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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Warren Huff, Reata Pharmaceuticals CEO

Rea­ta’s ‘reg­u­la­to­ry con­cerns’ turn in­to three-month de­lay on FDA de­ci­sion for Friedre­ich’s atax­ia drug

In its Q2 report Monday, Reata Pharmaceuticals said that the FDA continues to have concerns about its Friedreich’s ataxia drug.

On Tuesday, those concerns manifested in a three-month delay on an FDA approval decision. Reata’s new FDA decision deadline for its Friedreich’s ataxia drug, omaveloxolone, is the end of February 2023, it announced this morning.

In the Q2 report, Reata noted that the FDA was concerned about the efficacy of omaveloxolone. The Plano, TX-based biotech said that in response to those concerns, it submitted additional data from its clinical trial. But in order to review that new data, the FDA needs more time, hence the three-month delay, Reata said Tuesday morning.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.