Months af­ter se­cur­ing up to $21 mil­lion in fund­ing from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) for its Chikun­gun­ya vac­cine — which is be­ing prepped for a late-stage tri­al — Vi­en­na, Aus­tria-based Themis Bio­science en­tered in­to a pact with US drug­mak­er Mer­ck.

The Eu­ro­pean vac­cine de­vel­op­er formed in 2009 and a year lat­er joined forces with the In­sti­tut Pas­teur — gain­ing ex­clu­sive ac­cess to a measles virus vac­cine vec­tor tech­nol­o­gy, which now forms the back­bone of its plat­form.

Con­sid­er­ing it has been used to vac­ci­nate bil­lions of peo­ple, the at­ten­u­at­ed measles virus is one of the most ef­fec­tive and safe vac­cines avail­able, mak­ing it an at­trac­tive can­di­date vec­tor to avert in­fec­tious dis­ease.

In con­trast to oth­er ap­proach­es, Themis has de­vel­oped the tech­nol­o­gy to in­cor­po­rate mul­ti­ple large re­com­bi­nant pro­tein anti­gens in­to the vec­tor, which then acts as a de­liv­ery ve­hi­cle to trans­port the anti­gen pay­load di­rect­ly to macrophages and den­drit­ic cells. Fur­ther, since the vec­tor it­self repli­cates — there­by ex­press­ing anti­gens even af­ter im­mu­niza­tion — Themis’ vac­cine can­di­dates are en­gi­neered to con­fer long-term im­mu­ni­ty, chief Erich Tauber told End­points News.

Apart from its lead ex­per­i­men­tal Chikun­gun­ya vac­cine, Themis has a Zi­ka vac­cine and Las­sa fever in ear­ly-stage de­vel­op­ment. It al­so has a range of pre­clin­i­cal pro­grams, in­clud­ing those for res­pi­ra­to­ry syn­cy­tial virus (RSV), cy­tomegalovirus (CMV), norovirus and Mid­dle East Res­pi­ra­to­ry Syn­drome (MERS).

The vec­tor al­so has the in­trin­sic abil­i­ty to at­tack can­cer cells, which has been demon­strat­ed in var­i­ous pre­clin­i­cal stud­ies, he added. The com­pa­ny is there­fore cap­i­tal­iz­ing on that po­ten­tial by equip­ping the vec­tor with ad­di­tion­al tu­mor-killing pay­loads to de­vel­op on­col­o­gy treat­ments. Themis’s first im­muno-on­col­o­gy vac­cine is set to en­ter the clin­ic this year.

The terms of the Mer­ck $MRK part­ner­ship are shroud­ed in mys­tery. The two will work on a “block­buster in­di­ca­tion” and the New Jer­sey-based drug man­u­fac­tur­er will grant up to $200 mil­lion in mile­stone pay­ments, in ad­di­tion to roy­al­ties. Mer­ck has al­so made an undis­closed eq­ui­ty in­vest­ment in Themis.

Mer­ck, which has been bask­ing in the suc­cess of its flag­ship check­point in­hibitor Keytru­da, caus­ing some to wor­ry it may be lean­ing too heav­i­ly on the block­buster, has sharp­ened its fo­cus on its vac­cine port­fo­lio. In May, its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date aimed at top­pling Pfiz­er’s best­seller, Pre­vnar 13, cleared a mid-stage study — and is al­so be­ing eval­u­at­ed in var­i­ous Phase III tri­als. Mer­ck al­so has a part­ner­ship with mR­NA com­pa­ny Mod­er­na $MR­NA, fo­cused on per­son­al­ized can­cer vac­cines that are cus­tomized for each pa­tient.

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Bristol-Myers Squibb’s efforts to expand their checkpoint inhibitor combination have run into another recalcitrant cancer.

The NJ-based pharma announced that a combination of Yervoy and Opdivo didn’t beat out Opdivo alone in patients with resected high-risk melanoma who had very low levels of PD-L1. The drug combo couldn’t improve recurrence-free survival in these post-surgery patients.

Vertex’s golden quarter just got brighter. About a month after the US drugmaker finally clinched a deal with UK authorities to cover its slate of cystic fibrosis (CF) drugs following years of protracted negotiations, the company on Wednesday secured a deal with France for its CF therapy, Orkambi.

After the UK, France has one of the largest CF populations outside the United States. Achieving French reimbursement unlocks an ~7000-patient CF population, around ~2500-3000 of which will likely be eligible to receive (and be reimbursed for) Orkambi, Stifel’s Paul Matteis wrote in a note.

Kymera Therapeutics is turning to a co-founder to run the company.
The protein degradation specialist with a deep-pocket syndicate behind them has opted to give the helm officially to Nello Mainolfi. The new CEO is a veteran of the Novartis Institutes for Biomedical Research. He joined Atlas Venture in their entrepreneur-in-residence program and helped launch Kymera as the CSO three years ago with Atlas’ Bruce Booth.
The boast at Kymera is that they’re angling to create a new class of protein degraders, a popular field where there’s been a variety of startups. One of its chief advocates is NIBR head Jay Bradner, who launched C4 just ahead of joining Novartis, where he’s also been doing new work in the field.