Johns Hop­kins spin­out Wind­MIL grabs $32.5M to fu­el its work on a next-gen ap­proach to cell ther­a­py

New ap­proach­es to per­son­al­ized can­cer cell ther­a­pies are in no short­age these days. But ex­ecs at Wind­MIL Ther­a­peu­tics, which has just closed a $32.5 mil­lion Se­ries B round, be­lieve they have some­thing “tru­ly dif­fer­en­ti­at­ed.”

Ivan Bor­rel­lo

The Bal­ti­more-based start­up is tap­ping mem­o­ry T cells re­sid­ing in the bone mar­row — and their in­nate abil­i­ty to rec­og­nize tu­mors — to make what they call a nov­el class of can­cer ther­a­py. Found­ed out of the labs of Johns Hop­kins Uni­ver­si­ty pro­fes­sors Ivan Bor­rel­lo and Kim Noo­nan, Wind­MIL got its name, in part, from the re­sult of re­ac­ti­vat­ing and ex­pand­ing these mem­o­ry T cells ex­tract­ed from the pa­tient’s body: mar­row in­fil­trat­ing lym­pho­cytes, or MILs.

While the ap­proach is first be­ing stud­ied as a treat­ment for mul­ti­ple myelo­ma, Wind­MIL is prepar­ing to gen­er­ate mul­ti­ple datasets with this round of fi­nanc­ing, CEO Bri­an Ha­lak tells me. That will cov­er both un­mod­i­fied MILs — those that have sim­ply gone through the re­ac­ti­va­tion and ex­pan­sion process — and ge­net­i­cal­ly mod­i­fied MILs, with the for­mer be­ing ex­tend­ed to sol­id tu­mors and the lat­ter bring used as a cell source in CAR-T ther­a­pies. Tin­ker­ing with the al­ready pow­er­ful MIL is thought to help it per­form even in im­muno­sup­pres­sive tu­mor mi­croen­vi­ron­ments.

Kim Noo­nan

Tra­di­tion­al CAR-T cells, Ha­lak ex­plains, are usu­al­ly tak­en from pe­riph­er­al blood lym­pho­cytes that cir­cu­late in the blood. While po­tent in killing, on their own they are un­able to rec­og­nize the can­cer they need to kill — thus the need for chimeric anti­gen re­cep­tors, which bind to the tu­mor and fire up the T cell.

MILs, on the oth­er hand, have na­tive T cell re­cep­tors that rec­og­nize dif­fer­ent el­e­ments of the tu­mor, re­quir­ing no ge­net­ic en­gi­neer­ing be­fore they could be giv­en back to the pa­tient to fight can­cer. For Ha­lak, a part­ner at Do­main As­so­ci­ates who got his PhD in tu­mor im­munol­o­gy, this ap­proach makes sci­en­tif­ic sense and dis­tin­guish­es Wind­MIL from the crowd.

That’s al­so why MILs can be ef­fec­tive in sol­id tu­mors where CAR-T has strug­gled, Ha­lak says. One of the chal­lenges of us­ing a CAR-T ap­proach in that space has been to dis­cov­er suit­able tu­mor anti­gens in sol­id tu­mors; iden­ti­fy­ing a tu­mor-spe­cif­ic anti­gen ex­pressed on a cell sur­face and then mak­ing a CAR that rec­og­nizes it has proven elu­sive.

“With an un­mod­i­fied MIL, we do not need to pre-iden­ti­fy tu­mor-spe­cif­ic anti­gen,” he says. “The body has al­ready done that.”

And as a tool, MILs aren’t just re­plac­ing CAR-T ther­a­py al­to­geth­er; the sci­en­tists at Wind­MIL are al­so look­ing to cre­ate MIL CARs — ther­a­pies based on mem­o­ry T cells rather than pe­riph­er­al blood lym­pho­cytes — which they be­lieve can achieve bet­ter killing, more per­sis­tent ef­fect and a safe­ty net pro­tect­ing against pa­tient re­lapse when the anti­gen that the CAR is sup­posed to be tar­get­ing is lost.

All of that, on top of an on­go­ing Phase II mul­ti-cen­ter, ran­dom­ized tri­al as­sess­ing pro­gres­sion-free sur­vival, will re­quire a “sig­nif­i­cant ex­pan­sion” of the cur­rent 12-mem­ber team, Ha­lak says.

The Se­ries B was led by Qim­ing Ven­ture Part­ners USA, the state­side op­er­a­tion of a top-tier Chi­nese health­care VC fund that Ha­lak built a re­la­tion­ship with while work­ing for Do­main in Chi­na. Man­ag­ing part­ner Mark Mc­Dade is join­ing Wind­MIL’s board along­side as­so­ciate An­na French.

New in­vestors Medi­vate Part­ners, Cam­den Part­ners Nexus and the Kin­neret Group al­so joined the round, along­side old back­ers Do­main As­so­ci­ates and FoxKiser.

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.