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Precision BioSciences Announces Closing of In Vivo Gene Editing Collaboration and License Agreement with Eli Lilly and Company

On January 7, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, reported the closing of its in vivo gene editing research collaboration and exclusive license agreement with Eli Lilly and Company following clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (Press release, Precision Biosciences, JAN 7, 2021, View Source [SID1234576680]).

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As previously announced on November 20, 2020, Precision and Lilly entered into a research collaboration agreement to use Precision’s proprietary ARCUS genome editing platform for pre-clinical and IND-enabling activities for up to six gene targets, with an initial focus on Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.

Under the terms of the agreement, Precision will receive an upfront cash payment of $100 million, and has received $35 million from Lilly’s purchase of newly issued shares of Precision’s common stock. Precision is also eligible to receive up to $420 million in potential development and commercialization milestones per product, as well as tiered royalties ranging from the mid-single digits to low-teens on product sales should Lilly successfully commercialize a therapy from the collaboration. Precision will lead pre-clinical research and IND-enabling activities, with Lilly then assuming responsibility for clinical development and commercialization. Lilly will have the right to select up to three additional gene targets for this collaboration. Precision can co-fund clinical development of one product in exchange for an increased royalty rate on co-funded product sales.

About ARCUS
ARCUS is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock-in), remove (knock-out), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision’s platform and products are protected by a comprehensive portfolio including more than 65 patents to date.

Oncternal Therapeutics and Karolinska Institutet Establish Collaboration for Research and Development of ROR1-targeting CAR-T and CAR-NK Cell Therapies

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]).

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."

Vincera Pharma Announces Name Change to Vincerx

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.

Theratechnologies Announces Preliminary Fourth Quarter And Full Fiscal Year 2020 Revenues And Provides Update On R&D Activities

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]).

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.

Biohaven Acquires Kleo Pharmaceuticals And Licenses Platform Technology From Yale University To Form Biohaven Labs

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.

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."