Con­tend­ing for CD47 throne, Arch On­col­o­gy scores $50M as it ramps up PhI stud­ies

Arch On­col­o­gy, one of the old­er star­tups in a crop of im­muno-on­col­o­gy play­ers chas­ing af­ter the CD47 tar­get, has bagged $50 mil­lion to fu­el a long dri­ve in the clin­ic that re­cent­ly be­gan.

Julie Cher­ring­ton

Some might re­mem­ber the com­pa­ny as Tioma Ther­a­peu­tics, break­ing out in 2016 with some years of pre­clin­i­cal work and in­vest­ments from Glax­o­SmithK­line, Roche and No­vo. A year lat­er, it re­named it­self to Arch On­col­o­gy and brought in new CEO Julie Cher­ring­ton to re­place John Dono­van in pur­suit of a “more high­ly dif­fer­en­ti­at­ed” com­pound.

In the process, River­Vest Ven­ture Part­ners, Roche Ven­ture Fund and 3×5 Part­ners be­came the main back­ers, all of whom par­tic­i­pat­ed in the Se­ries B, led by new in­vestor Lightchain. Lightchain is the fam­i­ly of­fice of Rodger Riney, a bil­lion­aire, mul­ti­ple myelo­ma sur­vivor and St. Louis res­i­dent who’s pre­vi­ous­ly do­nat­ed to the Wash­ing­ton Uni­ver­si­ty School of Med­i­cine — where Bris­bane, CA-based Arch had its sci­en­tif­ic roots.

Both the cor­po­rate/clin­i­cal de­vel­op­ment team in the Bay Area and the re­search group at St. Louis will be ex­pand­ing in the com­ing year, bring­ing the to­tal head­count from 20 to 30, Cher­ring­ton tells me.

The big idea at Arch On­col­o­gy — pop­u­lar­ized by the likes of Forty Sev­en and Boehringer In­gel­heim — is to block the “don’t eat me” sig­nal emit­ted by CD47 and there­by help im­mune cells spot and de­stroy can­cer.

What makes its lead pro­gram dif­fer­ent, the biotech says, is that in ad­di­tion to tear­ing down the bar­ri­er for macrophages and in­cit­ing a T cell re­sponse, AO-176 al­so works by di­rect­ly killing tu­mor cells, fur­ther ac­ti­vat­ing the adap­tive im­mune re­sponse.

The hy­poth­e­sis is now be­ing test­ed in a Phase I tri­al, with a slate of dis­cov­ery-stage can­di­dates lin­ing up to fol­low. Pro­grams range from SIR­Pα (a pro­tein on the sur­face of macrophages that’s key to CD47 sig­nalling) to oth­er tar­gets har­ness­ing the pow­er of in­nate im­mu­ni­ty, ac­cord­ing to Cher­ring­ton.

“We be­lieve AO-176 has a best-in-class pro­file among agents in the an­ti-CD47 space and we are ex­cit­ed to see the progress ad­vanc­ing the pipeline,” John McK­earn, man­ag­ing di­rec­tor of River­Vest and chair­man of Arch On­col­o­gy, said in a state­ment.

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

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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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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.

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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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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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.