On December 31, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that the first patient has been dosed in its GYNet Phase 1b/II clinical study (Press release, Netris Pharma, DEC 31, 2020, View Source [SID1234573345]).

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GYNet is a randomized, multicenter, open label Phase Ib/II study that will enroll up to 240 patients with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy. In the Phase1b part, the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NP137 administered in combination with KEYTRUDA and/or chemotherapeutic agents. The Phase 2 part will assess the clinical activity of the combination in both tumor types. More information on GYNet study can be found at View Source (NCT04652076).

NP137 is a monoclonal antibody that targets netrin-1, which is a protein overexpressed in over 80% of uterine tumors. In early clinical studies, NP137 monotherapy demonstrated encouraging clinical signs of efficacy as measured by objective response and prolonged stable disease. In addition, preclinical data confirmed that netrin-1 interference via NP137 alleviates resistance to chemotherapy and immune checkpoint inhibitors, reinforcing the strong scientific rationale of this combination trial.

"We look forward to seeing the first clinical result of the GYNet trial, given the anti-tumor activity as single agent observed in the Phase 1a trial and unique mode of action of NP137," said Professor Isabelle Ray Coquard, MD, Ph.D. from the Centre Leon Bérard in Lyon, France and Principal Investigator of the trial.

Patrick Mehlen, CEO and Founder of NETRIS Pharma added: "The inclusion of the first patient in this phase 1b/2 clinical trial is a new milestone in the development of Netris. We look forward to seeing the results of this study as well as additional clinical advances in the near future."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About NP137

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

On December 31, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that the first patient has been dosed in its GYNet Phase 1b/II clinical study (Press release, Netris Pharma, DEC 31, 2020, View Source [SID1234611185]).

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GYNet is a randomized, multicenter, open label Phase Ib/II study that will enroll up to 240 patients with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy. In the Phase1b part, the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NP137 administered in combination with KEYTRUDA and/or chemotherapeutic agents. The Phase 2 part will assess the clinical activity of the combination in both tumor types. More information on GYNet study can be found at View Source (NCT04652076).

NP137 is a monoclonal antibody that targets netrin-1, which is a protein overexpressed in over 80% of uterine tumors. In early clinical studies, NP137 monotherapy demonstrated encouraging clinical signs of efficacy as measured by objective response and prolonged stable disease. In addition, preclinical data confirmed that netrin-1 interference via NP137 alleviates resistance to chemotherapy and immune checkpoint inhibitors, reinforcing the strong scientific rationale of this combination trial.

"We look forward to seeing the first clinical result of the GYNet trial, given the anti-tumor activity as single agent observed in the Phase 1a trial and unique mode of action of NP137," said Professor Isabelle Ray Coquard, MD, Ph.D. from the Centre Leon Bérard in Lyon, France and Principal Investigator of the trial.

Patrick Mehlen, CEO and Founder of NETRIS Pharma added: "The inclusion of the first patient in this phase 1b/2 clinical trial is a new milestone in the development of Netris. We look forward to seeing the results of this study as well as additional clinical advances in the near future."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About NP137
NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

On December 30, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that BiocurePharm Korea ("BPK") and Pharos Vaccine Inc. ("PVI") have jointly submitted an Investigational New Drug ("IND") application to the Korean Ministry of Food and Drug Safety ("KFDS") to proceed with clinical trial Phase 1 for CD19 CAR-T therapy to treat Acute Lymphocyte Leukemia ("ALL") (Press release, Biocure Technology, DEC 30, 2020, View Source [SID1234628750]).

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CD19 CAR-T is an immune cell therapy for relapse and refractory B-cell precursor acute lymphoblastic leukemia, demonstrating a significantly high CR ("Complete Remission") rate as an individual medical prescription for a custom-made product for an individual patient.

BPK plans to conduct a clinical trial at two renowned hospitals in Korea, Seoul A-San Medical Center and Seoul St. Mary`s Hospital upon the approval of the IND application by KFDS. BPK anticipates the completion of the Phase 2 clinical trial no later than the first half of 2023. Once completed and pending positive results in the clinical trials, the drug would be released for commercialization in Korea and potentially internationally.

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This is an important milestone for the Company to advance its CAR T technology. We are about to start a clinical trial in Korea and are confident that if we have positive outcomes from the Korean clinical trial, this should enable the therapy to be readily available and offer affordable CAR T Therapy to save more lives."

On December 30, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that the Company will present at Biotech Showcase Digital 2021 (Press release, Cyclacel, DEC 30, 2020, View Source [SID1234573337]). The conference is taking place online between January 11-15 and will feature prerecorded sessions of company presentations. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs.

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Cyclacel will host one-on-one meetings with investors and industry stakeholders during the event. Registered Biotech Showcase Digital 2021 attendees may request one-on-one meetings with Cyclacel through the partneringONE system.

A live webcast of the presentation will be available through the Company’s website: www.cyclacel.com. The webcast will be archived for 90 days.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported the grant of patent number 10,874,713 entitled "Combined Preparations for the Treatment of Cancer or Infection" by the United States Patent & Trade Mark Office (Press release, Immutep, DEC 30, 2020, View Source [SID1234573355]).

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This United States patent follows the grant of the corresponding European patent announced in November 2018. The claims of the patent protect Immutep’s intellectual property relating to combined preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a PD-1 pathway inhibitor. In this case, the PD-1 pathway inhibitor is either pembrolizumab or nivolumab.

The expiry date of the patent is 8 January 2036.

This new patent is particularly significant as it covers the combination of active ingredients evaluated in the Company’s phase II TACTI-002 and phase I TACTI-mel trials. It also further highlights the ongoing and important steps being taken by the Company to protect its lead product candidate in a range of novel and commercially relevant combination formats, in both immuno-oncology (IO)-IO and chemo-IO settings.

"We are very pleased that this United States patent has been granted covering our lead product candidate, efti, in combination with key anti-PD-1 therapies. This is particularly so in view of the highly encouraging data we have seen from both our TACTI (Two Active Immunotherapies) trials which evaluate efti in combination with pembrolizumab. Furthermore, this new patent and our corresponding patents and patent applications in other key markets continue to underpin our ongoing investment in clinical development", said Marc Voigt, CEO of Immutep.

Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer, also welcomed the news, noting that, "This United States patent grant represents another important milestone for the Company, and along with the clinical data we have seen from our trials, supports our long held view that combining efti with an anti-PD-1 checkpoint inhibitor should result in a very meaningful therapeutic benefit to cancer patients."