King Abdullah International Medical Research Center

Plus, news about Bavarian Nordic, Nuvectis Pharma, Flashpoint Therapeutics, Sparian Biosciences and TFF Pharmaceuticals: Vitalli Bio axes Daewoong asset: Vitalli, founded by Joe Jimenez’s Aditum Bio , plans to terminate its licensing agreement for an autoimmune disease drug developed by Daewoong Pharmaceutical, according to a regulatory filing . The deal was worth up to $477 million for Daewoong. Vitalli still has the option for two additional candidates from Daewoong, the company said. Jimenez declined to comment, citing “confidentiality with our partners.” — Kyle LaHucik Alector takes out $50M loan: The money from Hercules Capital will help fund two studies: a Phase 3 for latozinemab in frontotemporal dementia, and a Phase 2 for AL002 in early Alzheimer’s disease. Alector will receive $10 million immediately and can get another $15 million at any time before June 30, 2026. The final $25 million will be available at Hercules’ approval. — Max Gelman Bavarian Nordic secures $340M in mpox, smallpox vaccine orders for 2025: The company told investors that the additional mpox orders contributed to its decision to upgrade its financial guidance for this year. Nearly three million doses of the company’s mpox vaccine MVA-BN have been pledged to Africa so far. — Anna Brown Nuvectis Pharma’s stock dives on Phase 1b data: Of 11 evaluable patients with late-line ovarian cancer who took NXP800, a GCN2 kinase activator, only one patient achieved an unconfirmed partial response, the company said . Nuvectis tested multiple dosing regimens, including different amounts and once- or twice-a-day. Nuvectis’ stock $NVCT closed 46% lower on Thursday. — Max Gelman Flashpoint Therapeutics partners with Saudi Arabia, Northwestern University: The biotech is teaming up with the King Abdullah International Medical Research Center in Riyadh in a $50 million effort to establish a new nanomedicine research center, which will receive the money over five years. Flashpoint also said it expanded its IP to include “150 issued patents and patent applications” through a deal with Northwestern. — Max Gelman Sparian Biosciences’ $19.5M NIH grant: The New York biotech got a five-year grant from the National Institute on Drug Abuse to help develop an opiate use disorder drug through Phase 1. It got a similar grant last year for another drug that aims to treat stimulant use disorder. — Kyle LaHucik TFF Pharmaceuticals to wind down: The Fort Worth, TX-based biotech let go all employees and will shut down . It had been working on dry powder formulations for drugs, including for lung transplant rejection, flu and Covid. It had $4.4 million in cash and equivalents at the end of June. — Kyle LaHucik

WASHINGTON, July 3, 2023 /PRNewswire/ -- The Association for the Accreditation of Human Research Protection Programs has accredited King Abdullah International Medical Research Center (KAIMRC), a leading research center with physical presence in Riyadh, Jeddah, and Al-Aḥsa, Saudi Arabia. KAIMRC is the third organization in Saudi Arabia to achieve AAHRPP accreditation. "Protecting research participants is a worldwide goal, one which AAHRPP accreditation recognizes. In achieving AAHRPP accreditation, KAIMRC has demonstrated its dedication to this important objective," AAHRPP President and CEO Elyse I. Summers said. "With each accreditation, we are adding to our global network of organizations that share a commitment to high-quality, ethical research." AAHRPP has accredited more than 600 research entities across the U.S. and in Australia, Belgium, Brazil, Canada, China, India, Japan, Jordan, Mexico, Republic of Korea, Saudi Arabia, Singapore, Taiwan, and Thailand. All major U.S. independent institutional review boards have earned AAHRPP accreditation. In addition, more than 85% of the top U.S. National Institutes of Health-funded academic medical centers and 70% of U.S. medical colleges are AAHRPP-accredited or have begun the accreditation process. Research institutes, clinical research centers, and community hospitals also are among those that have attained accreditation. About AAHRPP: A nonprofit organization, AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the international guidelines and laws governing research involving humans in the U.S. and other countries. To learn more, visit . FOR MORE INFORMATION CONTACT: Michelle Feige Executive Vice President [email protected] 202-783-1112 SOURCE Association for the Accreditation of Human Research Protection Programs

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Foundation Medicine, Inc ., a pioneer in molecular profiling for cancer, today announced that the company and its collaborators will present a total of 10 studies at the 2023 American Association for Cancer Research (AACR) Annual Meeting from April 14-19 in Orlando, Florida. Presentation highlights: Over the past several years, there has been great progress in the ability to identify shed pieces of tumor, called circulating tumor DNA (ctDNA), within a cancer patient’s blood. In partnership with South Australian Immunogenomics Cancer Institute, Saint Bartholomew’s Hospital and Genentech, Foundation Medicine researchers used its novel methylation sequencing research platform to detect ctDNA as a prognostic biomarker in overall survival for patients with metastatic castrate resistant prostate cancer (mCRPC). Results from ctDNA evaluation as early as 6 weeks post treatment initiation were comparable to prostate specific antigen (PSA) response in second line mCRPC, providing an early non-invasive readout that is independent of PSA for monitoring therapy response in late stage mCRPC . Historical barriers in the study of small cell lung cancer (SCLC) include the relative lack of human tumors studied, limited real-world data, and the lack of access to longitudinal samples to understand tumor evolution. In partnership with Stanford University and Vanderbilt University Medical Center, Foundation Medicine researchers conducted what is believed to be the largest SCLC study known to date to provide an improved understanding of genetic subtypes in SCLC, including patient ancestry and biopsy site-specific patterns, and better inform mechanisms of transformation to SCLC from non-small cell lung cancer that may further guide the development of personalized therapies for subsets of patients with this fatal tumor . “Our experience sequencing over one million patient samples has allowed us to continuously improve our approach and have high confidence in the genomic abnormalities we detect and the results we deliver,” said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. “We are committed to bringing high-quality, differentiated and sustainable solutions, like options for sensitive ctDNA monitoring, to our physician and researcher partners so that they can provide all patients with the best treatment options for their unique cancers.” The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at AACR, please visit AACR.org . Follow Foundation Medicine on Twitter and LinkedIn for more updates from #AACR23 and visit us in person at Booth #3053. Abstract # Title Collaborator Product Posters 305 Sunday, April 16 1:30 – 5:00 PM POLE variant detection and classification is critical for identifying patients who may benefit from immunotherapy FoundationOne®CDx and FoundationOne®Liquid CDx 228 Sunday, April 16 1:30 – 5:00 PM Recurrent mitochondrial mutations in thyroid cancer FoundationOne®CDx 931 Sunday, April 16 1:30 – 5:00 PM Comprehensive analysis of 3,600 small cell lung cancer cases reveals rare genetic subtypes and multiple mechanisms of histological transformation Stanford University & Vanderbilt University Medical Center FoundationOne®CDx, Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database 933 Sunday, April 16 1:30 – 5:00 PM The landscape of treatment patterns in non-small cell lung cancer post EGFR TKI treatment described by real world data from 428 patients Flatiron Health, One Oncology Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database 938 Sunday, April 16 1:30 – 5:00 PM Outcomes of Molecular Tumor Board recommendations for cancer patients with progression on standard of care therapies in Saudi Arabia King Abdulaziz Medical City, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center FoundationOne®CDx 966 Sunday, April 16 1:30 – 5:00 PM Exploration of a novel HRD signature (HRDsig) as a biomarker for rucaparib benefit in ARIEL2 Clovis Oncology, Imperial College London FoundationOne®CDx 305 Monday, April 17 9:00 a.m. – 12:30 p.m. Co-occurrence of alterations impacting telomere elongation FoundationOne®CDx 2289 Monday, April 17 9:00 a.m. – 12:30 p.m. Predicting tumor somatic vs versus clonal hematopoiesis (CH) origin for short variants (SV) with FoundationOne®Liquid CDx assay FoundationOne®Liquid CDx 3362 Monday, April 17 1:30 – 5:00 p.m. Evaluation of circulating tumor DNA kinetics as a prognostic biomarker for overall survival in metastatic castrate resistant prostate cancer using a novel methylation sequencing research assay South Australian Immunogenomics Cancer Institute, Genentech, St. Bartholomew’s Hospital Research methylation assay 3395 Monday, April 17 1:30 – 5:00 p.m. Clinical Impact of FGFR inhibitors on FGFR2 Fusion Positive Pancreatic Cancer Ohio State University FoundationOne®CDx About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn . Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. Source: Foundation Medicine