Af­ter weath­er­ing fail­ure, re­jec­tion and lay­offs, Im­muno­Gen touts a new 'break­through' drug in its come­back plan

While the come­back plan for its lead drug is still up in the air, Im­muno­Gen says it has a sec­ond shot at an an­ti­body-drug con­ju­gate break­through.

Mark Enyedy

The FDA has grant­ed break­through ther­a­py des­ig­na­tion to IMGN632, which tar­gets CD123, in re­lapsed or re­frac­to­ry blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm. The ag­gres­sive can­cer pri­mar­i­ly af­fects the skin, bone mar­row and lymph nodes.

Hav­ing pre­sent­ed ini­tial da­ta on the first-in-hu­man study at ASH 2019, the biotech said it will re­port up­dates from the dose ex­pan­sion co­hort in De­cem­ber.

“We look for­ward to con­tin­u­ing to work with FDA to fur­ther de­fine the de­vel­op­ment path for IMGN632 in BPD­CN, in ad­di­tion to pur­su­ing our on­go­ing eval­u­a­tion of IMGN632 in AML and oth­er hema­to­log­i­cal ma­lig­nan­cies,” CEO Mark Enyedy said in a state­ment.

IMGN632 was one of three pro­grams that Jazz Phar­ma paid $175 mil­lion in cash to col­lab­o­rate on, in an R&D pact stretch­ing out to 2024.

A long­time play­er in the ADC game, Im­muno­Gen’s tech plat­form had a sig­nif­i­cant role in de­vel­op­ing Roche’s Kad­cy­la. But it’s had less luck with its own pro­grams, get­ting slapped down by the FDA af­ter the lead drug, mirve­tux­imab so­rav­tan­sine, failed a Phase III study for ovar­i­an can­cer.

Hav­ing ini­tial­ly sought ac­cel­er­at­ed ap­proval based on a sec­ondary end­point, the com­pa­ny is now count­ing on a new, sin­gle-arm tri­al to sup­port the OK. The SO­RAYA study ze­roes in on women with fo­late re­cep­tor al­pha (FRα)-high plat­inum-re­sis­tant ovar­i­an can­cer who have been pre­vi­ous­ly treat­ed with Avastin.

Amid the twists and turns Enyedy — who slashed the head­count by a few months af­ter he took the job in 2016 — reached again for the axe to con­serve cash. In ad­di­tion to lay­ing off 220 staffers, he al­so shelved IMGN779, the pro­gram for adults with re­lapsed/re­frac­to­ry CD33-pos­i­tive AML, and sub­leased the ex­tra emp­ty space.

Im­muno­Gen re­port­ed $219.5 mil­lion in cash and cash equiv­a­lents as of June 30, 2020, com­pared with $176.2 mil­lion at the end of 2019.

The big idea around AD­Cs is that by at­tach­ing a can­cer-killing tox­in to a spe­cif­ic an­ti­body, drug­mak­ers can di­rect the pay­loads pre­cise­ly to where they want them. While Im­muno­Gen boasts of ex­per­tise in all as­pects — tar­gets, an­ti­bod­ies, pay­loads and link­ers — the key com­po­nent of IMGN632 is the in-house nov­el in­dolino-ben­zo­di­azepine pay­loads, which they promise to be more po­tent than tra­di­tion­al chemother­a­py to can­cer cells but less tox­ic to nor­mal mar­row prog­en­i­tors.

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.

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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?

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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.

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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.

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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.

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.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

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.

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