Med­i­ci­No­va flops in PhII metham­phet­a­mine de­pen­dence tri­al, stock slips

San Diego drug­mak­er Med­i­ci­No­va has flunked a mid-stage tri­al test­ing its lead drug can­di­date against metham­phet­a­mine de­pen­dence, send­ing the com­pa­ny’s stock quick­ly south in pre-mar­ket trad­ing.

Yuichi Iwa­ki

The com­pa­ny an­nounced Thurs­day that its Phase II clin­i­cal tri­al as­sess­ing MN-166, a drug called ibudi­last, failed to achieve the study’s pri­ma­ry end­point: metham­phet­a­mine ab­sti­nence dur­ing the last weeks of treat­ment.

Med­i­ci­No­va is hop­ing to get a lot out of ibudi­last, test­ing the drug in mul­ti­ple neu­rode­gen­er­a­tive and sub­stance de­pen­dence in­di­ca­tions, in­clud­ing MS, ALS, and opi­oid de­pen­dence. The drug has been around for a long time treat­ing post-stroke com­pli­ca­tions and bronchial asth­ma, and has been on sold in Japan and Ko­rea since 1989. Med­i­ci­No­va says ibudlilast’s an­ti-neu­roin­flam­ma­to­ry and neu­ro­pro­tec­tive ac­tions back up the com­pa­ny’s rea­son­ing for the drug’s use in neu­rode­gen­er­a­tive dis­or­ders and sub­stance abuse. In ad­di­tion to this flopped metham­phet­a­mine de­pen­dence tri­al, Med­i­ci­No­va has five oth­er on­go­ing Phase II tri­als of the drug.

Med­i­ci­No­va’s stock $MNOV was down 15% in pre­mar­ket trad­ing as of press time, trad­ing for $10.17 per share.

Med­i­ci­No­va’s pres­i­dent and CEO Yuichi Iwa­ki had this to say in a state­ment:

We will con­duct fur­ther analy­ses of the da­ta with UCLA re­searchers, which will help us to bet­ter un­der­stand how to op­ti­mize study de­sign and set­ting for any fu­ture clin­i­cal tri­als in sub­stance de­pen­dence.  We will dis­cuss the re­sults with NIH/NI­DA, who pro­vid­ed the fund­ing for this tri­al, the opi­oid de­pen­dence tri­als and the al­co­hol de­pen­dence tri­al.  We plan to meet with FDA af­ter we have da­ta from the on­go­ing study of MN-166 in metham­phet­a­mine use dis­or­der at Ore­gon Health & Sci­ence Uni­ver­si­ty.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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J&J ad­comm live blog: J&J is al­so test­ing a two-dose vac­cine. What hap­pens if it's more ef­fec­tive?

J&J has spent the day touting the data behind their Covid-19 vaccine, but one advisor pointed that, in a few months, another batch of data could force them into a curious dilemma.

J&J was the only major vaccine developer to attempt to produce a single-dose vaccine, a huge asset when trying to rapidly inoculate the world against an ongoing public health threat, but they hedged their bets. Alongside their main Phase III trial, they also launched another that would test two doses, each spaced two months apart.

Genen­tech plots $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Genentech has committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Roche’s big South San Francisco hub will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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