Alexander Vos, VarmX CEO

'Fun­da­men­tal­ly dif­fer­en­t' from Por­to­la, Dutch biotech lands €32M to steer an­ti-an­ti­co­ag­u­lant through the clin­ic

Por­to­la may not have had much suc­cess prov­ing the com­mer­cial val­ue of an an­ti-an­ti­co­ag­u­lant, but that’s not stop­ping Eu­ro­pean in­vestors from pour­ing $36.2 mil­lion (€32 mil­lion) in­to what they see as a su­pe­ri­or ap­proach put forth by a Dutch biotech.

Var­mX’s blood thin­ner re­ver­sal agent stems from re­search done by founder and CSO Pieter Re­its­ma at Lei­den Uni­ver­si­ty Med­ical Cen­ter. A mod­i­fied re­com­bi­nant form of fac­tor X, VMX-C001 “has an in­ser­tion of 16 amino acids that re­places a stretch of 7 amino acids in the so-called ser­ine pro­tease do­main” com­pared to the na­tive co­ag­u­la­tion fac­tor, CEO Alexan­der Vos told End­points News.

“This in­ser­tion leaves suf­fi­cient clot­ting ac­tiv­i­ty, whilst in­tro­duc­ing vir­tu­al­ly com­plete in­sen­si­tiv­i­ty to fac­tor Xa DOACS,” he added, re­fer­ring to oral fac­tor Xa in­hibitors.

Un­like Por­to­la’s An­dexxa — which is on­ly ap­proved to quick­ly dis­arm Eliquis and Xarel­to — Var­mX’s drug promis­es to counter the ef­fect of any DOAC. The biotech said it’s al­so eas­i­er to ad­min­is­ter and doesn’t lead to pro-throm­bot­ic risk.

Re­ports sug­gest that 2% to 3% of the 10 mil­lion pa­tients tak­ing FXa DOACs ex­pe­ri­ence spon­ta­neous se­vere bleed­ing, Vos said, which could be life-threat­en­ing. And there are al­ways pa­tients on an­ti­co­ag­u­lants who need to re­store some blood clot­ting func­tions for an emer­gency surgery.

The Se­ries B is de­signed to put the drug through clin­i­cal proof-of-con­cept, all the way up to the thresh­old of reg­is­tra­tional stud­ies for both se­vere bleed­ing and emer­gency surgery.

At that point — and there’s no guar­an­tee they will get there — Var­mX will find it­self fac­ing off with Alex­ion, which bagged Por­to­la and An­dexxa in a $1.4 bil­lion buy­out in May. The ac­qui­si­tion val­ued Por­to­la at $18 per share, a frac­tion of where it was at peak.

“The da­ta gen­er­at­ed so far sug­gests that VMX-C001 can be­come a dif­fer­en­ti­at­ed treat­ment so­lu­tion in an ever grow­ing mar­ket,” Guillem La­por­ta, whose Ys­ios Cap­i­tal co-led the fi­nanc­ing with INKEF Cap­i­tal, said in a state­ment.

Lund­beck­fonden Ven­tures joined the round, to­geth­er with ex­ist­ing in­vestors Bio­Gen­er­a­tion Ven­tures and In­no­va­tion­Quar­ter.

In ad­di­tion to the lead pro­gram, the lean team of 5 at Var­mX is de­vel­op­ing re­ver­sal agents for fu­ture class­es of an­ti­co­ag­u­lants, such as those tar­get­ing fac­tor XI(a).

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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