Affini­vax, Astel­las be­gin clin­i­cal quest to beat Pfiz­er's Go­liath with a new kind of pneu­mo­coc­cal vac­cine

Days af­ter the FDA blessed Mer­ck’s ef­fort to chal­lenge Pfiz­er’s mega-block­buster Pre­vnar 13 with a break­through des­ig­na­tion, Affini­vax is mak­ing the leap in­to the clin­ic with its own take on the pneu­mo­coc­cal vac­cine.

It’s no small feat for a biotech play­er that got start­ed with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion in 2014 and has been run­ning pure­ly on grants as well as part­ner­ship dol­lars from Astel­las — which is shoul­der­ing much of clin­i­cal work in the Phase I/II study.

“We’ve done in less than five years at Affini­vax what the big vac­cine play­ers like Mer­ck and Pfiz­er and Sanofi and GSK have been try­ing to do for over 20 years,” CEO Steve Brug­ger tells me. “We have ac­tu­al­ly de­vel­oped a true next gen­er­a­tion tech­nol­o­gy for vac­cines.”

Rick Mal­ley

Hav­ing spent the past few years in­dus­tri­al­iz­ing the tech­nol­o­gy that came out of Rick Mal­ley’s lab at Boston Chil­dren’s Hos­pi­tal, Brug­ger and his crew of 68 are con­fi­dent that its prod­uct, ASP3772, can pro­vide “broad­er pro­tec­tion than any vac­cine in the mar­ket or any vac­cine that we’re aware of in clin­i­cal test­ing to­day.”

The spe­cif­ic num­ber of serotypes it will cov­er, though, will be kept se­cret for a lit­tle longer.

Dubbed the mul­ti­ple anti­gen pre­sent­ing sys­tem, or MAPS, Affini­vax’s tech plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, thus re­duc­ing cross-link­ing be­tween pro­teins and poly­sac­cha­rides. More im­por­tant­ly, the pro­teins — mere car­ri­ers in tra­di­tion­al vac­cines — are de­signed to elic­it B and T cell re­spons­es along­side the poly­sac­cha­rides they are bound to.

It’s an ap­proach that’s sup­posed to sep­a­rate Affini­vax from both the big guys and small­er chal­lengers like SutroVax, which has $170 mil­lion to push its own first-in-class con­ju­gate vac­cine to the clin­ic.

That will all be put to the test in the 618-pa­tient tri­al, as ASP3772 gets ad­min­is­tered to both adults and el­der­ly, and com­pared against Pre­vnar 13 as well as Pneu­movax.

Mean­while, the launch of the tri­al has trig­gered a mile­stone pay­ment from Astel­las — $10 mil­lion in cash that will fund Affini­vax’s oth­er bac­te­r­i­al vac­cine projects and some ear­ly, ex­plorato­ry work on im­muno-on­col­o­gy, where the abil­i­ty to present mul­ti­ple im­mune-re­sponse in­duc­ing anti­gens seems to hold promise.

“We stayed home for the first four years and fo­cused on let’s get the lead flag­ship pro­gram in­to the clin­ic, let’s val­i­date the tech­nol­o­gy clin­i­cal­ly, which we’re on track to do,” Brug­ger says. “Now as we look at be­gin­ning of 2019, where else can we ap­ply this tech­nol­o­gy?”

Im­age: Steve Brug­ger.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.