Tri­al soft­ware group rais­es $45M to push de­cen­tral­ized stud­ies; $120M SPAC makes its way to Nas­daq

Af­ter watch­ing the en­tire clin­i­cal tri­al process go through a ma­jor makeover dur­ing the pan­dem­ic, an­oth­er soft­ware out­fit is mak­ing a play to help de­vel­op­ers get on the cut­ting edge of tri­al de­sign and de­cen­tral­ized ex­e­cu­tion.

Hobo­ken, NJ-based Cas­tor has just raised $45 mil­lion to fund de­vel­op­ment of soft­ware in­tend­ed to scale up their “di­rect-to-pa­tients” ap­proach glob­al­ly. This new round brings their to­tal fund­ing to $65 mil­lion.

Eight Roads Ven­tures and F-Prime Cap­i­tal led the round, with par­tic­i­pa­tion from ex­ist­ing in­vestors Two Sig­ma Ven­tures and Inkef Cap­i­tal.

The big idea here is that pa­tients can en­roll in tri­als on­line, up­load­ing da­ta as they go through the study and cut­ting out the old re­liance on brick-and-mor­tar tri­al sites. Eas­i­er in­ter­ac­tions with pa­tients should go a long way to im­prove the odds of com­plet­ing a tri­al and get­ting it done more ef­fi­cient­ly.

“Cas­tor was cre­at­ed with the mis­sion to help re­searchers glob­al­ly con­duct more ef­fec­tive clin­i­cal tri­als while im­prov­ing the pa­tient ex­pe­ri­ence,” said Cas­tor founder and CEO Derk Arts in a state­ment. “Pri­or­i­tiz­ing the pa­tient and site user ex­pe­ri­ence is par­tic­u­lar­ly im­por­tant to­day, when COVID-19 has fun­da­men­tal­ly changed the na­ture of clin­i­cal tri­als.” — John Car­roll

JATT Ac­qui­si­tion SPAC is head­ed to Nas­daq

One of the newest life sci­ences SPACs out there is ready for its Nas­daq close­up.

JATT Ac­qui­si­tion, the SPAC from a co-founder of Pathios Ther­a­peu­tics and CEO of Akaza Bio­science and Izana Bio­science, priced Wednes­day morn­ing to the tune of a $120 mil­lion raise. The blank-check com­pa­ny will launch at $10 per share with the tick­er $JAT­TU.

Someit Sid­hu

The SPAC is run by Someit Sid­hu, a rel­a­tive un­known who be­fore his biotech ex­pe­ri­ence worked at the con­sult­ing firm McK­in­sey, where he cut his teeth ad­vis­ing un­named glob­al phar­ma com­pa­nies. He al­so holds a de­gree from Ox­ford Med­ical School with an em­pha­sis on car­di­ol­o­gy and gen­er­al surgery.

Al­so on the team are Tauhid Ali, a for­mer Take­da vet who launched three biotechs out of the phar­ma’s in­cu­ba­tor, and Arnout Ploos van Am­s­tel, for­mer head of No­var­tis’ im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy fran­chis­es. — Max Gel­man

Alkeus nabs BTD for de­gen­er­a­tive eye dis­ease

Alkeus Phar­ma­ceu­ti­cals has won a new en­dorse­ment from the FDA.

The Somerville, MA-based biotech an­nounced Wednes­day the agency has be­stowed a Break­through Ther­a­py Des­ig­na­tion up­on its ex­per­i­men­tal drug ALK-001 to treat Star­gardt dis­ease. De­signed to be tak­en once a day, the can­di­date is a chem­i­cal­ly-mod­i­fied form of vi­t­a­min A de­vel­oped for mul­ti­ple reti­nal de­gen­er­a­tive dis­eases, the com­pa­ny said. Alkeus’ BTD came af­ter a Phase II ran­dom­ized place­bo study.

The biotech es­ti­mates that be­tween 40,000 and 60,000 pa­tients cur­rent­ly live with the dis­ease, and al­most every­one di­ag­nosed ul­ti­mate­ly be­comes legal­ly blind. — Max Gel­man

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

FDA ac­cepts In­tel­li­a's IND for CRISPR and TCR-T cell ther­a­py; San­té clos­es Fund IV at $260M

Riding the coattails of a massive $600 million cash raise in June, Intellia announced that the FDA accepted their IND application for their gene editing treatment NTLA-5001, built as a treatment for acute myeloid leukemia.

The Cambridge, MA biotech said that they have plans to start patient screening in a Phase I/IIa study by the end of 2021. The study will evaluate the effects of a single dose of the treatment in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants.

Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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