Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flag­ship is build­ing a big-name C-suite at its new, $220 mil­lion merged biotech.

Reper­toire Im­mune Med­i­cines, which al­ready boasts for­mer Biover­a­tiv chief John Cox as its CEO, an­nounced yes­ter­day that An­tho­ny Coyle, the for­mer Pfiz­er CSO and the found­ing CEO of Pan­dion, will join as their head of R&D.

“As we progress clin­i­cal tri­als for our mul­ti-clon­al T cell can­di­dates in im­muno-on­col­o­gy, Tony’s deep ex­per­tise in cel­lu­lar im­munol­o­gy and nov­el ther­a­peu­tic de­vel­op­ment will help us achieve our vi­sion of cre­at­ing a new class of trans­for­ma­tive med­i­cines for pa­tients,” Cox said in a state­ment.

Coyle comes on as Reper­toire looks to bridge the tech­nolo­gies of their two pre­de­ces­sor com­pa­nies: ear­li­er this year out of a merg­er of the Flag­ship star­tups Co­gen Im­mune Med­i­cines and Torque Ther­a­peu­tics. The idea was to com­bine Co­gen’s T cell analy­sis tech with Torque’s T cell ther­a­pies. Al­though the com­pa­ny has been pri­mar­i­ly fo­cused so far in can­cer, they’ve re­cent­ly point­ed to the po­ten­tial in au­toim­mune dis­or­ders, where Coyle has worked for the bet­ter part of 20 years.

Be­tween the two plat­forms, they’ll al­so work on fig­ur­ing out what and how T cells “see,” de­cod­ing the pre­cise in­ter­ac­tions be­tween these im­mune cells and the anti­gens they sur­veil. They use that in­fo to prime T cells to see par­tic­u­lar can­cer anti­gens, and fur­ther equip the cells with cy­tokines like IL-15 that ac­ti­vate in the tu­mor mi­cro-en­vi­ron­ment. A Phase I is on­go­ing for their lead ther­a­py, TRQ-1501, in both lym­phoma and sol­id tu­mors.

Coyle doesn’t have ex­ten­sive ex­pe­ri­ence in cell ther­a­py but his most re­cent work was T cell-ad­ja­cent and he brings a wealth of ex­pe­ri­ence in im­munol­o­gy dat­ing back to his post­doc days at the In­sti­tut Pas­teur and the Na­tion­al Jew­ish Cen­ter for Im­munol­o­gy in Den­ver. He spent 13 years di­rect­ing re­search in in­flam­ma­tion bi­ol­o­gy at Mil­len­ni­um and then Med­im­mune be­fore be­com­ing CSO of Pfiz­er, where he tried to rein­vig­o­rate the ag­ing phar­ma’s re­search en­gine by launch­ing the Glob­al Cen­ters for Ther­a­peu­tic In­no­va­tion.

Most re­cent­ly, in 2017, he found­ed Pan­dion on the promise of a next-gen ap­proach to im­munol­o­gy. With back­ing from Po­laris, they would de­vel­op bis­pecifics that can fine-tune in­flam­ma­tion in par­tic­u­lar tis­sues, ac­ti­vat­ing some T cells and de­ac­ti­vat­ing oth­ers while lim­it­ing the ef­fects to one area of the body. They’re fo­cused on in­flam­ma­to­ry dis­or­ders.

In a state­ment, Coyle not­ed the ap­pli­ca­tion for Reper­toire’s tech­nol­o­gy, in not on­ly can­cer, but al­so in­fec­tious dis­ease and au­toim­mune dis­or­ders.

He’ll have plen­ty of cash to help make that hap­pen. When they merged the two com­pa­nies, Flag­ship al­so in­clud­ed a new in­vest­ment of $220 mil­lion.

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.