Tom Lemberg, Curebase CEO

DCT start­up look­ing to forge bet­ter com­mu­ni­ty re­la­tion­ships nets a mod­est Se­ries B

The de­cen­tral­ized clin­i­cal tri­al in­dus­try went through a huge boom dur­ing the Covid-19 pan­dem­ic as biotechs and Big Phar­ma com­pa­nies alike were forced to shift gears. Look­ing to cap­i­tal­ize on that mo­men­tum, a San Fran­cis­co start­up is rais­ing funds to en­sure clos­er part­ner­ships with the com­mu­ni­ties DCTs serve.

Cure­base pulled to­geth­er a $40 mil­lion Se­ries B on Thurs­day, rough­ly 13 months af­ter clos­ing its Se­ries A. While on the sur­face this may seem like an­oth­er DTC com­pa­ny, CEO Tom Lem­berg tells End­points News the com­pa­ny is look­ing to sep­a­rate it­self from the pack by go­ing straight to the com­mu­ni­ty to bring greater di­ver­si­ty to clin­i­cal tri­als.

What sets Cure­base apart from most com­pa­nies in the DCT space, Lem­berg says, is the com­pa­ny ac­tive­ly seeks to part­ner with com­mu­ni­ty doc­tors. Lem­burg em­pha­sized that the com­pa­ny has part­nered with around 100 com­mu­ni­ty physi­cians, such as pri­ma­ry care doc­tors, ur­gent care sites, test­ing sites and spe­cial­ists through their op­er­at­ing sys­tem.

“We would lever­age the com­mu­ni­ty sites that are in those com­mu­ni­ties, we would lever­age dig­i­tal cam­paigns to reach pa­tients where we’re able to reach that di­verse pop­u­la­tion and we’re not lim­it­ed by peo­ple who can dri­ve in­to a few elite re­search cen­ters,” Lem­berg said.

Lem­berg is a life­long soft­ware en­gi­neer and un­der­grad­u­ate in com­put­er sci­ence at Har­vard. He be­came in­vest­ed in health­care bi­ol­o­gy and pas­sion­ate about tak­ing his tech­nol­o­gy back­ground to health­care, spawn­ing the Cure­base ef­fort.

The com­pa­ny has con­tin­ued to scale up and it now has over 120 peo­ple on staff, work­ing with sev­en dif­fer­ent pub­licly trad­ed com­pa­nies to run in­ter­ven­tion­al drug tri­als. Cure­base se­cured a $15 mil­lion Se­ries A last April, and Thurs­day’s round was led by In­dus­try Ven­tures and in­clud­ed new in­vestors Acrew Cap­i­tal, World In­no­va­tion Lab and Pos­i­tive Sum.

Ex­ist­ing in­vestors were GGV Cap­i­tal, which led their Se­ries A, Bold Cap­i­tal and Xfund. The round al­so in­clud­ed an in­vest­ment from Gilead to deep­en the ex­ist­ing part­ner­ship with Cure­base on im­ple­ment­ing DCT and hy­brid ca­pa­bil­i­ties in tri­als.

“We did our Se­ries B not be­cause we were run­ning out of cash, but be­cause we want­ed to ac­cel­er­ate our growth. We have re­al­ly am­bi­tious goals in terms of in­vest­ing in our soft­ware plat­form, con­tin­u­ing to ab­solute­ly in­vest in an amaz­ing pa­tient ex­pe­ri­ence,” Lem­berg said. “We want to ag­gres­sive­ly grow our site, op­er­at­ing sys­tem and site net­work to be able to reach more pa­tients in the com­mu­ni­ty.”

Apart from look­ing to scale up its clin­i­cal op­er­a­tions ef­forts and soft­ware de­vel­op­ment, the com­pa­ny is look­ing to go more glob­al. Cure­base is cur­rent­ly in four coun­tries, but Lem­berg said he would like to grow that to 10. The com­pa­ny’s ser­vices are avail­able in three lan­guages but would al­so like to of­fer them in 10 lan­guages by the end of the year.

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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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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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.”

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.