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

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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