Sanofi and GSK are keep­ing the R&D en­gine churn­ing for Covid-19 vac­cines.

The part­ners, which have yet to get their first shot on the mar­ket, re­port­ed that their next-gen­er­a­tion boost­er — mod­elled on the Be­ta vari­ant of the SARS-CoV-2 virus and in­cor­po­rat­ing GSK’s ad­ju­vant — kicked up a stronger im­mune re­sponse to adults who re­ceived mR­NA jabs than both its own first-gen­er­a­tion shot and Pfiz­er/BioN­Tech’s Comir­naty.

Cit­ing da­ta from two tri­als, Sanofi first not­ed that in the Phase III COV­I­BOOST VAT02 Co­hort 2 study, the next-gen can­di­date “gen­er­at­ed dou­ble the num­ber of neu­tral­iz­ing an­ti­bod­ies against Omi­cron BA.1 and BA.2 com­pared to the D614-based (orig­i­nal par­ent virus) boost­er.”

Then from the much small­er COV­I­BOOST VAT013 study, which was con­duct­ed by a hos­pi­tal in Paris, in­ves­ti­ga­tors al­so ob­served high­er neu­tral­iz­ing an­ti­body titers — with 76.1% of all par­tic­i­pants see­ing at least a “10-fold in­crease for the wild-type strain.” By com­par­i­son, 63.2% of those who got the Pfiz­er/BioN­Tech boost­er reached that thresh­old, and 55.3% of those who got the first-gen Sanofi/GSK boost­er did.

“Covid-19 keeps evolv­ing and the com­bi­na­tion of emer­gence of vari­ants and wan­ing im­mu­ni­ty is like­ly to lead to the need for ad­di­tion­al boost­er shots, at least in some pop­u­la­tions,” said Thomas Tri­om­phe, ex­ec­u­tive VP, Sanofi vac­cines.

The first-gen­er­a­tion can­di­date is now un­der reg­u­la­to­ry re­views, the com­pa­nies said.

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.