Po­sei­da pitch­es a $115M IPO on its claim that the sci­ence team has cre­at­ed a bet­ter BC­MA CAR-T

Is there enough en­thu­si­asm among biotech in­vestors to push through a $115 mil­lion-plus IPO on the lat­est biotech stak­ing out their claim with a new-and-im­proved BC­MA CAR-T ther­a­py?

Po­sei­da Ther­a­peu­tics is aim­ing to find that out in the very near fu­ture.

Er­ic Os­tertag

The San Diego-based biotech filed their S-1 on a busy Fri­day, just ahead of the big JP­Mor­gan con­fab that gets un­der­way Mon­day morn­ing in San Fran­cis­co. In it, they lay out an ear­ly snap­shot on Phase I da­ta for P-BC­MA-101 tar­get­ing mul­ti­ple myelo­ma — a fa­mil­iar tar­get in the CAR-T world these days.

Ac­cord­ing to the fil­ing, re­searchers have tracked 14 clin­i­cal re­spons­es among the first 19 pa­tients in their first hu­man study. And they in­clud­ed in that ORR every sign of ac­tiv­i­ty, from a com­plete re­sponse all the way through to a “min­i­mal re­sponse.” They al­so flagged CRs in 3 of 3 pa­tients get­ting the dose they plan to take in­to Phase II. And they down­played some se­ri­ous ad­verse events as like­ly linked to lym­phode­ple­tion, used to prep pa­tients for the drug.

The Phase II gets un­der­way in the first half of this year, and they’re plan­ning to push for an ac­cel­er­at­ed ap­proval on that study. No, the FDA has not signed off on that plan, but it wouldn’t be wild­ly un­rea­son­able to ex­pect that they might.

The rest of the pipeline is pre­clin­i­cal.

The way the orig­i­nal CAR-T works is pret­ty sim­ple. You take a pa­tient’s cell and adapt it, adding chimeric anti­gen re­cep­tors to di­rect T cells to can­cer. Po­sei­da is sell­ing its IPO on the as­ser­tion that they’ve de­vel­oped bet­ter tech to do the same job, us­ing a DNA mod­i­fi­ca­tion sys­tem that they say will se­lect more mem­o­ry T cells to do the work, which should make them more durable.

That’s the pitch, but they haven’t proved it yet.

Po­sei­da is rolling ahead in­to a tur­bu­lent stock mar­ket, where con­cerns about an eco­nom­ic slow­down and a trade war with Chi­na have tak­en a heavy toll on tech stocks. An­oth­er big con­cern: Mod­er­na $MR­NA was not able to hold on to its lofty mar­ket val­u­a­tion af­ter go­ing pub­lic, rais­ing con­cerns that in­vestors have grown tired of see­ing too many biotechs with too lit­tle da­ta to back up these of­fer­ings.

That en­vi­ron­ment will make this IPO and oth­ers filed re­cent­ly ones to watch.

Ma­lin Life Sci­ences out of Ire­land has the biggest stake in the biotech, at 33%. CEO Er­ic Os­tertag’s trust holds 15% while Ti­tan LLC has 13.6% of the stock and Lon­gi­tude Ven­ture Part­ners III holds 7.7%.

Os­tertag’s back­ground in­cludes found­ing Trans­posagen, based in Lex­ing­ton, KY. That com­pa­ny has been work­ing with gene edit­ing tech and cell reengi­neer­ing for year. Po­sei­da is a spin­out of that com­pa­ny, us­ing much the same tech, with an eye to de­vel­op­ing off-the-shelf cell ther­a­pies as well.

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.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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.