On March 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that Virginia Oncology Associates, PC (Norfolk, Virginia) has been activated as the second clinical trial site in the Phase 1 Deltacel-01 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAR 1, 2024, View Source [SID1234640701]).

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"Virginia Oncology Associates is known for its excellence in oncology-focused research and patient care, and we are delighted to add them as the second Deltacel-01 clinical trial site. With encouraging preliminary results from the first patient in Deltacel-01, we are proud to expand trial access to more sites with the goal of enhancing enrollment efficiency and data quality," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

The site initiation process at Virginia Oncology Associates has been completed and patient enrollment is expected to begin in April, following receipt of preliminary results from the first three-patient cohort in Deltacel-01. Dr. Gary Simmons, D.O., MSHA, will serve as the principal investigator at this site, and brings to Deltacel-01 extensive experience in clinical studies focused on oncology and on CAR T-cell therapies.

Kiromic also announces that the third patient in Deltacel-01 completed treatment at the Beverly Hills Cancer Center on February 21. Kiromic expects to announce initial safety and tolerability data, as well as preliminary efficacy results, from this patient and from the trial’s second patient by the end of March.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On March 1, 2024 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate" or the "Company"), a clinical-stage precision oncology company, and Pierre Fabre Médicament, SAS ("Pierre Fabre Laboratories"), a global player in oncology, reported their agreement to the sale of the Company’s investigational pan-RAF inhibitor, exarafenib, and other pan-RAF program assets pursuant to the APA entered into by the parties (Press release, Kinnate Biopharma, MAR 1, 2024, View Source [SID1234640700]). The sale of global rights is in furtherance of the Company’s previously announced exploration of strategic alternatives.

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"We are delighted to partner with Pierre Fabre Laboratories, a company that brings significant expertise in the global development and commercialization of targeted therapies in RAF and RAS driven solid tumors," said Nima Farzan, Chief Executive Officer of Kinnate. "The sale of exarafenib and our pan-RAF program assets to Pierre Fabre will expand the reach of these programs globally, allowing the promise of targeted therapies for patients with NRAS driven melanoma and BRAF driven solid tumors to further develop."

"Based on the clinical and preclinical data generated to date, we believe exarafenib may present a best-in-class product profile as a pan-RAF inhibitor targeting solid tumors such as NRAS mutant melanoma, for which there are currently no approved targeted therapies. The addition of exarafenib and other pan-RAF program assets from Kinnate is complementary to our existing BRAF and MEK inhibitors portfolio with encorafenib and binimetinib. This acquisition continues to expand our efforts in precision oncology and provide us with the opportunity to broaden our reach to patients in need for targeted therapies in RAF and RAS solid tumors," added Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

Under the terms of the APA, Pierre Fabre Laboratories has purchased exarafenib and other pan-RAF assets and will assume 100% of the ongoing program and costs associated with these assets. In consideration, Kinnate will receive a total consideration of up to $31 million, consisting of $500,000 at closing, and a $30.5 million payment, contingent upon the earlier of the dosing of the first patient in the first pivotal trial for exarafenib or any other acquired asset, or the application for an accelerated approval pursuant to the FDA’s Accelerated Approval Program for exarafenib or any other acquired asset, or the submission of a marketing application for regulatory approval for exarafenib or any other acquired asset. In addition, Pierre Fabre Laboratories will assume up to $5 million of trade payables for the transferred assets. The transaction is not subject to closing conditions and closed upon signing.

As previously announced in connection with Kinnate’s transaction with XOMA Corporation ("XOMA"), Kinnate stockholders will receive 100% of the net proceeds (after deducting appliable costs, expenses, taxes or other deductions pursuant to the Contingent Value Rights Agreement to be entered into in connection with the proposed transaction with XOMA (the "CVR Agreement")) payable from the $30.5 million contingent payment, assuming the closing of the proposed transaction with XOMA occurs and such proceeds are received within five years from the closing date thereof, pursuant to the CVR Agreement. There will be no net proceeds from the $500,000 closing payment, as such payment will only cover transaction expenses.

Lazard served as financial advisor to Kinnate, and Wilson Sonsini Goodrich & Rosati served as legal counsel.

On March 1, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following conferences (Press release, Iovance Biotherapeutics, MAR 1, 2024, View Source [SID1234640699]):

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TD Cowen’s 44th Annual Health Care Conference
Fireside Chat: March 4, 2024 at 11:10 a.m. ET
Boston, MA
Barclays 26th Annual Global Healthcare Conference
Fireside Chat: March 12, 2024 at 10:45 a.m. ET
Miami, FL
H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference
Fireside Chat: March 26, 2024 at 1:30 p.m. ET
Virtual
The live and archived webcasts will be available at View Source

On March 1, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the following investor conferences in March (Press release, Immunocore, MAR 1, 2024, View Source [SID1234640698]):

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TD Cowen 44th Annual Healthcare Conference

Fireside Chat: Tuesday, March 5, 2024, at 11:10 a.m. EST

Leerink Partners Global Biopharma Conference

1×1 and small group meetings: Tuesday, March 12, 2024

Jefferies Biotech on the Bay

1×1 and small group meetings: Wednesday, March 13, 2024

Barclays 26th Annual Global Healthcare Conference
Fireside Chat: Thursday, March 14, 2024, at 9:30 a.m. EST

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events’, under ‘News & Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

On March 1, 2024 FogPharma, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon peptide platform, reported the successful closing of a $145 million Series E financing round (Press release, FogPharma, MAR 1, 2024, View Source [SID1234640697]). The financing was led by Nextech Invest with participation from other new investors including RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and former chairman and CEO of Johnson & Johnson, Alex Gorsky.

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There was strong support by existing investors, including ARCH Venture Partners, Fidelity Management & Research Company, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Farallon Capital Management, venBio Partners, Invus and Milky Way Investments. Alexis Borisy, an accomplished investor and entrepreneur, also joined the company’s board of directors in the position designated to Nextech.

The financing will fund the ongoing clinical development of FOG-001, the company’s first-in-class intracellular TCF-blocking β-catenin inhibitor currently being evaluated in a Phase 1/2 study in solid tumors. The round will also accelerate the development of its robust portfolio of unique discovery programs, deepen its data science capabilities and strengthen its core Helicon therapeutics platform.

FOG-001 is a Helicon designed to block the key oncogenic step in the Wnt/β-catenin signaling pathway, one of the most frequently activated pathways in a variety of cancers. Mutations in the pathway are particularly prevalent in colorectal cancer, the second leading cause of all global cancer deaths, with an estimated two million new cases per year, according to the World Health Organization. Despite significant biological validation of the β-catenin:TCF interaction as a cancer driver, no existing treatment has been able to disrupt it due to its inaccessibility to antibody and traditional small molecule medicines.

"Millions of colorectal cancer patients have been told by their oncologists that no more can be done for them. We believe FOG-001 may represent the long-awaited major technological breakthrough needed to address one of the most common yet unaddressed oncogenic signaling pathways," said Mathai Mammen, M.D., Ph.D., FogPharma’s chairman, president and chief executive officer. "This financing will allow us to execute on our expanded clinical development and commercialization strategy to deliver FOG-001 to patients, while simultaneously strengthening our discovery efforts against other compelling intracellular targets that drive a range of diseases."

FOG-001 is the first of several wholly-owned programs generated by FogPharma’s Helicon platform being advanced to address biologically validated disease-driving intracellular targets by modulating protein-protein and protein-DNA interactions inside the cell. FogPharma’s Helicon platform combines ultra-diverse and tunable stabilized helical peptides with custom-built computational physics and artificial intelligence (AI) techniques to enable the discovery and development of novel programs across a vast array of intracellular targets that have never before been drugged.

"We are excited by the tremendous potential of FOG-001 to meaningfully change the therapeutic landscape through a novel approach, and are equally impressed by FogPharma’s robust pipeline of programs for significant drivers of cancer," said Nextech Managing Partner Thilo Schroeder, Ph.D. "The company’s rapid progress across its growing pipeline demonstrates FogPharma’s team is enabled to deliver on the vast potential of its Helicon therapeutics platform."

The financing follows a period of rapid growth for the company as its leadership team has expanded with industry veterans with track records in clinical, commercial and data science execution. This includes the company’s Chairman, President and Chief Executive Officer Mathai Mammen, M.D., Ph.D.; healthcare data science pioneer and Chief Data Officer Brandon Allgood, Ph.D.; Chief Technical Operations Officer Rohin Mhatre, Ph.D.; and Chief Business Officer Gregory Miller, MPH, MBA.