Fo­cus­ing on the tu­mor mi­croen­vi­ron­ment, On­coRe­sponse gar­ners $40 mil­lion for the next stage of the R&D jour­ney

On­coRe­sponse has en­tered the on-ramp for its im­muno-on­col­o­gy clin­i­cal plans. And the biotech now has a $40 mil­lion B round from a mix of main­stream and non­tra­di­tion­al in­vestors to get them over the hur­dle and in­to hu­man stud­ies.

The Seat­tle-based com­pa­ny has spent the last 3 years sort­ing through prospec­tive an­ti­bod­ies iden­ti­fied through their re­search of the “elite re­spon­ders” to check­point in­hibitors, in­ves­ti­gat­ing the an­ti­bod­ies they pro­duce in ef­fec­tive­ly re­pelling can­cer. That work has been part­nered with MD An­der­son, which has been pro­vid­ing the tis­sue sam­ples.

Clif­ford Stocks

Con­cen­trat­ing on the im­muno­sup­pres­sive na­ture of the tu­mor mi­croen­vi­ron­ment, CEO Clif­ford Stocks tells me the com­pa­ny has come a long way in iden­ti­fy­ing some next-gen com­bo drugs for check­point in­hibitors as well as their ap­proach to pre­vent­ing the ex­haus­tion of nat­ur­al killer cells — putting a “rich­er se­lec­tion of im­mune cells in­to the tu­mor mi­croen­vi­ron­ment.”

To com­plete the pre­clin­i­cal work on ad­vanc­ing 5 pro­grams, the biotech has now raised $40 mil­lion. River­Vest Ven­ture Part­ners led the round, which in­clud­ed new in­vestors Qatar In­vest­ment Au­thor­i­ty and Red­mile Group, plus ex­ist­ing in­vestors Alexan­dria Ven­ture In­vest­ments, ARCH Ven­ture Part­ners, HT Fam­i­ly Of­fice, Canaan Part­ners, Helsinn In­vest­ment Fund and William Marsh Rice Uni­ver­si­ty.

“The fund­ing will take us in­to 2021,” says the CEO, with “one or two INDs.”

The new mon­ey has al­so al­lowed the biotech to ex­pand its base camp to 18 staffers, with plans to add a few more to the core team.

New staffers in­clude Anil Sing­hal and Ka­mal Puri. Sing­hal is an Ab­b­Vie vet, where he worked on on­col­o­gy, im­munol­o­gy and oth­er dis­eases. Puri joined from Cel­gene, where he “dis­cov­ered new mol­e­c­u­lar en­ti­ties for the im­munol­o­gy pipeline and iden­ti­fied and sup­port­ed new in­di­ca­tions for port­fo­lio mol­e­cules.” Sing­hal and Puri have been ap­point­ed CSO and vice pres­i­dent of R&D, re­spec­tive­ly.

At this point, Stock says that he can see do­ing one more ven­ture round ahead of an IPO as they gar­ner sol­id hu­man da­ta for in­vestors to look at. But, if the very ear­li­er da­ta is great, he can see ad­vanc­ing the time­line.

But all the stars would have to align. In the mean­time, now that the B round is com­plete, Stocks wants to shift fo­cus more to the part­ner­ing realm, hop­ing to build cred­i­bil­i­ty with some high-pro­file al­lies in the busi­ness.

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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