Adam Gridley, Allay Therapeutics CEO

Pain play­er Al­lay makes good on launch promis­es, lock­ing down lat­est fundrais­ing round to ad­vance lead im­plant

Drug­mak­ers in the pain space have a dif­fi­cult road to ap­proval, even out­side of opi­oids, but a fresh-faced start­up that launched this sum­mer felt con­fi­dent that in­vestors would like what it brought to the ta­ble. Turns out it was right.

Al­lay Ther­a­peu­tics on Wednes­day closed a $60 mil­lion Se­ries C round the biotech plans to use to ad­vance its lead lo­cal anal­gesic im­plant in­to a key Phase IIb study in pa­tients post-knee re­place­ment surgery.

The round was led by Ar­bore­tum Ven­tures with NEA, Temasek, Pavil­ion Cap­i­tal, Bran­don Cap­i­tal Part­ners, Ver­tex Growth, Ver­tex Ven­tures HC, and WTT In­vest­ment all par­tic­i­pat­ing.

Al­lay launched back in May with lead can­di­date ATX-101, a poly­mer­ized bupi­va­caine im­plant, through Phase I and on its way to a Phase II test. Since then, the plan hasn’t changed much, and Al­lay most­ly called its shots.

In May, Al­lay was eye­balling a $60 mil­lion C round with a slate of crossover in­vestors in both the US and Sin­ga­pore on board: check. The biotech hoped to kick­start the Phase IIb in the US by the end of 2021 and ex­plore oth­er mar­ket op­por­tu­ni­ties for fol­low-on can­di­dates: check so far. If any­thing, the on­ly thing that hasn’t gone to plan is the com­pa­ny’s man­u­fac­tur­ing scale-up plans have ac­cel­er­at­ed faster than an­tic­i­pat­ed, putting Al­lay on track for more clin­i­cal sup­ply and mul­ti­ple 10x in­creas­es in ca­pac­i­ty in the com­ing years.

“We’ve been very pleased with the progress over the course of the past sev­er­al months, and, can­did­ly, that cat­alyzed this round,” CEO Adam Gri­d­ley told End­points News. “Clear­ly these in­vestors said, ‘Look, we’re re­al­ly en­cour­aged by these ear­ly re­sults, let’s see how we can ex­pand that lead­er­ship else­where.'”

In May, Al­lay re­leased Phase I/IIa da­ta in 22 pa­tients show­ing ATX-1 cut the num­ber of opi­oids pa­tients took af­ter 14 days by half to two-thirds com­pared with stan­dard of care and place­bo. Mean­while, 80% of pa­tients were off opi­oids at the 14-day mark com­pared to around 50% on stan­dard of care.

Those re­sults were promis­ing enough to ra­tio­nal­ize Phase IIb and get Al­lay think­ing about how to ex­pand its plat­form of con­trolled-re­lease pain im­plants over many in­di­ca­tions. The process of de­cid­ing fol­low-on can­di­dates is on­go­ing, but the team has two fi­nal­ists iden­ti­fied — in post-shoul­der arthro­plas­ty and hernior­rha­phy. But the po­ten­tial is wide open, in Al­lay’s telling, with plen­ty of po­ten­tial pain in­di­ca­tions in the line of fire. With that in mind, the com­pa­ny hopes to en­ter a new can­di­date in­to clin­i­cal tri­als every year, Gri­d­ley said.

“There’s pros and cons to which one would be first, but our de­ci­sion in the last six months was to tar­get both — now it just comes down to a mat­ter or re­sources to which one makes sense to go in­to,” CTO Patrick Ru­ane told End­points. “I don’t think we’re ever go­ing to run out of in­di­ca­tions, be­cause what we have … there’s a lot of win­dows and doors to be opened here to help pa­tients out.”

Mean­while, Al­lay is still on track to have at least 50 em­ploy­ees on board by the end of 2021 — an­oth­er of its May pre­dic­tions that have come true — and re­cent­ly hired a CMO that Gri­d­ley said had ex­pe­ri­ence in the pain space.

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.

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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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

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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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.

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.

Wen Wang, IASO CEO

Chi­nese CAR-T play­er books a megaround to dri­ve bustling cell ther­a­py port­fo­lio through the clin­ic

China has quickly emerged as a major driver of oncology R&D in recent years, particularly in cell therapies where the potential for cheaper development has investors drooling. Now, one player, with a handful of early data, is swimming in a new round of investor cash.

IASO Bio has closed a $108 million Series C that the Chinese and California-based biotech said it will use to advance its slate of cell therapy lead programs, while also propping up a roster of next-gen allogeneic cell therapies for the future, according to a release.