Strug­gling Heat gets a warm re­sponse to a snap­shot on can­cer vax da­ta

Jeff Hutchins, Heat Bi­o­log­ics

Heat Bi­o­log­ics man­aged to at least tem­porar­i­ly ex­tri­cate it­self from pen­ny stock ter­ri­to­ry af­ter of­fer­ing a pos­i­tive up­date on its com­bi­na­tion study for non-small cell lung can­cer. Its stock surged more than 20% this morn­ing based on an up­date for a hand­ful of pa­tients tak­ing a com­bi­na­tion of HS-110 and Bris­tol-My­ers Squibb’s check­point in­hibitor Op­di­vo.

The up­dat­ed snap­shot from the Durham, NC-based biotech in­clud­ed a note that 3 of 5 pa­tients en­rolled in a co­hort for low tu­mor in­fil­trat­ing lym­pho­cytes “ex­pe­ri­enced sig­nif­i­cant tu­mor re­duc­tion, which is high­er than the 10% re­sponse rate of low TIL pa­tients re­port­ed for ex­ist­ing da­ta on nivolum­ab alone.” 5 of 12 evalu­able pa­tients ex­pe­ri­enced an im­mune re­sponse to the com­bo.

As a re­sult Heat’s stock $HBTX nosed above the $1 mark.

Heat has ex­pe­ri­enced re­peat­ed set­backs that ground down its share price.  Last spring, the biotech cut staff. Then in the fall their drug HS-410 failed a mid-stage study for blad­der can­cer. The com­pa­ny cur­rent­ly has a mi­cro mar­ket cap hov­er­ing around $24 mil­lion, putting it in a very vul­ner­a­ble group. And Nas­daq is­sued a delist­ing warn­ing just a few days ago.

“Check­point in­hibitors, such as nivolum­ab, are cur­rent­ly ef­fec­tive in treat­ing ap­prox­i­mate­ly 10% of lung can­cer pa­tients with low TIL and about 20% of pa­tients over­all in the 2nd line set­ting,” said Jeff Hutchins, Heat’s top sci­en­tist and SVP, Pre­clin­i­cal De­vel­op­ment. “Our re­sults ap­pear to fur­ther val­i­date the ex­pect­ed mech­a­nism of ac­tion of our ap­proach in com­bi­na­tion with check­point in­hibitors, with a con­tin­u­ing trend to­wards ear­ly and sus­tained T cell ac­ti­va­tion in the pe­riph­er­al blood cells.”

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.