SK Bioscience made its initial public offering (IPO) last week on the Korea Composite Stock Price Index at 65,000 won ($57.30) per share, jumping as high as 169,000 won on its first day of trading.

The company previously said it would use the offering’s proceeds to accelerate its pneumococcal conjugate shot, SKYPAC, expand its vaccine portfolio and contract manufacturing capacity, and explore overseas investments.

Médecins Sans Frontières (MSF) used Wednesday’s World Tuberculosis Day to announce that its candidate six-month, all-oral regimen is superior to locally accepted 9-20-month care standards for multidrug-resistant TB. MSF has now stopped enrollment in the Phase 2/3 trial of the treatment—containing bedaquiline, linezolid, moxifloxacin and pretomanid—based on an independent data safety and monitoring board recommendation, the press release said…

Chinese CDMO WuXi Biologics announced last week that it has bought Pfizer’s GMP biologics plant in Hangzhou. WuXi expects production at the facility—which houses two 2,000-liter single-use bioreactors and fill-finish capabilities—to begin shortly after the deal closes in the first half of the year. WuXi did not disclose financial terms for the transaction. Pfizer invested $350 million in the plant in 2016 in hopes of entering the local…

Mentions: Wuxi, Pfizer, vaccines, CDMOs

The state of the hunt:

  • Moderna began clinical trials of its vaccine in children.
     
  • New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
     
  • France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European…

On the final day of last week’s annual Conference on Retroviruses and Opportunistic Infections (CROI), Spanish biotech Aelix Therapeutics touted positive topline results from the first-in-human Phase 1/2a trial of its investigational HTI T cell therapeutic vaccine in early-treated people living with HIV.

The AELIX-002 trial evaluated people who interrupted their antiretroviral treatment (ART) after vaccine administration. In a subset of…

Mentions: CROI, Aelix, HIV, vaccines, drugs, ART, Gilead

Gilead and Merck announced on Monday a deal to co-develop and market long-acting HIV treatments combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s nucleoside reverse transcriptase translocation inhibitor candidate, islatravir.

According to the press release, Gilead and Merck will share costs at a ratio of 60% and 40%, respectively, and lead commercialization efforts in different geographies depending on the…

Mentions: Gilead, Merck, HIV, drugs

Portland-based Hemex Health announced Monday that its Gazelle Malaria one-minute point-of-care test outperforms current rapid diagnostic tests (RDTs) and is “nearly as accurate” as expert microscopy in detecting P. vivax malaria.

The press release referenced trial results from Brazil published last week in Malaria Journal: compared to optical microscopy, the battery-powered Gazelle test achieved 96.2% sensitivity versus 83.9%…

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced on Thursday that it has awarded a total of $2.5 million in grants to 12 institutes to support research on bacteriophage therapy as a potential strategy to combat antibacterial resistance.

In other AMR news, New York-based ContraFect announced Thursday an award from the U.S. Biomedical Advanced Research and Development Authority of $9.8 million upfront and…

Roche announced Monday that it will buy California-based GenMark Diagnostics for $1.8 billion in cash.

The Swiss biotech will expand its portfolio with GenMark’s molecular diagnostic tests, including the ePlex Respiratory Pathogen Panel, which simultaneously screens for several bacteria and 21 viruses (including influenza A and B, RSV and SARS-CoV-2). The announcement came days after the U.S. FDA issued a warning about false positives…

Roche announced last week that WHO has awarded prequalification (PQ) status to the HIV-1 and hepatitis C virus tests on its cobas 6800/8800 Systems.

The company’s Global Access Program—launched in 2014—provides special pricing to LMICs for diagnostic tests for HIV, tuberculosis, hepatitis B and C, and HPV.

Mentions: Roche, WHO, PQ, HIV, hep C, HCV, diagnostics

The state of the hunt:

  • J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
     
  • A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
     
  • Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization…

Amgen will acquire California-based immuno-oncology and cancer therapy specialist Five Prime Therapeutics for approximately $1.9 billion, the companies announced last week.

Five Prime’s lead asset—an investigational “Phase 3 ready” antibody targeting gastric and other cancers—fits Amgen’s international expansion strategy: gastric cancer is prevalent in the Asia-Pacific region “where Amgen expects to generate significant volume growth in…

The Clinton Health Access Initiative (CHAI) and the American Cancer Society (ACS) announced Monday that Biocon Biologics will join their Cancer Access Partnership (CAP), which aims to increase access to cancer treatments in low- and middle-income countries in Africa and Asia.

The addition of the Bangalore-based company—“India’s largest biopharma,” according to Biocon’s website—and an expanded portfolio of biosimilars from Pfizer will…

CARB-X committed up to $3.5 million to Affinivax to support the Massachusetts-based biotech’s development of a new vaccine to prevent Staphylococcus aureus infections, according to a CARB-X press release on Tuesday.

The Boston University-led nonprofit may add up to $18.5 million to the award if the vaccine—which will use the company’s Multiple Antigen Presenting System to include a variety of staphylococcal protein antigens—reaches…

The Coalition for Epidemic Preparedness Innovations (CEPI) released a $3.5 billion investment case on Wednesday, outlining a five-year plan that includes a “moonshot” objective: compressing vaccine development timelines to 100 days.

Among the plan’s other goals are developing vaccines for known threats (such as chikungunya, Lassa fever and Nipah), producing a “library of prototype vaccines” from critical viral families, and supporting…

Merck, Gilead and ViiV captured headlines for their HIV portfolios at this week’s annual Conference on Retroviruses and Opportunistic Infections (CROI).

First, Merck announced on Monday that a reformulated version of its islatravir NRTTI subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP) may provide protection for “at least one year,” based on Phase 1 data. A company researcher told NAM Aidsmap that planned Phase 2 trials of…

Mentions: Merck, Gilead, ViiV, GSK, HIV, CROI, PrEP, drugs

The Pediatric Praziquantel Consortium announced new funding last month from Japan’s Global Health Innovative Technology (GHIT) Fund and the European & Developing Countries Clinical Trials Partnership.

The separate awards—worth a combined $9.3 million—will fund the ADOPT program, dedicated to “wide acceptance and equitable access” for a child-friendly dispersible tablet formulation of schistosomiasis drug praziquantel.

With…

Médecins Sans Frontières (MSF), Save the Children, UNICEF and WHO issued a press release last week welcoming the addition of GSK’s rotavirus vaccine, Rotarix, to their Humanitarian Mechanism, which allows civil society organizations in countries not otherwise eligible for Gavi support to buy shots at manufacturers’ lowest available price for use in emergencies.

Founded in 2017, the Humanitarian Mechanism was previously limited to…

Seoul’s International Vaccine Institute (IVI) announced last week that South Korea-based Sumagen will pursue recombinant vesicular stomatitis virus (rVSV)-based vaccines against MERS and Crimean-Congo hemorrhagic fever with $1.2 million in funding, to include work on wider pandemic response platforms. The project is part of a collaboration between IVI and the government-sponsored Vaccine Innovative Technology Alliance Korea (VITAL-Korea)…

The Lundquist Institute announced Monday that the Bill & Melinda Gates Medical Research Institute will develop its synthetic lung surfactant formulation for use in preterm infants with respiratory distress syndrome in low- and middle-income countries.

The Los Angeles-based research institute currently maintains patents on the therapy in Canada, Europe and the United States.