On December 19, 2023 InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, reported that InxMed licensed EZWi-Fit linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs (Press release, InxMed, DEC 19, 2023, View Source [SID1234638698]).

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The license agreement provides InxMed with right to use EZWi-Fit platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules.

InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC’s efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy.

InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped with payload from EZWi-Fitplatform will be one of key differentiations.

On December 19, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA) for use in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are susceptible to febrile neutropenia (Press release, Mabwell Biotech, DEC 19, 2023, View Source [SID1234638697]).

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8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intellectual property rights owned by Mabwell. 8MW0511 is produced by fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin with gene fusion technology. It significantly inhibits the G-CSF receptor-mediated clearance pathway, which prolongs the half-life period, reduces the frequency of drug administration, and improves the treatment compliance in clinical use. 8MW0511 is produced by yeast expression system, which brings better homogeneity, simplifies production process, and is expected to reduce the cost of production by avoiding the PEG modification reactions.

The results of the Phase III clinical study of 8MW0511 presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in 2023 showed that 8MW0511 was clinically effective, non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and improved the incidence and duration of Grade 4 neutropenia, especially in cycle 2-3 where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans.

On December 19, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that it will be eligible to receive a milestone payment of $10 million from AstraZeneca (LSE/STO/Nasdaq: AZN), when the first patient is dosed in AstraZeneca’s ARTEMIDE-Bil01 trial with rilvegostomig (Press release, Compugen, DEC 19, 2023, View Source [SID1234638696]). Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.

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"I am delighted to see the advancement of rilvegostomig into Phase 3 by AstraZeneca, a global leader in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "I believe that the progress of the rilvegostomig clinical program in this Phase 3 trial along with the Phase 1 and 2 trials in additional indications, demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902."

About the Compugen-AstraZeneca license agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen’s monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described here which Compugen will be eligible to receive on dosing of the first patient in the Phase 3 ARTEMIDE-Bil01 trial, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific products are developed based on Compugen’s monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.

On December 19, 2023 TC BioPharm (Holdings) plc ("TC BioPharm" or the "Company") (NASDAQ: TCBP), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported the pricing of a public offering of 1,750,000 of its American Depositary Shares (the "ADSs") (or pre-funded warrants in lieu thereof), together with Series E warrants (the "Series E Warrants") to purchase up to 1,750,000 of its ADSs at a public offering price of $2.00 per ADS (or pre-funded warrant in lieu thereof) and associated Series E Warrant (Press release, TC Biopharm, DEC 19, 2023, View Source [SID1234638695]). The Series E Warrants will have an exercise price of £1.5814 per ADS, are exercisable upon issuance and will expire five years following the date of issuance. Each ADS represents twenty ordinary shares of the Company. The closing of the offering is expected to occur on or about December 21, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $3.5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.

A registration statement on Form F-1 (File No. 333-274244) relating to the securities described above has been filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on December 18, 2023. The offering will be made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The Company also has agreed that a certain existing warrant to purchase up to an aggregate of 623,750 ADSs of the Company that was previously issued on September 5, 2023, at an exercise price of £7.00 per ADS and an expiration date of March 5, 2029, will be amended effective upon the closing of the offering so that the amended warrant will have a reduced exercise price of £1.5814 per ADS.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On December 19, 2023 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported grants awarded to support clinical studies that will evaluate the efficacy and safety of elranatamab in the treatment of multiple myeloma (Press release, NCCN, DEC 19, 2023, View Source [SID1234638694]). Funding will be provided through support from Pfizer Global Medical Grants.

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Globally, there are approximately 176,000 new cases and 117,000 deaths annually attributed to multiple myeloma. Multiple myeloma patients typically cycle through many lines of treatment, as resistance develops to preceding regimens. Elranatamab is a BCMA-directed bispecific antibody that was recently granted accelerated approval by the FDA. The registrational study evaluated the efficacy and safety of elranatamab monotherapy in patients with relapsed, refractory multiple myeloma after prior treatment with at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 antibody.

"The aim of this initiative is to fund studies that will expand the growing body of evidence on the use of elranatamab to help advance treatment of patients with multiple myeloma," explained Crystal S. Denlinger, MD, Chief Executive Officer, NCCN. "Congratulations to these dedicated investigators. Their research will help further our understanding of how to optimize care for people with multiple myeloma."

The projects selected for approval are:

David Avigan, MD, Beth Israel Deaconess Medical Center
NCCN Pfizer Investigator-Sponsored Research Project to Evaluate the Effectiveness of a Personalized Cancer Vaccine in Conjunction with Elranatamab in the Treatment of Multiple Myeloma
Ah-Reum Jeong, MD, UC San Diego Moores Cancer Center
Phase II MRD Adapted Study of Elranatamab in Relapsed/Refractory Multiple Myeloma
Michael Slade, MD, Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance Using Peripheral Blood Clonotypic Mass Spectrometry
Attaya Suvannasankha, MD, Indiana University Melvin and Bren Simon Comprehensive Cancer Center and Richard L. Roudebush Veterans Administration Medical Center
Response-guided Treatment Discontinuation of Elranatamab in Frail/Elderly Patients
Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert oncologists from NCCN Member Institutions. The selected projects are set to be completed within five years. Approximately $5 million in funding will be provided across all grants.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website, an informed consent database, and points to consider on the best practices for biorepositories, registries, and databases. For more information, visit NCCN.org/orp.