Roiled by C-suite tur­moil and a CRL, Im­munomedics salutes CMO Rob Ian­none as he makes a quick ex­it

Just days af­ter cel­e­brat­ing his first an­niver­sary as chief med­ical of­fi­cer at Im­munomedics $IM­MU, I/O vet Rob Ian­none is hit­ting the ex­it door. 

Rob Ian­none

In a state­ment out this morn­ing, Ian­none said he was mak­ing an­oth­er ca­reer leap to Penn­syl­va­nia, go­ing where he could be close to his fam­i­ly “af­ter many years of hav­ing worked far away from home.” The can­cer R&D vet, who jumped to Im­munomedics af­ter a stint at As­traZeneca, didn’t men­tion ex­act­ly where he’s head­ed.

His de­par­ture comes as the Mor­ris Plains, NJ-based biotech is be­ing roiled by set­backs and de­par­tures. The CEO ex­it­ed just two months ago, af­ter the biotech’s lead drug — the an­ti­body drug con­ju­gate IM­MU-132, or sac­i­tuzum­ab govite­can — was re­ject­ed by the FDA.

Michael Pehl

Michael Pehl’s res­ig­na­tion right af­ter the CRL came 15 months af­ter he ar­rived to help end the long-run­ning dra­ma over the drug and the com­pa­ny, which had been tak­en over by the crew led by ven­Bio’s Be­hzad Ag­haz­adeh. Ag­haz­adeh de­railed a $300 mil­lion up­front pact with Im­munomedics on their lead drug — oust­ing the hus­band and wife team who had run the com­pa­ny for years in the process — in the spring of 2017 and lat­er land­ed a $250 mil­lion roy­al­ty deal to fund the com­pa­ny’s work. 

It didn’t work out though. Just be­fore Pehl de­part­ed from the biotech, an agency re­port be­gan to cir­cu­late show­ing that the FDA had cit­ed the com­pa­ny for a breach of da­ta in­tegri­ty af­ter an Au­gust in­spec­tion. The reg­u­la­to­ry re­port on the fa­cil­i­ty spot­light­ed the agency’s con­cerns about ma­nip­u­lat­ed sam­ples and back­dat­ed doc­u­ments.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Simba Gill, Evelo Biosciences CEO

Sim­ba Gill stay­ing on at Evelo to weath­er lay­offs and a PhII fail

Simba Gill will be staying put as CEO of Evelo Biosciences for now.

Gill announced last year that he would be leaving the head position at Evelo to take on the role of executive partner at Flagship Pioneering. He was aiming to stay on until a successor was selected, but there’s a new course of action in the wake of a Phase II miss and a reduced headcount.

“I want to emphasize that I remain personally committed to Evelo and staying on to lead the organization. I continue to believe that Evelo is a remarkable opportunity in terms of the science, the platform, the type of products that we’re able to produce, and most importantly, the potential of millions of patients suffering from all stages of inflammatory disease,” Gill said on a conference call.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

John Roberts, exiting Vyant Bio CEO

Neu­rode­gen­er­a­tive biotech Vyant warns of po­ten­tial wind-down

The CEO and chief scientific officer of Vyant Bio are out the door as the little-known but publicly-listed neurodegenerative biotech searches for an exit or, if all else fails, a wind-down.

The soul-searching bookends a winding journey for the biotech, which rebranded and transitioned from diagnostics company Cancer Genetics in 2021 after a merger with StemoniX. That came after a failed merger attempt with NovellusDx (now Fore Biotherapeutics) in 2018. In the last few years, units have been sold off and the stock price $VYNT has plummeted from the $30 range to penny stock territory.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Medicago's vaccine greenhouse (Medicago via YouTube)

Cana­di­an plant-based vac­cine de­vel­op­er Med­ica­go shut­ters months af­ter lay­offs

Plant-based Covid-19 vaccine developer Medicago shut down this week with little fanfare. And its two subsidiaries, Medicago R&D and Medicago USA, are also closing their doors, according to a company news release.

The lone shareholder left standing, Japan-based Mitsubishi Chemical Group, “has determined not to make further investments in Medicago and to proceed with an orderly wind-up of its business and operations in Canada and in the United States.”

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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