Sriram Subramaniam, Gandeeva Therapeutics founder and CEO

Cryo-EM fo­cused biotech from long­time NIH vet­er­an se­cures $40M back­ing from Bay­er in Se­ries A

“It’s al­ways nice to get mon­ey in the bank.”

That’s what Gan­dee­va Ther­a­peu­tics’ founder and CEO Sri­ram Sub­ra­ma­ni­am said af­ter re­veal­ing that his com­pa­ny land­ed $40 mil­lion in Se­ries A fund­ing. Gan­dee­va will use the mon­ey for its ar­ti­fi­cial in­tel­li­gence-en­abled plat­form to iden­ti­fy small mol­e­cules and bi­o­log­ics at a faster pace.

The com­pa­ny is on a mis­sion to show that it can lever­age cryo-EM and AI to make a mean­ing­ful im­pact on drug dis­cov­ery, and it plans to do so with speed, us­ing AI for ex­per­i­ment pre­dic­tion.

Lux Cap­i­tal and Leaps by Bay­er led the round, with Ob­vi­ous Ven­tures, Am­gen Ven­tures, Am­pli­tude Ven­tures and Air Street Cap­i­tal al­so par­tic­i­pat­ing.

It’s a jour­ney that start­ed more than 20 years ago for Sub­ra­ma­ni­am, who spent 15 years as an in­ves­ti­ga­tor for the Na­tion­al In­sti­tute of Health’s in­tra­mur­al re­search pro­gram be­fore branch­ing out on his own.

“Walk­ing in­to cells and tis­sues was sci­ence fic­tion at that time,” he said in a call with End­points News Fri­day,

Over time, though, new tools emerged, most no­tably cryo-EM, a method by which sci­en­tists can im­age pro­teins and oth­er bi­o­log­i­cal en­ti­ties by freez­ing them and as­sault­ing them with elec­trons.

“It was clear to me that this ap­proach would be a turn­ing point for struc­tur­al bi­ol­o­gy, and it has been,” he said. “There’s no doubt that it’s been rev­o­lu­tion­ary. “

Jür­gen Eck­hardt

Speed is the foun­da­tion up­on which the plat­form is built, and for­tu­nate tim­ing is what has shaped the com­pa­ny’s work so far. Sub­ra­ma­ni­am said that his aca­d­e­m­ic lab was on­ly per­mit­ted to con­tin­ue its worth through the start of the Covid-19 pan­dem­ic if they of­fered to work on so­lu­tions for the virus. Most re­cent­ly, the com­pa­ny pub­lished a pa­per about the struc­tur­al analy­sis of the Omi­cron vari­ant in Sci­ence.

“I had nev­er worked on coro­n­avirus­es be­fore, but overnight, we switched to work­ing on coro­n­avirus­es and pret­ty much have looked at the struc­tures of every vari­ant, and pret­ty much every mu­tant,” he said. “From the be­gin­ning, I knew that’s where it would be head­ed, that there would be mu­ta­tions.”

In a state­ment, Jür­gen Eck­hardt, head of Leaps by Bay­er, said:

We be­lieve Gan­dee­va’s plat­form will al­low us to com­bine pre­dic­tion and ex­per­i­men­ta­tion to vi­su­al­ize and op­ti­mize drug de­sign at atom­ic scale and with un­prece­dent­ed speed. Gan­dee­va’s re­lent­less fo­cus on us­ing their pow­er­ful imag­ing tech­nolo­gies to cast a spot­light on the im­por­tance of pro­tein con­for­ma­tion in drug de­sign is aligned with our am­bi­tion to use nov­el da­ta-dri­ven meth­ods to bring pre­ci­sion med­i­cines and break­through cures to pa­tients.

This is the sec­ond time Leaps has led a fi­nanc­ing round for a start­up in just three weeks, as it led the $80 mil­lion Se­ries A for Celli­no, a Boston-based biotech fo­cused on cell ther­a­py man­u­fac­tur­ing. Sub­ra­ma­ni­am said that hav­ing the bal­ance of in­vestors, from the tech-fo­cused minds of Lux Cap­i­tal to the in­no­va­tion-mind­ed Leaps is a “dream come true.”

“We sit at this re­al­ly in­ter­est­ing in­ter­face, so to have an in­vest­ment syn­di­cate that re­flects the vi­sion and mis­sion of the com­pa­ny, that’s very spe­cial to me,” he said.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.