Vaxess announced last week that the U.S. National Institute of Allergy and Infectious Diseases has awarded the Massachusetts-based company up to $2.9 million to advance the commercialization of its MIMIX smart release patch technology. The grant will accelerate the company’s CMC activities in preparation for a Phase 1 proof-of-concept trial—set to begin in the first half of 2022—of a MIMIX product with “a seasonal flu and a Covid-19 vaccine…

The state of the hunt:

  • European, South African and U.S. regulators cleared J&J’s single-dose vaccine for resumed use.
     
  • Pfizer/BioNTech’s vaccine showed 85% effectiveness against any infection—symptomatic or not—in a 23,000-participant British study of health workers, published in The Lancet.
     
  • India authorized a Zydus Cadila hepatitis therapy for emergency use against Covid-19.

Funders made new investments in antibiotics, diagnostics and bacteriophage drugs in recent days.

Boston University-led CARB-X announced two new awards. On Monday, the nonprofit said it would give Britain’s Phico Therapeutics up to $5.3 million (plus up to $12.9 million in milestones) to develop a new intravenous engineered bacteriophage drug to treat ventilator-associated pneumonia caused by P. aeruginosa. On Tuesday, CARB-X announced…

Brii Biosciences, VBI Vaccines and Vir Biotechnology jointly announced on Wednesday that the first patient has been dosed in a Phase 2 combination trial of a potential functional cure for chronic hepatitis B infection.

The companies are studying BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV…

In its 13th annual G-FINDER report, released last week, Australian think tank Policy Cures Research said global funding for neglected diseases R&D remained “stable” at $3.88 billion in 2019, one year before the start of the Covid-19 pandemic.

However, the overall stability masked underlying changes. Private sector funding from the year prior dropped 19%, a shift offset by a 2.8% increase in public sector funding and a 5.2% jump in…

Britain’s Hull York Medical School touted Phase 2a results last week showing that its therapeutic vaccine candidate for post-kala-azar dermal leishmaniasis (PKDL) was safe and immunogenic in people with the infection.

Of the 23 people who received the simian adenovirus-based vaccine candidate (ChAd63-KH) and were followed to study completion, seven resolved their PKDL lesions without the need for chemotherapy, according to results…

Russia’s Microgen—a subsidiary of state-owned holding company Rostec—announced last week that it will expand its vaccine and drug production at a new facility in the central city of Perm.

Microgen will use the new plant to produce diphtheria, tetanus and acellular pertussis (DTaP) vaccines and a pentavalent shot against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type B—the first domestic pentavalent vaccine…

Washington state-based Viome announced last week that Emmanuel Hanon—current head of vaccine R&D at GSK—will join the gut microbiome-focused company as its global head of R&D beginning July 1. Hanon will lead Viome’s efforts to develop vaccines and drugs for chronic diseases using the company’s database of gene expression, the press release said.

The news comes amid reports of an “exodus of scientists” from GSK’s vaccine group—…

Thermo Fisher announced last week that it will buy North Carolina-based clinical research organization PPD for $17.4 billion in cash and approximately $3.5 billion in assumed debt.

In a boost to its pharma services business, the Massachusetts-based company will acquire PPD’s drug development platform, patient recruitment capabilities and laboratory services, the press release said.

The deal is one of several acquisitions for…

Mentions: Thermo Fisher, PPD, M&A, drugs

Boston-based Vertex Pharmaceuticals and Swiss biotech CRISPR Therapeutics announced a significant amendment on Tuesday to their collaboration on a potential sickle cell disease (SCD) cure.

Vertex will pay CRISPR $900 million upfront (plus up to $200 million in milestones) to expand its interest in CTX001, an investigational CRISPR/Cas9-based gene editing therapy that the companies say may provide a cure to both SCD and transfusion-…

The state of the hunt:

  • A subcutaneous dose of Regeneron’s REGEN-COV mAb reduced the risk of symptomatic Covid-19 by 81% among household contacts of people with the disease.
     
  • South Africa and the United States suspended their rollouts of J&J’s vaccine on safety concerns.
     
  • The EMA committee reviewing safety signals in J&J’s vaccine will announce a conclusion on Tuesday, while a U.S. CDC…

CanSino Biologics has started enrollment in a Phase 3 trial of its 13-valent pneumococcal conjugate vaccine candidate (PCV13i), the Tianjin-based company disclosed Tuesday in a regulatory filing.

Meanwhile, in an apparent attempt to distance itself from safety concerns over AstraZeneca’s and J&J’s Covid-19 shots, CanSino claimed Wednesday that “no blood clot related serious adverse events” had been reported to date in approximately…

Italian laboratory diagnostics producer DiaSorin announced a deal Sunday to buy Texas-based biological test maker Luminex for $1.8 billion.

The deal—funded through a mix of cash and external financing—will broaden DiaSorin’s presence in the United States and expand its growing diagnostics portfolio with access to Luminex’s “multiplexing technology,” the press release said.

The merger comes just weeks after Roche announced plans to…

Moderna highlighted clinical progress on its mRNA vaccines portfolio during its second annual Vaccines Day on Wednesday.

The Massachusetts-based company touted interim Phase 1 data from its mRNA-1345 RSV vaccine candidate showing that the shot was generally well-tolerated and increased RSV neutralizing antibodies in the seropositive younger adult cohort (age 18-49) through one month post-vaccination (for both RSV-A and RSV-B). Moderna…

Mentions: Moderna, vaccines, RSV, CMV, HIV, flu, mRNA

Belgium-based biomanufacturing platform company Univercells announced Tuesday that it has signed letters of intent with two Senegal-based organizations to strengthen local vaccine manufacturing capacity. The company will work with the Institute for Health Research, Epidemiological Surveillance and Training to strengthen its R&D capabilities and create bioproduction capacity for routine immunization vaccines, and will also partner with…

Sanofi announced on Monday a $476 million investment over five years to build a vaccine production facility in Singapore to strengthen its supply in Asia and “answer more rapidly to future pandemics.”

According to the press release, the site will allow production of “three to four vaccines simultaneously” (versus only one in current industrial sites) and have the “modularity and flexibility” to scale up production for specific vaccines…

Vaccine makers Vaccitech and Valneva separately filed plans last week for initial public offerings on Nasdaq.

Oxford-based Vaccitech is the Jenner Institute spinout that owns the technology underlying the AstraZeneca/Oxford Covid-19 vaccine. Its pipeline includes a Phase 1 MERS vaccine and a preclinical zoster shot.

France’s Valneva, already listed on Euronext and proposing to list American depositary shares via a new offering, is…

The state of the hunt:

  • Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
     
  • Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
     
  • COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid…

CARB-X announced Tuesday an award of up to $3.6 million (plus up to $10.2 million in milestones) to Maryland-based Novel Microdevices to develop a rapid, point-of-care, battery-powered diagnostic for sexually transmitted infections such as chlamydia and gonorrhea.

The test—which will also identify antibiotic resistance—will diagnose infections in about 25 minutes from a vaginal swab or urine sample and require no sample preparation,…

France’s bioMérieux has secured European CE marking for three fully automated immunoassays for dengue, the company announced Wednesday.

Performed on the company’s Vidas family platforms, the Vidas Dengue NS1 Ag, Anti-Dengue IgM and Anti-Dengue IgG are “cost-effective and suitable for low- and middle-income countries,” according to the press release.

The company plans to add a chikungunya assay to its diagnostic offerings, per the…