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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.