, CARB-X, antibiotics, AMR, Acurx, CDI, drugs, clinical trials

November 10, 2021 — India’s Bugworks Research announced Monday that it administered doses in the first human trial of its novel broad-spectrum antibiotic against multidrug-resistant Gram-negative bacteria. Bugworks is one of four CARB-X grantees conducting Phase 1 studies this year, the Bugworks press release noted. Boston University-led CARB-X has supported the company’s…

Mentions: Bugworks

GE plans to spin off its healthcare business into a separate public company as part of a broader restructuring, the conglomerate announced Tuesday. Targeted for early 2023, the transaction would create a freestanding diagnostics specialist. GE Healthcare had $18 billion in 2020 revenue and about 47,000 employees, according to a company presentation.

GE also intends to launch its energy business as a separate entity in 2024, leaving the…

Japan’s Global Health Innovative Technology (GHIT) Fund will invest $6.6 million in diagnostics, drugs and vaccines development, the nonprofit announced last week.

One award will advance an ongoing Chagas disease drug development project by the Drugs for Neglected Diseases Initiative (DNDI). The five other are new projects: a TB diagnostic, a placental malaria vaccine, a malaria drug, and two separate Chagas drugs (by DNDI/Takeda and…

Washington state-based startup Inventprise revealed Wednesday that it has won up to $90 million from the Gates Foundation to advance its pediatric 25-valent pneumococcal conjugate vaccine candidate (IVT-25) through Phase 2.

The company will make IVT-25 “available and accessible at an affordable price” to LMICs and make its proprietary “linker” platform technology available for future global health vaccine development, the press release…

The Lancet Microbe published results last week from a Phase 1b study evaluating the safety and tolerability of U.K.-based Vaccitech’s ChAdOx1 MERS vaccine candidate.

The results—from Saudi Arabia’s first clinical trial—showed the simian adenovirus-vectored shot was safe and well-tolerated at all dosage levels while a single high-dose jab improved immunogenicity through six months.

The vaccine uses the same platform as the…

Mentions: Vaccitech

Moderna “does not have plans” to advance its chikungunya antibody candidate to Phase 2, the company revealed last week in its third-quarter earnings press release. The Massachusetts-based mRNA specialist said it had completed a Phase 1 study of mRNA-1944 and would publish full results soon. Moderna also deprioritized a chikungunya vaccine candidate (mRNA-1388) in January 2020.

In other news, the New York Times reported Tuesday on an…

After more than 20 years as a shareholder, Novartis has agreed to sell its 33% stake in Roche to its Basel-based cross-town rival for $20.7 billion, the companies separately announced last week.

“We concluded that now is the right time to monetize our investment,” Novartis CEO Vas Narasimhan said in a press release. Meanwhile, Roche’s press release claimed the move disentangles the two competitors and enables it to regain “full…

Mentions: Novartis, Roche, M&A

Chinese CDMO WuXi Biologics launched its new 12,000-square-meter facility in its eponymous hometown last week. The plant will produce monoclonal antibodies, bispecifics and fusion proteins, among other drug products, with up to 60 million vials per year in capacity, the press release said.

The investment delivers an eighth global facility to the company.

Mentions: Wuxi, drugs, mAbs, CDMOs

The state of the fight: 

  • WHO issued an Emergency Use Listing for Bharat Biotech’s Covaxin vaccine.
     
  • Kenya’s Revital Healthcare will more than triple its annual syringe production amid a “looming shortfall” in LMICs.
     
  • Pfizer’s Paxlovid antiviral slashed Covid-19 hospitalizations or death by 89%.

 

AUTHORIZED VACCINES

 
WHO listed Bharat Biotech’s Covaxin vaccine…

Fueled by its fill-finish contract for J&J’s Covid-19 vaccine, South Africa’s Aspen Pharmacare last week opened a general anesthetics manufacturing line at its Gqeberha facility. Part of a $222 million expansion, the line is the southern hemisphere’s largest for general anesthetics, according to Bloomberg.

Aspen noted on social media that South Africa to date has “imported the general anaesthetics needed in our healthcare system.”…

The International AIDS Vaccine Initiative (IAVI) has entered another agreement to use Batavia Biosciences’ novel HIP-Vax platform to manufacture doses for clinical trials, the Dutch CDMO announced last week. This time around, the vaccine candidate is IAVI’s Sudan ebolavirus shot.

Batavia is already using the high-volume, low-cost, small-footprint technology to produce doses for Phase 1 trials of IAVI’s Lassa fever vaccine candidate.…

As world leaders descended on the COP26 climate change conference in Glasgow this week, several pharma companies promoted their own ESG pledges.

First, Moderna on Monday outlined a commitment to achieve net-zero carbon emissions globally by 2030. The announcement touted a plan to use renewable or offset energy in all U.S. facilities starting this year and to implement sustainable construction for new plants in Africa and Canada. CEO…

A polyvalent inactivated coxsackievirus B (CVB) vaccine candidate met the primary endpoint in a first-in-human trial, its New Jersey-based developer announced last week.

Citing interim results, Provention Bio said in a press release that its PRV-101—a shot targeting “all five key CVB strains associated with type 1 diabetes (T1D) autoimmunity”—was well-tolerated and induced high titers of viral-neutralizing antibodies against all…

Merck KGaA’s MilliporeSigma subsidiary will help Saudi Arabia-based SaudiVax design and launch a new biologics and vaccine manufacturing facility serving the Middle East and North Africa, MilliporeSigma announced Wednesday.

The collaboration aims to “localize” the production of “high-quality, Halal, and affordable vaccines and biotherapeutics” in Saudi Arabia, according to MilliporeSigma’s press release.

Gilead’s once-daily single-tablet Biktarvy regimen (bictegravir, emtricitabine and tenofovir alafenamide) showed high effectiveness and high levels of adherence in interim results from an ongoing “real-world” study, the California-based company announced last week at the 18th European AIDS Conference.

Conducted at sites in Canada, Europe and Israel, the BICSTaR study in adults living with HIV found that 97% of treatment-naïve…

Ten pharma companies have joined a U.S. FDA and U.S. National Institutes of Health initiative to streamline the gene therapy development process for rare diseases.

Armed with $76 million from the NIH and private partners, the Bespoke Gene Therapy Consortium will pursue a standardized therapeutic development model based on the adeno-associated virus (AAV) vector. The initiative will support four to six clinical trials, each focused on a…

Vaxess has opened a new facility in Woburn, Massachusetts, to manufacture its MIMIX smart release microneedle patch for clinical trials, the company announced last week. Looking ahead, a planned expansion at the facility will provide additional space for developing the patch, according to a company press release.

Vaxess has several deals in the works for the platform, including with South Korea’s GC Pharma and Taiwan’s Medigen Vaccine…

Mentions: Vaxess, MAP, vaccines

Venatorx Pharmaceuticals announced Monday that it has entered into a licensing agreement with Roche to advance drug treatments for infections caused by carbapenem-resistant Enterobacterales (CRE) bacteria.

Boston University-led nonprofit CARB-X gave the Pennsylvania-based company $15 million between 2019 and 2020 to develop a new class of oral antibiotics to treat infections caused by multidrug-resistant N. gonorrhoeae.

Wellcome Leap announced new grantees last week for its R3 (“RNA readiness and response”) program.

Co-founded in July by the Wellcome Trust spinout and the Coalition for Epidemic Preparedness Innovations (CEPI), the $60 million R3 initiative aims to increase the number of RNA-based biologic products on the market (thereby driving down production costs) and create a self-sustaining network of manufacturing facilities for surge capacity.…

Mentions: Wellcome Leap, R3, mRNA, CEPI, R&D

Thirteen leading pharma companies released third-quarter 2021 financial results in October, while one Japanese firm reported first-half 2021 results for the fiscal year ending in March. (Figures exclude exchange rate and portfolio changes where applicable.)

South Korea’s LG Chem saw its third-quarter numbers soar 70.7% over the same period last year, delivering $9.1 billion in sales. However, operating profit tumbled 20%, mainly due to…