Leidos Biomedical Research, Inc.

Program Will Facilitate Filing an IND Application Toward Human Clinical TrialsNESS ZIONA, Israel, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Nanocarry Therapeutics, a pioneering biopharmaceutical company focused on advancing treatments for brain diseases through its innovative AxS nanoparticle platform, announced the selection of its lead product, AxS007, by the U.S. National Cancer Institute’s (NCI’s) Nanotechnology Characterization Laboratory (NCL) for comprehensive preclinical characterization. The NCL is located at the Frederick National Laboratory for Cancer Research, operated for NCI by Leidos Biomedical Research, Inc. Over 400 million people globally suffer from brain diseases that remain insufficiently treated due to the Blood-Brain Barrier (BBB) blocking most therapeutics. Nanocarry's AxS technology utilizes an insulin-based nanoplatform to cross the BBB, enabling the delivery of multiple copies and combinations of antibodies, small molecules, and other therapeutics to the brain, thus targeting various central nervous system disorders. AxS007 specifically targets brain metastases of HER2+ breast cancer, which affects 50% of metastatic breast cancer patients and represents a significant unmet need. The NCL was established to advance the use of nanotechnology in cancer research and accelerate the development of promising nanomedicine-based therapeutics. The NCI partners with the National Institute of Standards and Technology (NIST) and the FDA, offering preclinical testing and services on a competitive acceptance basis, to expedite the transition of nanomedicines from early-stage development to clinical applications. Through this collaboration, the NCL will conduct detailed preclinical evaluations of AxS007. These studies will support the advancement of AxS007 towards filing an Investigational New Drug (IND) application with the FDA and facilitate future clinical development. This partnership will also strengthen collaborations focused on utilizing AxS technology with diverse therapeutic agents to treat various brain diseases. "We are very pleased and honored that AxS007 has been selected for the NCL program, marking a pivotal moment for Nanocarry Therapeutics," said Revital Mandil-Levin, Co- founder and CEO of Nanocarry Therapeutics. "The detailed characterization by the NCL will significantly accelerate the development of AxS007 towards clinical trials. Our lead product addresses breast cancer brain metastases, a severe complication of HER2+ metastatic breast cancer in which current treatments often fail due to the BBB, drastically reducing survival rates. Our mission is to replicate the prominent success of HER2+ therapeutic antibodies and extend it to the brain, aiming to improve outcomes for the 1 in 8 women who will develop breast cancer in their lifetime.” About Nanocarry Therapeutics Nanocarry Therapeutics is a biopharmaceutical company dedicated to transforming brain disease treatment through an advanced insulin-based nano delivery system that crosses the blood-brain barrier. Founded in 2021 and rooted in the nano-bioengineering lab at Bar Ilan University, the company's lead product targets HER2+ breast cancer brain metastases and is now entering IND-enabling studies. The early pipeline also includes neurodegenerative diseases. Nanocarry Therapeutics aims to improve patient outcomes by delivering innovative therapies to previously unreachable areas of the brain. For more information about Nanocarry Therapeutics, visit www.nanocarry.com. Nanocarry contact:Michal Roytman Chief Business Officer Tel: +972-50-8460424michal@nanocarry.com

Funding will support BridgeBio Oncology Therapeutics and "significant clinical inflection points over the next 18-24 months." BridgeBio Pharma has spun its Rolodex to fund a subset of its sprawling list of opportunities. Busy with launch and late-phase activities, BridgeBio has secured $200 million to equip a cancer-focused offshoot to push a pipeline led by a KRAS inhibitor through early-phase tests. In 2017, TheRas, which is now doing business as BridgeBio Oncology Therapeutics (BBOT), struck a deal with Leidos Biomedical Research that led to the licensing of a KRAS G12C inhibitor and two other assets. TheRas was a wholly owned subsidiary of BridgeBio for years but required limited funding, with R&D expenses related to the Leidos agreements totaling $3.6 million in 2023.  Now, with one asset in the clinic and two approaching human testing, BridgeBio has decided to spin the molecules out to create BBOT and bring outside investors on board. The funding gives BBOT the “runway to achieve significant clinical inflection points over the next 18-24 months,” BridgeBio said.  BBOT began a phase 1 trial of KRAS G12C inhibitor BBO-8520 in non-small cell lung cancer last month. The start date of the study, which will test the molecule as a single agent and in combination with Keytruda, puts the program years behind approved KRAS drugs sold by Amgen and Bristol Myers Squibb. But BBOT and its backers contend a feature of BBO-8520 could lead to better efficacy.  KRAS cycles between an “on” and “off” state. Amgen’s Lumakras and BMS' Krazati target the off state, as does Roche’s challenger divarasib. BBOT believes molecules also need to inhibit KRAS in its on state to achieve optimal target coverage and prevent adaptive mechanisms of resistance. BBOT’s preclinical tests suggest BBO-8520 has advantages over Amgen, BMS and Roche’s molecules. And the biotech's researchers saw responses when the molecule was administered after the development of resistance to Lumakras.   The spinout is working to generate human data on BBO-8520 while preparing to move two other assets into the clinic. BBO-10203 is designed to block an interaction between RAS and PI3Ka. In doing so, the molecule may inhibit a tumor signaling pathway without causing the high blood sugar that affects people on PI3Kα inhibitors. BBOT is aiming to start enrolling patients in a clinical trial this year. A pan-KRAS inhibitor, BBO-11818, is following close behind. Like Lumakras and Krazati, BBOT’s lead drug candidate only targets a subset of patients with KRAS mutations. BBO-11818 is designed to target the on and off states of multiple forms of KRAS, potentially making it effective in more patients. BBOT is aiming to file to study the molecule in humans next year. Eli Wallace, Ph.D., and Pedro Beltran, Ph.D., will oversee the programs as BBOT’s CEO and chief scientific officer, respectively. Wallace joined BridgeBio as CSO in residence for oncology in 2019. Beltran arrived the following year to work with Wallace on programs targeting RAS biology.  The financing round was led by Cormorant Asset Management and co-led by Omega Funds. Affiliates of Deerfield Management, GV, EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital, Aisling Capital, Casdin Capital and Longwood Fund also participated. Securing outside investment frees BridgeBio to spend its cash on launching acoramidis and enrolling patients in a clutch of phase 3 studies.

Pictured: 3D image of a KRAS oncogene iStock/Gilnature BridgeBio announced Thursday that it has secured $200 million in financing to spinout a former subsidiary to develop a KRAS-focused oncology portfolio. Called BridgeBio Oncology Therapeutics (BBOT), the company was initially formed as a subsidiary of BridgeBio known as TheRas. According to an SEC filing, the subsidiary has existed since 2016 and formed a research and development agreement with Leidos Biomedical Research in 2017. BBOT’s mission now is to generate a pipeline of small molecule therapeutics targeting RAS and PI3K malignancies. The company aims to advance three programs, including BBO-8520, a direct inhibitor of KRAS that seeks to bind to the protein’s “on” and “off” states. The spinout is enrolling patients with mutant non-small cell lung cancer in a Phase Ia/Ib trial. A second asset that BBOT will be advancing is BBO-10203, a PI3Kα:RAS breaker that blocks the interaction between RAS and PI3Ka to inhibit the PI3Kα/AKT effector signaling in tumors. The company plans to IND application sometime in the second quarter of 2024 and enroll patients later this year. The other asset is BBO-11818, a pan-KRAS inhibitor that is going after the “on” and “off” states of KRASG12X, and BBOT plans to IND sometime in early 2025. The company is also pursuing a discovery-stage research program focused on developing assets that target additional oncogenic drivers within the RAS and PI3K pathways. “We believe the launch of BBOT better aligns investors with an opportunity that was being hidden in our pipeline, and our partnership with these new investors enables us to prosecute these oncology programs more quickly and with higher fidelity,” BridgeBio CEO Neil Kumar said in a statement. The spinout secured its $200 million financing in an oversubscribed round led by Cormorant Asset Management and co-led by Omega Funds. There was also participation from GV (Google Ventures), Deerfield Management, EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital, Casdin Captial, Aisling Capital, and Longwood Fund. BBOT will headed by Eli Wallace, BridgeBio’s CEO of oncology R&D. Wallace joined BridgeBio in 2019 after serving as the chief scientific officer at Peloton Therapeutics. Kumar will also serve as a director of BBOT. “In conjunction with BridgeBio and an amazing suite of investors, we look forward to seeing all three of our programs progress into the clinic over the next 12 months,” Wallace said in a statement. BridgeBio has gone down the spinout path before, launching QED Therapeutics in 2018. The company secured $65 million and aimed to develop infigratinib, a cancer asset that Novartis abandoned. Infigratinib was given accelerated approval by the FDA in 2021. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.