May 18, 2022

Paul Schloesser Associate Editor Ear­li­er this year, Mod­er­na and non­prof­it re­search group IAVI (In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive) an­nounced that the first dos­es of an mR­NA an­ti-HIV vac­cine can­di­date had been ad­min­is­tered in a tri­al called IAVI G002. That was, at least some­what, in line with Mod­er­na CEO Stéphane Ban­cel’s goal for the com­pa­ny last year to launch three Phase I tri­als for an HIV pro­gram. Based on re­sults from stud­ies in pre­vi­ous years (G001 launched in 2018), Mod­er­na and IAVI are now jump­ing in­to a new col­lab­o­ra­tive tri­al: IAVI G003, a Phase I tri­al that IAVI will spon­sor. Mod­er­na said ear­ly Wednes­day that par­tic­i­pant screen­ings are start­ing soon for the biotech’s mR­NA HIV vac­cine anti­gen in two places: Rwan­da and South Africa. The biotech said that the new study builds off of re­sults from IAVI G001, an­oth­er Phase I tri­al which, ac­cord­ing to Mod­er­na, showed that vac­ci­na­tion safe­ly brought out an im­mune re­sponse in 97% of healthy, US adults. The goal for this new study? To see if the im­mune re­sponse from the first tri­al — in an Amer­i­can pop­u­la­tion — will trans­late and bring a sim­i­lar im­mune re­sponse in the new study’s African pop­u­la­tion. Mod­er­na list­ed sev­er­al spon­sors be­hind the study, in­clud­ing the US’ Pres­i­dent’s Emer­gency Plan for AIDS Re­lief (PEP­FAR) through US­AID and the Bill & Melin­da Gates Foun­da­tion through var­i­ous grants. Ban­cel said in a state­ment that “Mod­er­na’s HIV vac­cine de­vel­op­ment pro­gram, to­geth­er with our port­fo­lio of Covid-19, Zi­ka, and Ni­pah pro­grams, ad­vances 4 of the 15 pri­or­i­ty vac­cine pro­grams we com­mit­ted to de­vel­op by 2025.” Ac­cord­ing to the biotech, tri­al sites are ex­pect­ed to en­roll a com­bined to­tal of 18 healthy, HIV-neg­a­tive adult vol­un­teers for IAVI G003, which will not be blind­ed or ran­dom­ized. All par­tic­i­pants will re­ceive two dos­es of the can­di­date and then be mon­i­tored for six months, and the pri­ma­ry end­points will be safe­ty and im­muno­genic­i­ty. This is Mod­er­na’s newest step to­ward Africa af­ter the biotech en­tered a mem­o­ran­dum of un­der­stand­ing with the Kenyan gov­ern­ment ear­li­er this year for its first man­u­fac­tur­ing fa­cil­i­ty on the con­ti­nent. Mod­er­na’s ef­forts in the HIV space are just one of sev­er­al at­tempts be­ing made to go af­ter what was once con­sid­ered a death sen­tence. Biotech and phar­ma alike have been en­gag­ing in re­search to try to cure the dis­ease for good through var­i­ous mit­i­ga­tion and pro­phy­lac­tic mea­sures. New­er fo­cus­es in­clude Gilead’s ex­per­i­men­tal lenaca­pavir or test­ing al­ready-ap­proved drugs with po­ten­tial, such as a study pub­lished in Sci­ence Trans­la­tion­al Med­i­cine back in Jan­u­ary that looked at Keytru­da with some op­ti­mism. Max Gelman Senior Editor Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why. The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.” Keep reading Endpoints with a free subscription Unlock this story instantly and join 142,300+ biopharma pros reading Endpoints daily — and it's free. SIGN UP John Carroll Editor & Founder Flagship has crafted a new startup out of pieces from a pair of fledglings in the VC’s nest. And a prominent Roche veteran who ran one of the biotechs won’t be making the next leg of the journey. The new company is called Sonata Therapeutics, which is picking up the work that Inzen was doing related to the cellular microenvironment and combining with Flagship’s Cygnal Therapeutics, which came out of stealth more than 3 years ago and put Pearl Huang — the BeiGene founder and former Roche SVP — at the helm. Keep reading Endpoints with a free subscription Unlock this story instantly and join 142,300+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Tyler Patchen News Reporter The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case. After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news. Read More Tyler Patchen News Reporter Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint. At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program. Keep reading Endpoints with a free subscription Unlock this story instantly and join 142,300+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Tyler Patchen News Reporter A plan to broaden access to CRISPR has attracted a chunk of funding and is now seeing its wings spread. Fargo-based DNA and mRNA producer Aldevron has signed an agreement with life sciences company Inscripta to manufacture and commercialize the Eureca-V Nuclease, a wild-type MAD7 CRISPR Type-V nuclease. This partnership will aim to offer this nuclease as a standard research-grade and GMP catalog item. According to a press release, the production of Eureca-V is slated to start in Q3 of 2022. Financial details of the deal were not immediately made available to Endpoints News. Read More