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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or the "Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the issuance and sale of 1,237,113 shares of its common stock in a registered direct offering at a purchase price of $2.425 per share (Press release, Intensity Therapeutics, NOV 21, 2024, View Source [SID1234648578]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In a concurrent private placement (the "Private Placement" and together with the Registered Offering, the "Offerings"), the Company also agreed to issue to the same investor warrants to purchase up to 1,237,113 shares of its common stock (the "Common Warrants"). The Common Warrants have an exercise price of $2.95 per share, will be exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.

The gross proceeds from the Offerings, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $3 million. The Company expects to use the net proceeds from the Offerings for general working capital.

A.G.P./Alliance Global Partners is acting as lead placement agent for the Offerings and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the Offerings.
The Offerings are expected to close on or about November 22, 2024, subject to the satisfaction of customary closing conditions.

The shares (or common stock equivalents in lieu thereof) offered to the institutional investor described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-280681), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The Offering is being made only by means of a prospectus which is a part of the effective registration statement. The Common Warrants will be issued in a concurrent private placement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected], or Brookline Capital Markets, a division of Arcadia Securities, LLC, 600 Lexington Avenue, 20th Floor, New York, NY 10022, or by telephone at (646) 256-5258, or by email at [email protected].
The private placement of the Common Warrants and the shares underlying the Common Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placements may not be offered or sold 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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 20, 2024 Lepu Biopharma Co., Ltd. (Lepu Biopharma) and Beijing DP Tech Co., Ltd. (DP Technology) reported a significant milestone in their Antibody-Drug Conjugate (ADC) drug collaboration (Press release, Lepu Biopharma, NOV 21, 2024, View Source [SID1234648561]). This partnership has effectively integrated DP’s ADC Linker-Payload design platform with Lepu’s ADC technology development platform, capitalizing on their respective strengths. The overall optimization of the ADC drug has been achieved in a relatively short time. This project has reached an important milestone, further validating the approach of accelerating ADC innovative drug development through computational design. Moving forward, both parties will continue to deepen their R&D collaboration in this field, jointly committed to promoting the continuous optimization and advancement of innovative drug development processes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The ADC Linker Payload design platform, meticulously crafted by DP Technology, utilizes "RiDYMO", an AI-for-Science driven hit discovery platform. Furthermore, "AI + first principles" based computational methods are employed to predict linker cleavage sites and ensure the correct payload release, achieving outstanding cell-killing and bystander effects. Additionally, the designed antibody-drug conjugates (ADCs) maintain excellent hydrophilicity and plasma stability. Leveraging Lepu’s mature and complete ADC development system, candidates developed by the new ADC platform have demonstrated significant efficacy in CDX models targeting multiple targets. This project has been successfully validated in animal models and is currently advancing the candidate ADC to the clinical stage.

Lei Fang, Ph.D., Vice President of Lepu Biopharma and CEO of CtM Bio Co., Ltd., expressed high appreciation for this cooperation: "Introducing advanced computational methods to solve scientific problems and jointly pioneering breakthrough explorations is our goal in the ADC project collaboration. As a leader in ‘AI for Science’, DP Technology has played a crucial role in this project with its newly developed ADC design platform. By integrating Lepu Biopharma’s advanced ADC development platform with AI-driven design, we proposed novel perspectives on ADC development while significantly expediting the process. By complementing each other’s strengths, we jointly provide new inspiration and ideas for innovative ADC drug design."

Weijie Sun, CEO of DP Technology, expressed great anticipation for future collaboration: "Lepu Biopharma, as an innovative biopharmaceutical company focused on cancer treatment, particularly in the areas of targeted therapy and immunotherapy, has extensive experience and a long-standing track record in developing innovative ADC drugs. We firmly believe that our close cooperation will significantly accelerate the design and development of ADC drugs, and we are optimistic about the potential to develop innovative, highly effective, and differentiated new ADC therapies. I am eagerly anticipating the ongoing and deepened collaboration between both companies in the field of pharmaceutical innovation!"

Concerning the various demands from industry partners in the ADC field, DP Technology’s ADC platform has successfully empowered various scenarios and projects. For instance, it utilizes AI combined with first-principles calculations to predict linker cleavage sites and improve attachment stability. By integrating pre-trained models with fine-tuning strategies and expert insights, the platform can predict and modify physicochemical properties such as payload efflux and bystander effects. Additionally, there is ongoing exploration and collaboration in the overall evaluation of properties like aggregation effects in ADCs.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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).