A lit­tle more than 3 years ago Al­ler­gan paid $90 mil­lion in a cash up­front to part­ner with gene edit­ing play­er Ed­i­tas on a CRISPR al­liance fo­cused on the eye. The lead pro­gram cen­tered on LCA10, a rare, in­her­it­ed reti­nal de­gen­er­a­tive dis­ease that ap­pears in child­hood and leads to blind­ness.

Al­ler­gan then went to Ab­b­Vie $AB­BV in a buy­out, and the phar­ma gi­ant has no in­ter­est in mov­ing for­ward on the gene edit­ing front. The com­pa­ny punt­ed it all back to Ed­i­tas Thurs­day, with the biotech $ED­IT not­ing in a state­ment af­ter the mar­ket closed Thurs­day that it is re­gain­ing all rights for its oc­u­lar med­i­cines, in­clud­ing ED­IT-101.

Cyn­thia Collins

Ed­i­tas CEO Cyn­thia Collins says she’s “pleased” to get the pro­grams back un­en­cum­bered. She added:

“We are cur­rent­ly fo­cused on ad­vanc­ing ED­IT-101 with dos­ing re­sumed in the Phase 1/2 BRIL­LIANCE clin­i­cal tri­al. We re­main on track to com­plete dos­ing of the adult low-dose co­hort and to dose at least one pa­tient of the adult mid-dose co­hort by the end of this year. We look for­ward to shar­ing ad­di­tion­al up­dates from BRIL­LIANCE clin­i­cal tri­al and oth­er med­i­cines in de­vel­op­ment in our oc­u­lar pro­gram lat­er this year.”

The biotech’s stock, which had jumped 13% dur­ing reg­u­lar trad­ing hours Thurs­day, im­me­di­ate­ly turned south and dropped 11% af­ter the bell.

Brent Saun­ders

This is a high-pro­file pi­o­neer­ing clin­i­cal ef­fort. Back in March Ed­i­tas and Al­ler­gan spot­light­ed the first use of CRISPR in an in vi­vo hu­man sub­ject, the first time re­searchers had used the tech­nol­o­gy to ed­it a cell — rather than do­ing the edit­ing ex-vi­vo and then re­turn cells to the sub­ject.

But Al­ler­gan CEO Brent Saun­ders nev­er got much cred­it for his R&D deals, as en­thu­si­as­tic as he was about them. Ab­b­Vie’s big in­ter­est was amp­ing up rev­enue from the leg­endary Botox fran­chise, not break­ing new ground with CRISPR.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.