A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Re­my Luthringer Min­er­va

A to­tal of 365 pa­tients with no oth­er psy­chi­atric con­di­tions were en­rolled in the study and ran­dom­ized in­to five groups: three dif­fer­ent dos­es of sel­torex­ant, place­bo, and Am­bi­en. Un­like the house­hold drug, which pro­motes sleep by ac­ti­vat­ing the GA­BA neu­ro­trans­mit­ter, Min­er­va’s drug is “de­signed to mim­ic the nat­ur­al sleep process by in­hibit­ing the brain mech­a­nisms that pro­mote ex­ces­sive wake­ful­ness,” CEO Re­my Luthringer said in a state­ment.

The drug scored a clear win in im­prov­ing la­ten­cy to per­sis­tent sleep (LPS) com­pared to place­bo, as re­searchers tracked es­ca­lat­ing least squares mean on changes from base­line on Night 1: 16.4 min­utes (5 mg), 32.2 min­utes (10 mg) and 36.6 min­utes (20 mg), with p ≤0.001 on the two high­er dos­es. “Ad­van­tages over place­bo were al­so ob­served at Night 13: 5.2 min­utes for the 5 mg, 28.6 min­utes for the 10 mg (p ≤0.001), and 21.0 min­utes for the 20 mg (p ≤0.001),” the com­pa­ny added.

But per­haps more in­ter­est­ing were the sec­ondary analy­sis in which sel­torex­ant seems to work bet­ter than Am­bi­en in terms of LPS as well as WA­SO-6, a mea­sure­ment of dis­turbed sleep through­out the night. That was true on Night 13 on both scores, no­table be­cause Am­bi­en did not show su­pe­ri­or­i­ty over place­bo on the same night, like­ly due to a known, wan­ing ef­fect of the stan­dard-of-care drug.

Min­er­va had much less to say about safe­ty — a big deal on sleep drugs — oth­er than that it’s well tol­er­at­ed, with treat­ment-emer­gent ad­verse events (TEAEs) tak­ing place in 33.8% of pa­tients across the three drug arms com­pared to 49.3% in place­bo group and 42.5% in the Am­bi­en co­hort. The FDA sets a high bar on safe­ty for sleep drugs, cre­at­ing a chal­lenge that has kept most small play­ers out of a dif­fi­cult field. Mar­ket­ing is al­so a big chal­lenge, even for the ma­jor bio­phar­mas.

The sub­se­quent surge on share price $NERV — up 51.93% and reach­ing $6.43 — helped Min­er­va re­cov­er some lost grounds from the con­tro­ver­sial read­out in May. At one point pre-mar­ket trad­ing brought the stock over $7 but the en­thu­si­asm has sub­sided as in­vestors pon­der on the mar­ket­ing chal­lenges ly­ing ahead.

That tri­al saw a de­crease in the Mont­gomery-As­berg De­pres­sion Rat­ing Scale among the 20 mg group, where pa­tients were treat­ed with the oral pill along­side stan­dard an­ti­de­pres­sant ther­a­pies.

Ven­tur­ing in­to a field most biotechs have steered clear of, Min­er­va’s over­all propo­si­tion with sel­torex­ant is to treat in­som­nia and re­lat­ed mood dis­or­ders by tin­ker­ing with the orex­in sys­tem, which is as­so­ci­at­ed with feed­ing, home­osta­sis, arousal, mod­u­la­tion of sleep-wake cy­cles and mo­ti­va­tion. J&J signed on as a part­ner to the ORX2 in­hibitor on two in­di­ca­tions in 2014, but re­turned the rights for in­som­nia three years lat­er.

Pa­tients with de­pres­sion who al­so strug­gle to sleep — around 105 to­tal be­tween the drug and place­bo arms — showed a big­ger im­prove­ment in the MADRS than the over­all tri­al pop­u­la­tion, the com­pa­ny had re­port­ed.

So­cial im­age: Shut­ter­stock

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.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

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.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.