Craig Gibbs, Asher Bio CEO (Asher)

Ash­er Bio­ther­a­peu­tics joins search for a bet­ter IL-2 sans the tox­i­c­i­ties

Can IL-2 ther­a­pies — which can be pow­er­ful against can­cer but in­fa­mous for their tox­ic side ef­fects — be made in­her­ent­ly more spe­cif­ic? For Ash­er Bio­ther­a­peu­tics, that’s the $55 mil­lion ques­tion.

Ivana Djuret­ic and Andy Ye­ung left their jobs in can­cer im­munol­o­gy and pro­tein en­gi­neer­ing at Pfiz­er in 2019 to start Ash­er with the idea that they could im­prove the ef­fi­ca­cy of im­munother­a­pies. More specif­i­cal­ly, they want­ed to know if re­strict­ing the ac­tiv­i­ty of a cy­tokine to on­ly the cells that mat­ter would coun­ter­in­tu­itive­ly re­sult in bet­ter ther­a­peu­tics.

They de­cid­ed to start with IL-2, what Djuret­ic called “one of the most ex­cit­ing chal­lenges to­day.” And that work, she said, led them to an “aha mo­ment.”

Ivana Djuret­ic

“We sort of re­al­ized that we could … mod­u­late spe­cif­ic im­mune cell sub­sets in many con­texts, not on­ly IL-2, not on­ly CD8,” through a process called cis-tar­get­ing, Djuret­ic said. Cis-tar­get­ing is an en­gi­neer­ing ap­proach that works by re­quir­ing the si­mul­ta­ne­ous en­gage­ment of two re­cep­tors on the same im­mune cell for ac­ti­va­tion.

Djuret­ic and Ye­ung ran in­to Third Rock at an ear­ly 2020 meet­ing in Boston, and the rest is his­to­ry. Wash­ing­ton Uni­ver­si­ty pro­fes­sor Robert Schreiber and Nether­lands Can­cer In­sti­tute top sci­en­tist Ton Schu­mach­er, who were in­volved with Third Rock, hopped on board as co-founders. And on Tues­day morn­ing, the com­pa­ny un­veiled a $55 mil­lion Se­ries A to take its lead on­col­o­gy pro­gram, AB248, to the clin­ic next year.

Andy Ye­ung

“So a lot of peo­ple are try­ing to tar­get IL-2 spa­tial­ly to the site of the tu­mor, but it’s an in­her­ent­ly non­spe­cif­ic mol­e­cule. So we think there’s on­ly a lim­it­ed amount of speci­fici­ty we can get out of that,” CEO Craig Gibbs said. “What we’re try­ing to do is make IL-2 in­her­ent­ly spe­cif­ic, so it on­ly binds CD8+ T cells, which is the ones that we want, and not to T regs which are go­ing to be im­muno­sup­pres­sive, and not to NK cells which just cause tox­i­c­i­ty, and not to en­dothe­lial cells which cause vas­cu­lar leak.”

Gibbs left his job as CBO at Forty Sev­en to join Ash­er last sum­mer, af­ter the for­mer was bought by Gilead for near­ly $5 bil­lion. That Sep­tem­ber, he was “grat­i­fied” by some “re­al­ly stel­lar” da­ta from Schreiber’s lab. In vit­ro and mon­key stud­ies have shown a “much larg­er ex­pan­sion” of CD8 cells, with­out the ac­ti­va­tion of reg­u­la­to­ry T cells or NK cells, he said.

In ad­di­tion to on­col­o­gy, the Ash­er team be­lieves the plat­form could have ap­pli­ca­tions in au­toim­mu­ni­ty and in­fec­tious dis­ease.

The Se­ries A was led by Third Rock with par­tic­i­pa­tion from Box­er Cap­i­tal of Tavi­s­tock Group, In­vus, Y Com­bi­na­tor and MBC Bi­o­labs.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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