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In­ovio files for $50M of­fer­ing amid Covid-19 vac­cine hunt; Zy­dus Cadi­la signs on with XO­MA on IL-2 deal

→ Inovio, the company now building a DNA vaccine against the novel coronavirus, has filed for a $50 million equity offering. Touting its experience bringing a vaccine for MERS — a related virus — into Phase II, Inovio has called itself “the leader in coronavirus vaccines” and, with funding from the Center for Epidemic Preparedness, has said it will have a vaccine in a Phase I human trial in April.

Coro­n­avirus up­date: Trump signs $8.3B spend­ing bill in­to law; Pfiz­er con­sid­ers mR­NA vac­cine pact with BioN­Tech

→ As the global case count of infections attributed to the new coronavirus climbed to 100,000 and the WHO urged global leaders to pull out all the stops, US President Donald Trump signed into law an $8.3 billion emergency spending bill to confront the outbreak.

→ After revealing at a White House meeting that it’s screening an in-house antiviral library for a potential covid-19 treatment, Pfizer told Reuters it is considering working with BioNTech on an mRNA vaccine. The two companies are already allied on a flu vaccine program.

No­body but Deer­field wants Melin­ta; No­var­tis finds a new drug dis­cov­ery part­ner

→ Melinta Therapeutics — one of the myriad of companies that crashed and burned in the ‘broken’ market for antibiotics — will be officially swallowed by Deerfield. Melinta had filed for chapter 11 bankruptcy late last year and had signed a deal to turn over control to Deerfield in exchange for the $140 million of senior debt it holds in the company. The plan was to complete a reorganization in bankruptcy, and wait for better offers — but on Wednesday Melinta said the auction scheduled for March 6 would not proceed, as no party submitted a higher and better bid than Deerfield.

Bris­tol-My­ers joins forces with dig­i­tal ther­a­peu­tics co; Wear­able car­diovert­er de­fib­ril­la­tor scores $145M+ in Se­ries C haul

→ Bristol-Myers Squibb has signed on digital therapeutics player Voluntis to develop a mobile app that will give cancer patients tips on managing their therapy and track symptoms. Paris-based Voluntis said the deal is part of its transition to focus on oncology while dropping direct commercialization plans for its diabetes business in favor of a partnering strategy.

→ A US company developing a wearable cardioverter defibrillator has just secured a mammoth $145.6 million in Series C financing. The round for Element Science was led by Deerfield Healthcare and Qiming Venture Partners USA and included the participation of investors Third Rock Ventures and Google Ventures​. Their “Jewel patch” product rivals Zoll Medical’s LifeVest wearable, but Element contends its offering is more discreet and comfortable.

$7.5B in emer­gency con­gres­sion­al coro­n­avirus prep; Sick­le cell biotech sets terms for IPO

→ Multiple outlets, including the Washington Post, are reporting that Congress is preparing to approve a $7.5 billion emergency coronavirus spending package. It’s not clear how much of that will go to drug and vaccine development, although the original — and much smaller — White House funding request included $1 billion for vaccines.  The bill is reportedly likely to be introduced today and pass the House later this week, before heading to the Senate.

No­var­tis re­it­er­ates its faith in Eylea ri­val Beovu; An­ti-NGF drug from Lil­ly, Pfiz­er is ac­cept­ed for FDA re­view

→ Last month, the Chicago-based American Society of Retina Specialists highlighted 14 cases of retinal vasculitis that have recently emerged with Regeneron’s Eylea rival — Novartis’ Beovu. Analysts also identified 36 serious cases reported to the FDA Adverse Event Reporting System, with 2 cases of vasculitis, 6 cases of blindness and 4 cases of eye inflammation. Novartis, which has previously said it had engaged an external safety review committee to look into these post-marketing safety concerns, issued a press release on Monday backing the drug, saying it believes the incidence of these events is consistent with the medicine’s package insert.

Sage con­firms sus­pen­sion of 2 de­pres­sion tri­als af­ter PhI­II flop; Es­pe­ri­on fol­lows up maid­en ap­proval with com­bo OK

→ In the wake of a flop in the crucial Phase III MOUNTAIN study, Sage Therapeutics confirmed in its quarterly update that it’s suspended enrollment in two other pivotal trials for the oral depression drug SAGE-217 (or zuranolone) as it awaits guidance from the FDA. While REDWOOD (measuring relapse) and RAINFOREST (for patients with both major depressive disorder and insomnia) are on hold pending amendments, though, the open-label SHORELINE has completed enrollment. CEO Jeff Jonas remained tight-lipped about what specific tweaks they are considering for the program, reiterating only there have been issues with compliance and room for a higher dose.

Tes­sa gets RMAT des­ig­na­tion for new CAR-T; FDA ad­comm nar­row­ly votes to ex­pand Eli Lil­ly NSCLC la­bel

→ Tessa Therapeutics has received a Regenerative Medicine Advanced Therapy designation for its experimental CAR-T therapy. The therapy, which showed a 67% complete response rate in two trials covering 27 patients, is being developed for relapsed and refractory Hodgkin’s lymphoma. A pivotal Phase II trial is expected for fall of this year.

→ Jim Wilson’s preclinical biotech — focused on developing gene therapies for rare CNS disorders — has expanded its proposed share offering for its upcoming IPO. It now plans to raise $170 million by offering 10 million shares at a price range of $16 to $18. Previously it had set the goal at $126 million by offering 7.4 million shares within the same price range. At the midpoint, the Philadelphia, PA-based company could command a fully diluted market value of $757 million, according to Renaissance Capital. Founded in 2017, Passage Bio will make its debut on the Nasdaq under the symbol $PASG.

Scott Got­tlieb in the run­ning for pos­si­ble coro­n­avirus czar; The drug Van­da sued the FDA over fails a piv­otal study

→ Former FDA commissioner Scott Gottlieb is among a handful of candidates being considered for coronavirus czar, a new role that the Trump administration may set up to oversee the US’s response to the spreading outbreak, Politico reported. The president has yet to make the final decision, but has announced a press conference later today upon his return from India.

→ Days after a court ruled against Vanda in its lawsuit against the FDA over a partial clinical hold on tradipitant, the biotech said the drug has failed a Phase III study for pruritus associated with atopic dermatitis. While the neurokinin 1 antagonist missed the primary endpoint of reducing itching among all patients, Vanda pointed to “robust” antipruritic effect in the mild AD subpopulation as a reason to remain optimistic and said it will reassess its second, ongoing late-stage study.

IDO-de­rived can­cer vac­cine scores in com­bo tri­al with Keytru­da; Vir teams up with WuXi on coro­n­avirus an­ti­bod­ies

→ Copenhagen-based IO Biotech said that its cancer vaccine has passed the high bar set for its interim futility analysis in Phase II, showing “a substantially higher” overall response rate among non-small cell lung cancer patients when combined to Keytruda than the PD-1 alone —which according to the company induced historical ORR of 39%.

Investigators will carry on evaluating IO-102 plus Keytruda, with final data expected by the end of the year. The candidate is an IDO-derived peptide sequence designed to stir up T cell action against IDO — the enzyme target for an ill-fated class of small molecule drugs. “In that sense you have flags on the surface of immune suppressive cells and [tumor cells] that our T cells can recognize and thereby actually get rid of those IDO positive cells, hence a completely different MOA than IDO SMI,” CEO Mai-Britt Zocca told Endpoints News.