Bristol Myers Squibb Co. (BMS) and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate (ADC) MORAb-202 for advanced solid tumors. Eisai’s first ADC, MORAb-202, pairs the company’s anti-folate receptor alpha (FRα) antibody with the Tokyo-based firm’s cancer agent eribulin using an enzyme cleavable linker. It is characterized as a potential best-in-class candidate and is under investigation for tumors that include endometrial, ovarian, lung and breast cancers in two studies: a phase I effort in Japan and a phase I/II experiment in the U.S. The companies plan to enter the registrational stage of development as early as 2022.

Disaster for Orphazyme as FDA rejects rare disease drug arimoclomol

Shares in Orphazyme A/S cratered after the FDA rejected its arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition where fat builds in tissues and organs. The stock (NASDAQ:ORPH) was down 45% at midday on the latest bad news from the Copenhagen-based biotech.

CAR T developer Carsgen debuts on HKEX with $400M IPO, targets BCMA first

CAR T specialist Carsgen Therapeutics Holdings Ltd.’s shares started trading on the Hong Kong Stock Exchange on June 18, helping the company raise HK$3.1 billion (US$400 million) from an IPO that will allow it to advance its phase II-stage BCMA CAR T therapy candidate, CT-053, in multiple markets. The company sold 94.7 million shares at HK$32.8 apiece. Retail investors oversubscribed the available shares by 434.6 times, underlining the growing interest in China’s CAR T development. The shares (HK:2171) opened 17% lower than the IPO price on June 18, ending the day at HK30, down 8.5%.

BIO Digital 2021: Prepping for future pandemics, industry reflects and presses forward beyond COVID-19

About a year-and-a-half after the sequencing of the SARS-CoV-2 virus and the onslaught of COVID-19 therapeutic and vaccine development that followed, the biopharma industry boldly tackles a slew of ongoing issues from vaccine hesitancy and supply inequities to the ramifications of a potential intellectual property waiver and the pressing need to prepare global systems for the next pandemic. At BIO Digital 2021 held this week, sponsored by the Biotechnology Innovation Organization, the world’s most disruptive virus in a century remained the top subject of conversation.

Time to shift drug pricing debate to accelerated approval?

Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.

Ubix and Debiopharm partner on new antibody degraducer conjugates

A co-research agreement between Ubix Therapeutics Inc. and Debiopharm International SA aimed at creating a new antibody degraducer conjugates (ADEC) drug modality to treat cancer will combine Ubix’s Degraducer molecule with Debiopharm’s antibody-drug conjugate linker Multilink to specifically target cancer cells. “This synergy of technologies works like a Lego system that assembles pieces that separately have limited activities, and which together achieve therapeutic impact,” Frederic Levy, executive director at Debiopharm, told BioWorld. “Our goal is to maximize the efficacy and minimize the toxicity of drugs in order to make it as effective as necessary and as safe as possible.”

Newco news: Oncolytic virus specialist Immvira moves oHSV to China and U.S. phase II trials

Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration (MVR-T3011 IT) at the 2021 American Society of Clinical Oncology annual meeting this month, drawing attention to oncolytic viruses developed by Chinese scientists. Last week, Immvira also completed the first dosing of MVR-T3011 IT in phase II trials in China and the U.S. Next, the biotech is looking to test MVR-T3011 as an intravenous infusion.

PolyU develops biomimetic nanosheet for cancer therapy and imaging

Researchers from The Hong Kong Polytechnic University (PolyU) said they have used two-dimensional nanosheets (FePSe3) to develop a biomimetic nanosheet that can monitor tumor development, treat tumors and monitor the treatment progress in real-time. With positive results from mice, the team hopes to further test it on larger animals, then move onto clinical studies. “The biomimetic nanosheet offers three imaging modalities, magnetic resonance imaging, photoacoustic imaging, photothermal imaging, as well as two therapeutic options, immunotherapy and photothermal therapy, to realize the possibility of one-in-all theranostics,” Summy Lo Wai-sum, a professor from Department of Applied Biology and Chemical Technology at PolyU, told BioWorld.

Also in the news

ADC, Aim, Altan, Alzamend, Ambrx, Anheart, Anpac, Antengene, Astrazeneca, Atai, Athira, Biontech, Century, Cyteir, Edesa, Ethypharm, Geron, Gilead, Hutchmed, Innocare, Innovent, Iveric, Jacobio, Karolinska, Merck, Nuevocor, Orphazyme, PDS, Processa, Reven, Sanofi, TG