LianBio announces terms for IPO next week; NIH and White House officials discuss hypothetical bio-med research agency
LianBio, a biotech that has operations in both the US and China, announced the terms yesterday for its initial public offering.
The biotech plans to raise $325 million by offering 20.3 million shares priced between $15 and $17.
At the midpoint of the proposed range, LianBio could command a fully diluted market value of $1.8 billion, based on a number of expected outstanding shares.
The two year old biotech has focused on in-licensing and commercialization of therapeutics in China, Hong Kong, Taiwan, Macau and other Asian markets. The company currently has nine programs across five therapeutic areas, including oncology, cardiovascular, and inflammatory diseases.
The IPO is expected to price sometime next week.
White House officials, NIH Director Collins discuss proposed DARPA-esque agency for biomedical research — and some of the agency’s goals
White House and NIH officials hopped onto a 90-minute Zoom call yesterday to discuss the proposed NIH entity “Advanced Research Projects Agency for Health,” or ARPA-H.
As the proposed agency may have similar autonomy to other agencies such as DARPA, this agency would focus primarily on biomedical research, according to NIH Director Francis Collins, who will be retiring from his position by the end of the year.
To Collins, ARPA-H is an opportunity to stretch boundaries and see what could be possible. By way of example, he named technology to deliver drugs to only the exact right cell type, or an mRNA vaccine that would immunize a patient against the fifty most common mutations that cause solid tumors, to next-gen wearable sensors to help a patient manage chronic disease.
Tara Schwetz, from the White House Office of Science and Technology Policy (OSTP), concurred with Collins.
“The goals of ARPA-H are really to support transformative, high risk, high reward medical research, and embracing a sense of urgency to speed, the application and implementation of breakthroughs at a variety of different levels,” Schwetz said.
In the rest of the presentations and following Q&A, there was an emphasis on failing fast and failing early.
“Again, I understand this, you do want to fail early. So if we don’t fail at anything … maybe we’re not taking enough bold, innovative chances,” said NIH principal deputy director Lawrence Tabek.
After talking about having milestones in place as a type of safeguard, he continued, “If failure is happening, you will know that early, and you won’t keep throwing resources at something that’s not going to succeed. So fail frequently, but fail fast.”
So far, there is funding for the agency in Congress’s FY22 bills — but the House and Senate still need to reconcile on an amount.
Antengene and LegoChem pair up in ADC deal
Chinese biotech Antengene is teaming up with South Korean biotech LegoChem Biosciences in an ADC-focused research and license agreement.
Under the deal announced this morning, both companies will jointly discover and evaluate potential ADC candidates using Antengene’s antibodies and LegoChem’s ADC platform.
Antengene will retain the option to license global rights for the development and commercialization of resulting ADC candidates. When the option is exercised, LCB will receive upfront and milestone payments, as well as tiered royalties. In addition, LCB is eligible to receive a pre-specified percentage of any sub-licensing income received by Antengene.
“LCB and Antengene will team up to accelerate the development of new therapies that combine Antengene’s expertise in oncology with LCB’s clinically validated ADC technology platform,” said LegoChem president and CEO Yong-Zu Kim.
Opdivo receives approval in EU in combination with chemo for HER2-negative cancer types
Bristol Myers Squibb announced the European Commission’s approval of PD-L1 inhibitor Opdivo today.
The approval is for use in combination with fluoropyrimidine- and platinum-based combination chemotherapy — and it will serve as a first-line treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) in adults.
The approval allows for the use of Opdivo in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.
The EC’s decision is based on results from the Phase III CheckMate -649 trial, in which first-line treatment with Opdivo plus either chemotherapy protocol FOLFOX or CapeOX was compared to solely chemo.
“We are especially pleased to move the field forward and introduce this Opdivo-based combination for patients in the European Union,” said Bristol Myer’s development lead for gastrointestinal cancers, Ian Waxman.
bluebird bio files with SEC to withdraw marketing authorization for multiple drugs
bluebird bio had announced that as part of the winding down of its operations in Europe, it would withdraw its marketing authorization for neurological gene therapy treatment Skysona from the EU, along with its marketing application for the treatment from the UK. In a form 8-K filed with the SEC earlier today, that withdrawal is official.
Additionally, bluebird bio anticipates withdrawing marketing authorizations for blood disorder medication Zynteglo from both the EU and the UK by early next year.
While bluebird expects to continue activities for the long-term follow-up of patients previously enrolled in EU clinical trials as planned, the biotech does not intend to initiate any new clinical trials in Europe for beta-thalassemia, CALD or sickle cell disease, according to the form 8-K.
Charles River Laboratories expands Cambridge real estate for early-stage drug research
Just as Charles River Laboratories offloaded two assets last week, the company is expanding — again.
The firm announced yesterday the expansion of its Charles River Accelerator and Development Lab, or CRADL, on Binney Street in Cambridge, along with adding a second Cambridge location on Bent Street.
After CRADL’s flagship location opened on Binney Street in 2018, the lab had 15,000 square feet of space. The latest addition has tripled the space to 45,000 square feet.
Additionally, Charles River has begun the process of opening a second CRADL location on Bent Street in Cambridge, adding an additional 18,000 square feet of capacity for clients, with the first phase planned to open by the end of the year.
Both locations offer rental space for biotechs and research institutions, allowing scientists to focus on research while leaving animal husbandry and vivarium management to “a trusted partner,” according to a company statement.
“In the biopharmaceutical industry, both infrastructure and staffing can be prohibitively expensive and take significant time to develop,” said CRADL operation director at Charles River Julie Freebersyser. “By outsourcing their vivarium space, researchers can focus on research, instead of logistics.”
Sabin Vaccine Institute receives millions from BARDA from contract option
Sabin announced today that BARDA has exercised a $34.5 million contract option from their 2019 contract — to advance vaccine development against ebola sudan and marburg viruses through Phase II clinical trials.
BARDA had awarded Sabin a development contract in September 2019, valued up to $128 million. So far, more than $40 million has been provided.
The contract option will enable Sabin to continue efficacy and safety studies, Phase II clinical trials in Africa, and vaccine manufacturing processes to ensure quality and safety, according to a Sabin statement.
“We are grateful for BARDA’s continued support of Sabin’s efforts to advance vaccines against these deadly viruses,” said Sabin CEO Amy Finan. “We also thank our partners at the Vaccine Research Center of the NIH National Institute of Allergy and Infectious Diseases for their continued collaboration, and GSK for their earlier work on the candidates.”
The two candidate vaccines, based on a GSK proprietary platform, were exclusively licensed to the Sabin Vaccine Institute in 2019.