On January 7, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it established a research and development collaboration with world-renowned Karolinska Institutet in Stockholm, Sweden, to advance novel ROR1-targeting cell therapies focused on CAR-T cells and CAR-NK (Natural Killer) cells from the laboratory into the clinic (Press release, Oncternal Therapeutics, JAN 7, 2021, View Source [SID1234576292]).

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As part of the collaboration, IND-supporting preclinical studies will be performed in the Cell and Gene Therapy Group led by Evren Alici, M.D. Ph.D., within the NextGenNK Center, which is a Competence Center for the development of next-generation NK cell-based cancer immunotherapies. The Center is coordinated by Karolinska Institutet and collaborates with the Karolinska University Hospital as well as prominent national and international industrial partners. The Center was launched in 2020, and is jointly funded by Sweden’s innovation agency Vinnova, Karolinska Institutet, and the industrial partners.

"Given that NK cells were discovered at Karolinska Institutet, we are excited to work together with industry partners to translate scientific advances into next-generation cell therapies that will benefit cancer patients," said Hans-Gustaf Ljunggren, M.D. Ph.D., Director of the NextGenNK competence center. "We look forward to collaborating with the outstanding team at Oncternal to develop cutting-edge T and NK cell therapies targeting ROR1, which is a promising target in many oncology indications. It could be ideally suited for cell therapy."

"We are honored to work together with the world-leading academic team at Karolinska Institutet to accelerate the development of our ROR1-targeting CAR-T cell immunotherapy program," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "ROR1 has emerged as an important and underexplored target for cancer therapy, and we believe that ROR1-targeting CAR-T and CAR-NK therapies hold significant promise for patients with both hematologic cancers and solid tumors. We believe that utilizing the ROR1 binding domain of our clinical-stage antibody cirmtuzumab as a component of the CAR has the potential to give us a safety and efficacy advantage."

On January 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it has changed its corporate name from Vincera Pharma, Inc. to Vincerx, Inc (Press release, Vincerx Pharma, JAN 7, 2021, View Source [SID1234575163]). The Company’s common stock, units and warrants will continue to trade under the current ticker symbols, "VINC," "VINCW" and "VINCU," respectively.

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On January 7, 2021 Theratechnologies Inc. (Theratechnologies or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported net revenue estimates for its fourth quarter and its full fiscal year ended November 30, 2020 and provided an update on its R&D activities (Press release, Theratechnologies, JAN 7, 2021, View Source [SID1234574982]).

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Consolidated net revenues for the Company’s fourth quarter fiscal year 2020 are expected to be between US$18.9 million and US$19.2 million, compared to US$16.4 million for the same quarter last year, representing an increase of approximately 15% to 17%, and the Company’s highest reported quarterly revenues to date.

Consolidated net revenues for the Company’s full fiscal year 2020 are expected to be between US$65.8 million and US$66.1 million, compared to US$63.2 million for the fiscal year ended November 30, 2019, representing an increase of approximately 4.1% to 4.6%, and the Company’s highest reported annual revenues to date.

On January 7, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN; the "Company" or "Biohaven") reported the acquisition of the remaining 58% interest of Kleo Pharmaceuticals, Inc. ("Kleo") that it did not previously own and the execution of an exclusive license agreement with Yale University for a novel extracellular degrader technology licensed from the Spiegel Lab (Press release, Biohaven Pharmaceutical, JAN 7, 2021, View Source [SID1234574496]). In connection with these two transactions, Biohaven assumed Kleo’s laboratory facilities located in Science Park in New Haven, Connecticut and formed Biohaven Labs to serve as the integrated chemistry and discovery research arm of Biohaven. Biohaven Labs will continue several existing Kleo discovery partnerships, including with the Bill and Melinda Gates Foundation for the development of a Hyperimmune Globulin Mimic (HGM) for COVID-19 and PeptiDream for the development of immuno-oncology therapeutics.

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Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Inherent to the value creation of biopharmaceutical companies is the ability to continue to develop innovative technology platforms to deliver future treatments to patients. With these two transactions, Biohaven is excited to formally launch Biohaven Labs at Science Park in New Haven, Connecticut. Biohaven Labs will combine two cutting-edge platform technologies from Yale University in immune modulation (MATE and ARM) plus their extracellular target degrader technology with our existing small molecule discovery programs. We have a world class development team that has demonstrated the ability to advance novel treatments to the clinic and will harness the full potential of these novel technology platforms to create value for patients and investors."

On January 7, 2021 National Brain Tumor Society reported that the GBM AGILE adaptive clinical trial platform is opening two new treatment arms, with one evaluating Kintara Therapeutics’s chemotherapy, VAL-083, and Kazia Therapeutics’s targeted therapy, paxalisib (Press release, National Brain Tumor Society, JAN 7, 2021, View Source [SID1234573755]).

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"NBTS has long supported GBM AGILE as a scientifically cutting-edge and more patient-friendly way to develop and evaluate emerging new treatments for patients," says David Arons, chief executive officer, National Brain Tumor Society. "As a patient advocacy partner to the GBM AGILE program, we’re truly encouraged to see the trial expand toward realizing its potential as a dynamic system to support drug development for glioblastoma. Today’s exciting news means more opportunities for glioblastoma patients to access promising therapies in development and offers the hope of new treatment approvals for a patient population that currently lacks adequate options to fight this devastating disease. With the urgency of now, GBM AGILE is exactly the kind of innovation we need in brain tumor clinical research to change the unacceptable status quo facing patients and their families with glioblastoma."

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is what’s known as an "adaptive clinical trial platform." Adaptive platform trials offer a unique system for the discovery and testing of various experimental drugs and create a more efficient and cost-effective mechanism for accelerating treatments to patients. The "platform," or "master protocol," aspect of the trial allows for testing of more than one investigational drug, and GBM AGILE will simultaneously evaluate multiple therapies for newly diagnosed and recurrent GBM patients and identify effective new treatments for subtypes of this tumor based on patients’ biological characteristics in a rapid manner.

GBM AGILE opened for patient enrollment in 2019 with its first arm studying the drug regorafenib (developed by Bayer Oncology). The addition of paxalisib and VAL-083 arms will provide the GBM AGILE platform with two new, promising therapies, both of which have shown encouraging results from early-phase clinical trials.

According to yesterday’s release, both new arms will enroll newly diagnosed and recurrent GBM patients. Henry Ford Cancer Institute in Detroit will be the first trial site to enroll patients on these arms, which will subsequently open at over 30 trial sites across the United States with additional global sites in Canada, Europe, and China to follow.

GBM AGILE is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. As an adaptive study, the number of patients recruited for GBM AGILE arms, and their allocation within the study, will be continuously adjusted in the light of emerging results. This is considered a more efficient approach to drug development, and one that has received significant interest and support from clinicians, industry, and regulatory agencies. NBTS believes this design will allow new potential treatments being tested to move the trial process much faster and require significantly fewer patients, especially for the control arm. We also believe these benefits will be attractive to the companies that make drugs, encouraging even more of them to take shots at developing drugs for brain tumors, creating a multiplying effect.

NBTS was there when the concept for this type of adaptive trial was first born in a meeting with leaders from across the neuro-oncology field, when the trial was announced with fanfare (including a cameo from then Vice President, and now, President-elect Joe Biden) in Washington, D.C., and made two substantial investments in the trial’s operations in 2019, totaling more than $1.25 million. We continue to support GBM AGILE as a major, revolutionary approach to clinical trials for brain tumor patients. We will keep the community updated when we learn important news about the trial. To learn more visit: View Source

"NBTS thanks the Global Coalition for Adaptive Research, who are sponsoring GBM AGILE; the trial’s investigators; the biopharmaceutical companies involved; and other platform partners, including NFCR and StacheStrong, together with support from the Uncle Kory Foundation, for their collaborative work to get to this important milestone," Mr. Arons added. "We also offer our deepest appreciation and support for the patients and families who are or will be participating in this pivotal trial."