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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

UP­DAT­ED: A mi­cro-cap with a po­ten­tial­ly promis­ing coro­n­avirus drug en­lists mask-skep­tic con­gress­man for DSMB

A small biotech that has talked up a potentially promising but unproven treatment for Covid-19 enlisted an unusual member for its study’s Data and Safety Monitoring Board: a sitting Republican congressman with close ties to the CEO and a history of mask skepticism.

NeuroRx, an Israeli biotech testing a lung inflammation drug in Covid-19 patients, tapped Maryland Rep. Andy Harris for the DSMB, Politico reported. Harris is an anesthesiologist but not a biostatistician, and he has questioned the CDC about a “cult of masks” in the US. Harris has known NeuroRx CEO Jonathan Javitt since the two worked at Johns Hopkins together over 20 years ago.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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News brief­ing: Com­pa­ny de­vel­op­ing 'mag­ic mush­room' treat­ment hits Nas­daq; Spring­Works en­ters spon­sored re­search agree­ment with Fred Hutch

Compass Pathways seeks to raise $127.5 million in an upsized IPO, by offering 7,500,000 shares priced at $17 apiece. The London-based company had initially filed for a $100 million IPO, according to its F-1 filing.

The company is researching psilocybin therapy, which combines psilocybin — a psychoactive ingredient found in some species of “magic mushrooms” — with psychological support to treat mental illnesses such as depression, anxiety and addiction. It plans on using IPO money to fund research and clinical development of its COMP360 psilocybin therapy.

Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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Leen Kawas, Athira

Seat­tle-based Athi­ra, aim­ing for tough Alzheimer's and Parkin­son's tar­gets, rais­es $204M for IPO

Following an $85 million Series B round back in June, Athira Pharma is set to become the third biotech in the last three days to go public Friday.

Athira raised $204 million for its IPO after pricing shares at $17 apiece, the high-point of its expected range. Initially pegging $100 million in financing, Athira said it offered 12 million total shares and will trade under the ticker $ATHA.

Now that Athira plans to hit the Nasdaq, there have been more than 50 biotech IPOs this year, more than the total from last year. Combined, the companies have raised more than $11 billion. Over half of those biotechs, including Athira, raised at least $200 million each.