The challenge of getting a mesenchymal stromal cell (MSC) product approved in the U.S. was on full display today as the FDA’s Oncologic Drugs Advisory Committee convened to consider Mesoblast Ltd.’s Ryoncil (remestemcel-L) as a therapy for steroid-refractory acute graft-vs.-host disease (GVHD) in children. Not only could the cell therapy be the first FDA-approved GVHD treatment for children younger than 12, it would be the first MSC product approved in the U.S., should the FDA greenlight it. But getting to approval will not be an easy lift. The FDA spent the first half of the meeting focused on questions about Ryoncil’s mechanism of action and its concerns about the potential variability of an off-the-shelf cell therapy.

Cansino's shares up 86% on STAR debut, plans annual production of 200M doses of COVID-19 vaccine

Cansino Biologics Inc. launched its second pre-revenue IPO on Aug. 13 and reaped ¥5.2 billion (US$749 million) from Shanghai’s STAR market. Trading under the ticker 688185, its shares surged 87.5% to close at ¥393 on the first trading day. Cansino issued 24.8 million shares at ¥209.71 apiece, the second-highest offering price for China’s bourse after Beijing Roborock Technology. In March 2019, the vaccine maker launched a $161 million pre-revenue IPO in Hong Kong, where its shares have added 470% to date. Among its pipeline, Cansino is advancing COVID-19 vaccine candidate Ad5-nCoV, which is due to enter phase III trials in Saudi Arabia shortly.

TREM2 targeting can synergize with checkpoint blockade

Triggering receptor expressed on myeloid cells 2 (TREM2) was first discovered because variants affect the risk of developing late-onset Alzheimer’s disease. Now, two papers published in the Aug. 11, 2020, online issue of Cell have used different approaches to show a role for TREM2 in the suppression of immune responses by tumors.

Immunoscape to scale up immune profiling technology with $11M in new global funding

Immunoscape closed an $11 million global equity financing round led by U.S.-based venture firm Anzu Partners along with University of Tokyo Edge Capital in Japan, and Indonesia's NPR Holdings. The Singapore-based company plans to use the funds to ramp up its immune profiling technology platform, which performs deep T-cell analysis, and expand partnerships to develop vaccines for COVID-19 and other viruses as well as targeted oncology therapies.

China’s Arctic Vision to tap into first-in-class ophthalmology products after deal with Eyenovia

HONG KONG – Arctic Vision Biotechnology Co. Ltd., of Shanghai, has entered an exclusive deal with New York’s Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Under the deal, Arctic Vision will commercialize Eyenovia’s Micropine and Microline formulations in greater China and South Korea in exchange for $45.75 million in up-front payments and additional milestone and royalty payments.

Kahr Medical’s IND application for anti-CD47 candidate gets FDA clearance

HONG KONG – Israel-based Kahr Medical Ltd.’s lead product, DSP-107, has received U.S. FDA approval for its IND application. The candidate is a second-generation CD47- and 41BB-targeting compound that targets cancer cells, weakens their defenses and activates an effective, local response of both innate and adaptive immunity. The company intends to initiate a phase I/II trial to evaluate the safety, pharmacokinetics and pharmacodynamics of DSP-107 as both a monotherapy and in combination with Roche Holding AG's PD-L1-blocking checkpoint inhibitor, Tecentriq (atezolizumab).

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