In­vestors give ail­ing Unum a lease on life and a whole new suite of ex­per­i­men­tal can­cer drugs

In­vestors, it seems, are will­ing to give Unum Ther­a­peu­tics one last shot — or at least one last shot to a com­pa­ny of that name.

The ail­ing can­cer biotech, be­set by a se­ries of clin­i­cal holds and mul­ti­ple failed lead pro­grams, an­nounced to­day that they’ve ac­quired Kiq LLC and that in­vestors are putting in $104 mil­lion to ad­vance Kiq’s pipeline of ki­nase in­hibitors. Unum share­hold­ers will now own on­ly 16.2% of the com­pa­ny and CEO Chuck Wil­son in­di­cat­ed that the cell ther­a­pies the biotech has worked on since its found­ing may be on their way out, say­ing Unum will “ex­plore strate­gic op­tions” for those prod­ucts.

Chuck Wil­son

“Unum has ex­plored a range of strate­gic al­ter­na­tives through an or­der­ly process to max­i­mize share­hold­er val­ue, and we be­lieve this ac­qui­si­tion rep­re­sents the high­est-po­ten­tial val­ue cre­ation op­por­tu­ni­ty for Unum stock­hold­ers,” Wil­son said in a state­ment. “We are ex­cit­ed by Kiq’s lead clin­i­cal pro­gram and the po­ten­tial to build a pipeline of nov­el ki­nase in­hibitors while con­tin­u­ing to ex­plore strate­gic op­por­tu­ni­ties for our cell-based ther­a­py pro­grams.”

The move re­stored some in­vestor faith in the biotech, lift­ing them out of deep pen­ny stock ter­ri­to­ry to $2.20 per share.

The com­pa­ny-chang­ing move comes four months af­ter Unum sig­naled they were ready to con­sid­er any op­tion that might keep the biotech afloat. In a sin­gle week at the start of March, the com­pa­ny an­nounced they were lay­ing off 60% of its work­force, los­ing their CSO and that their lead pro­gram had been hit with an FDA hold af­ter it may have led to a new ma­lig­nan­cy in a pa­tient. It was the lat­est in a se­ries of holds dat­ing back to the com­pa­ny’s IPO, when the At­las-backed and Bruce Booth-chaired com­pa­ny dis­closed in the S-1 that their lead drug had led to the death of 2 pa­tients.

Unum an­nounced that month they would scrap the lead pro­gram and, for a sec­ond time in their short his­to­ry, shift fo­cus to a pre­clin­i­cal can­di­date. In­vestors ex­pressed their faith in the move by push­ing the stock deep­er in­to pen­ny stock ter­ri­to­ry, scrap­ing 30 cents.

The new deal will put Unum’s fo­cus on a lead can­di­date called PLX9486. It al­ready has re­sults in Phase I for GIST tu­mors, lead­ing to a pro­gres­sion-free sur­vival of 11 months in 18 pa­tients, and will al­so be test­ed in ad­vanced sys­temic mas­to­cy­to­sis and in­do­lent sys­temic mas­to­cy­to­sis. They have cash run­way through 2022.

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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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: 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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC deal in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

UP­DAT­ED: 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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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.