On September 18, 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 U.S. FDA (FDA) authorization of an Expanded Access Policy (EAP) for metastatic breast cancer (MBC) patients (Press release, BriaCell Therapeutics, SEP 18, 2024, View Source [SID1234646765]).

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FDA requires BriaCell to have an EAP policy, as a condition of granting BriaCell’s Fast Track designation , and to help MBC cancer patients in need of novel treatments. The EAP provides access to cancer patients beyond the scope of BriaCell’s pivotal Phase 3 trial (ClinicalTrials.gov as NCT06072612 ) to receive treatment with the Bria-IMT regimen.

"FDA authorization for the EAP highlights its awareness of the safety and efficacy profile of Bria-IMT and patients’ need to access such a novel treatment. While we are conducting our pivotal Phase 3 trial of Bria-IMT regimen with an immune checkpoint inhibitor, Bria-IMT may provide a treatment option for cancer patients in need," stated Dr. William V. Williams, BriaCell’s President and CEO. "Despite numerous approved drugs, breast cancer remains the second leading cause of cancer death in American women. With our novel immunotherapy, we expect to bring hope to patients and families suffering from this deadly disease."

"Given the recently reported impressive survival and clinical benefit of Bria-IMT regimen in metastatic breast cancer patients who failed multiple prior treatments, more patients would be able to benefit from the EAP with BriaCell’s novel immunotherapy approach," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We hope that our novel immunotherapy will become a new standard of care for metastatic breast cancer patients."

On September 18, 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $100.00 per share (Press release, Nuvalent, SEP 18, 2024, View Source [SID1234646728]). The gross proceeds of the offering were approximately $575.0 million, before deducting underwriting discounts and commissions and other offering expenses. All shares in the offering were offered by Nuvalent.

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J.P. Morgan, TD Cowen, Jefferies and Stifel are acting as joint book-running managers for the offering.

The shares were offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. This offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

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

On September 18, 2024 GlyTherix Ltd (GlyTherix) an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors reported a new global clinical supply agreement with Wisconsin-based SHINE Technologies, a pioneer in next-generation fusion-based technology and North America’s largest producer of non-carrier added lutetium-177 (n.c.a. Lu-177) chloride (Press release, Glytherix, SEP 18, 2024, View Source [SID1234646729]). SHINE will supply its n.c.a. Lu-177 chloride, Ilumira, for use in GlyTherix’s clinical trials focused on innovative treatments for aggressive and invasive cancers.

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As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality, n.c.a. Lu-177 to patients. SHINE will supply n.c.a. Lu-177 for use in GlyTherix’s clinical trials with a particular focus on the expansive U.S. market.

GlyTherix’s radiotherapy combines Lu-177 with a molecule targeting Glypican-1, a protein in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Their 177Lu-DOTA-Miltuximab will enter Phase Ib trials in early 2025.

GlyTherix will use 177Lu-DOTA-Miltuximab targeting tumors expressing Glypican-1 in its planned Australian Phase Ib therapeutic dose escalation trial scheduled to commence early 2025. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer.

Dr. Brad Walsh, GlyTherix’s Chief Executive Officer said, "SHINE’s investment in high-quality isotope production places them at the forefront of the radiopharmaceutical supply chain with particular strength in servicing the U.S. market. This supply agreement for the medical radioisotope Lu-177 adds to GlyTherix’s global clinical supplier network, which also includes a clinical supply agreement with the Australian Nuclear Science and Technology Organization (ANSTO)".

Greg Piefer, SHINE founder and CEO added, "Our partnership with GlyTherix, a true pioneer in targeted radiotherapy, represents an important step in advancing next-generation cancer treatments. GlyTherix’s innovative approach has the potential to transform cancer care for patients with some of the most challenging solid tumors. By providing a reliable supply of high-quality Ilumira, we’re proud to support their groundbreaking work that could offer new hope to patients with limited treatment options."

SHINE’s Ilumira is produced in the company’s Cassiopeia facility in Janesville, Wisconsin – the largest of its kind in North America. With an initial production capacity of 100,000 doses per year and the potential for expansion to 200,000 doses annually, SHINE is well-positioned to meet the growing demand for Lu-177 in cancer therapies.

This partnership with GlyTherix marks another significant milestone in SHINE’s mission to harness nuclear technology for human health. By providing a reliable, high-quality supply of Ilumira for innovative clinical trials, SHINE is playing a crucial role in advancing targeted radiotherapy. As SHINE continues to expand its production capabilities and pursue vertical integration in Lu-177 supply, collaborations like this have the potential to transform cancer treatment worldwide, offering new hope to patients facing aggressive and hard-to-treat cancers.

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 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China (Press release, InnoCare Pharma, SEP 18, 2024, View Source [SID1234646730]).

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Acute myeloid leukemia (AML) is a malignant hematological disease originating from hematopoietic stem/progenitor cells, accounting for about 80% of acute leukemia in adults. The risk of developing AML increases with age and is more common in middle-aged and elderly people. AML is also not uncommon in individuals under 18 years old, representing about 15-20% of pediatric leukemia and 80% of leukemia in neonates and infants1.

BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. It has anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "With strong pipeline in hemato-oncology, InnoCare is dedicated to developing therapeutics with diverse mechanisms of action (MoA) to achieve comprehensive coverage of blood tumor indications. ICP-248 is an important global asset of our company in the field of hematology. We will accelerate clinical development and look forward to bringing greater benefits to patients with hematological malignancies early."