Aarvik Therapeutics, Inc.

ArriVent BioPharma\'s plan is to get the nod from the FDA in the first half of the year to begin U.S. human trials of MRG007 in colorectal, pancreatic and other gastrointestinal cancers.\n A year after going public, ArriVent BioPharma is continuing to bolster its antibody-drug conjugate pipeline via licensing deals. The latest involves handing Lepu Biopharma $47 million in near-term cash for a preclinical candidate aimed at gastrointestinal cancers.The ADC in question, dubbed MRG007, has shown “robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies,” ArriVent explained in a Jan. 21 release.As well as the $47 million from a combination of upfront cash and a near-term milestone payments, ArriVent will be liable to pay Shanghai-headquartered Lepu up to $1.16 billion in development, regulatory and sales milestones for the rights to develop and commercialize MRG007 outside of greater China.The plan now is to get the nod from the FDA in the first half of the year to begin U.S. human trials of the ADC in colorectal, pancreatic and other GI cancers.\"We believe MRG007 is a potential best-in-class ADC for the treatment of GI malignancies based on preclinical and IND enabling studies,” ArriVent’s CEO Bing Yao said in the release. “Expanding our pipeline with MRG007 furthers our mission to develop novel medicines for cancers with high unmet needs worldwide and accelerates our ADC portfolio by adding a program which plans to enter the clinic in the near-term.” Pennsylvania-based ArriVent is on a mission to bring China-developed drugs to Western markets via in-licensing deals. The biotech’s lead asset, furmonertinib, is being developed for non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitor received approval in China in 2021 to treat locally advanced or metastatic NSCLC.To this end, ArriVent joined the Nasdaq via a $175 million IPO a year ago. Since then, the company has avoided the fate of many of its biotech peers by keeping its valuation above water—the company’s stock ended Tuesday trading at $25.31, compared with its debut price of $18 per share in January 2024.Its first year as a publicly listed company has also seen a concerted effort to bulk out its portfolio, including a $100 million biobucks deal with Aarvik Therapeutics to work on an undisclosed “novel oncology drug” as well as a $615.5 million deal with Jiangsu Alphamab Biopharmaceuticals to collaborate on multiple ADCs.

Bing Yao’s ArriVent BioPharma has inked another licensing deal with a Chinese biopharma. The late-stage oncology biotech is picking up a new antibody-drug conjugate from Shanghai-based Lepu Biopharma, according to a Tuesday night disclosure. The deal — for $47 million upfront and up to a hefty $1.16 billion in biobucks — adds to a steady drumbeat of US drug developers acquiring the ex-China rights to therapies initially created or developed by Chinese biotechs. It marks at least the 11th such China-to-US biotech pact in the first three weeks of 2025, according to an Endpoints News tracker. The move is core to the operating model of ArriVent, which debuted in June 2021 with the goal of picking up drug candidates and medicines from Chinese biotechs and bringing them into the US and other geographies. The Pennsylvania biotech also has ADC collaborations with Alphamab and Aarvik Therapeutics. Lepu, meanwhile, has a joint venture with Keymed Biosciences called KYM Biosciences. AstraZeneca licensed an ADC from KYM in February 2023. Keymed has also done multiple China-to-US deals of its own in recent months. ArriVent’s pipeline is led by an oral, brain penetrant EGFR inhibitor known as furmonertinib. The medicine is approved in China, where it’s marketed by ArriVent partner Allist Pharmaceuticals. Global Phase 3 non-small cell lung cancer data are slated for this year, ArriVent said in its most recent quarterly update. With Lepu, ArriVent is staking a bet on MRG007, an experimental medicine for gastrointestinal cancers. ADCs like MRG007 are intended to target tumor cells with cytotoxic payloads and have become darlings among pharma’s oncology dealmaking teams in recent years. MRG007 will enter human trials later this year, the companies said in their announcement on Tuesday evening, or Wednesday morning in China . The move does not change ArriVent’s previously projected cash runway, which should take it “into 2026,” the biotech said. ArriVent said in November that it ended the third quarter with $282.9 million in cash and equivalents. The drug developer went public as $AVBP almost a year ago in a $175 million IPO, and it’s one of the few biotechs to have floated in the last few years that is still trading above its initial pricing. ArriVent is led by Yao, who previously took AstraZeneca spinout Viela Bio to an FDA approval for Uplizna in 2020 and then an M&A exit to Horizon Therapeutics a year later.

ArriVent Biopharma, a company that secures rights to drugs from emerging markets to develop them for Western markets, is adding to its pipeline with a Phase 1-ready drug candidate from China that has potential applications in gastrointestinal cancers. The company on Wednesday announced it paid $47 million up front to license MRG007, a drug developed by Lepu Biopharma, a Shanghai-based developer of cancer therapies. MRG007 is an antibody drug conjugate (ADC), a type of therapy made by linking a toxic drug payload to a targeting antibody. Lepu has not disclosed the target of the drug, nor has ArriVent. But ArriVent said that based on preclinical studies, it believes the Lepu ADC has best-in-class potential. presented by Sponsored Post 3D Medical Animation Services: A Revolution in Healthcare Education and Marketing 3D medical animation services have emerged as a groundbreaking tool in the healthcare industry, revolutionizing the way medical concepts are taught, understood, and marketed. By Start Grid It’s possible the drug class ArriVent is referring to is drugs that target claudin 18.2, a protein highly expressed in gastrointestinal cancers. Claudin 18.2, or CLDN18.2, is a top target for GI cancer drug research. This past October, Astellas Pharma’s Vyloy became the first FDA-approved CLDN18.2-targeting drug. Vyloy, a monoclonal antibody, is approved for use with chemotherapy to treat advanced cases of gastroesophageal junction adenocarcinoma, a rare type of GI cancer. The Japanese pharma company’s clinical development program for the drug also includes testing the drug in GEJ cancers with a checkpoint inhibitor and chemotherapy. A separate study is evaluating the drug in pancreatic adenocarcinoma. Other companies are pursuing CLDN18.2, but with ADCs. AstraZeneca’s AZD0901 is in Phase 3 testing in advanced gastric and GEJ cancers. Elevation Oncology’s ADC, EO-3021, is in early clinical development for advanced solid tumors, including GI cancers. Data are expected in the first half of this year. According to ArriVent, MRG007 has shown robust antitumor activity in preclinical models of GI cancers. The research also shows a favorable therapeutic index based on studies that could support an investigational new drug application. The company said it plans a submission for the first half of this year. The initial focus will be in colorectal and pancreatic cancers as well as other GI cancers. ArriVent’s most advanced program is firmonertinib (also known as furmonertinib), a brain-penetrating oral small molecule licensed from Shanghai-based Allist Pharma. This drug is already approved in China. ArriVent has advanced the drug to Phase 3 testing in non-small cell lung cancer driven by EGFR exon 20 insertion mutations. The ArriVent pipeline also includes two discovery-stage ADCs, one from Aarvik Therapeutics and the other from Jiangsu Alphamab Biopharmaceuticals. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The deal for the Lepu ADC comes nearly a year after ArriVent debuted on the Nasdaq with a $175 million IPO. ArriVent, which is based in Newtown Square, Pennsylvania, has rights to develop MRG007 for all indications outside of greater China, where Lepu retains rights. Lepu could receive up to $1.16 billion in milestone payments, plus royalties from sales of a commercialized product. “Expanding our pipeline with MRG007 furthers our mission to develop novel medicines for cancers with high unmet needs worldwide and accelerates our ADC portfolio by adding a program which plans to enter the clinic in the near-term,” Arrivent Chairman and CEO Bing Yao said in a prepared statement. “We look forward to collaborating with Lepu Biopharma in advancing this program globally.” Image: Getty Images