Siol­ta Ther­a­peu­tics, a mi­cro­bio­me com­pa­ny tar­get­ing al­ler­gic dis­eases, raked in a $30 mil­lion Se­ries B to de­vel­op its lead can­di­date, STMC-103H. The drug, which has been FDA fast-tracked, is head­ed for proof-of-con­cept tri­als, ac­cord­ing to the com­pa­ny. Its var­i­ous in­di­ca­tions in­clude al­ler­gic asth­ma, food al­ler­gies, atopic der­mati­tis, al­ler­gic rhini­tis, and al­ler­gy pre­ven­tion.

The news comes just af­ter the Cal­i­for­nia-based biotech added a promi­nent bio­phar­ma vet­er­an as an ad­vi­sor: 20-year Gilead CEO John Mar­tin. The biotech al­so gained Richard Shames as CMO, who came by way of Pro­tag­o­nist Ther­a­peu­tics.

Marc Be­nioff, CEO of the soft­ware gi­ant Sales­force, in­vest­ed in the com­pa­ny’s Se­ries A and re­turned to chip in to the B round. Khosla Ven­tures, Sev­en­ture (Health for Life Cap­i­tal Fund), Sym­Bio­sis, and Glob­al Brain (Kirin Health In­no­va­tion Fund/GB-VII) al­so pitched in.

Vac­cinex drug flops in PhII Hunt­ing­ton’s dis­ease tri­al

Vac­cinex $VC­NX an­nounced its drug pepinemab missed both pri­ma­ry end­points in a Phase II tri­al for ear­ly man­i­fest and pro­dro­mal Hunt­ing­ton’s dis­ease, caus­ing its stock to plunge more than 57% on Tues­day morn­ing.

Pepinemab didn’t show sta­tis­ti­cal sig­nif­i­cance com­pared to a place­bo in two as­sess­ments from the Hunt­ing­ton’s Dis­ease Cog­ni­tive As­sess­ment Bat­tery and Clin­i­cal Glob­al Im­pres­sion of Change (CG­IC), ac­cord­ing to topline da­ta. The hu­man­ized mon­o­clon­al an­ti­body is de­signed to bind and block the ac­tiv­i­ty of sem­a­phorin 4D. De­spite the fail­ure, CEO Mau­rice Za­ud­er­er said the re­sults sug­gest the an­ti­body po­ten­tial­ly tar­gets cor­ti­cal cen­ters, which might ben­e­fit pa­tients at a more ad­vanced stage of HD. This study co­hort in­clud­ed 179 par­tic­i­pants.

“The in­sights gained from this study al­so sug­gest that pepinemab might be an im­por­tant treat­ment op­tion for Alzheimer’s and oth­er neu­rode­gen­er­a­tive dis­eases known to pri­mar­i­ly af­fect frontal cor­tex and to im­pact cog­ni­tion,” Za­ud­er­er hoped in a state­ment.

Vac­cinex says it’s look­ing to en­roll pa­tients this month in a new Alzheimer’s dis­ease study of pepinemab at 15 sites in the US.

The biotech’s shares dipped to $2.36 apiece on Tues­day, down from $5.47 at close on Mon­day.

Ex-CRO boss scores vet­er­an VCs and $59M for his Eu­ro-fo­cused fund

Hav­ing worked with hun­dreds of biotechs as a clin­i­cal tri­al ser­vice provider, Novotech founder Alek Sa­far­i­an is piv­ot­ing to a new ca­reer in ven­ture cap­i­tal.

His firm, AL­SA Ven­tures, has raised $59 mil­lion for the first close of a Eu­rope-fo­cused fund. The fi­nal tar­get? $150 mil­lion.

With the ex­cep­tion of chief in­vest­ment of­fi­cer Graeme Mar­tin, the AL­SA team is based in Lon­don, scout­ing dis­cov­ery stage to late pre­clin­i­cal star­tups that could use their help speed­ing up a move in­to the clin­ic. Mar­tin, the for­mer CEO of Take­da Ven­tures, is based in Pa­lo Al­to.

So far they have al­ready backed three com­pa­nies: UK based Ep­silo­gen and Ox­ford Bio­ther­a­peu­tics, as well as the Bel­gian start­up Mon­tis Bio­sciences. All are tack­ling can­cer from dif­fer­ent an­gles.

That said, “we’re ag­nos­tic to modal­i­ty or ther­a­peu­tic area,” Sa­far­i­an not­ed in a state­ment.

ALX and Mer­ck col­lab­o­rate on car­ci­no­ma com­bo

ALX On­col­o­gy is team­ing up with Mer­ck to study its CD47 block­er ALX148 in com­bi­na­tion with Keytru­da to treat head and neck squa­mous cell car­ci­no­ma (HN­SCC).

As part of the agree­ment, ALX will con­duct two Phase II stud­ies: one to test the two drugs as a first-line treat­ment in pa­tients with PD-L1 ex­press­ing metasta­t­ic or un­re­sectable re­cur­rent HN­SCC, and an­oth­er to test a cock­tail with the two drugs plus stan­dard chemother­a­py as a first-line treat­ment for metasta­t­ic or un­re­sectable re­cur­rent HN­SCC.

The stud­ies are based on Phase Ib da­ta re­leased at AS­CO 2020, which showed that ALX148 plus Keytru­da achieved a 40% ob­jec­tive re­sponse rate and a me­di­an pro­gres­sion-free sur­vival of 4.6 months in HN­SCC pa­tients who re­ceived pri­or treat­ment.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Clovis Oncology needs a serious leg up after posting a $71.3 million net loss in Q2.

According to the company’s Q2 report, based on its current cash, cash equivalents and liquidity the company will need to raise additional capital in the near term to continue going on beyond February of next year.

A proposed reverse stock split of Clovis’ common stock, which would have freed up more capital, was not approved at its annual meeting of stockholders. The company said in the report it is looking at other sources of funding such as strategic partnerships or licensing arrangements for one or more of its products or candidates.