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Regeneron Announces Investor Conference Presentations

On August 23, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, AUG 23, 2023, View Source [SID1234634652]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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• 2023 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 6, 2023

• Morgan Stanley 21st Annual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 11, 2023

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

OXC-101 as a novel therapy for AML will be presented at 18[th] Annual Congress of International Drug Discovert Science & Technology, Amsterdam 12-14 July, 2023

On August 23, 2023 Oxcia reported that it’s CEO Ulrika Warpman Berglund has been invited to present "OXC-101: A Novel Way to Treat Acute Myeloid Leukemia by Inducing Mitotic Arrest, ROS and Oxidative Damage" at the 18th Annual Congress of International Drug Discovery Science & Technology (IDDST) conference, Amsterdam, the Netherlands, July 12-14, 2023 (Press release, Oxcia, AUG 23, 2023, View Source [SID1234634651]).

OXC-101 is a mitotic MTH1 inhibitor, with a unique synergistic dual mechanism of action. It arrests cancer cells in mitosis by disturbing microtubule polymerization, thereby accumulating ROS which in turn generates e.g. oxidized nucleotides. By inhibiting the enzyme MTH1, OXC-101 incorporates more oxidized nucleotides into DNA resulting in DNA damage and the cancer cell dies via apoptosis and mitotic catastrophe. Hematological cancers are highly responsive to OXC-101 treatment. Importantly, OXC-101 has been demonstrated to kill primary human AML blast cells as well as chemotherapy resistant leukemic stem cells. The latter are often responsible for AML progression. OXC-101 significantly improves survival in different AML disease models and is an excellent combination partner to the standard of care treatment of AML. The preclinical data supports that OXC-101 is a promising novel anticancer agent for AML, providing rationale for the on-going clinical phase 1 trial in advanced hematological cancers. Oxcia recently obtained a Swelife/MedTech4Health grant together with Karolinska University Hospital Örebro University Hospital and Karolinska institutet to further explore the clinical benefit and safety of OXC-101 in refractory/relapsed AML patients at the recommended phase 2 dose.

The IDSST congress focuses on drug discovery, practical pharmaceutical science, clinical studies, translational medicine and new drugs in the pipeline. The meeting is intended for industrial executives, principle investigators, and investors with the aim that constructive discussions will create ideas to translate new discoveries into better clinical practice and application.

Full program can be found: https://www.iddst.com/iddst2023europe/ScientificProgram.asp

U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Multiple Myeloma

On August 23, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood cancer, multiple myeloma (Press release, Immix Biopharma, AUG 23, 2023, View Source [SID1234634649]). NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.

"We are pleased to receive FDA’s orphan drug designation in multiple myeloma for NXC-201, the only clinical-stage BCMA-targeted CAR-T cell therapy with no neurotoxicity observed in over 50 patients dosed to date," said Ilya Rachman, MD, PhD, Immix Biopharma Chief Executive Officer. Dr. Rachman continued, "We are thrilled to potentially expand therapeutic options for multiple myeloma patients, while eliminating the most feared adverse effect of this therapeutic class, neurotoxicity."

Gabriel Morris, Immix Biopharma Chief Financial Officer, added, "Orphan drug designation for NXC-201 represents a substantial value creating step along our path to unlocking planned wide adoption of CAR-T technology by transitioning it to an outpatient domain."

About Multiple Myeloma

Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

FORE Biotherapeutics Announces $75M in Series D Financing and CEO Transition

On August 23, 2023 FORE Biotherapeutics reported the closing of its $75 million Series D financing, led by the SR One and co-led by Medicxi and joined by existing investors (Press release, Fore Biotherapeutics, AUG 23, 2023, View Source [SID1234634648]). FORE Biotherapeutics’ syndicate now includes new investor Medicxi, as well as existing investors OrbiMed, HBM Healthcare Investments, Novartis Venture Fund, 3B Future Health Fund, Cormorant Asset Management, Wellington Management and Samsung Securities. In connection with the financing, Giovanni Mariggi, Partner at Medicxi, was appointed to FORE Biotherapeutics’ Board of Directors.

"At SR One, we invest in companies turning truly innovative discoveries into transformational new therapies in areas with significant unmet clinical needs," said Matthew Foy, Partner at SR One. "FORE Biotherapeutics is well-positioned to deliver on the promise of plixorafenib, which has demonstrated promising single-agent activity against BRAF-altered tumors, including primary central nervous system tumors. We look forward to continuing to support the company as it further progresses its ongoing Phase 2 FORTE global, registrational trial."

Proceeds from the financing will be used to accelerate the development of plixorafenib, the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations. Positive updated data from the Phase 1/2a trial evaluating plixorafenib in patients with BRAF-altered advanced solid and central nervous system tumors were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. Plixorafenib demonstrated both promising antitumor activity with durable responses and favorable tolerability as a single agent in patients with advanced BRAF-altered tumors.

In conjunction with the Series D financing, Matthew E. Ros will step down from his role as Chief Executive Officer and member of the Board of Directors to redirect his energy toward other professional pursuits, effective September 1, 2023. Shawn M. Leland, PharmD, RPh, current advisor to SR One and former Founder, President, and Chief Executive Officer of Elevation Oncology, has been appointed to the Board of Directors and will transition into the role of interim Chief Executive Officer overseeing the day-to-day activities of the company in collaboration with the management team, until a CEO successor is identified.

"On behalf of the Board of Directors, I would like to sincerely thank Matt for his leadership, dedication and many contributions toward the advancement of plixorafenib to its next seminal phase of clinical development," said Dieter Weinand, Chairman of the Board of FORE Biotherapeutics. "We welcome Shawn as interim CEO and Board member as we enter this next phase of growth for the company. We are also thrilled to welcome Giovanni to our Board as his expertise will be invaluable in advancing the clinical development strategy for plixorafenib."

About Plixorafenib

Plixorafenib is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and other alterations found in a range of cancers. Unlike first-generation RAF inhibitors, plixorafenib does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," plixorafenib could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors.

Interim Report Second Quarter 2023

On August 23, 2023 Nykode Therapeutics reported its interim financial report 2023 (Presentation, Nykode Therapeutics, AUG 23, 2023, View Source [SID1234634645]).