With ma­jor fund­ing from No­var­tis, Sur­face On­col­o­gy launch­es a CD47 tri­al amid a swarm of ri­vals and files for $75M IPO

With a lead can­cer drug now in the clin­ic in pur­suit of a trendy tar­get, biotech start­up Sur­face On­col­o­gy is mak­ing a bid for IPO glo­ry, boast­ing of a heavy­weight al­ly that’s been pro­vid­ing much of the op­er­at­ing cash.

Jeff Goater, CEO

The biotech filed its S-1 late Fri­day, pen­cil­ing in $75 mil­lion as the goal while out­lin­ing close to $200 mil­lion in back­ing — the li­on’s share com­ing from its close part­ner No­var­tis.

The Cam­bridge, MA-based biotech at­tract­ed con­sid­er­able ear­ly at­ten­tion for its work jump­ing in­to the in­tense­ly com­pet­i­tive field of tu­mor mi­croen­vi­ron­ment en­gi­neer­ing work. With the CT­LA-4/PD-/L1 check­points mak­ing im­pres­sive in­roads for some seg­ments of can­cer pa­tients, Sur­face is one of a myr­i­ad of star­tups look­ing to add some ad­di­tion­al fire­pow­er with add-ons that can ei­ther take the brakes off of an im­mune as­sault or bring in ad­di­tion­al weapons to take down can­cer cells. In their case, the key fo­cus is on coun­ter­ing im­muno­sup­pres­sion.

No­var­tis has a PD-1 in late-stage de­vel­op­ment, but ex­ecs tend to down­play its im­por­tance, con­cen­trat­ing on their strate­gic mis­sion to have their own check­point to use in com­bos rather than as a ri­val to the 5 PD-1/L1s cur­rent­ly on the mar­ket, with Re­gen­eron/Sanofi and many more crowd­ing in. Their work with Sur­face has brought them in on one pre­clin­i­cal al­liance on CD73, with an IL-27 part­ner­ship hang­ing in the bal­ance.

So far, ac­cord­ing to the S-1, No­var­tis has front­ed their work with $163.5 mil­lion in cash, in­clud­ing a $70 mil­lion up­front, $80 mil­lion for op­tions and mile­stones and $13.5 mil­lion in stock. That in­cludes a $45 mil­lion pay­ment last month fol­low­ing “re­ceipt of the first fi­nal au­dit­ed GLP tox­i­col­o­gy study re­port for SRF373.” Four VCs — At­las, F-Prime, Lil­ly Ven­tures and NEA — split up $28 mil­lion in shares, with each adding $7 mil­lion. At­las owns the largest chunk shares, with 23%.

Their deal with No­var­tis al­so orig­i­nal­ly in­clud­ed $1.17 bil­lion in mile­stones, which wasn’t dis­closed at the sign­ing time, though the phar­ma gi­ant al­so dropped two of the four po­ten­tial op­tions it had signed up for. No­var­tis will al­so help out with the IPO, pur­chas­ing $11.5 mil­lion more in stock.

Sur­face had burned through $74 mil­lion of its cash by the end of last year, with 56 staffers.

Ini­tial­ly fo­cused on CD47, a “don’t-eat-me” tar­get that has whipped up a line­up of con­tenders, No­var­tis ul­ti­mate­ly passed on that pro­gram and left world­wide rights to the Phase I as­set to Sur­face. Sur­face al­so owns the CD-39 pro­gram.

Sur­face has some im­pres­sive back­ers, in­clud­ing for­mer Bris­tol-My­ers R&D chief El­liott Si­gal, who owns some stock and sits on the board.

“As we dis­cussed last year, it is crit­i­cal in the im­mune-on­col­o­gy field to ‘skate to where the puck will be’, that is, to ad­dress the ques­tion of what is be­yond PD-1 and oth­er T-cell, check­point in­hibitors,” Si­gal not­ed to me back in ear­ly 2016, when No­var­tis signed on. But they’re by no means the on­ly biotech with the same ap­proach.

Com­pet­i­tive? The burst of in­vest­ment in im­muno-on­col­o­gy has left Sur­face with a long ros­ter of ri­vals. Their list in­cludes the fol­low­ing ex­am­ples:

For CD47 alone: Alexo Ther­a­peu­tics, Arch On­col­o­gy, Au­ri­gene, Blink Bio­med­ical, Cel­gene, Forty Sev­en, Novim­mune, OSE Im­munother­a­peu­tics, Sor­ren­to, Syn­thon Hold­ing and Tril­li­um Ther­a­peu­tics.

For the rest of the tu­mor mi­croen­vi­ron­ment: Ar­cus Bio­sciences, As­traZeneca, Bris­tol-My­ers Squibb, Corvus Phar­ma­ceu­ti­cals, In­nate Phar­ma and Palo­bio­far­ma, to name a few.

Not every­thing has gone com­plete­ly ac­cord­ing to plan at Sur­face. Found­ing CEO Dnetlev Bin­iszkiewicz re­signed with­out ex­pla­na­tion last fall, re­placed by the CBO, Jeff Goater. Goater now is in line for a $465,000 an­nu­al salary plus op­tions, which brought his com­pen­sa­tion pack­age last year to $1.4 mil­lion.

Gold­man Sachs, Cowen and Ever­core ISI are do­ing the hon­ors on the un­der­writ­ing.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.