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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.