Uni­corn Mod­er­na joins line­up to list on Hong Kong's ex­change; Proces­sa li­cens­es com­pound from Con­cert

→ Ru­mors are fly­ing that biotech’s biggest uni­corn, Mod­er­na, which was re­cent­ly val­ued at $7 bil­lion, is plan­ning a dual IPO list­ing on both the Nas­daq and the Hong Kong ex­changes. That’s ac­cord­ing to a Wall Street Jour­nal re­port, which cites un­named sources fa­mil­iar with the com­pa­ny’s plans. The list­ing, they say, could be as ear­ly as next year. Mod­er­na would be one of sev­er­al biotechs lin­ing up to list on Hong Kong’s ex­change, which just re­cent­ly an­nounced a rule change that would al­low life sci­ence star­tups to list. An­nounced in De­cem­ber (and tak­ing ef­fect this year), the rule change will al­low com­pa­nies that haven’t earned rev­enue or prof­it to ap­ply for IPOs in Hong Kong — as long as they’re val­ued at HK$1.5 bil­lion (US$192 mil­lion). The com­pa­nies must meet some cri­te­ria first, like be­ing at least 2 years old and hav­ing some patents. An­oth­er biotech uni­corn, Grail, which has raised over $1 bil­lion and whose back­ers in­clude GV (for­mer­ly Google Ven­tures) and Bill Gates, is al­so gear­ing up for a $500 mil­lion Hong Kong list­ing. The rules for the Hong Kong ex­change are ex­pect­ed to be fi­nal­ized in late April. When the gate lifts, we ex­pect to see lots of biotechs trot­ting through.

→ Hanover, Mary­land-based Proces­sa Phar­ma­ceu­ti­cals has picked up a li­cense for a com­pound called CTP-499, which it says has po­ten­tial for mul­ti­ple phar­ma­co­log­i­cal tar­gets. First, the com­pa­ny says its tack­ling a chron­ic, dis­fig­ur­ing con­di­tion called Necro­sis Lipoidi­ca (NL). “The Proces­sa de­vel­op­ment team has al­ready met with the FDA on NL and has a sol­id strat­e­gy for mov­ing for­ward with the de­vel­op­ment of CTP-499 in NL start­ing with a Phase II clin­i­cal tri­al in NL pa­tients in 2018,” said Proces­sa’s CEO David Young in a state­ment. “We al­so hope to meet with the FDA on a sec­ond clin­i­cal stage in­di­ca­tion for CTP-499 in the next few months.” For the li­cense, Proces­sa is pay­ing $8 mil­lion in shares to Con­cert Phar­ma­ceu­ti­cals. Con­cert is el­i­gi­ble to re­ceive roy­al­ties on com­mer­cial sales.

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

AstraZeneca has made a stride toward realizing its ambitions in China as regulators greenlight Imfinzi as a treatment for non-small cell lung cancer.

In particular, the PD-L1 agent is filling a void for immunotherapies in Stage III unresectable case, the company said, where the cancer has not spread to the rest of the body. It is to be used, with curative intent, in patients whose cancer hasn’t progressed following concurrent platinum-based chemotherapy and radiation therapy.

Cor­re­vio is putting it­self up on the auc­tion block af­ter FDA re­view pan­el points to an­oth­er re­jec­tion

For 13 years, the Canadian biotech Correvio tried to get the FDA to accept a heart drug since abandoned by Merck and Astellas. Yesterday, the agency’s outside experts voted 11-2 against approval, all but assuring another rejection for the atrial fibrillation compound vernakalant.

And today Correvio announced that Correvio may soon be no more. The company said it is looking to sell itself as its stock plummets into penny-stock territory $CORV and its potential moneymaker sputters once more.

Psilocybin mushrooms (via The Denver Post)

In a key step for psy­che­del­ic re­search, mag­ic mush­room com­pound clears first clin­i­cal safe­ty hur­dle

Exasperated with the often-ineffective existing slate of antidepressants, COMPASS Pathways set up shop in London 2016 — and made a beeline for psilocybin, the psychoactive ingredient in magic mushrooms.

On Wednesday, the startup said its man-made version of the chemical — which is illegal across geographies in its natural fungi form — had been well-tolerated in an early-stage, placebo-controlled trial in 89 healthy volunteers.

Al­pham­ab On­col­o­gy rounds out HKEX's sec­ond biotech IPO year with $230M raise and high lo­cal in­ter­est

Alphamab Oncology has inspired a surge of local interest in what will likely be the Hong Kong Stock Exchange’s last biotech run of the year, pricing its IPO on the high end of the range and raising over $230 million (HK$1.83 billion).

After rejigging the offering structure and making up to 50% available for enthusiastic local investors, the biotech sold 179.4 million shares at $1.31 (HK$10.2) and saw its stock rise to $1.77 ($13.8) on the first day of trading.

For sale: Long-act­ing PhI­II GLP-1 di­a­betes drug that’s way be­hind ri­vals, now spurned by Sanofi

Almost exactly 4 years ago Sanofi came to the bargaining table with South Korea’s Hanmi bearing $434 million dollars in cash and offering about $4 billion in milestones to in-license their once-weekly GLP-1 injectable. The pact was intended to revive their ailing diabetes division. Instead, it turned into a very expensive grave to mark the end of Sanofi’s R&D ambitions in the field.

Sanofi CEO Paul Hudson used efpeglenatide’s demise — while committing to paying hundreds of millions of more dollars to push it through 5 late-stage studies — as a marker of the company’s determination to stay focused on first and best-in-class drugs.

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Parkin­son's trans­plants emerge as stem cell pi­o­neer Jeanne Lor­ing joins R&D race

Jeanne Loring hadn’t studied Parkinson’s in 22 years when she got an email from a local neurologist.

The neurologist, Melissa Houser, didn’t know Loring had ever published on the disease. She was just looking for a stem cell researcher who might hear her out. 

“I think I was just picked out of a hat,” Loring told Endpoints News. 

At a meeting in Loring’s Scripps Research office, Houser and a Parkinson’s nurse practitioner, Sherrie Gould, asked her why there was so much research done in stem cell transplants for other neurodegenerative diseases but not Parkinson’s. They wanted to know if she would work on one.