PACT Phar­ma bags $75M for neoanti­gen TCR work, man­u­fac­tur­ing; Bay­er grabs ex­per­i­men­tal con­tra­cep­tive from Daré

→ With a new pres­i­dent and chief tech­ni­cal of­fi­cer in place, next-gen T cell ther­a­py play­er PACT Phar­ma has $75 mil­lion in fresh fi­nanc­ing to ex­pand the scope of its nascent clin­i­cal pro­grams and open its own man­u­fac­tur­ing fa­cil­i­ty in South San Fran­cis­co. By iso­lat­ing spe­cif­ic neoanti­gen re­cep­tors in pa­tients that ap­pear to be dri­ving an im­mune re­sponse, PACT promis­es to tack­le some of the tough­est sol­id tu­mors pre­vi­ous­ly im­pen­e­tra­ble to cell ther­a­pies. Vi­da Ven­tures, which has close ties to promi­nent cell ther­a­py biotechs such as Kite and Al­lo­gene, led the Se­ries C round. CTO Tim Moore, who jumped from Kite last Oc­to­ber, will su­per­vise ef­forts to au­to­mate some pro­duc­tion and an­a­lyt­ics process “to re­duce cy­cle time and man­u­fac­tur­ing costs.”

→ Large CRO Charles Riv­er is en­ter­ing a mul­ti-year drug dis­cov­ery col­lab­o­ra­tion with Take­da, fo­cus­ing on four ar­eas the Japan­ese drug­mak­er cham­pi­ons — on­col­o­gy, gas­troen­terol­o­gy, neu­ro­science and rare dis­ease. Un­der the deal, Charles Riv­er gets an undis­closed up­front fee from Take­da, and is el­i­gi­ble to re­ceive de­vel­op­ment pay­ments of up to $50 mil­lion per can­di­date as well as po­ten­tial com­mer­cial mile­stones of up to $120 mil­lion plus roy­al­ties on launched prod­ucts.

Bay­er has inked a li­cens­ing agree­ment with Daré Bio­science for com­mer­cial­iza­tion rights of an in­ves­ti­ga­tion­al hor­mone-free month­ly vagi­nal con­tra­cep­tive, Ovaprene, in the US. San Diego-based Daré will re­ceive an undis­closed up­front and $20 mil­lion if Bay­er de­cides to ex­er­cise its op­tion, plus mile­stones that add up to $310 mil­lion. The biotech ex­pects to launch a piv­otal study in the sec­ond half of 2020.

→ Af­ter tout­ing in­ter­im Phase II re­sults on its lead COPD drug last March, Verona Phar­ma has chalked up an­oth­er win in the next stage. The com­pa­ny re­port­ed pos­i­tive da­ta in the 4-week Phase IIb study eval­u­at­ing neb­u­lized en­sifen­trine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or place­bo as an add-on treat­ment to tiotropi­um (Spiri­va Respi­mat), a long-act­ing an­ti-mus­carinic (“LAMA”) bron­chodila­tor mar­ket­ed by Boehringer In­gel­heim. The pri­ma­ry end­point was met at all dos­es, with sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in lung func­tion at week 4.

Al­lo­gene and Spring­Works Ther­a­peu­tics — two not­ed star­tups de­vel­op­ing port­fo­lios of drugs flow­ing from Pfiz­er are team­ing up to eval­u­ate Al­lo­gene’s BC­MA Al­lo­CAR T ther­a­py, AL­LO-715, in com­bi­na­tion with Spring­Works’ gam­ma sec­re­tase in­hibitor (GSI), nirogace­s­tat, in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. Un­der the terms of agree­ment, Al­lo­gene will spon­sor and con­duct the Phase I study — which is ex­pect­ed to com­mence in the sec­ond half of 2020.

→ Back in No­vem­ber 2018, Eli Lil­ly showed their faith in NextCure by drop­ping $40 mil­lion in up­front and eq­ui­ty cash. Now, Lil­ly is ter­mi­nat­ing the deal, ef­fec­tive as of March 3, 2020.

→ For his lat­est com­pa­ny cre­ation, Vivek Ra­maswamy is look to serve the peo­ple who serve drug­mak­ers. Loka­vant’s stat­ed goal is to cen­tral­ize da­ta from over 1,000 tri­als “to pow­er a ma­chine learn­ing mod­el that an­tic­i­pates tri­al risk, pro­vides risk mit­i­ga­tion strate­gies, and pre­dicts the im­pact of mit­i­ga­tion strat­e­gy im­ple­men­ta­tion. Rhit Nam­bisan, head of dig­i­tal prod­uct at Roivant, will serve as pres­i­dent. The new com­pa­ny has al­so en­tered its first mul­ti-year en­ter­prise li­cense agree­ment with Parex­el, which re­cent­ly inked a re­al world ev­i­dence pact with an­oth­er Roivant sub­sidiary, Data­vant.

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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