRC" study is currently under review by the European regulatory authorities and will be conducted with the participation of expert clinicians in early-phase immuno-oncology units in Europe, and subsequently in the United States. It is based on very positive preclinical studies obtained in vitro, in ovo and ex vivo, showing extremely encouraging safety and efficacy results, validated by a committee of international immuno-oncology experts.

Phase I will evaluate the tolerability of different dose levels of STC-1010, combined with low-dose immunostimulants and standard chemotherapy. Subsequently, the Phase IIA study will further evaluate treatment efficacy, with a particular focus on progression-free survival at 12 months. Innovative exploratory assays will evaluate the immune response and the dynamics of circulating tumor DNA (ctDNA). The ambition is to make STC platform products a permanent part of precision medicine by anticipating patient responses, thanks to a set of analyses unprecedented at this level of development.

On September 18, 2024 Imugene Limited (ASX:IMU), a clinical-stage immuno‐ oncology company, reported that it has received Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA) for its novel oncolytic virotherapy CF33-hNIS (VAXINIA), for the treatment of cholangiocarcinoma, a rare and aggressive form of bile tract cancer (Press release, Imugene, SEP 18, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/d4c82d92-18f3-59f9-598e-a451d46a7ffe/Imugene_Receives_Orphan_Drug_Designation_for_VAXINIA.pdf [SID1234646708]).

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The FDA grants Orphan Drug status to promote development of drugs for rare diseases that affect fewer than 200,000 people in the United States. This designation provides Imugene with a range of incentives, including tax credits, potential grant funding, waiver of certain administrative fees, and seven years of market exclusivity upon FDA approval.

Imugene’s application was supported by preclinical and clinical data from its ongoing Phase 1 MAST (Metastatic Advanced Solid Tumours) trial, which is investigating the safety and efficacy of VAXINIA. Promising results have already been observed, including one patient with cholangiocarcinoma achieving a complete response and another achieving stable disease after treatment with VAXINIA.

The MAST trial, which involves delivering the oncolytic virus either as a monotherapy or in combination with checkpoint inhibitors, is currently in the dose-escalation phase. This has recently been expanded into a further cohort of 10 patients with bile tract cancers, including cholangiocarcinoma.

Imugene’s Managing Director & CEO, Leslie Chong, commented: "Receiving Orphan Drug Designation from the FDA is a major milestone for us. It reflects the potential of VAXINIA to address the urgent need for new treatments for cholangiocarcinoma, a disease with limited therapeutic options. We are excited to continue advancing this program, which has already shown meaningful clinical responses in patients."

Cholangiocarcinoma is a rare malignancy arising from the bile ducts, which has a poor prognosis and is often resistant to conventional treatments, including chemotherapy and immunotherapy. Imugene’s innovative oncolytic virotherapy, VAXINIA, is designed to selectively target and destroy cancer cells, while also stimulating an immune response against the tumour.

On September 17, 2024 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, and researchers from multiple cancer centers including, Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, Weill Cornell Medicine and Washington University School of Medicine in St. Louis and others, reported the online publication of the manuscript "Deep Clinical Responses and Limited Inflammatory Toxicity in Patients with Relapsed/Refractory T-cell Lymphomas Receiving Duvelisib and Romidepsin"* in Nature Medicine (Press release, BostonGene, SEP 17, 2024, View Source [SID1234646714]). The study highlights significant clinical responses and reduced inflammatory toxicity in patients with relapsed and refractory T-cell lymphomas treated with a combination of duvelisib and romidepsin.

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Historically, PI3K inhibitors have been associated with autoimmune and infectious toxicities, often leading to market withdrawals. Researchers from multiple leading cancer centers had previously demonstrated single-agent activity of the PI3K-γδ inhibitor duvelisib in T-cell lymphomas, although inflammatory adverse events were noted. Based on this preliminary work, a new phase 1b/2a clinical trial was launched to investigate the safety and efficacy of duvelisib in combination with either romidepsin or bortezomib in patients with relapsed/refractory T-cell lymphomas. Combining duvelisib and romidepsin significantly improved treatment outcomes in patients with peripheral T-cell lymphomas (PTCL).

To explore tumor molecular features that may be linked to therapeutic response to this novel therapeutic combination, BostonGene performed DNA whole exome (WES) and RNA transcriptome (RNAseq) sequencing on both pre-treatment and on-treatment biopsies. BostonGene then performed integrated multi-omic molecular analyses, including cellular deconvolution, mutational landscape analyses, longitudinal genetic reconstruction to study tumor evolution, and deciphering immune microenvironment dynamic changes. BostonGene uncovered that PTCL patients with a follicular helper T-cell subtype showed increased response rates to the combination and identified gene expression patterns potentially linked to therapeutic resistance.

"Our findings offer a promising new approach for treating patients with relapsed and refractory T-cell lymphomas, specifically those with the follicular helper T-cell subtype. We are excited about the potential of this combination therapy to improve patient outcomes and expand treatment options in this challenging disease," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

*Research conducted in collaboration with Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, Dana-Farber Cancer Institute, Washington University School of Medicine in St. Louis, Stanford University, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center Collaborative Innovation Center for Cancer Medicine, Merck and Co.

On September 17, 2024 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the Cell & Gene Therapy International 2024 meeting, to be held September 23-26, 2024 in Boston, MA (Press release, ImmPACT-Bio, SEP 17, 2024, View Source;gene-therapy-international-2024-302248187.html [SID1234646713]). Sylvain Roy, ImmPACT Bio’s chief technology officer, will provide a presentation about cell therapy manufacturing entitled, "Transitioning from Manual to Automated Processing in Autologous CAR T Manufacturing: A Case Study," on Wednesday, September 25, 2024 at 12:00 PM ET.

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"While the efficacy and durability of autologous CAR T therapies remain unparalleled, a key challenge for scalability and continued adoption is the complexity and cost of manufacturing," said Mr. Roy. "At this meeting, ImmPACT Bio will present a case study of transition from an established GMP manual process to an automated, closed-processing manufacturing platform, and address key aspects on the optimization of CAR T-cell therapy manufacturing."