LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial. There was no benefit for patients who were just as ill, but who were seropositive on admission to hospital.

Zai Lab and Macrogenics partner in $1.5B cancer deal

Zai Lab Ltd. and Macrogenics Inc. have announced a collaboration and license agreement involving up to four immuno-oncology molecules in a deal potentially worth upwards of $1.5 billion. The deal makes sense as both are upcoming companies at around the same stage in development – making progress in oncology with first products recently approved by regulators. Zai Lab markets the PARP inhibitor Zejula (niraparib) in China after partnering with Glaxosmithkline plc’s Tesaro unit, while Macrogenics had its first drug Margenza (margetuximab) approved by the FDA in HER2-positive breast cancer in late 2020.

Gap closes on year-over-year clinical data; COVID-19 activity drops

While phase I-III clinical trial data continues to rise above the same timeframe in 2020, the gap is closing and a smaller percentage of this year’s reports are focused on the COVID-19 pandemic. With 1,803 clinical entries tracked by BioWorld through mid-June, 2021 has recorded 14% more than its 2020 counterpart, which posted 1,579 by this point. In April, that gap was at 26%, suggesting clinical activity is slowing. Also dropping is the amount of clinical news focused on or affected by COVID-19. Although 26% (407) of the clinical entries through mid-June 2020 was related to COVID-19 therapeutics and vaccines or clinical trial delays due to the pandemic, this year’s figure is only 18% (328).

Funding Mnemo: Transatlantic startup closes $91M series A round for CAR T therapies targeting epigenetic antigens

DUBLIN – Mnemo Therapeutics SAS emerged from stealth mode having raised €75 million (US$91 million) in a series A financing round to take forward a new chimeric antigen T-cell (CAR T) platform, which is focused on selectively targeting both solid and liquid tumors expressing a previously undescribed class of antigens and on improving the persistence and fitness of CAR T cells.

Newco news: New GAIM in town, as Amyl rakes in $22M to target misfolded proteins

LONDON – Newco Amyl Therapeutics Ltd. has raised €18.3 million (US$22.3 million) in a series A, to pick up the baton on a technology for neutralizing toxic protein aggregates by binding to their amyloid folds. The mechanism of action makes it possible to target misfolded proteins implicated in both peripheral amyloidosis and neurodegenerative diseases. Amyl said that approach will prevent the further accumulation of aggregates and clear existing aggregates from peripheral organs, whilst also blocking further cell-to-cell spread of misfolded proteins

Mallinckrodt wins FDA nod for regenerative skin therapy for burns

More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. The company said the regenerative skin tissue therapy could reduce or eliminate the need for autografting of healthy skin to treat burn wounds.

Ochre Bio closes $10M seed round to map and drug the liver

DUBLIN – Ochre Bio Ltd. has raised $9.6 million in seed financing to drug the liver like never before, by combining genetics, single-cell genomics, spatial sequencing, imaging and machine learning to build a high-resolution, in silico model of the organ, which can provide new insights into disease biology and open up new drug targets. In parallel, it is building alliances with liver transplant centers across the world, which are providing it with access to donated but unused organs, which it is perfusing extracorporeally, to power its preclinical drug development efforts.

Daiichi Sankyo wins approval in Japan for first-ever oncolytic virus therapy treating malignant glioma

Daiichi Sankyo Co. Ltd. has received conditional approval from Japan’s Ministry of Health, Labour and Welfare for its oncolytic virus Delytact (teserpaturev/G-47delta) to treat malignant glioma. The approval marks “the first-ever oncolytic virus therapy option to patients with glioblastoma and other malignant gliomas that are not controlled with currently available treatments,” said Wataru Takasaki, executive officer and head of the company’s R&D division in Japan at Daiichi Sankyo. The therapy is Daiichi Sankyo’s fourth cancer medicine approved in Japan over the past two years.

Hifibio closes $75M series D to move TNFR2 and OX-40 candidates to the clinic by 2021

Multinational antibody specialist Hifibio Therapeutics Inc. closed an oversubscribed $75 million series D financing round to move its anti-TNFR2 antibody HFB-200301 and the anti-OX-40 antibody HFB-301001 to phase I trials by the end of this year. The biotech plans to move toward an IPO next and is in talks with a potential partner to support a combination therapy approach for its COVID-19 antibody program.

Inmagene raises $100M series C to initiate U.S.-China phase II trials of IL-17 inhibitor

Startup Inmagene Biopharmaceuticals Co. Ltd. has raised $100 million in a series C financing to move its IL-17 inhibitor to phase II trials in the U.S. and China this year. Highlight Capital and Panacea Venture led the round, with further support from VMS Asset Management, Triwise, Epiphron Capital, Kunlun Capital and South China Venture Capital.

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