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 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.

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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.

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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 AbCellera (Nasdaq: ABCL) reported that executives from the Company will present at the following investor conferences (Press release, AbCellera, NOV 21, 2024, View Source [SID1234648563]):

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Piper Sandler 36th Annual Healthcare Conference in New York, NY on Tuesday, December 3, 2024, at 11:30 a.m. Pacific Time (2:30 p.m. Eastern Time)
43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 15, 2025, at 4:30 p.m. Pacific Time (7:30 p.m. Eastern Time)

Live audio webcasts of the presentation may be accessed through the link that will be posted on AbCellera’s Investor Relations website. Replays of the webcast will be available through the same links following the presentations.

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.