On­coIm­mune pulls in $56M Se­ries B, hop­ing GvHD pro­gram can prove use­ful for Covid-19

A lit­tle over three and a half years since com­ing out of stealth, On­coIm­mune is back with a new fundraise.

The Mary­land-based biotech an­nounced a $56 mil­lion Se­ries B ear­ly Wednes­day morn­ing, seek­ing to sup­port two Phase III tri­als for its lead pro­gram CD24Fc. The can­di­date is be­ing test­ed in the treat­ment of se­vere Covid-19 cas­es in one study and leukemia pa­tients prone to acute GVHD in the oth­er.

On­coIm­mune’s ex­ist­ing in­vestors, 3E Bioven­tures Cap­i­tal and Kaitai Cap­i­tal, led the round and were joined by new in­vestors, GBA Fund and GF Xinde.

The CD24Fc com­pound is a re­com­bi­nant fu­sion pro­tein reg­u­lat­ing in­flam­ma­to­ry re­spons­es that On­coIm­mune hopes will have broad ap­pli­ca­tions in can­cer, au­toim­mune dis­eases, meta­bol­ic syn­drome and GvHD. The biotech’s Phase IIa study in aGvHD showed a sig­nif­i­cant im­prove­ment in sur­vival af­ter 180 days, which is al­so serv­ing as the Phase III pri­ma­ry end­point.

That in­di­ca­tion had been On­coIm­mune’s main tar­get be­fore the Covid-19 pan­dem­ic reared its ug­ly head. Giv­en the CD24Fc pro­gram’s func­tion as an in­flam­ma­to­ry damp­en­er, the biotech ini­ti­at­ed its Phase III for se­vere Covid-19 in late April aim­ing to tar­get the cy­tokine storm caused by the virus. On­coIm­mune is test­ing a sin­gle dose of its can­di­date — 480 mg by IV in­fu­sion.

On­coIm­mune’s Phase III Covid-19 tri­al is ex­pect­ed to en­roll 270 pa­tients, and the com­pa­ny an­nounced the first 70 had been ran­dom­ized for CD24Fc or place­bo around mid-June. Those be­ing eval­u­at­ed in the study ei­ther re­quire sup­ple­men­tal oxy­gen sup­port or high flow oxy­gen non-in­va­sive ven­ti­la­tion, in ad­di­tion to ICU pa­tients re­quir­ing in­va­sive me­chan­i­cal ven­ti­la­tion. Topline re­sults are ex­pect­ed “soon,” the com­pa­ny said Wednes­day.

Since CD24Fc works via a mech­a­nism that does not du­pli­cate that of oth­er ex­per­i­men­tal ther­a­peu­tics, On­coIm­mune is op­ti­mistic that, should it be au­tho­rized or ap­proved in Covid-19, the can­di­date can be used in ad­di­tion to oth­er treat­ments like remde­sivir.

Cur­rent­ly, remde­sivir is the on­ly drug proven to have any marked ef­fect in Covid-19 cas­es fol­low­ing FDA au­tho­riza­tion ear­li­er this year. US reg­u­la­tors had pre­vi­ous­ly au­tho­rized hy­drox­y­chloro­quine for emer­gency use, but were forced to un­do that ac­tion fol­low­ing the re­trac­tion of two ma­jor stud­ies in­to the drug’s ef­fec­tive­ness.

The FDA al­so re­cent­ly grant­ed sim­i­lar des­ig­na­tion to con­va­les­cent plas­ma treat­ments, though com­mis­sion­er Stephen Hahn has come un­der fire for over­stat­ing its po­ten­tial ben­e­fits, among oth­er things. There has been in­creas­ing wor­ry among the Amer­i­can pub­lic that Covid-19 treat­ment and vac­cine ap­proval have been dri­ven by pol­i­tics in­stead of sci­ence, and a re­cent  End­points News poll of in­dus­try in­sid­ers re­flect­ed a ma­jor­i­ty thought a EUA for plas­ma should not have been is­sued at all.

So­cial im­age: Yang Liu, On­coim­mune

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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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.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

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.

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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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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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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