Robert Fos­ter Con­traVir

→ As hoped, Cel­gene $CELG and its part­ners at Ac­celeron $XL­RN have se­cured pri­or­i­ty re­view for their red blood cell boost­ing drug, lus­pa­ter­cept, which has been pegged to even­tu­al­ly gen­er­ate peak sales of $2 bil­lion. The bi­o­log­ic has been de­vel­oped to man­age ane­mia re­sult­ing from myelodys­plas­tic syn­drome (MDS) as well as be­ta tha­lassemia. The FDA ex­pects to make its de­ci­sion on the be­ta-tha­lassemia in­di­ca­tion by De­cem­ber 4, while the MDS in­di­ca­tion will be dealt with by April 4, 2020. The Eu­ro­pean re­view of the drug is al­so un­der­way, the com­pa­nies said on Tues­day.

→ Au­rinia’s $AUPH largest share­hold­er is skep­ti­cal that the com­pa­ny’s lead­er­ship team is up to task com­mer­cial­iz­ing its lead drug, vo­closporin, as the Cana­di­an biotech revs up late-stage stud­ies in lu­pus and dry eye dis­ease. Ko­rea-based Iljin has nom­i­nat­ed three in­de­pen­dent di­rec­tors to the eight-mem­ber board in an at­tempt to rein in in­sid­ers who they say have been plac­ing self-in­ter­ests above those of in­vestors. Chief among the three nom­i­nees is Robert Fos­ter, the ex-CEO of Isotech­ni­ka whom Iljin cred­its for the dis­cov­ery of vo­closporin. The oth­er two, Soon-Yub (Samuel) Kwon and Myeong-Hee Yu, bring reg­u­la­to­ry and sci­en­tif­ic ex­per­tise, re­spec­tive­ly. CEO Pe­ter Green­leaf — re­cent­ly ap­point­ed af­ter stints at Cere­cor, Su­cam­po and Med­Im­mune — and chair­man George Milne have pre­vi­ous­ly urged in­vestors to re­ject Iljin’s nom­i­na­tions.

Robert Ian­none Linkedin

→ In April, the chief med­ical of­fi­cer of the em­bat­tled biotech Im­munomedics $IM­MU Robert Ian­none said he was leav­ing the com­pa­ny to work in Penn­syl­va­nia to be “close to his fam­i­ly.” On Mon­day, it was re­vealed that the for­mer As­traZeneca $AZN ex­ec­u­tive is head­ed to Jazz Phar­ma­ceu­ti­cals $JAZZ, where he will lead glob­al R&D.

→ Peanut al­ler­gy drug mak­er Aim­mune $AIMT pre­sent­ed da­ta from a rollover 28-week study on Tues­day that fol­lowed its land­mark piv­otal study. The re­sults sug­gest­ed that its treat­ment, AR101, can help pa­tients tol­er­ate high­er dos­es of peanut pro­tein, thus re­in­forc­ing the ra­tio­nale for con­tin­ued dai­ly dos­ing of AR101 be­yond one year, as test­ed in the late-stage PAL­ISADE tri­al. An FDA ap­proval de­ci­sion for AR101 is ex­pect­ed in Jan­u­ary 2020.

John Oyler BeiGene

→ In a sign of Chi­na’s grow­ing in­flu­ence on glob­al biotech, BeiGene chief John Oyler has been elect­ed to BIO’s board of di­rec­tors as well as the or­ga­ni­za­tion’s health sec­tion gov­ern­ing board.

→ Cam­bridge, Mass­a­chu­setts-based Strand Ther­a­peu­tics — which is fo­cused on gene ther­a­pies — has se­cured a $6 mil­lion seed round led by Play­ground Glob­al with par­tic­i­pa­tion from Alexan­dria Ven­ture In­vest­ments, AN­RI, and a group of pri­vate in­vestors. “This cap­i­tal will be in­stru­men­tal to build­ing out and scal­ing Strand’s mR­NA pro­gram­ming tech­nol­o­gy,” said Ja­cob Be­craft, the com­pa­ny’s co-founder and CEO, in a state­ment.

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.