On December 8, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has issued the Drug Master File (DMF no. 34938) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, distributed under the brand name GeGant (Press release, ITM Isotopen Technologien Munchen, DEC 8, 2020, View Source [SID1234572456]).The DMF will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use GeGant in clinical tests for radiopharmaceuticals and in other settings.

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The GeGant Generators will be manufactured at the RadioMedix Spica Center in Houston, Texas, U.S., a GMP radiopharmaceutical manufacturing facility that is dedicated to late-stage investigational and commercial stage radiopharmaceutical manufacturing and distribution. At this center, thousands of 68Ge/68Ga Generators can be produced annually. This high production capacity enables ITM and RadioMedix to meet the rapidly increasing demand for Gallium-68 in the United States and across the world.

The medical, short-lived radioisotope Gallium-68 is used for Positron Emission Tomography (PET) imaging when labeled to a tumor-specific targeting molecule for diagnosis and staging of various cancers, like neuroendocrine tumors or prostate cancer. PET-imaging is a state-of-the-art approach for precise localization of tumors or metastases pre-therapy as well as the evaluation of treatment response post-therapy. It is a highly sensitive method, providing quick procedures with short imaging time. GeGant allows onsite production of high-quality Gallium-68 for radiolabeling with disease specific tracers. As well as showing a low breakthrough of Germanium-68, GeGant is available in different sizes, and with 4 GBq (100 mCi), being among the largest 68Ge/68Ga Generators on the market.

"This announcement by the U.S. FDA takes us another step closer toward full adaptation of the GeGant Generators in the U.S market. The consumption of Gallium-68, as an on-demand positron emitter, will only increase in the field of Nuclear Medicine. There is exponential growth of several exciting molecules labeled with Gallium-68 and RadioMedix’s manufacturing bandwidth is prepared to respond to this unmet need", said Ebrahim Delpassand, M.D., CEO of RadioMedix.

Steffen Schuster, CEO of ITM said: "The Drug Master File in the U.S. will enable us to take full advantage of our long-term partner RadioMedix’s production capacity which is needed to address the rapidly growing demand for Gallium-68 in the United States as one of the largest markets for Targeted Radionuclide Therapies and Diagnostics. Together with Radiomedix, we are looking forward to scaling up the production of GeGant to provide high quality products for patients in need in North America as well as the global market."

On December 8, 2020 RayzeBio, Inc., which launched this year to develop a broad pipeline of targeted radiopharmaceuticals against validated solid tumor targets, reported a $105 million Series B financing led by Venrock Healthcare Capital Partners (VHCP) alongside new investors OrbiMed, Redmile Group, Viking Global Investors, Logos Capital, Cormorant Asset Management, LifeSci Venture Partners, Alexandria Venture Investments and others (Press release, RayzeBio, DEC 8, 2020, View Source [SID1234572455]). Also participating were existing investors from RayzeBio’s $45 million Series A financing, including venBio Partners, Versant Ventures and Samsara BioCapital.

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"In the past several months, we’ve built an exciting pipeline of seven programs, expanded our leadership team, and secured several key business partnerships," said Ken Song, M.D., president and CEO of RayzeBio. "I am appreciative of the enthusiastic support from our elite group of investors. This additional capital allows us to fully invest in the potential of radiopharmaceuticals as a transformative therapy for cancer patients."

With $150 million of capital from the two financings, RayzeBio will advance multiple programs in parallel toward the clinic. The company also is expanding its headquarters in San Diego with plans to further internalize key research and development capabilities.

"We’ve been following the radiopharmaceuticals space for several years and are impressed by the approach RayzeBio is taking to build a broad pipeline," said Bong Koh, M.D., lead investor from VHCP who is joining the RayzeBio Board of Directors in connection with the Series B.

In addition to the financing, RayzeBio also announced the appointment of Gary Li, Ph.D. as senior vice president and head of biology and translational medicine and Eric Bischoff as senior vice president of development and operations. Dr. Li is an accomplished cancer cell biologist with over 15 years of drug development experience, with leadership positions at Ignyta and QED Therapeutics prior to joining RayzeBio. Mr. Bischoff has had an extensive and diverse career in drug discovery and development for more than 20 years including key roles at two oncology companies, Aragon and Seragon, which were both acquired.

On December 8, 2020 Candel Therapeutics ("Candel") reported that Paul-Peter Tak, M.D., Ph.D., was appointed president and chief executive officer of Candel Therapeutics in a planned transition to lead a new phase of growth as the Company advances its broad pipeline of oncolytic viral immunotherapies (Press release, Candel Therapeutics, DEC 8, 2020, View Source [SID1234572454]). Dr. Tak is a world-renowned immunologist, drug developer, entrepreneur and patient advocate who brings more than 25 years of demonstrated success to the role. The company has also appointed Nathan Caffo as chief business officer, John Canepa as chief financial officer and Susan Stewart as chief regulatory officer.

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"Candel has tremendous potential to change the cancer treatment paradigm for the many patients who aren’t well served by currently available treatment options," said Paul-Peter Tak, M.D., Ph.D., CEO of Candel Therapeutics. "Our approach, which is based on two differentiated oncolytic virus-based platforms, enables local destruction of tumor cells while eliciting a robust, systemic, long-lasting immune response. With our lead compound currently in a phase 3 clinical trial, our rQNestin 34.5 oncolytic HSV in phase 1, and our recently initiated discovery program, Candel is leveraging a unique platform to develop innovative immunotherapies for patients with an unmet need."

Candel is focused on developing immunotherapies that induce immunogenic cell death in cancer cells at the site of injection, unmasking tumor neo-antigens while activating immuno-inflammation in the tumor microenvironment. This process leads to a broad, systemic immune response against the cancer cells, with the potential to change disease outcomes across a variety of solid tumor indications. Candel currently has clinical programs in prostate cancer, glioblastoma, non-small cell lung cancer and pancreatic cancer.

Dr. Aguilar-Cordova commented, "Candel has made tremendous progress in advancing its viral immunotherapy platforms. Having now administered our investigational therapies to over 700 patients in multiple phase 1 to phase 3 clinical trials, we are at an important stage of the company’s growth. Building on this foundation, we are proud to have attracted such accomplished industry veterans as Paul-Peter, Nathan, John and Sue to join us and help realize Candel’s potential in this next stage of growth."

With a career spanning nearly three decades in the life science and biopharma industry, Dr. Tak was most recently president and chief executive officer of Kintai Therapeutics as well as venture partner at Flagship Pioneering. Previously, he was senior vice president and global head of R&D for immuno-inflammation, oncology and infectious disease, as well as chief immunology officer and global development leader at GlaxoSmithKline (GSK), while also serving as co-chair of GSK’s scientific review board. Prior to that, Dr. Tak was president and CEO of Tempero Pharmaceuticals, where he facilitated the company’s acquisition by GSK. He co-founded Sitryx Therapeutics and Arthrogen, and serves on the boards of Sitryx Therapeutics, Levicept, and Citryll. He previously served on the board of a variety of companies, including ViiV Healthcare, Galvani Bioelectronics, and Omega Therapeutics. Dr. Tak is board certified in internal medicine, was trained as an immunologist, earned a Ph.D., and later became a professor of medicine at various universities. He has been elected Fellow of the Academy of Medical Sciences (UK).

"With his strong leadership, broad drug development experience and unwavering patient advocacy, Paul-Peter embodies Candel’s mission, values and core strengths," said Paul Manning, chairman of Candel and chairman and CEO of PBM Capital. "We, alongside CandeI’s board, look forward to working with this outstanding team as the company moves through its next evolution, advances multiple late-stage clinical programs across various tumor types, and evaluates its next steps in the capital markets."

Nathan Caffo brings a depth of experience to Candel. His 26-year industry career has been focused on cancer therapeutics, personalized medicine and applications of genomic technology. He was most recently chief business officer at ALX Oncology, an immuno-oncology company where he played an instrumental role in multiple private and debt financings totaling $120 million, as well as the company’s $186M IPO in July 2020. Prior to ALX Oncology, he was president and CEO of Presage Biosciences, an oncology company that developed the first intratumoral microdosing platform for evaluation of multiple oncology agents. While at Presage, he also led the company’s partnering strategy, resulting in numerous biopharma partnerships, including strategic equity investments from Celgene and Takeda. He also held business development and management roles at Perlegen, Applied Biosystems and Celera.

John Canepa has over 40 years of experience in the life science industry as an audit partner with a large international public accounting firm, and as a financial executive with public and private life science companies. Prior to joining Candel, he served as CFO of Frequency Therapeutics. During his tenure, Frequency completed several public and private financings, including its initial public offering in October 2019. Prior to joining Frequency, he served as CFO of Agilis Pharmaceuticals, Inc. and was instrumental in its sale to PTC Therapeutics in August 2018. Prior to Agilis, he was COO and CFO of Asterand Bioscience and led its sale to a private equity group in 2017. Mr. Canepa began his career at Arthur Andersen & Co. and was with the firm for 23 years.

Susan Stewart, J.D. has worked for more than 28 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. She served as the program lead on several products that received FDA approval including Renagel (sevelamercarbonate) and Thyrogen (thyrotropinalpha). As an independent consultant, she also serves as chief regulatory officer at Kaleido Biosciences, and had served as senior vice president of regulatory affairs and quality. She held previous regulatory and leadership positions at Abbott, Genzyme, Tokai, and Transmolecular.

On December 8, 2020 Paige, a global leader in AI-based digital diagnostics, reported it received a CE mark for Paige Breast, its breast cancer detection software that indicates suspicious areas for further review to pathologists evaluating breast biopsies (Press release, Paige AI, DEC 8, 2020, View Source [SID1234572453]). The company also received a CE mark for Paige Prostate Grading & Quantification, a digital diagnostic that offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning. With these CE marks, both products are now available for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK.

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"The CE mark in breast cancer represents an important regulatory validation for our computational pathology products as we broaden our applications in oncology, while the CE mark in prostate cancer adds valuable grading and quantification features for our existing CE marked Paige Prostate offering," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "We continue to rapidly advance new products that improve pathology workflow and improve diagnostic confidence for some of the most prevalent cancers including breast cancer. I am incredibly grateful to all the Paige team members and our physician colleagues worldwide who have helped advance this technology in order to ultimately optimize patient outcomes."

Paige Breast Enables Slide and Case Level Predictions on Breast Cancer Presence

For pathologists diagnosing breast cancer – the most commonly diagnosed cancer among women in European countries1 – the potentially large volume of breast tissue slides to be reviewed can pose challenges for workload management and pathologist productivity. Paige Breast is designed to draw pathologists’ attention to concerning features on a breast tissue slide and provides slide and case level predictions about the presence of cancer. This functionality enables pathologists to more easily, efficiently and confidently identify small foci of cancer that can be easily missed.

"By reducing inter-observer variability, uncertainty, and time, this technology will enable pathologists to drive informed treatment more efficiently, helping to ensure patients receive the best care," said Matthew Hanna, M.D., Director of Digital Pathology Informatics at Memorial Sloan Kettering Cancer Center. "These technologies have the potential to increase physician productivity while minimizing burnout, particularly for diseases with high incidence, such as breast cancer, where hospitals may be faced with a large volume of patient cases."

Paige continues to enhance functionality for Paige Breast, including quantification and subtyping functionality, for future deployment.

Streamlining Prostate Cancer Diagnosis Through AI-based Grading and Quantification

Grading and quantification of prostate tissue are time consuming tasks that are often subjective with high inter-observer variability as part of the diagnosis process. With the addition of the new grading and quantification functionality, Paige Prostate can enhance diagnostic confidence for the pathologist while increasing consistency and standardization.

Paige Prostate Grading & Quantification provides slide level information for primary and secondary Gleason patterns, tumor length and tumor percentage. The product provides visual overlays that indicate the specific regions of the slide corresponding to each Gleason pattern, which can reduce the time it takes a pathologist to determine and measure a grade. Furthermore, Paige Prostate Grading & Quantification exhibits high concordance with sub-specialized pathologists which means the technology has the potential to decrease a pathologist’s need to defer cases for additional review without compromising diagnostic accuracy. This technology thereby streamlines workflows to decrease turnaround time for the patient and clinician.

On December 8, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported its lead drug candidate, repotrectinib, has been granted breakthrough therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI-naïve) (Press release, Turning Point Therapeutics, DEC 8, 2020, View Source [SID1234572452]).

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"Breakthrough therapy designation is another milestone in our development of repotrectinib and one more step towards our goal to get this potentially important drug candidate to patients as quickly as possible," said Athena Countouriotis, M.D., president and chief executive officer. "I am incredibly proud of our Turning Point team with the achievement of our fourth regulatory designation from the FDA for repotrectinib, and pleased with how our enrollment specifically in the ROS1 TKI-naive population of the TRIDENT-1 study has progressed since we reported initial early Phase 2 data. We look forward to sharing more information on our overall study timelines early next year, and providing updated data from the TRIDENT-1 study next month."

Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.

The breakthrough therapy designation for repotrectinib was supported by the initial data from TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase 1 and Phase 2 portions of the TRIDENT-1 study, which is currently evaluating patients in multiple potentially registrational cohorts.

Breakthrough therapy designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Repotrectinib was previously granted three Fast Track designations by the FDA, in ROS1-positive NSCLC patients who are TKI naïve, ROS1-positive NSCLC patients who have been previously treated with one prior platinum chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs.