Cel­gene part­ners on Phase 0 can­cer drug stud­ies; FDA lifts clin­i­cal hold on Xen­cor's bis­pe­cif­ic

→  Cel­gene is ty­ing up with Seat­tle-based Presage Bio­sciences to test its ear­ly-stage can­cer drugs on pa­tients in Phase 0 stud­ies. In Phase 0, pa­tients are giv­en mi­cro­dos­es of a drug to test pa­tient re­spons­es. It’s one way to help in­crease the odds of suc­cess, and help over­come the in­her­ent lim­i­ta­tions of an­i­mal stud­ies.

Hide­ho Oka­da

Tmu­ni­ty and the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co will en­ter a li­cens­ing and re­search col­lab­o­ra­tion to ad­vance TCR ther­a­pies for cur­rent­ly in­cur­able pe­di­atric can­cers with high mor­tal­i­ty rates. The com­pa­ny says that ini­tial re­search will fo­cus on dif­fuse in­trin­sic pon­tine glioma (DIPG), a rare and high­ly ag­gres­sive brain stem tu­mor, which af­fects around 300 chil­dren in the US each year. Hide­ho Oka­da, a pro­fes­sor of neu­ro­log­i­cal surgery at UCSF who de­vised the TCR at the cen­ter of the pact, will work with Tmu­ni­ty through IND-en­abling stud­ies.

“This col­lab­o­ra­tion with UCSF em­bod­ies our com­mit­ment to ad­vance nov­el T cell ther­a­pies in­to the clin­ic faster. Sad­ly, chil­dren who are di­ag­nosed with DIPG cur­rent­ly have very few ther­a­peu­tic op­tions and there has been lit­tle progress in im­prov­ing treat­ments and over­all sur­vival rates for DIPG over the last few decades,” said CEO Us­man “Oz” Azam, adding that their new ther­a­py is al­so a po­ten­tial break­through for oth­er gliomas.

→ More than two months af­ter the FDA or­dered a par­tial hold on a Phase I study of Xen­cor’s CD123 x CD3 bis­pe­cif­ic, XmAb14045, the biotech says it can now re­sume re­cruit­ment of pa­tients. Reg­u­la­tors lift­ed the hold, ap­par­ent­ly sat­is­fied with an amend­ed pro­to­col that now fea­tures guid­ance on the mon­i­tor­ing and clin­i­cal man­age­ment of cy­tokine re­lease syn­drome — which caused one of the two deaths that in­ves­ti­ga­tors tracked in the study. The oth­er pa­tient died from acute pul­monary ede­ma.

→ Swiss biotech AMAL Ther­a­peu­tics is test­ing its can­cer vac­cine with Boehringer In­gel­heim’s PD-1, BI754091, in a Phase Ib tri­al that will re­cruit Mi­crosatel­lite Sta­ble (MSS) pa­tients with stage IV col­orec­tal can­cer. The idea is to see how ATP128 — which com­pris­es a cell pen­e­trat­ing pep­tide for anti­gen de­liv­ery, a TLR pep­tide ag­o­nist and a mul­ti­ple anti­genic do­main — per­forms both as a sin­gle agent and in com­bo. Boehringer is pro­vid­ing its drug for joint own­er­ship of the re­sults.

→ Sin­ga­pore’s tech­nol­o­gy agency has en­ticed a Hong Kong-based phar­ma­ceu­ti­cal group called Ap­to­rum to es­tab­lish a ven­ture fund catered to health care star­tups in Sin­ga­pore. To­geth­er, they will raise $90 mil­lion to fund up to 20 star­tups, some of which have al­ready been iden­ti­fied as com­pa­nies work­ing on 2D and 3D mag­net­ic res­o­nance imag­ing and sur­gi­cal ro­bot­ics. Ae­neas Cap­i­tal, which is al­so con­trolled by Ap­to­rum co-founder Ian Huen, will al­so chip in. 

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Covid-19 roundup: Roche pairs Actem­ra with remde­sivir in new PhI­II; GSK makes its own 1B vac­cine man­u­fac­tur­ing plan

A month after a small study in France suggested that Roche’s IL-6 inhibitor Actemra helped Covid-19 patients do better — even as Sanofi and Regeneron found somewhat disappointing results with their rival drug — Roche is doubling down on the strategy.

The Swiss pharma giant is kicking off a second Phase III global placebo-controlled study involving Actemra. But rather than testing it as a monotherapy, they will add Gilead’s remdesivir to the regimen.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tuesday issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.

The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).

Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Covid-19 roundup: Buoyed by soar­ing shares, No­vavax inks a $167M deal to buy Covid-19 vac­cine-mak­ing fa­cil­i­ty; France cools on hy­drox­y­chloro­quine

The pandemic has offered the best news Novavax has had in years. Its stock price is trading at 7x the pre-panic levels with a Covid-19 vaccine in the mix, as investors buy anything that moves in that field, and they’re flush to carve out their own pathway on the manufacturing front.

Wednesday morning Novavax reported that they are spending $167 million on the Czech-based Praha Vaccines, bagging a manufacturing facility along the way.

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