On October 1, 2024 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) and Philogen S.p.A (BIT: PHIL) ("Philogen") reported that they have entered into a global licensing agreement for commercializing Philogen’s specialty product, Fibromun (L19TNF) (Press release, Philogen, OCT 1, 2024, View Source [SID1234646934]). Fibromun, an innovative anti-cancer immunotherapy, is being investigated in registration trials by Philogen for the treatment of soft tissue sarcoma and glioblastoma.

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Under the terms of the agreement, Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun. Philogen will complete the ongoing pivotal clinical trials for the product, pursue Marketing Authorization with regulatory authorities, and manufacture commercial supplies. Sun Pharma will be responsible for commercialization activities. The two partner companies will share post-commercialization economics in about 45(Philogen):55(Sun Pharma) ratio. Other financial terms were not disclosed.

Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, "Fibromun’s progress through development has been quite encouraging and it has potential to be an important option for treatment of soft-tissue sarcomas and other cancers with significant unmet medical needs. This partnership expands our clinical pipeline into oncology in alignment with our current portfolio in skin cancers. We keenly look forward to providing this treatment option globally in due course of time."

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "We are pleased to extend our collaboration with Sun Pharma, a leading global pharmaceutical company, from our existing partnership on Nidlegy to Fibromun. This collaboration will focus on the global commercialization of Fibromun, a new immunotherapy that has the potential to serve patients with soft tissue sarcoma and certain malignant forms of brain tumors (e.g., glioblastoma), for which limited therapeutic alternatives exist. Our group has published data reflecting the promising therapeutic activity of Fibromun in glioblastoma, inducing long-lasting anti-tumor responses in a subset of patients. We have also announced that an independent monitoring board has evaluated safety and efficacy data of the pre-planned interim analysis of our Phase III clinical trial in soft tissue sarcoma and recommended continuing the study as planned by the protocol. In view of these promising developments, both companies are committed to the development and commercialization of Fibromun, making it widely available to patients who may benefit from it."

Previously, the two companies announced that on May 30, 2023, they entered into an Exclusive Distribution, License, and Supply Agreement for commercializing the specialty product Nidlegy in Europe, Australia and New Zealand. The first Marketing Authorization Application for Nidlegy has been submitted to European Medicines Agency (EMA) for the treatment of locally advanced, fully resectable melanoma in the neoadjuvant setting.

About Fibromun (L19TNF, onfekafusp alfa)
Fibromun is a biopharmaceutical product, proprietary to Philogen, studied for the treatment of advanced soft tissue sarcoma and glioblastoma. It consists of the L19 antibody genetically fused to Tumor Necrosis Factor (TNF). L19 binds selectively to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy adult tissues. TNF is a cytotoxic cytokine with anti-tumor activity that is preferentially localized by the L19 antibody to neoplastic masses. L19TNF is administered via intravenous infusion. Late-stage clinical trials with registration potential are on-going in soft tissue sarcoma and glioblastoma. The product has pan-tumoral potential and could be explored for the therapy of other cancer types (e.g., lung, breast, colon, prostate cancers).

On October 1, 2024 Owkin, the first end-to-end AI-biotech that uses cutting-edge causal AI to unlock precision drug discovery, development and diagnostics, reported a new partnership with AstraZeneca, a global biopharmaceutical company, to develop an AI-powered tool to pre-screen for gBRCA mutations (gBRCAm) in breast cancer directly from digitized pathology slides (Press release, Owkin, OCT 1, 2024, View Source [SID1234646987]). As part of Owkin’s ongoing collaboration with Gustave Roussy and The Centre Léon Bérard through PortrAIt, a French consortium to accelerate precision medicine through AI-enabled digital pathology, this tool aims to significantly accelerate and expand access to gBRCA testing that too many patients may not be considered for.

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Thomas Clozel, MD, CEO of Owkin, said: "We are excited to collaborate with AstraZeneca to bring the benefits of AI to BRCA testing with the gBRCA Pre-Screen solution. During Breast Cancer Awareness Month, it’s especially important to highlight how by streamlining the diagnostic process for determining BRCA mutation status, we can expand access to BRCA testing and identify more gBRCAm patients more rapidly. Our goal is to generate the best possible medical evidence through multiple clinical studies, making genetic testing more accessible and precise, and therefore reduce the inequity of care by allowing more patients to benefit from tailored care."

BRCA testing, which identifies mutations in the BRCA1 and BRCA2 genes, plays a vital role in determining an individual’s risk for developing certain cancers, including breast and ovarian cancers. Knowing the BRCA status of breast cancer patients is important to help identify familial risk and guide treatment options, including responses to targeted therapies. While many professional bodies have released guidelines recommending broader BRCA testing, it is not always consistently offered to eligible individuals, and implementation varies between countries. This is causing an inadvertent exclusion of individuals who may benefit from these tests. If routinely used, this gBRCA pre-screening solution could lead to the identification of thousands more gBRCAm HR-positive early breast cancer patients in France, Germany, Italy, Spain, and the United Kingdom by 2030.

Kristina Rodnikova, Head of Global Commercial Diagnostics, Oncology at AstraZeneca, said: "On average, a woman with a BRCA1 or BRCA2 gene mutation has up to a 7 in 10 chance of being diagnosed with breast cancer by age 80. This collaboration with Owkin underscores our commitment to advancing precision medicine, helping address the unmet need and identifying patients at risk of harboring BRCA mutations to improve their outcomes."

The typical BRCA testing journey for a patient can take several months and involve several healthcare professionals, from initial consultation to results, strongly impacting the patient’s outcomes. The gBRCA pre-screening solution has the potential to significantly enhance the efficiency of BRCA mutation identification. In less than one hour, the solution could identify a patient at high risk of harboring gBRCA mutation by leveraging existing material, including H&E slides. This could greatly streamline the gBRCA testing process, allowing oncologists and genetic counsellors to accelerate the gBRCA genetic testing for high-risk patients and incorporate these genetic test results into the treatment planning process without delays.

The solution is currently in development and undergoing validation.

On October 1, 2024 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 dramatic anti-tumor response including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study of BriaCell’s Bria-IMT plus an immune checkpoint inhibitor regimen (Press release, BriaCell Therapeutics, OCT 1, 2024, View Source [SID1234646970]). The patient demonstrated an initial partial response at 2 months in the brain lesion with no detectable disease following 8 and 11 months of treatment.

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The heavily pre-treated patient who had failed 8 prior regimens including ADC therapy, previously demonstrated significant reduction of her "Eye-Bulging" orbital tumor and continues treatment with the Bria-IMT regimen. She has completed 17 cycles of treatment and has been on BriaCell’s Phase 2 study for 12 months. Also noteworthy is a sustained drop in her tumor markers, confirming the imaging results of marked tumor reduction.

On October 1, 2024 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 the pricing of a best-efforts offering of 5,128,500 common shares and warrants to purchase up to 5,128,500 common shares at a combined offering price of $0.975 per share and associated warrant, priced at-the-market under Nasdaq rules (Press release, BriaCell Therapeutics, OCT 1, 2024, View Source [SID1234646972]). The warrants will have an exercise price of $0.85 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. All of the common shares and associated warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5 million. The offering is expected to close on October 2, 2024, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity is acting as sole placement agent for the offering.

The securities described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering is being made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 1, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported that results from the GARNER (Genomic Analysis of high-Risk Non-muscle invasive bladder cancER) study were published in Clinical Cancer Research (Press release, GeneCentric Therapeutics, OCT 1, 2024, View Source [SID1234646988]). The GARNER study, the largest high-risk non-muscle invasive bladder cancer (HR-NMIBC) patient cohort ever assembled with both clinical and genomic detail, investigated fibroblast growth factor receptor (FGFR) DNA alteration (ALT) frequency and activation in HR-NMIBC and the clinical outcomes associated with standard-of-care Bacillus Calmette-Guérin (BCG) treatment. The study was conducted by the Erasmus MC Urothelial Cancer Research Group (EUCRG) at the Erasmus MC Cancer Institute. Janssen Research & Development, LLC, a Johnson & Johnson company, and GeneCentric collaborated to perform genomic testing.

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Although many HR-NMIBC patients respond to BCG treatment, 50-70% have a recurrence, and up to 20% progress to muscle-invasive bladder cancer (MIBC) or locally advanced/metastatic disease. Alternative therapies including FGFR-targeting agents are being investigated. While eligibility for FGFR-targeted therapies has focused on patients who are FGFR ALT (+), DNA alterations may not fully identify all patients who could potentially benefit from FGFR-targeted therapy. In this study, GeneCentric’s novel RNA-based FGFR-PRS identified approximately two-fold more patients with an activated FGFR pathway compared to those who were FGFR ALT (+).

"GeneCentric is intensely focused on developing RNA-based signatures, because DNA alterations and other biomarkers may have limitations in identifying all patients who could potentially benefit from targeted therapies," said Kirk Beebe, PhD, Chief Scientific Officer at GeneCentric. "The GARNER study allowed us to apply the FGFR-PRS to tumors from a high-risk group of patients with bladder cancer to show that the prevalence of FGFR-PRS positive tumors was much higher than the number of tumors identified with FGFR DNA alterations. Beyond HR-NMIBC, we have developed gene signatures for a broad range of targeted therapies, with a vision for this approach eventually becoming the paradigm for patient selection as an adjunct or in place of DNA alteration testing."

Findings related to the FGFR-PRS from the study include:

The FGFR alteration frequency (i.e., FGFR ALT (+)) in HR-NMIBC tumors was 31%.
The frequency of FGFR-activated tumors using the FGFR-PRS was more than twice as high as FGFR ALT+ at 75%.
This enrichment of tumors that may be FGFR-activated identified by the FGFR-PRS compared to FGFR-altered tumors was also observed in more advanced-stage disease (muscle-invasive and metastatic urothelial cancer).
About the GARNER Study

The GARNER study is the largest HR-NMIBC real-world patient cohort ever assembled with both clinical and genomic detail and the first study of the broader GARNER Bladder Cancer Program. The study is comprised of a cohort of almost 1,200 NMIBC patients who underwent surgery and adjuvant BCG treatment. The study was conducted by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Department of Urology at Erasmus MC Urothelial Cancer Research Group (EUCRG) at the Erasmus MC Cancer Institute. Janssen Research & Development, LLC, a Johnson & Johnson company, and GeneCentric Therapeutics performed retrospective genomic analysis of longitudinal samples collected in this study.