Ab­Cellera ac­quires trans­mem­brane pro­tein pro­duc­er; Com­pass gains psy­che­del­ic IP port­fo­lio

Cana­di­an an­ti­body shop Ab­Cellera ac­quired Mass­a­chu­setts biotech Tetra­Ge­net­ics in an all-cash trans­ac­tion. While more spe­cif­ic de­tails were not made pub­licly avail­able, Ab­Cellera did say in a state­ment that the ac­qui­si­tion in­cludes an up­front pay­ment and po­ten­tial mile­stone pay­ments based on tech­ni­cal achieve­ments, suc­cess­ful R&D and com­mer­cial­iza­tion.

Carl Hansen

Found­ed in 2004, Tetra­Ge­net­ics spe­cial­izes in pro­tein pro­duc­tion — specif­i­cal­ly trans­mem­brane pro­teins, which have proven to be dif­fi­cult to pro­duce in the past. Where Tetra­Ge­net­ics comes in­to the equa­tion with Ab­Cellera is that Tetra­Ge­net­ics can make enough trans­mem­brane pro­teins to sup­port an­ti­body dis­cov­ery.

Hav­ing slow­ly built up a net­work of bio­phar­ma clients in re­cent years, Ab­Cellera shot to fame dur­ing the pan­dem­ic as Eli Lil­ly tapped it for Covid-19 an­ti­body part­ner­ship.

“We look for­ward to wel­com­ing the Tetra­Ge­net­ics team and be­lieve that these new ca­pa­bil­i­ties, once in­te­grat­ed in­to Ab­Cellera’s tech­nol­o­gy stack, will em­pow­er the dis­cov­ery of new an­ti­body ther­a­pies across a range of ther­a­peu­tic ar­eas,” said Ab­Cellera CEO Carl Hansen in a state­ment.

Com­pass Path­ways ac­quires IP port­fo­lio of psy­che­del­ic com­pounds

UK biotech Com­pass Path­ways has gained ac­cess to an in­tel­lec­tu­al prop­er­ty port­fo­lio in­clud­ing patent ap­pli­ca­tions cov­er­ing a va­ri­ety of psy­che­delics, em­pathogens and pro­drugs. The IP was de­vel­oped to­geth­er with Matthias Grill, founder and CEO of MiHKAL. Based in Basel, Switzer­land, Grill will be work­ing with Com­pass to de­vel­op new prod­uct can­di­dates.

Grill has been in­volved in psy­che­del­ic chem­istry re­search for over 15 years, and he has held po­si­tions as head of R&D at Ar­bolea, Lipomed and THC Pharm. He has al­so syn­the­sized psy­che­del­ic sub­stances for a num­ber of hu­man re­search stud­ies, in­clud­ing at the Uni­ver­si­ty of Basel and the Na­tion­al In­sti­tute of Men­tal Health in the Czech Re­pub­lic.

“We are de­light­ed to be work­ing with Matthias and MiHKAL GmbH. This agree­ment will strength­en and ex­pand our IP and de­vel­op­ment port­fo­lio with new com­pounds. We plan to move some of these com­pounds in­to clin­i­cal de­vel­op­ment with­in the next two years,” said Com­pass CBO and pres­i­dent Lars Wilde in a state­ment.

Zai Lab re­ceives BTD ap­proval in Chi­na for be­mar­ituzum­ab

Zai Lab re­ceived a break­through des­ig­na­tion to­day from the Cen­ter for Drug Eval­u­a­tion of NM­PA for be­mar­ituzum­ab — as first-line treat­ment for pa­tients with cer­tain types of mu­tat­ed gas­tric and GEJ can­cers in tan­dem with chemo pro­to­col FOL­FOX6 (flu­o­ropy­rim­i­dine, leu­cov­orin, and ox­ali­platin).

Alan San­dler

The des­ig­na­tion is sup­port­ed by re­sults from the Phase II FIGHT study, which eval­u­at­ed be­mar­ituzum­ab plus chemother­a­py ver­sus chemother­a­py alone in pa­tients with FGFR2b over­ex­pres­sion, HER2-neg­a­tive front­line ad­vanced gas­tric or GEJ can­cer.

All three ef­fi­ca­cy end­points in the FIGHT tri­al — PFS, OS and ORR — achieved pre-spec­i­fied sta­tis­ti­cal sig­nif­i­cance in the be­mar­ituzum­ab arm com­pared to the place­bo arm.

“We look for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties in Chi­na as we ad­vance be­mar­ituzum­ab in­to glob­al, reg­is­tra­tional stud­ies,” Zai Lab pres­i­dent and head of glob­al de­vel­op­ment for on­col­o­gy Alan San­dler said in a state­ment.

Zai Lab li­censed Chi­na rights to be­mar­ituzum­ab from Five Prime be­fore Am­gen bought it in a $2 bil­lion deal.

Novo­cure an­nounces col­lab­o­ra­tion with Roche to eval­u­ate tu­mor treat­ing fields in clin­i­cal tri­al

Novo­cure is col­lab­o­rat­ing with Roche in a Phase II clin­i­cal tri­al to test tu­mor treat­ing fields with Roche’s PD-L1 block­er Tecen­triq (ate­zolizum­ab) in metasta­t­ic pan­cre­at­ic duc­tal ade­no­car­ci­no­ma (mP­DAC).

William Doyle

“We are pleased to col­lab­o­rate with Roche, a glob­al leader in on­col­o­gy, to ex­plore the ef­fi­ca­cy of TTFields to­geth­er with ate­zolizum­ab im­munother­a­py in pan­cre­at­ic can­cer,” said Novo­cure ex­ec­u­tive chair­man William Doyle in a state­ment.

The Phase II study will test safe­ty and ef­fi­ca­cy of TTFields to­geth­er with Tecen­triq, gem­c­itabine and nab-pa­cli­tax­el as a first-line treat­ment for mP­DAC. With plans to en­roll ap­prox­i­mate­ly 75 pa­tients in the EU and Unit­ed States, the pri­ma­ry end­point of the study is dis­ease con­trol rate as de­fined by RE­CIST 1.1 guid­ance.

Novo­cure is the study spon­sor and Roche is pro­vid­ing Tecen­triq for the tri­al.

Biotech rais­es $40M to pay CEO and fund R&D, among oth­er things

Penn­syl­va­nia biotech Vir­pax re­vealed the pric­ing of an un­der­writ­ten pub­lic of­fer­ing of 6,670,000 shares of its com­mon stock. List­ed at a pub­lic of­fer­ing price of $6.00 per share, Vir­pax in­tends to raise gross pro­ceeds of just over $40 mil­lion be­fore de­duct­ing un­der­writ­ing dis­counts and of­fer­ing ex­pens­es.

Un­der­writ­ers have been giv­en a 45-day op­tion to pur­chase up to an ad­di­tion­al 1,000,500 shares of com­mon stock to cov­er over-al­lot­ments at the pub­lic of­fer­ing price, mi­nus the un­der­writ­ing dis­count.

Vir­pax in­tends to use the net pro­ceeds from the of­fer­ing to fund R&D for Epo­la­derm, Probudur, En­velta, An­Qlar and oth­er de­vel­op­ment pro­grams, re­pay out­stand­ing promis­so­ry notes and de­ferred com­pen­sa­tion to Vir­pax CEO An­tho­ny Mack, and then the rest of the funds for work­ing cap­i­tal.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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French biotech and Pfiz­er find pos­i­tives in da­ta for Ly­me dis­ease vac­cine can­di­date; Al­tim­mune's obe­si­ty drug shows promise in PhI tri­al

French biotech Valneva and partner Pfizer continued to reveal positive results from its Phase II trial for its Lyme disease vaccine candidate.

The Phase II study, which enrolled 246 healthy adults between 18-65 in the US, met its primary endpoint last October, demonstrating that the candidate, known as VLA15, was immunogenic across all dose groups tested and elicited high antibody responses one month after the primary vaccination series. Continued evaluation at Month 18 showed that antibody titers declined across all groups, but remained above baseline, confirming the need for a booster.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.