Merck is dipping its toes into a cell therapy partnership with A2 Biotherapeutics, with an offer to co-fund clinical development and allogeneic manufacturing activities through Phase I.
In particular, the pharma giant has its eyes on an undisclosed candidate utilizing A2’s Tmod platform, which combines activation and blocking mechanisms in order to kill tumor cells while sparing healthy ones.
The deal features an upfront, an equity investment and reimbursement of certain expenses. Merck is also promising opt-in and milestone payments plus royalties, while keeping the door open for collaboration on a separate program.
A2 Biotherapeutics, which closed $71.5 million in Series B funding in October, has two other programs that are further along in the lead optimization phase.
The new pact “brings Merck’s immunotherapy and other expertise for the Tmod candidate especially in the later stages of development, manufacturing and commercialization and enables A2 to build allogeneic product development and manufacturing capabilities,” said Scott Foraker, A2’s president and CEO. — Amber Tong
Soligenix shares crushed after PhIII flop in head and neck cancer
Small rare diseases biotech Soligenix $SNGX did not have a good Tuesday.
The Princeton, NJ-based company posted a Phase III fail in head and neck cancer, saying its SGX942 program did not produce a statistically significant outcome. Soligenix had been looking to treat severely inflamed mucous membranes resulting from other cancer therapies, but came up short.
Tuesday’s news crushed the company’s stock price, as shares were sliced by more than half at a 54% drop as the market opened. The price rebounded slightly by the end of the day, but still resulted in a 49% loss.
Soligenix did not report a p-value from the primary endpoint, which was the median duration of severe oral mucositis. They did note the data showed a 56% reduction compared to placebo, as the median in the control arm came in at 18 days and 8 days in the treatment arm.
The company tried to shine a light on a positive secondary endpoint — 50% reduction in the duration of SOM in the per-protocol population. Soligenix’s p-value came in here at 0.049, just clearing the statistically significant hurdle. The biotech said this endpoint may point to some evidence of biological activity.
The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo. Soligenix said it will turn its attention toward another program, SGX301, in the treatment of cutaneous T cell lymphoma. — Max Gelman
BridgeBio goes to neighbors at UCSF for gene therapy ideas
Tapping a new source for new gene therapy programs, BridgeBio has set up a three-year alliance with the University of California, San Francisco to identify early translational research that it can accelerate into the clinic.
BridgeBio, which is based in the Bay Area, said the deal follows a six-month pilot and is designed to formalize collaborative relationships with academic scientists.
The collaborations may initially take the form of sponsored research agreements with certain labs, it added, which may then lead to creation of new affiliate companies under the BridgeBio portfolio.
That pipeline currently lists three programs, utilizing AAV vectors to deliver corrective genes for congenital adrenal hyperplasia, Canavan disease and nonsyndromic hearing loss, respectively.
They are ready for more. Earlier this year, BridgeBio inked an agreement with Catalent to secure dedicated gene therapy development and manufacturing capacity to support its needs down the line. — Amber Tong
Gritstone raises $110M in private placement funding
Gritstone Oncology $GRTS has some new cash to play with.
The Emeryville, CA-based biotech announced Wednesday morning it had raised $110 million in private placement funding. Wednesday’s deal valued company shares at $3.34 apiece, or Tuesday’s closing price, and Gritstone said the funding would be primarily directed toward its GRANITE and SLATE pipeline candidates, two cancer immunotherapies.
News of the funding was met with cheers by investors, as Gritstone’s stock was up more than 13% in early Wednesday trading.
GRANITE, a personalized neoantigen-based immunotherapy, is being evaluated in combination studies in the Phase II portion of a Phase I/II study for microsatellite stable colorectal cancer. SLATE is also neoantigen-based and uses the same delivery system as GRANITE, but contains a fixed set of antigens rather than personalized. It’s also being looked at in combination studies at the Phase II portion of a Phase I/II trial for NSCLC.
The financing was led by existing and new investors, including Redmile Group, Avidity Partners and EcoR1 Capital. The deal is expected to close by Dec. 28. — Max Gelman
Epsilon Molecular Engineering closes extended Series A round
After closing its Series A round, Epsilon Molecular Engineering opened it back up, bagging ¥570 million ($5.5 million) total from investors, two bank loans and leasing.
The Saitama University spinout will use the funds for its work with heavy chain single domain antibodies, including collaborative research with Kitasato University and Kao Corporation on potential Covid-19 treatments.
“EME aims to discover medium sized molecular bio-drugs with new modalities using its proprietary VHH technology,” president Naoto Nemoto said in a statement. “We will leverage this financing to accelerate collaborative research with pharmaceutical manufacturers and internal research using its own pipeline.”
The round was led by Mitsubishi UFJ Capital, with help from Gunma Medical Engineering Vitalization Investments, Gunma Bank and Kao Corporation. EME also went forward with a subordinated loan from Shoko Chukin Bank, a loan from Saitama Resona Bank, and a lease from Syutoken Leasing. — Nicole DeFeudis