Although biopharma investors pulled back in 2022 – largely a response to freely flowing funds the previous two years during COVID-19 surges – they are cautiously returning to the sector, as the industry has raised $32.8 billion in the first half of 2023, a 23.6% jump over the same period last year. Investments in the second quarter (Q2) are also up over the first quarter (Q1). A total of 309 financings, including IPOs, follow-on offerings, private placements and other financings of public companies (public/other), and private venture capital rounds, have raised $17.16 billion in Q2, representing a 9.4% increase in value over Q1, as well as a 12% increase in volume.

Curis emerges from a partial clinical hold and raises $15M

The U.S. FDA has removed the partial clinical hold it placed in April 2022, prompted by a patient’s death, on Curis Inc.’s phase I/IIa study of emavusertib in treating leukemia. The company also said it just raised $15 million to keep everything going. The regulatory action sprang from the open-label, single-arm, dose-escalation and expansion study of emavusertib as a monotherapy and also with elapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome. The FDA had asked for data related to the death along with safety, efficacy and other results related to rhabdomyolysis, a dose-limiting toxicity of emavusertib the patient had experienced, along with Curis’ determination of the recommended dose for the study. The company also entered definitive agreements with existing investors in a registered direct offering designed to produce gross proceeds of about $15.1 million.

Brii expands hepatitis B partnership with VBI in deal worth $437M

In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan. In this latest deal, Brii establishes its leadership position “not only in an HBV functional cure, but also we are expanding to the prevention of hepatitis B,” Ankang Li, Brii Bio’s chief strategy and financial officer, said during a July 6 conference call.

Moderna hits global stride with transatlantic RSV vaccine regulatory filing, China R&D investment

Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older. And in China, Moderna signed a memorandum of understanding and a related land collaboration agreement that would initiate research, development and manufacturing of mRNA medicines in the country.

Tolerogenixx raises $8M to continue development of immune tolerance cell therapy in kidney transplant

Tolerogenixx GmbH raised €7 million (US$7.6 million) in an extension to its series A round, which will enable it to continue phase IIb development of a cell therapy that induces donor-specific immune tolerance in kidney transplant recipients. At the same time, the company disclosed five-year follow-up data from a phase Ib trial of the therapy, which demonstrated that recipients continue to have stable graft function and to avoid acute rejection and severe opportunistic infections while on a reduced regimen of immunosuppressive drugs.

State drug pricing bill sparks US constitutional challenge

The Association for Accessible Medicines (AAM) fired off a constitutional challenge in U.S. federal court this week to provisions in Minnesota’s budget law that would restrict price increases for generic and off-patent drugs. “The discriminatory law, an unconstitutional overreach passed in May 2023, and taking effect this month, grants Minnesota unprecedented powers to regulate the national pharmaceutical market, violating the United States Constitution and posing harm to vulnerable patient communities,” according to the AAM. In asking the court to block enforcement of the price-control provisions, AAM said they violate the Constitution’s Commerce Clause and right to due process.

Also in the news

ABVC, Acasti, Adocia, Aelis, Aicuris, Akamis, Allarity, Altamira, Amneal, Arvinas, Ayala, Biocardia, Biocytogen, Biosion, Boehringer Ingelheim, C4, Caribou, Carrick, Cassava, Clarity, Cognition, Curis, Edirna, Galderma, Genecode, Hansoh, Hillstream, Histogen, IGC, Impact, Incyte, Infant Bacterial, Innocare, Intensity, Jacobio, Janssen, Kashiv, Lyell, Metrion, Moderna, Nkarta, Oryzon, Oxford, Palisade, Pfizer, Pheon, Poseida, Protagonist, Rarestone, Sensorion, Shorla, Small, Sorrento, Taiho, Tempus, Tiumbio, Tscan, VBI Vaccines, Vertex