On June 10, 2021 InterVenn Biosciences reported it has completed clinical and analytical validation in compliance with standards set by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) of GLORITM, a liquid-biopsy diagnostic test capable of differentiating between malignant and benign female pelvic tumors (Press release, InterVenn Biosciences, JUN 10, 2021, View Source [SID1234583840]). This test marks a significant milestone for InterVenn as it seeks to establish its proprietary mass-spectrometry-based, AI-powered technology as a scalable clinical platform capable of efficiently deploying glycoproteomic diagnostic tests for a range of indications.

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GLORI is a laboratory-developed test (LDT) that has been validated using both retrospective patient samples and samples collected prospectively in InterVenn’s ongoing VOCAL clinical trial. Development of GLORI was advanced after compelling positive results were obtained in an interim analysis of the VOCAL trial. With an overall accuracy of 86%, GLORI outperforms all other currently available blood-based tests used to manage patients with suspected ovarian cancer.

"The company started by leveraging the decades-long work and accomplishments of its scientific co-founders, Drs. Carolyn Bertozzi and Carlito Lebrilla, and complementing them with a powerful, AI-driven data processing engine, to build a revolutionary discovery platform for analyzing the glycoproteome at unprecedented speed and scale, and, for the first time, making glycoproteomics accessible for actionable clinical research," said Erwin Estigarribia, InterVenn’s COO. "In less than three years InterVenn has successfully interrogated more than a dozen medical conditions, assayed thousands of patient blood samples, and established definitive evidence for the ubiquitous biological impact and, in parallel, for the clear clinical utility of glycoproteomics. This gave us the confidence to embark on our first prospective clinical trial, VOCAL; and the results generated, now reflected in the translational productization of data into GLORI as a fully validated LDT, are of course extremely gratifying. They are a major step forward not only for InterVenn and its platform, but also for basic and clinical science: this is the first-ever clinical glycoproteomic test and, most importantly, for women’s health, and for patients in need of better options."

"With the validation of GLORITM as the world’s first glycoproteomic LDT we have clearly demonstrated that glycoproteomics can be used to develop high-performance diagnostic solutions and that InterVenn has reached a new stage of operational maturity," said Aldo Carrascoso, InterVenn’s CEO. "We are now looking to accelerate the development of new liquid-biopsy assays in our product pipeline, including a precision-medicine test for immuno-oncology therapy, leveraging the opportunities for which GLORITM has paved the way."

The VOCAL clinical trial reached full enrollment of the targeted patient cohort in South-East Asia earlier this year, with the completion of the trial’s additional recruitment of patients in the US and Australia anticipated by the end of the year.

InterVenn has not yet announced a date for commercial availability of GLORI as it seeks to create a harmonized approach for market introduction of all products currently in its pipeline.

On June 10, 2021 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported the appointment of Robert (Xiaohua) Xin, M.D., Ph.D., as Chief Medical Officer, reporting to Zhenhai Gao, Ph.D, co-founder, president, and CEO of NiKang (Press release, NiKang Therapeutics, JUN 10, 2021, View Source [SID1234583839]). As a member of the executive leadership team, Dr. Xin will oversee the global clinical development of NiKang’s pipeline and will work closely with the discovery team to prioritize drug targets and formulate strategies.

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"NiKang is on the verge of rapid growth. We are thrilled to welcome Robert at this pivotal time. His successful track record in navigating all stages of clinical development will help us effectively execute our clinical development plans," said Zhenhai Gao. "His in-depth expertise in oncology drug development and strong leadership will be invaluable and instrumental to our patient-focused mission and to the transformation of NiKang into a fully-fledged drug discovery and development company."

Dr. Xin brings to NiKang more than 20 years of experience with an excellent track record of successfully developing novel oncology therapies including small molecules, therapeutic antibodies, antibody drug conjugates and immunotherapies. Previously, Dr. Xin served as SVP, head of clinical development at Turning Point Therapeutics, where he led early and late stage clinical programs for selective small molecule inhibitors for the treatment of cancer. Before Turning Point, he spent 7 years at Pfizer and had served in positions of increasing responsibilities, most recently as interim VP of oncology early clinical development. Prior to Pfizer, Dr. Xin served for 10 years at Genentech/Roche in senior leadership roles in oncology clinical development. His early career experience includes drug discovery and translational medicine at Chiron, Eli Lilly and Sugen. Dr. Xin obtained his M.D. from Zhejiang University School of Medicine in China and a Ph.D. in Cell and Molecular Physiology from the University of North Carolina at Chapel Hill School of Medicine.

"I am honored to serve as NiKang’s Chief Medical Officer. I have been incredibly impressed with the capability and productivity of NiKang’s extremely talented and passionate drug hunters. They have built an attractive portfolio of novel small molecules against hard-to-drug targets for cancer treatment. It is an exciting time at NiKang as the company is advancing multiple promising drug candidates into clinical development. I look forward to working with the team to accomplish NiKang’s mission of helping cancer patients with unmet medical needs."

On June 10, 2021 Monte Rosa Therapeutics, a biotechnology company focused on discovering and developing precision medicines that degrade disease-causing proteins, reported the appointment of Filip Janku, M.D., Ph.D., as the company’s first chief medical officer (Press release, Monte Rosa Therapeutics, JUN 10, 2021, View Source [SID1234583838]).

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"Our team is excited to welcome Filip on board as we continue to identify disease-causing protein targets that may be amenable to molecular glue-based degradation," said Markus Warmuth, M.D., CEO of Monte Rosa Therapeutics. "We are looking forward to continuing to advance our programs toward the clinic with Filip’s leadership and expertise."

Prior to joining Monte Rosa, Dr. Janku served in various roles at The University of Texas MD Anderson Cancer Center, or MD Anderson, including center medical director for the Clinical and Translational Research Center, associate professor and medical oncologist in its Department of Investigational Cancer Therapeutics. There, he specialized in the development of new cancer drugs with a special focus on proof-of-concept studies of novel personalized therapies. Dr. Janku received his M.D. and Ph.D. from Charles University Prague in the Czech Republic.

On June 10, 2021 Bright Peak Therapeutics, a biotechnology company developing next-generation cytokine immunotherapies to treat cancer and autoimmune disease, reported that it raised $107 million in a Series B financing (Press release, Bright Peak Therapeutics, JUN 10, 2021, View Source [SID1234583837]). The round was led by RA Capital, with participation by founding investor Versant Ventures and new investors Fidelity Management & Research Company, Invus, Qatar Investment Authority, funds and accounts managed by BlackRock, Alexandria Venture Investments and an undisclosed leading healthcare investment fund.

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Bright Peak uses a novel technology to chemically synthesize therapeutic cytokines by ligating together customized peptide segments. This proprietary technology provides unique flexibility to both tune and enhance cytokine biology through affinity modification and orthogonal, site-specific conjugation. The company’s platform also allows for the conjugation of its enhanced cytokines as payloads to certain antibodies, creating novel and proprietary "Bright Peak Immunocytokines." These Immunocytokines will allow tissue- and cell-specific targeting of the cytokine payload with the added potential for synergistic efficacy through potency-enhancing avidity effects.

"The investment from this accomplished crossover syndicate underscores the enthusiasm for our platform and re-affirms our commitment to transform the therapeutic utility of cytokines to treat people with cancer and autoimmune diseases," said Fredrik Wiklund, president and CEO of Bright Peak. "This capital will allow us to expand our Immunocytokine platform and advance our deep pipeline of programs across IL-2, IL-18 and IL-7."

Also today, Bright Peak announced key additions to its board of directors with the appointments of independent directors Laura Shawver, Ph.D., and Christine Siu. Dr. Shawver, currently CEO of Silverback Therapeutics, is an industry veteran with an extensive scientific, translational and clinical background as well as a broad range of strategic expertise. Most recently, she was president and CEO of Synthorx, a developer of engineered cytokines for cancer and autoimmune disorders that was acquired by Sanofi in 2020 for $2.5 billion. She received her Ph.D. in pharmacology from the University of Iowa.

Ms. Siu is the chief operating officer in-residence at BridgeBio Pharma Inc., and former CFO at Eidos Therapeutics Inc., a BridgeBio subsidiary, where she transformed Eidos from a preclinical biotech start-up company to a late-stage clinical public company. Prior to that, she was the CBO at The Bluefield Project to Cure Frontotemporal Dementia, where she built a therapeutic pipeline and executed seven collaborations with the pharmaceutical industry. Earlier, she was senior director, corporate development at Global Blood Therapeutics, Inc. (GBT), and before that, a venture principal at Third Rock Ventures. Previously, Ms. Siu invested in life science companies in venture capital and private equity and held roles of increasing responsibility at Warburg Pincus LLC and Thomas, McNerney & Partners, LLC and began her career in healthcare banking at Bear, Stearns & Co. Inc. Ms. Siu holds an MBA from Harvard Business School and a B.S. with distinction in cellular molecular biology and economics from the University of Michigan.

On the Bright Peak board, Dr. Shawver and Ms. Siu join RA Capital’s Josh Resnick, M.D., and Michael Rosenzweig DVM, Ph.D., who joined in connection with the Series B financing, as well as existing board members Alex Mayweg, Ph.D., and Tom Woiwode, Ph.D., of Versant Ventures.

"We are pleased to lead a financing that will enable Bright Peak to broadly invest in its platform technologies, development programs, people, and, ultimately, towards delivering a pioneering new category of cytokine immunotherapies to patients in need," said Dr. Resnick.

"We warmly welcome Laura, Christine, Josh, and Michael to our Board of Directors. Their deep domain expertise and business acumen will serve as a tremendous resource to the Company," said Dr. Mayweg.

On June 10, 2021 ITM AG, a leading radiopharmaceutical company, reported the close of a private equity financing round from existing and new investors, related and connected parties to Portland Holdings, along with FRIBA Investment, raising a total of EUR 25 million (USD 30 million) (Press release, ITM Isotopen Technologien Munchen, JUN 10, 2021, View Source [SID1234583836]). The funding will support the company’s ongoing global expansion and the addition of novel programs into its leading precision oncology pipeline, as well as the further advancement of ITM’s existing clinical candidates in a broad range of oncology indications. The EUR 25 million private financing is additional to the EUR 90 million convertible loan agreement announced in April, 2021. Further details on the financing were not disclosed.

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"We greatly value the continued support we receive from our current and new investors to fund our progress in providing the most precise cancer radiotherapeutics and diagnostics to patients in need of novel treatment options. This raise reinforces the commitment of both existing and new investors and highlights their confidence that we will successfully deliver on the potential of Targeted Radionuclide Therapy for cancer patients," commented Steffen Schuster, Chief Executive Officer of ITM.

"ITM’s data has proven compelling to date and the ongoing Phase III trial, COMPETE looks very promising, thereby further validating the company’s approach to addressing important therapeutic needs in the oncology field and contributing to the future wellbeing of patients. We are excited to contribute to the company’s financial strength and look forward to seeing ITM maintain this positive momentum in 2021," said Robert Collan, Managing Director at FRIBA Investment.

"The current private equity financing round represents a significant capital raise by a Canadian investment firm in the area of life sciences, where we are rapidly expanding our domain experience and investment portfolio. This investment is a product of our reputation, our global footprint, and access to capital, and represents our commitment to democratizing wealth by offering everyone – from the sophisticated institutional investors and family offices to eligible retail clients – an opportunity to co-invest with us in what we believe are high-quality firms. We welcome to ITM’s shareholder roster our friends and like-minded investors at FRIBA Investment. In keeping with our philosophy of doing well and doing good, we look forward to contributing toward the collective mission of improving medical outcomes for cancer patients worldwide," commented Michael Lee-Chin, Supervisory Board Member of ITM and founder and chairman of Portland Holdings.

ITM is a leader in the production and supply of high-quality medical radioisotopes for cancer treatment and diagnosis and has established its own global supply network. The company has forward-integrated to develop Targeted Radionuclide Diagnostics and Therapies designed to provide medical benefit for hard-to-treat cancer indications. ITM’s goal is to advance a broad pipeline by combining its first-class radioisotopes with targeting molecules capable of addressing a range of tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM will validate this approach with its lead candidate, n.c.a. 177Lu-Edotreotide currently in a Phase III clinical trial for GEP-NETs.