Steven Brugger, Affinivax CEO

Watch out, Pfiz­er: Affini­vax lands $226M in fund­ing to ad­vance Pre­vnar 13 ri­val as well as the rest of its pipeline

Affini­vax CEO Steven Brug­ger hit the clin­ic a cou­ple years ago with an un­con­ven­tion­al take on a pneu­mo­coc­cal vac­cine de­signed to de­throne Pfiz­er’s Pre­vnar 13. And now that the can­di­date’s ready for Phase III, Brug­ger has reeled in a $226 mil­lion mega-round to see it through.

The Se­ries C comes sev­er­al months af­ter a $120 mil­lion raise, with Viking Glob­al In­vestors, Bain and Ziff Cap­i­tal Part­ners par­tic­i­pat­ing in both rounds. It’s quite the ac­com­plish­ment for a com­pa­ny that launched with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion back in 2014.

Affini­vax is spread­ing the funds across its pipeline, which in­cludes its Astel­las-part­nered lead pro­gram for pneu­mo­coc­cal in­fec­tion. The can­di­date, which cov­ers 24 pneu­mo­coc­cal serotypes, is lin­ing up to ri­val Pfiz­er’s block­buster Pre­vnar 13, which bagged $6 bil­lion in rev­enue in 2019 — more than any oth­er ful­ly owned Pfiz­er prod­uct.

Affini­vax’s jab, dubbed ASP3772, re­cent­ly com­plet­ed a Phase II tri­al in adults 65 to 85 years old and is ready for a Phase III reg­is­tra­tional tri­al, al­though the com­pa­ny de­clined to com­ment on the time­line.

Brug­ger is af­ter what he calls a new class of vac­cines, us­ing the com­pa­ny’s MAPS tech­nol­o­gy, short for Mul­ti­ple Anti­gen Pre­sent­ing Sys­tem. It presents poly­sac­cha­ride and pro­tein anti­gens to the im­mune sys­tem to kick up both a B cell and T cell re­sponse. The plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, which Brug­ger com­pared to “the strongest Vel­cro you can imag­ine.”

“By not us­ing chem­i­cal con­ju­ga­tion, we be­lieve the im­muno­genic epi­topes on both the poly­sac­cha­rides and pro­teins are not com­pro­mised and re­tain their full im­muno­genic po­ten­tial,” Brug­ger said in an email. “The re­sult is quite dis­tinc­tive­ly dif­fer­ent than con­ju­gate vac­cines, where the poly­sac­cha­ride and the pro­teins are both rec­og­nized by the im­mune sys­tem.”

Affini­vax al­so has an on­go­ing Phase I tri­al in tod­dlers and plans to ini­ti­ate a Phase II proof-of-con­cept study in in­fants.

The Cam­bridge, MA-based biotech’s pre­clin­i­cal pipeline in­cludes can­di­dates for Staphy­lo­coc­cus au­reus, Kleb­siel­la pneu­mo­ni­ae and Pseudomonas aerug­i­nosa, Clostrid­i­um dif­fi­cile, and even Covid-19. Ac­cord­ing to Brug­ger, it’s now work­ing on a next-gen­er­a­tion pneu­mo vac­cine with broad­er cov­er­age than ASP3772.

“With the ad­di­tion­al cap­i­tal raised from the Se­ries C, we are in a po­si­tion to ad­vance these on our own to IND and clin­i­cal tri­als with­in the next few years,” Brug­ger said.

Last month, Pfiz­er got pri­or­i­ty re­view for its new pneu­mo­coc­cal vac­cine, 20vP­nC, which is de­signed to pro­tect against dif­fer­ent 20 strains of path­o­gen­ic pneu­mo­coc­cal bac­te­ria as op­posed to Pre­vnar’s 13. The FDA is set to de­liv­er a de­ci­sion by June 2021.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.