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Submitted URL: https://e.endpointsnews.com/t/t-l-vthhuc-jledlhjlt-jr/
Effective URL: https://endpts.com/legend-and-novartis-sign-100m-deal-for-next-car-t-bets/
Submission: On November 13 via api from US — Scanned from DE
Effective URL: https://endpts.com/legend-and-novartis-sign-100m-deal-for-next-car-t-bets/
Submission: On November 13 via api from US — Scanned from DE
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* Channels * All News * In Focus * Special * AI * Bioregnum * Biotech Voices * Cell/Gene Tx * China * Coronavirus * Deals * Diagnostics * Discovery * FDA+ * Financing * Health Tech * Law * Letters to the Editor * Manufacturing * Marketing * Opinion * Outsourcing * Peer Review * People * Pharma * R&D * Startups * Weekly * Webinars * Biopharma Jobs * More * Work at Endpoints * Letter to Editors * IPO Tracker * Webinars * Events * Sponsored Posts * Advertise * Privacy Policy * Endpoints Merch * About Us * Help * SIGN UP * LOG IN November 13, 2023 10:53 AM ESTUpdated 11:24 AM Deals Cell/Gene Tx LEGEND SIGNS $100M DEAL WITH NOVARTIS FOR NEXT CAR-T BETS, FOLLOWING UP ON JANSSEN SUCCESS KYLE LAHUCIK SENIOR REPORTER Legend Biotech, which came to the fore in cell therapy when Johnson & Johnson took a major bet in 2017 on what would become Carvykti, has found another Big Pharma partner for its CAR-T pipeline. It’s going with Novartis, the maker of the first FDA-approved CAR-T. Novartis will pay the New Jersey-based biotech $100 million upfront in exchange for the exclusive global license to certain CAR-T cell therapies that go after delta-like ligand protein 3, or DLL3. The pact includes Legend’s recently initiated Phase I of small cell lung cancer and large cell neuroendocrine carcinoma candidate LB2102. Legend will run the Phase I in the US and be reimbursed by Novartis, per a Monday morning SEC filing. The Swiss Big Pharma will handle all other development responsibilities. Up to another $1.01 billion could come Legend’s way if it hits certain clinical, regulatory and commercial events. Novartis could also pay tiered royalties in the high single digits to the low teens, according to the SEC paperwork. The partners are familiar with each other. In April, Novartis stepped in to help Legend and J&J’s Janssen make their blood cancer treatment Carvykti after facing supply issues. The duo has said it’s investing more resources into manufacturing of the cell therapy in hopes of eventually reaching more than $5 billion in peak sales. To get there, Legend and Janssen are seeking approval for earlier lines of treatment. For the most recent quarter, the pair reported $152 million in sales, which came in $21 million above the street’s expectations, per an Oct. 17 note from Jefferies analyst Kelly Shi. Novartis could use the tie-up as a test run for its so-called T-Charge manufacturing platform. Legend’s LB2102 would be the first solid tumor cell therapy to use the platform, which aims to shrink the amount of time needed to make autologous therapies and could lead to “greater proliferative potential” for the infused cells, the company said. The goal is to “deliver this therapy in 10 days or less,” Jennifer Brogdon, head of Novartis’ cell and gene therapies for immuno-oncology and hematology, told Endpoints News. The manufacturing platform is currently being used for two of Novartis’ CAR-T candidates, including YTB323 (rapcabtagene autoleucel) in blood cancers and autoimmune diseases and PHE885 in multiple myeloma. Guowei Fang “We believe LB2102 has an innovative CAR design and armor mechanism that increases its anti-tumor activity. The preclinical evidence shows that an autologous CAR-T could be a differentiated treatment option for patients with small cell lung cancer,” Guowei Fang, Legend’s chief scientific officer and head of business development, said in a statement. Novartis is betting on DLL3, which Amgen had also attempted to go after with a CAR-T but is now focused on a bispecific T-cell engager instead. “This is an ideal target for autologous cell therapy in solid tumor indications as we know that DLL3 is a lineage-specific biomarker for neuroendocrine cell lineage,” Fang said on an earnings call in August, per a transcript from AlphaSense. “And in this respect, it’s very similar to some of the very successful CAR-T targets in blood cancer, all of them targeting the lineage-specific biomarker.” Ying Huang CEO Ying Huang noted at the time LB2102 is the first clinical program that Legend has taken into US studies without first testing in human trials in China. The deal also represents a further dive into the field for Novartis, which makes the blood and bone marrow cancer cell therapy Kymriah. In the broader cell and gene landscape, Novartis also makes the gene therapy Zolgensma and recently bought a cystinosis gene therapy candidate from Avrobio. Editor’s note: This story was updated to include information from an interview with Jennifer Brogdon, head of Novartis’ cell and gene therapies for immuno-oncology and hematology. AUTHOR KYLE LAHUCIK SENIOR REPORTER klahucik@endpointsnews.com @ky_lahucik Kyle LaHucik on LinkedIn TRENDING NOW VERVE SHARES FIRST BASE EDITING RESULTS IN HUMANS, SUGGESTING THERAPY CAN LOWER CHOLESTEROL IN PATIENTS WITH GENETIC ... 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