In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. Eisai will make up-front and development milestone payments to Bliss, conduct a phase II study in breast cancer, and obtain option rights to develop and commercialize the ADC BB-1701 globally, excluding China, Hong Kong, Macau and Taiwan. Earlier in April, Biontech SE and Duality Biologics Co. Ltd. reached a $1.7 billion ADC development agreement. But everyone is following the lead of Astrazeneca plc’s $6.9 billion global development and commercialization agreement in 2019 with Daiichi Sankyo Co. Ltd. for the latter’s lead ADC, Enhertu (trastuzumab deruxtecan).

Junshi’s toripalimab gaining more ground via $728M Dr. Reddy’s deal

Continuing the global expansion for toripalimab, Junshi Biosciences Co. Ltd. entered a collaboration granting Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in Latin America, India and South Africa, with an option to add Australia, New Zealand and nine other countries. In addition, should Junshi opt to seek to out-license commercial rights to two other products, Dr. Reddy’s has an exclusive right to first negotiation for the countries included in its toripalimab territory. Though Junshi did not break out individual payments, the deal in aggregate could reach $728.3 million, including an up-front payment, potential expansion of Dr. Reddy’s territory and milestones, plus double-digit royalties.

HELPful tip: Preparedness must see beyond pandemics

Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act this year to ensure the country is better prepared for the next pandemic. But preparedness is more than being ready for a pandemic, Sen. Bill Cassidy (R-La.) reminded the Senate Health, Education, Labor and Pensions (HELP) Committee last week. Noting the government’s failures in responding to COVID-19, Cassidy said, “Mistakes were made; tough lessons learned. We’re here today to ensure a future generation is not forced to learn on the fly should another crisis occur. And we need to update the playbook and ensure our framework is flexible to address threats beyond just a pandemic.”

Luzhu nets $31M in Hong Kong IPO, shares slide 30%

Beijing Luzhu Biotechnology Co. Ltd. raised a net HK$242 million (US$31 million) from an initial public offering in Hong Kong but shares in the developer of vaccines and therapeutics for infectious diseases, cancer and autoimmune diseases plummeted on the first day of trading. Luzhu’s shares (HK:02480) started trading on May 8 at HK$31.50 and lost about 30% throughout the day to close at HK$22. Founded in 2001, Luzhu’s product pipeline consists of three clinical-stage product candidates, including the lead asset LZ-901, K-3 and K-193, as well as four candidates in preclinical studies.

Newco news: Exploring undruggable targets, Ten63 advances Myc inhibitor, raises $15.9M

The idea for a new company, Ten63 Therapeutics Inc., started in 2015, when Gilda Szacher Frenkel passed away at age 62 from pancreatic cancer. After sequencing her tumor, her son Marcel discovered that her cancer was driven by mutations to key proteins that regulate cellular processes – all the “usual suspects,” he said. At the time, he remembers they were initially encouraged by the discovery and excited to search for developed drugs that could help her. “Here was this blueprint telling us what was wrong,” Marcel Frenkel said, “but, unfortunately, those mutations were unactionable. There were no drugs to modulate the main oncologic drivers.”

FDA expands support for decentralized clinical trials

In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials to advance research in medical devices, drugs and biologics. This week’s announcement responds to the Food and Drug Omnibus Reform Act, signed into law late last year, which required the agency to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices.” The latest recommendations build on recommendations released since March 2020 in an effort to keep trials on track as much as possible during the COVID-19 pandemic, despite site closures, quarantines and restricted travel.

Also in the news

Abm, Acelink, Acorda, Aprea, Boehringer Ingelheim, Carsgen, Chance, Chiesi, Clearmind, Cyclica, Fibrogen, Formosa, Frontier Medicines, Ginkgo Bioworks, Golden, Inceptor, Incyte, Laronde, Morphic, Neuro3, Pieris, Recursion, Scisparc, Selecta