On­coSec signs on Dana-Far­ber as CAR-T part­ner; Do­va racks up an­oth­er Doptelet ap­proval

Dana-Far­ber is lend­ing a hand to lit­tle On­coSec’s nascent ef­fort to de­vel­op CAR-T ther­a­pies for sol­id tu­mor can­cers. The San Diego biotech has worked out an ex­clu­sive li­cens­ing deal with Wayne Maras­co — an ex­pert in an­ti­body en­gi­neer­ing — to ap­ply his method of link­ing two sin­gle-chain vari­able frag­ment (scFv) in a bis­pe­cif­ic CAR-T such that the T cells are on­ly ac­ti­vat­ed when both tar­gets are en­gaged, there­by lim­it­ing off-tu­mor tox­i­c­i­ty. On­coSec’s fi­nan­cial con­tri­bu­tion in the re­search, which in­volves test­ing the ex­per­i­men­tal treat­ment so­lo and in com­bi­na­tion with Ta­vo in triple-neg­a­tive breast can­cer, will be “mod­est” and spread over sev­er­al years, CEO Daniel O’Con­nor said.

→ Af­ter win­ning the FDA nod for low blood platelet count (throm­bo­cy­tope­nia) in adults with chron­ic liv­er dis­ease (CLD) who are sched­uled to un­der­go a med­ical or den­tal pro­ce­dure, the la­bel of Do­va Phar­ma­ceu­ti­cal’s Doptelet on Thurs­day was ex­pand­ed to in­clude pa­tients with chron­ic im­mune throm­bo­cy­tope­nia (ITP) who have had an in­suf­fi­cient re­sponse to a pre­vi­ous treat­ment. The com­pa­ny’s shares $DO­VA leapt about 27.5% to $13.50 in morn­ing trad­ing. The FDA’s en­dorse­ment comes about a week af­ter Eu­ro­pean reg­u­la­tors al­so backed the drug for use in se­vere throm­bo­cy­tope­nia in adult pa­tients with CLD who are sched­uled to un­der­go an in­va­sive pro­ce­dure. Mean­while, late-stage da­ta from a study eval­u­at­ing the drug’s use in chemother­a­py-in­duced throm­bo­cy­tope­nia are ex­pect­ed in the first half of 2020.

→ The re­cent­ly-pub­lic Ver­ri­ca Phar­ma­ceu­ti­cals$VR­CA ex­per­i­men­tal drug, VP-102, has cleared a mid-stage study in pa­tients with com­mon warts. The drug’s “ef­fi­ca­cy and tol­er­a­bil­i­ty has been fur­ther con­firmed with the pos­i­tive Phase II COVE-1 tri­al in com­mon warts, and is now de-risked in an ad­di­tion­al in­di­ca­tion. We be­lieve this pro­vides ad­di­tion­al (and not mod­eled) up­side for VR­CA as our val­u­a­tion tar­gets are based pure­ly on VP-102 in mol­lus­cum con­ta­gio­sum which re­mains on track for a po­ten­tial H2:2020 launch,” Cowen an­a­lysts wrote in a note. The com­pa­ny said it is on track to sub­mit an ap­pli­ca­tion to mar­ket the drug for pa­tients with mol­lus­cum con­ta­gio­sum — a vi­ral skin in­fec­tion some­times called wa­ter warts — lat­er this year.

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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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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.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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