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.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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