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.

On November 21, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Ayrmid Ltd. ("Ayrmid"), the parent company of Gamida Cell Ltd., reported that on November 20, 2024, the companies entered into a license agreement for motixafortide (commercially sold in the U.S. as APHEXDA), BioLineRx’s FDA-approved stem cell mobilization agent indicated in combination with filgrastim (G-CSF) for collection and subsequent autologous transplantation in patients with multiple myeloma (Press release, BioLineRx, NOV 21, 2024, View Source [SID1234648539]).

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Under the terms of the agreement, BioLineRx granted Ayrmid an exclusive license to develop and commercialize APHEXDA (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia. BioLineRx previously granted an exclusive license agreement to Gloria Biosciences for APHEXDA (motixafortide) in the Asia region.

In exchange for the license, BioLineRx will receive a $10 million upfront payment and is also eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties ranging from 18% to 23% on net sales of APHEXDA.

Ayrmid will add APHEXDA to its commercial portfolio, which also includes Gamida Cell’s OMISIRGE, the first and only FDA-approved, nicotinamide (NAM)-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. As part of this transaction, Ayrmid expects to transition certain members of BioLineRx’s U.S.-based commercial organization, who will support both stem cell transplant drugs.

Through this transaction, BioLineRx will significantly reduce its long-term debt and operational expenses, which will be reviewed in detail during the company’s upcoming Q3 results conference call and webcast.

BioLineRx also entered into a share purchase agreement for a $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC. This investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences, as well as royalties on net sales, are expected to provide a strong foundation for BioLineRx to advance its pipeline and identify potential additional assets for development. The equity investment is expected to close today, November 21, 2024, subject to the satisfaction of customary closing conditions.

BioLineRx will continue the development of motixafortide for pancreatic ductal adenocarcinoma (PDAC) through meaningful collaborations, including an active Phase 2b PDAC study led by Columbia University, and supported equally by BioLineRx and Regeneron, as well as a planned Phase 2b PDAC study in China led by Gloria Biosciences.

"Since APHEXDA’s launch last year, patients and transplant centers continue to see the tremendous benefits it can provide, and I could not be prouder of our commercial organization that has proven its value," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Our agreement with Ayrmid, and their vision of creating a strong commercial transplant portfolio, makes them the ideal partner to realize APHEXDA’s full commercial potential. BioLineRx will now leverage its proven expertise in drug development, with a continued focus on oncology and rare diseases. This new path forward aligns with our core strengths and allows us the opportunity to create enduring value for all stakeholders."

Dr. Joe Wiley, Chief Executive Officer of Ayrmid Ltd, added, "APHEXDA represents a significant advancement in improving the lives of multiple myeloma patients as they progress along the stem cell transplant journey. APHEXDA complements our existing portfolio by supporting OMISIRGE’s growth, doubling our transplant portfolio, and enhancing the capabilities Gamida Cell has already established in cell therapy. Our growing momentum positions us well for continued expansion in the U.S. and beyond, marking a key step in our journey as we continue to build on our success, strengthen our commitment to the transplant community, and execute our long-term strategy."

The equity investment offering is being made by BioLineRx pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov.

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.

MTS Health Partners, L.P. served as the exclusive financial advisor to BioLineRx Ltd. in connection with the transaction.

Moelis & Company LLC served as the exclusive financial advisor to Ayrmid Ltd. in connection with the transaction.