On March 9, 2022 Tyligand Bioscience, a clinical-stage biotechnology company focused on developing innovative therapies against drug resistant cancers, reported that the first subject had been dosed in US in a phase 1 trial for its innovative multi-kinase inhibitor TSN084 (Press release, Tyligand Bioscience, MAR 9, 2022, View Source [SID1234644989]). The study includes a dose escalation and dose expansion phase to evaluate the safety, tolerability, and preliminary anti-tumor activity in subjects with advanced or metastatic malignancies, to be conducted both in US and China. The first enrollment was led by Dr. Siqing Fu, Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, TX.

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Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience, commented: "TSN084 is the front runner of the Tyligand pipeline of innovative molecules. It hits a unique combination of kinase targets including CDK8/19 and offers the possibility of synergistic attack against cancers at multiple fronts. We are glad that it has reached this major milestone in a journey toward becoming a drug that can help patients. We appreciate the dedication of our team members, collaborators and clinical investigators for propelling the project forward with impressive quality and speed."

On March 9, 2022 Novo Nordisk reported the expansion of its existing research collaboration in oral drug delivery technologies with the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital (BWH) (Press release, Novartis, MAR 9, 2022, View Source [SID1234610088]).

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Since 2015, scientists from Novo Nordisk and the laboratories of Prof. Giovanni Traverso and Prof. Robert Langer have explored novel technologies as alternatives to syringes and pen injectors, by co-creating new devices that safely and effectively deliver biologic medicines through oral administration. This collaboration has resulted in several high-impact scientific publications describing breakthrough inventions, including the SOMA robotic pill, which has subsequently been licensed exclusively to Novo Nordisk for clinical development.

"Working with the Langer and Traverso teams continues to be a unique opportunity for Novo Nordisk to live out our aspiration of bringing transformational new solutions to patients by thinking big, working with the best, and using our distinct capabilities to aim to achieve what might otherwise seem impossible," said Marcus Schindler, PhD, professor, executive vice president and chief scientific officer of Novo Nordisk.

The new agreement extends the collaboration through 2026, expanding the scope to encompass the creation and integration of bioelectronics, biosensors and stimuli-responsive delivery devices.

"We continue to explore the immense potential for enhanced delivery of biologic drugs and stem cell-derived therapeutics through the platforms we are developing," said Giovanni Traverso, the Karl van Tassel, Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women’s Hospital, Harvard Medical School.

"Our group at MIT strives to combine engineering and medicine to solve important problems and find the best ways to get those solutions to the people who need them," added Robert Langer, David H. Koch Institute Professor at MIT. "Our work together with Novo Nordisk has shown that they share this vision, and we are thrilled to expand into this ambitious new program together".

On March 9, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 for the treatment of soft tissue sarcoma (Press release, C4 Therapeutics, MAR 9, 2022, View Source [SID1234609962]).

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The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

"Patients living with synovial sarcoma currently have limited treatment options. After first-line treatment with chemotherapy, the benefit of which is typically of limited durability, patients with metastatic synovial sarcoma tend to do poorly. The FDA’s decision to grant orphan drug designation to CFT8634 is an important recognition of the potential of our targeted protein degrader to address this dire unmet medical need faced by patients and their families," said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics.

CFT8634 is a BiDAC degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1 deleted cancers. BRD9 has been considered an "undruggable" target because inhibitors of the bromodomain of BRD9 are not effective in treating these cancers. However, C4T’s TORPEDO platform was leveraged to discover CFT8634, an orally bioavailable, selective degrader of BRD9. Unlike BRD9 inhibition, BRD9 degradation is efficacious in preclinical models of synovial sarcoma. In December 2021, the FDA cleared C4T’s investigational new drug (IND) application for CFT8634 to proceed with the proposed Phase 1/2 trial in patients with synovial sarcoma and SMARCB1-null solid tumors. Site activation efforts have commenced and the trial remains on track to begin dosing patients in the first half of 2022.

On March 9, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported its participation in the following investor conferences (Press release, Turning Point Therapeutics, MAR 9, 2022, View Source [SID1234609907]):

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March 15, 34th Annual Roth Conference, CFO Paolo Tombesi is scheduled to participate in one-on-one meetings.

March 16, Oppenheimer 32nd Annual Healthcare Conference, President and CEO Athena Countouriotis, M.D., is scheduled to present a company overview from 12:40 to 1:10 p.m. ET.

Dr. Countouriotis’ session will be accessible via webcast through the Investors page of www.tptherapeutics.com.

On March 9, 2022 IN3BIO Research Limited, a leader in developing cancer treatments that, based upon clinical data, show significant promise and appear to be more tolerable for patients, reported that it has received Clinical Trial Application approval from the British Medicines & Healthcare Products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial of its colorectal cancer vaccine (Press release, In3Bio, MAR 9, 2022, View Source [SID1234609850]). This is the company’s second global regulatory approval for the trial, having obtained approval to conduct the study in Bulgaria earlier this year.

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With these approvals, IN3BIO is one step closer to bringing its innovative cancer treatments to market. The company is in the process of a Series A financing round for the Phase I/II trial as well as for developing a second molecule to advance its global mission.