On August 1, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that its President and Chief Executive Officer, Markus Renschler, MD, will participate in the 2022 Wedbush PacGrow Healthcare Virtual Conference on August 9, 2022 (Press release, Cyteir Therapeutics, AUG 1, 2022, View Source [SID1234617219]).

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2022 Wedbush PacGrow Healthcare Conference
Date: Tuesday, August 9
Time: 12:00 PM EDT
Panel: Synthetic Lethal (Weapon) – Part 1

A live webcast of the Wedbush panel discussion will be available in the Investors & Media section of the Cyteir website at www.cyteir.com. A webcast replay will also be available on the website shortly after conclusion of the event for 30 days.

On August 1, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that it will prioritize NUV-868 and development of its novel small molecule DDC platform and discontinue clinical development of NUV-422 (Press release, Nuvation Bio, AUG 1, 2022, View Source [SID1234617218]).

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The decision to discontinue clinical development of NUV-422 is the result of an internal risk-benefit analysis factoring in feedback received from the U.S. Food and Drug Administration (FDA) in a partial clinical hold letter for the Company’s monotherapy Phase 1/2 study (Protocol NUV-422-02) and clinical hold letters for its combination Phase 1b/2 studies (Protocols NUV-422-03 and NUV-422-04). The FDA verbally placed a partial clinical hold on the Phase 1 dose escalation portion of the Company’s NUV-422-02 study in June 2022. At that time, the Company had proactively paused enrollment of new patients following the emergence of a safety signal, uveitis, which is a form of inflammation of the eye. Furthermore, the FDA requested a mitigation plan to address the adverse event of uveitis. Given that the etiology of uveitis associated with NUV-422 is not understood and that its development appears unpredictable, the Company believes that it would be difficult to craft an effective mitigation plan without significant further research.

Nuvation Bio will intensify its focus and concentrate its resources on the clinical development of NUV-868, its BD2-selective BET inhibitor, and identifying a lead clinical candidate from its novel small molecule DDC platform. Enrollment is ongoing in the Phase 1 monotherapy study of NUV-868, and the Company has planned Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide to enhance the potential value of this program across multiple tumor types.

A reduction in work force of 35% and other cost savings associated with the NUV-422 program discontinuation will enable Nuvation Bio to extend its cash runway through 2028. The Company expects to report a balance of approximately $703.8 million in cash, cash equivalents and marketable securities as of June 30, 2022.

"Nuvation Bio was founded on a commitment to advance a broad pipeline of innovative therapies as quickly and safely as possible for people with cancers that do not currently have adequate treatment options. As part of this commitment, we have always operated as a scientifically rigorous, data-driven company. Following an extensive analysis of the Phase 1 dose escalation study of NUV-422 in solid tumors, we made the determination that uveitis cannot be safely managed. We sincerely thank all patients and investigators who were part of the NUV-422 clinical program for their prodigious efforts. We also thank our employees for their commitment to the Nuvation Bio mission. It was a difficult decision to discontinue the program and we are extremely grateful for each of their contributions," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.

Dr. Hung added: "We believe that our disciplined, data-driven and timely decision to prioritize our other programs over the NUV-422 program based on our most recent clinical data serves to increase our probability of ultimate success in our efforts to bring game-changing drugs to patients who desperately need them. To that end, we are excited to continue enrolling patients in the NUV-868 Phase 1 study and are encouraged by our progress with our novel small molecule DDC platform. With a robust cash balance and a world class drug development team, we are well positioned to progress these priority programs in some of the most difficult-to-treat cancers."

On August 1, 2022 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported the appointment of Shuanglian (Lian) Li, M.D., Ph.D., as the company’s Senior Vice President and Chief Medical Officer (US) (Press release, AnHeart Therapeutics, AUG 1, 2022, View Source [SID1234617217]). In this role, Dr. Li will oversee and direct all U.S.-based clinical programs.

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Dr. Li is an accomplished clinical development physician with over 15 years of drug development experience from preclinical drug safety to late-stage drug development and post-marketing clinical research. Her clinical development expertise has specialized in precision medicine and adoptive cellular therapy.

Prior to joining AnHeart, Dr. Li was SVP, Clinical Development at Ansun Biopharma, where she led and drove the overall clinical development strategy of the company’s oncology pipeline and clinical development plan. She also led clinical and regulatory strategy as Head of Clinical Development at Skyline Therapeutics, a gene therapy company headquartered in Shanghai.

Dr. Li was also the Global Clinical Lead for mobocertinib, a first-in-class EGFR inhibitor that targeted EGFR exon 20 insertions, at Takeda Pharmaceuticals. Prior to its acquisition by Takeda, Dr. Li was Medical Director at ARIAD Pharmaceuticals and the medical lead for several oncology programs. Dr. Li has held various positions with increasing responsibilities at Biogen, Pfizer and Sugen.

"We’re delighted to welcome Dr. Li to AnHeart Therapeutics. She brings more than 15 years of experience leading high-performing teams in clinical development, and has a proven track record of success with multiple FDA approvals in oncology," said Junyuan (Jerry) Wang, Ph.D. CEO & Co-Founder, AnHeart Therapeutics. "Dr. Li is precisely the type of high-quality individual we are recruiting as we grow our company. She will be an invaluable asset to AnHeart and our leadership team as we advance our clinical pipeline focused on ROS1-directed therapeutics."

"I am excited to join AnHeart at such a dynamic time. The company is developing multiple cancer therapies including lead asset taletrectinib targeting ROS1-fusion and resistant mutations. AnHeart’s mission to transform the lives of cancer patients with breakthrough medicines and exciting programs attracted me to the role, and I look forward to working with the management and scientific teams to bring innovative therapies to cancer patients," said Dr. Li.

Dr. Li received her Ph.D. in Pharmaceutical Sciences & Pharmacogenomics, from the University of California, San Francisco and an M.D. from Beijing Medical University. She also obtained an M.S. in Pharmacology & Toxicology from the University of Mississippi.

On August 1, 2022 Carterra, Inc., the world leader in innovative technologies enabling high-throughput biology, and La Jolla Institute for Immunology (LJI), a globally recognized non-profit research organization dedicated to understanding the power of the immune system to promote human health, reported that LJI has acquired a Carterra LSA instrument to enhance its antibody screening and characterization work (Press release, the La Jolla Institute, AUG 1, 2022, View Source [SID1234617216]).

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In 2020, while leading the pandemic response, LJI’s Coronavirus Immunotherapy Consortium (CoVIC) partnered with Carterra to screen and characterize hundreds of antibodies from all over the world, bringing academic, non-profit, and commercial laboratories together to discover the best antibody therapeutics against COVID-19. Funded by the Bill and Melinda Gates Foundation and led by Dr. Erica Ollmann Saphire, CoVIC’s goal is to find the most potent antibodies against COVID-19 and its variants, the results of which could guide the development of vaccines and therapeutics for today but that also protect against future pandemics. It was through this collaboration that LJI discovered the power and magnitude of the LSA’s capabilities. This body of work was published in Science in September 2021: View Source

"The LSA was key to mapping the epitope landscape of the SARS-CoV2 spike, using the 400 antibodies in the consortium. That information was instrumental to understanding which target sites are still effective against emerging variants of concern," said Erica Ollmann Saphire, Professor at La Jolla Institute for Immunology and Director of the CoVIC consortium. "Having seen what the LSA can do first-hand, through our collaboration with Carterra as part of the CoVIC, we now look forward to using this instrument to propel our own discovery efforts."

The LSA will support La Jolla Institute’s discovery efforts of broadly reactive antibodies against a number of pathogens, enabling rapid characterization of hundreds of antibodies in the early stages, followed by in-depth analysis of leads during later stages of discovery. The LSA will also enable the rapid characterization of sera samples from vaccine studies, in addition to autoimmune and cancer targets.

Carterra launched the LSA antibody discovery and characterization platform in 2018 and has quickly made it the standard in 17 of the 20 largest pharmaceutical companies, biotechs, CROs, and government labs such as the FDA and the NIAID of the NIH. The speed at which antibodies can now be identified and characterized as potential drugs by Carterra’s LSA has improved on traditional methods by generating results 100 times faster while using 99% less sample. Sensitivity for finding the rarest of antibodies in a complex matrix is also now best-in-class.

"We’re proud to see the benefit of Carterra’s LSA platform being brought to bear for global good," says Tim Germann, Chief Commercial Officer at Carterra. "Working with Erica and her team at LJI has been truly enlightening—they understand the importance of breaking down the old paradigm of slow and inefficient biologics discovery. Bringing the LSA to LJI represents their commitment to leading the effort to end the suffering from pandemics like Ebola and COVID-19."

Other highlights from Carterra’s success with the LSA platform include the following:

The LSA was a primary tool used by Eli Lilly and AbCellera in the discovery of bamlanivimab, the world’s first COVID-19 therapeutic and fastest biologic ever to reach clinical trials: View Source
In December of 2020, Carterra closed an equity round of financing from industry giant, PerkinElmer who is also now the exclusive distributor of the LSA platform in the Asia-Pacific and Oceania regions.

On August 1, 2022 Amphera B.V., a late-stage biotechnology company developing cell therapies to treat cancer, reported that the last patient has completed the active follow-up in the Phase II/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma (Press release, Amphera, AUG 1, 2022, https://www.businesswire.com/news/home/20220801005324/en/Last-patient-completed-follow-up-period-in-Phase-IIIII-study-of-Amphera%E2%80%99s-MesoPher-cell-therapy-in-mesothelioma [SID1234617215]).

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Ilona Enninga PhD, COO of Amphera said: "Despite the challenges experienced during the pandemic, we were able to maintain strong enrolment to the study. The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis."

Rob Meijer, CEO of Amphera said: "This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year. The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients."

The DENIM (DENdritic cell Immunotherapy for Mesothelioma) study is a randomised open-label Phase II/III study of patients with pleural mesothelioma. The objectives are to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.

In Q4 2022, Amphera will also present the survival data of the expansion cohort of 28 patients in the Phase II REACtiVe study of MesoPher in resected pancreatic cancer. The promising results of the first cohort were recently published in the European Journal of Cancer (View Source(22)00159-9/fulltext).