Rid­ers on the storm: Ve­na­toRx bags a $42M round to back an­tibi­otics pipeline

The small group of ex­pe­ri­enced biotech vets that start­ed Ve­na­toRx took their time get­ting the lead an­tibi­ot­ic pro­gram in­to the clin­ic. But af­ter get­ting rolling with an NIH con­tract and funds from the Well­come Trust in Lon­don, they are now bank­ing a $42 mil­lion B round led by Ver­sant Ven­tures with plans to take a di­rect shot at a pos­si­ble FDA ap­proval.

Chris Burns

“It took sev­er­al years of med­i­c­i­nal chem­istry in or­der to fi­nal­ly get the pro­file we want­ed,” Chris Burns, the CEO and co-founder at Ve­na­toRx, tells me. That wasn’t un­ex­pect­ed. The com­pa­ny, based in Malvern, PA, was launched by a vir­tu­al group of just three af­ter No­var­tis ac­quired their old com­pa­ny — Pro­tez, with a lead an­tibi­ot­ic of its own — in 2008. And this is the first time the com­pa­ny has as­sem­bled a big block of cash to fund the next leg of de­vel­op­ment.

Their lead is VN­RX-5133, a β‐lac­ta­mase in­hibitor de­signed to go hand in hand with a β‐lac­tam an­tibi­ot­ic, play­ing a block­ing role for the en­zymes that can de­feat an an­tibi­ot­ic’s ef­fi­ca­cy. Burns and his team be­lieve they have a new ther­a­peu­tic weapon that can take down the 4 ma­jor class­es of β‐lac­ta­mases, in­clud­ing met­al­lo‐β‐lac­ta­mases, giv­ing a new lease on life to an­tibi­otics in wide use.

Drug-re­sis­tant bac­te­ria is a grow­ing prob­lem, but the team at Ve­na­toRx are still very much think­ing longterm. The typ­i­cal life span of an an­tibi­ot­ic starts with care­ful, re­served use for spe­cial cas­es in­clud­ing drug re­sis­tance, fol­lowed by a prof­li­gate stage where it’s rou­tine­ly used.

As the an­tibi­ot­ic moves down the pyra­mid, it be­comes less valu­able.

“You build the house,” says Burns, “and the ground moves un­der the house.”

Ve­na­toRx wants their new prod­uct ap­proved in time for what they see as a com­ing round of grow­ing re­sis­tance for the an­tibi­otics they plan to pro­tect. Says Burns, “You ar­rive at the place as the storm is about to hit.”

By Burns’ reck­on­ing, the key pe­ri­od for Ve­na­toRx will be 2020-2030. And he hopes to be ready.

“We’re go­ing right for reg­is­tra­tion stud­ies af­ter Phase I,” says the CEO. “We ex­pect to be in reg­is­tra­tion stud­ies in the first half of next year.”

Watch­ing the cash they have now, Burns says BAR­DA of­fers a shot at ad­di­tion­al rev­enue to fund the piv­otal pro­gram. And the com­pa­ny is ex­pand­ing the pipeline with new projects as well.

The three founders are now sup­port­ed by a grow­ing team of 40 and a syn­di­cate of in­vestors. Ver­sant Ven­tures, which en­joys trav­el­ing off the beat­en path as it looks for new op­por­tu­ni­ties, took the lead on this fundrais­ing, joined by Abing­worth and Fore­site Cap­i­tal.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.

As­traZeneca sets stage for mar­ket­ing ap­pli­ca­tion with promis­ing piv­otal lu­pus drug da­ta

After fumbling in its first late-stage lupus study, AstraZeneca disclosed that a second pivotal trial testing its experimental drug, anifrolumab, had met the main goal, in August. Earlier this week, the British drugmaker broke out the numbers from its successful study.

Last year, anifrolumab failed to meet the main goal of diminishing disease activity in the 460-patient TULIP I study, a 52-week trial that tested two doses of the drug versus a placebo. But in the 373-patient TULIP II study, the higher dose (300 mg) was compared to patients given a placebo — patients in both arms were on baseline standard care.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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