On November 20, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported the nomination of BDTX-1535 as the Company’s development candidate for the treatment of glioblastoma multiforme (GBM), as well as the commencement of Investigational New Drug (IND)-enabling studies (Press release, Black Diamond Therapeutics, NOV 20, 2020, View Source [SID1234571569]).

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Additionally, Black Diamond Therapeutics reported a presentation at the 2020 Society for Neuro-Oncology Annual Meeting (SNO) of the pre-clinical data for BDTX-1535 and the biological rationale for a MasterKey approach to treating GBM patients whose tumors harbor allosteric oncogenic mutations in epidermal growth factor receptor (EGFR).

"These pre-clinical data demonstrate the achievement of our program’s key design principles, including potent and selective inhibition of the family of EGFR variants implicated in GBM and penetration of the blood-brain barrier, and further support our ability to develop a novel and differentiated candidate for the treatment of this disease," said Elizabeth Buck, Ph.D., Executive Vice President, Discovery and Translational Sciences at Black Diamond Therapeutics. "This profile, coupled with the in vivo data that showed tumor growth inhibition in intracranial patient-derived xenograft (PDX) tumor models expressing allosteric EGFR mutants, supports the potential for BDTX-1535 to meaningfully transform the treatment paradigm for patients with GBM."

GBM tumors express a family of allosteric oncogenic EGFR variants that often appear together in GBM and, as shown by the Company’s pre-clinical work, must all be effectively inhibited to secure a meaningful anti-tumor response. In cell-based assays, BDTX-1535 achieved potent MasterKey inhibition of all members of the family of oncogenic EGFR variants expressed in GBM with selectivity v. wild-type-EGFR (WT-EGFR). Additionally, in mouse models, BDTX-1535 demonstrated a pharmacokinetic profile that supports its ability to penetrate the blood-brain barrier. BDTX-1535 achieved complete and sustained inhibition of the phosphorylated state of EGFR in mouse models bearing Ba/F3 allosteric EGFR mutants, as well as tumor growth inhibition in mouse models bearing intracranial PDX tumors expressing allosteric EGFR mutants.

"Glioblastoma places an enormous burden on patients and their families, and we’re encouraged by these pre-clinical data that support BDTX-1535’s potential to improve treatment options for those impacted by GBM. The advancement of BDTX-1535 into early development is a critical step in our pursuit of a truly innovative approach for the treatment of this devastating disease," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain committed to the broad deployment of our proprietary MAP platform to produce novel MasterKey inhibitor therapies for a range of genetically defined diseases."

The presentation from the SNO 2020 meeting is available on the "Scientific Presentations and Publications" section of the Black Diamond Therapeutics website.

On November 20, 2020 Shanghai Antengene, a three-year old oncology company, reported that it completed a $340 million IPO in Hong Kong (Press release, Antengene, NOV 20, 2020, View Source [SID1234571518]). The company, which was originally backed by Celgene, said the offering was significantly oversubscribed . Antengene has built a portfolio of 12 first-in-class, only-in-class and best-in-class cancer therapies, six of which have begun clinical trials. It combines in-licensings with internal research. The company says it uses a synergistic approach to "unlock the full therapeutic potential" of its candidates.

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On November 20, 2020 Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that it has entered into a settlement and license agreement with Pepscan Systems B.V. regarding Bicycle’s use of Pepscan’s CLIPS peptide technology (Press release, Bicycle Therapeutics, NOV 20, 2020, View Source [SID1234571517]).

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The companies have agreed to settle all intellectual property disputes worldwide. Under the terms of the settlement, Bicycle has been granted a license to use CLIPS peptide technology in the development of its product candidates BT1718 and THR-149. Bicycle will pay €3 million upfront, will pay €1 million on the first anniversary of the date of settlement, and will make potential additional payments to Pepscan based on achievement of specified clinical, regulatory and commercial milestones.

On November 20, 2020 CARsgen Therapeutics, a clinical-stage biopharmaceutical company, reported that data from its global multiple myeloma program will be presented, including two oral presentations and one poster session, at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually December 5-8, 2020 (Press release, Carsgen Therapeutics, NOV 20, 2020, View Source [SID1234571494]).

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Presentations will include updated safety and efficacy results from investigator-initiated clinical studies of CT053 and preliminary data from the ongoing Phase 1 and 1b/2 clinical studies of CT053 in China (LUMMICAR STUDY 1) and the United States (LUMMICAR STUDY 2). CT053 is an investigational anti-BCMA (B cell maturation antigen) autologous chimeric antigen receptor (CAR) T-cell product for the treatment of adult patients with relapsed and/or refractory multiple myeloma.

Results from LUMMICAR-1: A Phase 1 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Chinese Subjects with Relapsed and/or Refractory Multiple Myeloma
Presenting Author: Wenming Chen, MD, PhD, Beijing Chao-Yang Hospital of Capital Medical University, Beijing, China
Date/Time: Poster #1396, Saturday, December 5, 2020: 7:00 AM-3:30 PM PST

Results from LUMMICAR-2: A Phase 1b/2 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Patients with Relapsed and/or Refractory Multiple Myeloma
Presenting Author: Shaji K. Kumar, MD, Division of Hematology, Mayo Clinic, Rochester, MN
Date/Time: Oral #133, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST

Two-Year Follow-up of Investigator-Initiated Phase 1 Trials of the Safety and Efficacy of Fully Human Anti-BCMA CAR T Cells (CT053) in Relapsed/Refractory Multiple Myeloma
Presenting Author: Siguo Hao, MD, PhD, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Date/Time: Oral #132, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST

About CT053 and LUMMICAR

CT053 is a CAR T-cell therapy that targets B-cell maturation antigen (BCMA), a protein expressed on the surface of malignant and normal plasma cells. The CT053 construct utilizes a fully human anti-BCMA scFv domain, hypothesized to reduce immunogenicity and improve safety. CT053 T cells are proposed to recognize, bind, and eradicate multiple myeloma cells that express BCMA.

CT053 has received regenerative medicine advanced therapy (RMAT) and orphan drug designations from the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) and orphan drug designations from the European Medicines Agency.

CARsgen Therapeutics’ clinical development program for CT053 includes the clinical studies: LUMMICAR STUDY 1 (NCT03975907 Phase 1, China) and LUMMICAR STUDY 2 (NCT03915184 Phase 1b/2, United States and Canada). These are open-label, multicenter studies evaluating the safety and efficacy of CT053 in adult patients with relapsed and/or refractory multiple myeloma. CT053 studies also include three investigator-initiated trials (NCT03380039; NCT03716856; NCT03302403). For more information, visit clinicaltrials.gov.

On November 20, 2020 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported the opening of a phase I/IIa trial for its lead product oNKord for the treatment of AML patients (Press release, Glycostem Therapeutics, NOV 20, 2020, View Source [SID1234571493]). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord is the company’s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house.

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"During our phase I safety study, in which ten elderly AML patients were treated, we verified our lead product oNKord to be a safe therapeutic agent in the field of cellular immunotherapy. Interestingly, year 1 survival data showed promising efficacy outcome (80%) compared to historical cohort data (40%)," tells Troels Jordansen, CEO at Glycostem. "The opening of this phase I/IIa / pivotal trial is an important step and we are looking forward to the data from this study, which will allow us to draw conclusions regarding oNKord safety and tolerability and most importantly its efficacy for treatment of AML patients."

Professor Doctor Arnold Ganser, MD of Hannover Medical School in Germany and WiNK trial coordinating investigator said: "The preliminary efficacy data obtained with oNKord was very promising and NK-cells have proven to be highly capable of targeting cancer cells. Therefore, I am excited about participating and being able to enroll patients in the WiNK trial." He continues: "Currently there is a risk of relapse for 80% of the successfully treated patients. This new form of cellular treatment can change the lives and future prospects of many patients with AML worldwide who do not proceed to allogeneic hematopoietic stem cell transplantation, in particular elderly patients, who represent the majority of patients with AML."

WiNK is a prospective two-stage, open-label, single arm, multicenter phase I/IIa trial to evaluate the safety and efficacy of oNKord, an off-the-shelf, ex. vivo-cultured allogeneic NK cell preparation, in 33 adults with AML who are in complete morphologic remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.