On November 21, 2024 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen (Press release, Replimune, NOV 21, 2024, View Source [SID1234648547]). The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting.

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Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases when preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This Breakthrough Therapy designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.

"Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens," said Sushil Patel, Ph.D., CEO of Replimune.

The confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment is currently enrolling patients. For more information, visit View Source

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On November 21, 2024 NETRIS Pharma, a clinical-stage biopharmaceutical company pioneering therapies to overcome resistance in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to NP137 for the treatment of pancreatic cancer (Press release, Netris Pharma, NOV 21, 2024, View Source [SID1234648546]). NP137 is being developed to block metastases and prevent treatment resistance when used in combination with chemotherapy or immunotherapy.

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Pancreatic cancer remains a devastating disease, with over 66,000 new cases diagnosed annually in the U.S. alone. The five-year survival rate is less than 5%, underscoring the urgent need for novel therapeutic approaches.

"The FDA’s decision to grant ODD for NP137 highlights the critical need for innovative treatments in Pancreatic Cancer, including those designed for combination with current standards of care such as FOLFIRINOX" said Patrick Mehlen, Founder and Chief Executive Officer of NETRIS Pharma. "Further to the publication of NP137’s mode of action in two back-to-back Nature papers, this designation supports our ambition in addressing some of the most challenging cancers," he added.

NP137 is currently being investigated in the LAP-NET1 study (NCT05546853), in combination with mFOLFIRINOX as a first-line treatment for locally advanced Pancreatic Ductal AdenoCarcinoma (PDAC). "Given the upregulation of NETRIN-1 in pancreatic cancer and its role in promoting epithelial-to-mesenchymal transition (EMT), a major driver of metastasis and of resistance to chemotherapy, we believe that NP137 can significantly improve treatment outcome," explained Patrick Mehlen. « Very encouraging interim results from the first 20 patients in the LAP-NET1 trial strongly validate the potential of NP137, and we are actively preparing the next steps in NETRIS Pharma’s development."

Gael Roth, GI Oncologist at Grenoble-Alpes Hospital, France and Principal Investigator for LAP-NET1, commented: "FOLFIRINOX is the most widely used FDA-approved chemotherapy for pancreatic cancer and the LAPNet1 study did not show any unexpected additional toxicity of the combination with NP137. Patient enrollment in this study has been very active and I look forward to the primary analysis of the full 43 patients enrolled in LAP-NET1 in the first quarter of 2025."

The FDA grants Orphan Drug Designation to drugs or biologics that address rare diseases affecting fewer than 200,000 people in the U.S. This designation qualifies NETRIS Pharma for incentives, including tax credits for clinical trials, waiver of user fees, and potential seven years of market exclusivity upon approval of NP137 for all pancreatic cancer indications.

About NP137

NP137 is a humanized monoclonal antibody of isotype IgG1 directed against netrin-1. Netrin-1 is overexpressed in a large number of human cancers, preventing cells from apoptosis. Expression of netrin-1 often correlates with disease severity and no therapy has ever been tested against this new pathway. Preclinical studies show NP137 has an anti-cancer effect as a monotherapy as well as synergistic effects in combination with chemotherapy or immune checkpoint inhibitors. After confirmation of the excellent safety profile in human, NETRIS Pharma is currently actively recruiting in four clinical trials: GyNET trial (NCT04652076), ImmunoNET (NCT05605496) and Liver-NET1 (NCT05546879) and LAP-NET1 (NCT05546853).

On November 21, 2024 – Helix BioPharma Corp. (TSX: "HBP", OTC PINK: "HBPCD", FRANKFURT: "HBP0") ("Helix" or the "Company), a clinical-stage biopharmaceutical company developing novel and unique therapies in the field of immuno-oncology, based on its proprietary technological CEACAM6 platform, DOS47, reported the issuance of U.S. Patent No. 11931422 (Press release, Helix BioPharma, NOV 21, 2024, View Source [SID1234648544]).

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U.S. Patent No. 11931422, entitled ‘Antibody-Urease Conjugates for Therapeutic Purposes’, relates to Helix’ first-in-class antibody-drug conjugate (ADC) platform, L-DOS47, and the optimization of conjugation ratios for a proprietary antibody that precisely binds to tumor cells expressing high levels of CEACAM6, conjugated to urease, an enzyme capable of alkalizing the acidic tumor microenvironment (TME).

CEACAM6 is a tumor antigen highly expressed on hard-to-treat, prevalent cancers where currently available treatments are not achieving meaningful enough clinical benefits for patients (including non-small cell lung cancer, pancreatic and colorectal cancers). Binding to CEACAM6, Helix’ LDOS47 converts urea into ammonia and alkalizes the TME, promoting tumor regression, restoring function to local immune cells (such as T cells) and opening the possibility to significantly enhance the treatment outcomes of available, established therapies, including chemotherapy, checkpoint inhibitors (immunotherapies) and targeted small molecules.

Jacek Antas, CEO of Helix, stated: "We are very pleased to receive the issuance of this patent in the U.S., an important oncology market with a significant need for novel treatment modalities and better clinical outcomes. The timing is also advantageous, considering our ongoing discussions about expanding our pipeline with synergistic oncology products."

On November 21, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that it has entered into a securities purchase agreement with certain investors to raise up to approximately $105 million in gross proceeds (Press release, Cidara Therapeutics, NOV 21, 2024, View Source [SID1234648543]). The private placement is being led by new investor, Venrock Healthcare Capital Partners, and includes significant participation by new and existing life sciences-focused investors, including RA Capital Management, TCGX, BVF Partners LP, Vivo Capital, Spruce Street Capital, Adage Capital Partners LP, and Checkpoint Capital.

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Pursuant to the terms of the securities purchase agreement, Cidara will issue an aggregate of 3,892,274 shares of its common stock at a purchase price of $14.912 per share. In lieu of shares of common stock, certain investors are purchasing pre-funded warrants to purchase an aggregate of 3,149,035 shares of common stock at a purchase price of $14.9119 per pre-funded warrant, which equals the purchase price per share of common stock, less the $0.0001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about November 25, 2024, subject to satisfaction of customary closing conditions.

Cidara intends to use the net proceeds from the private placement to fund research and development of product candidates, working capital and general corporate purposes.

RBC Capital Markets acted as the sole placement agent for the private placement. Guggenheim Securities acted as financial advisor to the Company.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the Securities Act), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Cidara has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the pre-funded warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On November 21, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel immunotherapies to transform cancer care, reported that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS, BriaCell’s personalized next generation immunotherapy (Press release, BriaCell Therapeutics, NOV 21, 2024, View Source [SID1234648542]). The study will investigate Bria-OTS alone and in combination with immune check point inhibitor tislelizumab (manufactured and supplied by BeiGene, Ltd. ) for the treatment of metastatic breast cancer. Bria-OTS is an enhanced form of Bria-IMT, currently in pivotal Phase 3 study for metastatic breast cancer.

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"Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs)," stated Sant P. Chawla, MD, FRACP, Head of the Sarcoma Oncology Center in Santa Monica, CA, and Principal Investigator for the Bria-OTS study. "We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes."

"Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy."

"Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy," stated William V. Williams, MD, BriaCell’s President & CEO. "We are delighted that Dr. Chawla and his team of experts at the Sarcoma Oncology Center are supporting BriaCell as we bring our novel immunotherapy platform one step closer to delivering safe and effective treatment options for patients with melanoma, prostate and lung cancers."

The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with tislelizumab in advanced breast cancer. Key inclusion criteria include metastatic or locally recurrent breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design will include a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with tislelizumab . Additionally, BriaCell plans to evaluate Bria-OTS+, a more advanced version of the immunotherapy platform, in prostate and other cancers.