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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Neu­vo­gen un­cloaks with broad plan of at­tack for whole-cell can­cer vac­cines, clin­i­cal hopes with­in the year

After about four stealthy years in the development phase, San Diego-based Neuvogen is emerging with a new approach to whole-cell cancer vaccines and nine solid tumor programs bound for the clinic.

Whole-cell tumor vaccines are developed by taking cancer cells from patients and modifying them to make them immunogenic.

“What’s different from what we do, is most people use one cell line. We use six,” CEO Todd Binder said. From there, the company builds out six modifications to eliminate problematic immunosuppressive factors, and add what the executive called three “stimulatory factors” to generate a prime and overcome peripheral tolerance.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.