NVS - Week In Review: CMBG Out-Licenses Two CAR-T Candidates To Janssen For $245 Million Upfront
2023-07-02 04:45:00 ET
Summary
- Cellular Biomedicine Group has out-licensed global rights to its two lead CAR-T candidates to Janssen Biotech for $245 million upfront.
- We have more on latest deals and financings from Sichuan Kelun-Biotech, Sichuan Kelun-Biotech, Lion TCR, Beijing Brii Bio, and Changchun BCHT Biotechnology.
- And there are more trials and approvals for Suzhou CStone Pharma, AusperBio, Insilico Medicine, and Suzhou Innovent Biologics.
Deals and Financings
Cellular Biomedicine Group ( CBMG ), a Maryland cell therapy company with a China arm, out-licensed global rights (ex-China) to its two lead CAR-T candidates to Janssen Biotech for $245 million upfront plus milestones (see story ). Janssen has the right to negotiate for China rights before CBMG files a BLA in China for the candidates. The agreement includes C-CAR039, an anti-CD19 & CD20 bi-specific CAR-T therapy, and C-CAR066, an anti-CD20 CAR-T. Both candidates have started trials for Non-Hodgkin Lymphoma. In 2020, CMBG’s management took the company private in a $385 million privatization.
Sichuan Kelun-Biotech could reap up to $208.5 million in its upcoming Hong Kong IPO, if it prices at the top of the range, which drops to $175.5 million if it prices in the middle (see story ). Founded in 2016, Kelun is a prominent developer of ADC drugs that is best known for signing three deals in 2022 to out-license 10 ADC candidates to Merck ( MRK ) for deals that brought in $257 million upfront – more than the IPO – and could be worth up to $12.7 billion if everything goes perfectly. Kelun considers itself a leader in ADC candidates, though it also develops other biologics and small-molecule drugs.
Shanghai Laekna Therapeutics completed an IPO on the Hong Kong Exchange that raised $100 million for its portfolio of biologic therapies. The shares traded 20% higher in its first trading day (see story ). Founded in 2016, the company has a portfolio consisting of two core products, both in-licensed from Novartis ( NVS ), plus 14 other pre-clinical candidates aimed at cancer and liver fibrosis. It has started six clinical trials for its two lead projects, including three multi-regional studies, one of which is a pivotal trial. The company will use the funds to advance its portfolio and build a manufacturing facility.
Lion TCR, a Singapore-Guangzhou T-cell immunotherapy company, closed a $40 million Series B2 financing round to support a global Phase Ib/II trial of its hepatitis B virus (HBV)-specific T cell receptor therapy (see story ). Lion TCG has engineered hepatitis B virus (HBV)-specific T cells that recognize and kill HBV-expressing tumor cells, using mRNA to encode HBV specific T cell receptors in a patient’s T cells. HBV causes about 50% of hepatocellular carcinoma (HCC) globally and 80% in China. The company will also build a GMP facility in Guangzhou.
Beijing Brii Bio (HK: 2137) will earn $24 million from the sale of Qpex, a San Diego anti-infectives company that is being acquired by Japan’s Shionogi Pharma for $100 million. As part of the deal, Brii agreed to make major changes to its in-licensing of three Qpex assets. The company will own global rights to BRII-693, a Qpex-discovered novel gram-negative anti-infective. Previously, it had Greater China rights. In return, Brii will transfer China rights to Shionogi for two other Qpex anti-infectives. Brii, an Opex shareholder, will receive the $24 million when the takeover deal is closed.
Changchun BCHT Biotechnology (SHA: 688276), a vaccine company, announced a long-term plan to acquire Transcend Biomedical Suzhou, a mRNA vaccine developer. Initially, BCHT will pay $21 million for a 20% stake in Transcend. The two companies have signed a stepped agreement allowing BCHT to acquire additional Transcend shares based on Transcend’s achieving specific development milestones. The companies expect BCHT will complete the takeover in the next three to four years. Transcend is a full-process mRNA startup developing a pipeline of vaccines with expertise in product design, synthesis, pilot production, and quality control.
Trials and Approvals
Suzhou CStone Pharma (HK: 2616) reported Gavreto® (pralsetinib), a selective rearranged during transfection (RET) inhibitor, was approved as a first-line therapy for China patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC) . Two years ago, Gavreto was approved as a second-line therapy for the indication following platinum chemotherapy, the first RET inhibitor green-lighted in China. The latest milestone was CStone’s eleventh NDA approval in China. In 2018, CStone acquired China rights to the RET inhibitor and two other candidates in a $386 million deal with Blueprint Medicines of Cambridge, Mass.
AusperBio, a Hangzhou-Boston biotech, has been approved to start China trials of its lead drug, AHB-137, an unconjugated antisense oligonucleotide that aims to provide a functional cure for chronic hepatitis B. The company believes AHB-137 has the potential to be a backbone for a functional CHB cure, implying additional drugs will be needed. As a long-term strategy, AusperBio plans to combine its oligonucleotide therapies with other medications, including therapeutic antibodies and mRNA vaccines, to address a range of unmet medical needs.
Insilico Medicine, a generative artificial intelligence-driven biotech, dosed the first patients in a Phase II trial of INS018_055, the world's first anti-fibrotic inhibitor discovered and designed using generative AI. With the potential to be a first-in-class drug, INS018_055 is aimed at treating Idiopathic Pulmonary Fibrosis, a chronic lung disease. The candidate is a small molecule inhibitor with a novel target discovered by Insilico's target identification engine, PandaOmics, and a novel molecular structure designed by its generative chemistry engine, Chemistry42. Insilico has operations in Hong Kong and New York.
Suzhou Innovent Biologics (HK: 01801) formed a clinical collaboration with RemeGen (SHA: 688331; HK: 09995) that will test its PD-1 inhibitor with one of two RemeGen ADC assets for advanced solid tumors. Innovent will contribute TYVYT® (sintilimab injection), which has been approved in China for seven oncology indications. RemeGen will add either RC88, a novel mesothelin (MSLN)-targeting antibody-drug conjugate, or RC108, a novel c-Met-targeting ADC. RemeGen will be responsible for conducting Phase I/IIa clinical studies to assess the antitumor activity and safety of the combination.
Disclosure: None
Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.
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Week In Review: CMBG Out-Licenses Two CAR-T Candidates To Janssen For $245 Million Upfront