CEO John Celebi (Sensei)

Sen­sei Bio­ther­a­peu­tics rakes in $28.5M to give can­cer im­munother­a­pies a push

Less than a month af­ter of­fer­ing a glimpse at ear­ly clin­i­cal da­ta for its lead can­cer im­munother­a­py at vir­tu­al ES­MO, Sen­sei Bio­ther­a­peu­tics has reeled in $28.5 mil­lion to wade deep­er in­to Phase II.

The Mary­land-based biotech, for­mer­ly known as Panacea, is look­ing to ex­pand Phase II tri­als for SNS-301, an en­gi­neered in­ac­ti­vat­ed bac­te­rio­phage de­signed to “awak­en” the im­mune sys­tem. “Right now we’re re­al­ly fo­cused on adding ad­di­tion­al Phase II clin­i­cal and trans­la­tion­al da­ta to sup­port SNS-301,” CEO John Celebi said.

The round, which the com­pa­ny is call­ing a Se­ries AA, fol­lows sev­er­al seed rounds, Celebi said. It was led by Cam­bri­an Bio­phar­ma and H&S Ven­tures, and will fund the Phase II de­vel­op­ment of SNS-301. It will al­so help ready the biotech’s ear­li­er can­di­dates for IND ap­pli­ca­tions, which could come some­time in the next 12 to 18 months. That in­cludes SNS-401, a po­ten­tial vac­cine cock­tail against Merkel cell car­ci­no­ma, and SNS-VISTA, an an­ti­body-based ther­a­peu­tic.

Last sum­mer, Sen­sei joined forces with As­traZeneca to test SNS-301 in com­bi­na­tion with Imfinzi in two Phase II tri­als across mul­ti­ple sol­id tu­mors. And at ES­MO, the biotech read out ear­ly da­ta from a Phase I/II study of the can­di­date and Mer­ck’s Keytru­da for ad­vanced head and neck can­cer. One of 9 pa­tients eval­u­at­ed at the time had a par­tial re­sponse, with a tu­mor re­duc­tion of 43%, ac­cord­ing to the com­pa­ny.

“The ap­proval of pem­brolizum­ab is an ex­cit­ing event for pa­tients, but clear­ly there’s a lot of room for im­prove­ment,” Celebi said, cit­ing a Keynote-012 study which showed Mer­ck’s drug achieved an 18% over­all re­sponse in pa­tients with metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck.

CMO Marie-Louise Fjaell­skog not­ed in a state­ment:

To date, we have ob­served promis­ing clin­i­cal ac­tiv­i­ty that is cor­re­lat­ed with im­mune re­sponse for SNS-301, in­clud­ing a par­tial re­sponse in a pa­tient with PD-L1-neg­a­tive dis­ease. This ini­tial da­ta from 9 pa­tients pro­vides us with the ra­tio­nale to con­tin­ue ex­plor­ing its safe­ty and ef­fi­ca­cy in 1st and 2nd line SC­CHN pa­tients.

Fu­ture Ven­tures, Chris­t­ian Anger­may­er’s Ape­iron In­vest­ment Group, and Pre­sight Ven­tures al­so chipped in to the round.

“With ex­pe­ri­enced man­age­ment and sci­en­tif­ic teams, Sen­sei is well po­si­tioned to be­come a leader in next gen­er­a­tion of im­mune-on­col­o­gy ther­a­peu­tics,” Cam­bri­an Bio­phar­ma CEO James Pey­er said in a state­ment.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.