Asit Parikh, MOMA Therapeutics CEO

Work­ing like a ma­chine dur­ing the pan­dem­ic, MO­MA taps in­vestors to bankroll its 'mol­e­c­u­lar ma­chi­nes'

For a biotech that opened its lab the week be­fore the pan­dem­ic shut­tered many of­fices, MO­MA Ther­a­peu­tics has ex­pe­ri­enced hard­ly a blip in op­er­a­tions, so much so that it at­tract­ed 15-year Take­da vet Asit Parikh last year as CEO and — amid a wilt­ing fi­nanc­ing en­vi­ron­ment — a $150 mil­lion Se­ries B to take on the ma­chine.

So-called mol­e­c­u­lar ma­chines, that is. The Third Rock Ven­tures-in­cu­bat­ed start­up will use the pro­ceeds to bankroll con­tin­ued work on the class of en­zymes that “gen­er­ate force and mo­tion with­in cells,” Parikh told End­points News.

About half of the near­ly 500 en­zymes in this class “have been linked to some form of dis­ease,” the CEO said, not­ing some are known for un­wind­ing DNA to aid its repli­ca­tion, oth­ers for de­grad­ing pro­teins to as­sist in shut­tling through­out the cell.

The en­zymes “grind like a work cy­cle, if you will,” Parikh said. Sim­i­lar to the seem­ing­ly non-stop work that MO­MA’s 54 em­ploy­ees have been putting in­to the start­up, the CEO said.

“Peo­ple start­ed work­ing nights and week­ends. Some of our ju­nior sci­en­tists, one of them pulled a 24-hour shift on a Sun­day to keep the projects go­ing and to keep the sci­ence mov­ing,” the CEO said. “And it’s thanks to their hard work, but al­so their risk tol­er­ance and sac­ri­fices and just want­i­ng to get some of this stuff done, that we are able to have a strong foun­da­tion that’s got­ten us to where we are to­day.”

That work is geared to­ward MO­MA’s tar­get­ed mid-2024 clin­i­cal en­try, as the biotech is boost­ing its team by an­oth­er 10 po­si­tions this year and more in 2023 to fu­el three pre­ci­sion on­col­o­gy pro­grams, Parikh said. All three pro­grams re­volve around a com­mon thread: DNA re­pair, the CEO added.

“The ide­al would be yes­ter­day, but that’s prob­a­bly not go­ing to hap­pen now,” Parikh jok­ing­ly said of MO­MA en­ter­ing its first hu­man tri­al.

As for the fo­cus on on­col­o­gy — out of a vast field of op­por­tu­ni­ties with mol­e­c­u­lar ma­chines, which in­flu­ences car­dio­vas­cu­lar and res­pi­ra­to­ry dis­eases, im­munol­o­gy and oth­er ar­eas — MO­MA de­cid­ed it was the right path be­cause of the swath of ge­net­ic can­cer data­bas­es to tap in­to.

“The premise to un­der­stand these mol­e­c­u­lar ma­chines at a lev­el that no­body else does, and through the in­tense fo­cus on just one class, have a ben­e­fit on hu­man suf­fer­ing from that,” Parikh said.

Now, 25 months af­ter un­veil­ing it­self, MO­MA is out with its sec­ond big round of fi­nanc­ing to set the biotech apart from oth­ers in its na­tive Cam­bridge, MA, and else­where in the drug de­vel­op­ment land­scape. And it on­ly took a few months for Parikh and team to gath­er up the funds af­ter start­ing the raise in mid-Jan­u­ary.

“The key for MO­MA is to be ready for re­al­ly any pos­si­ble for­ward sce­nario, which is the mar­ket im­proves some­what, mar­ket stays the same, or mar­ket gets even tougher than it is to­day, which is hard to imag­ine, but not in­con­ceiv­able,” Parikh said. He pre­vi­ous­ly helmed Take­da’s GI unit af­ter lead­ing En­tyvio clin­i­cal stud­ies.

Gold­man Sachs led the round and was joined by oth­er new in­vestors Sec­tion 32, Pavil­ion Cap­i­tal, In­vus and LifeSci Ven­ture Part­ners. MO­MA’s en­tire Se­ries A in­vestor line­up al­so par­tic­i­pat­ed, in­clud­ing Third Rock, Nex­tech In­vest, Cor­morant, Cas­din Cap­i­tal, Rock Springs Cap­i­tal, Crea­cion Ven­tures, Alexan­dria Ven­ture In­vest­ments and oth­ers kept un­der wraps.

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.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

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.

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(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.

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Alan Wise (L) and Peter Trill (Duke Street Bio)

They sold their last biotech to Mer­ck. Now they're back with a PARP out­fit named af­ter a Lon­don street

In 2016, Peter Trill and Alan Wise sold IOmet Pharma (an I/O outfit as the name suggests) to Merck for $400 million.

Now, some six years later, the duo has returned with another cancer biotech, Duke Street Bio, that emerged from stealth Tuesday. Duke Street Bio, named for the street where it’s located in London, is making its public debut as a next-gen PARP player, hoping to break into a field that already has a number of Big Pharma competitors.

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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.

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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.

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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.”