Bioreg­num Opin­ion Col­umn by John Car­roll

We’re see­ing the C-suites of a whole group of biotech and phar­ma com­pa­nies in flux this week as lead­er­ship groups evolve and top ex­ecs hunt big­ger and bet­ter things for their ca­reers. Most of this news is en­cap­su­lat­ed in short, dry re­marks re­served for SEC fil­ings.

But the de­part­ing CMO at Ther­a­vance $TBPH, Brett Hau­mann, clear­ly want­ed it wide­ly known that he’s mak­ing a re­luc­tant ex­it at the com­pa­ny af­ter a 7-year stint. His 8-K this week notes he’s go­ing to change scenes and move to the UK as much for fam­i­ly rea­sons as any­thing else. And the note quotes him di­rect­ly.

(A)s you know, my wife and I are be­com­ing le­gal guardians to my sis­ter-in-law’s young son af­ter she sad­ly passed away. In or­der to sup­port his tran­si­tion in­to our fam­i­ly this year, I will need to be based full-time in the UK, rather than spend­ing the ma­jor­i­ty of my time in the US as I have done for the past sev­er­al years pri­or to the cur­rent pan­dem­ic trav­el re­stric­tions. Al­though I was not ac­tive­ly look­ing for a role, I have been for­tu­nate enough to be pre­sent­ed with a unique op­por­tu­ni­ty that is dif­fer­ent from Ther­a­vance Bio­phar­ma in both stage and ther­a­peu­tic fo­cus, that will al­low me to ap­ply my ex­per­tise and ex­pe­ri­ence to new chal­lenges and be based in the UK, aligned with our plans for our nephew. I have not come to this de­ci­sion light­ly and will be sad­dened to leave the com­pa­ny that has pro­vid­ed me with such a re­ward­ing set of per­son­al and pro­fes­sion­al ex­pe­ri­ences over the past 7 years.

It’s im­por­tant to re­mem­ber that be­hind every move in the in­dus­try is a host of per­son­al events we don’t usu­al­ly know any­thing about.

Hau­mann, a physi­cian, spent 15 years de­vel­op­ing his skills at GSK be­fore de­part­ing and tak­ing the biotech trail.

Ther­a­vance is look­ing for his re­place­ment now.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.