Image: Amber Tong for Endpoints News

Bel­lus hopes to fu­el up on IPO cash as it squares off with gi­ant Mer­ck on a ri­val drug

Fu­eled by a suc­cess­ful Phase I tri­al treat­ing chron­ic cough and lured by the promise of tak­ing their lead drug to oth­er ap­pli­ca­tions, Mon­tre­al-based Bel­lus Health is look­ing to make its de­but on Nas­daq with a $60 mil­lion IPO.

The pub­lic of­fer­ing could be a ma­jor boon to the small Cana­di­an com­pa­ny as it looks to out­pace phar­ma gi­ant Mer­ck in the race to bring a P2X3-block­ing drug to mar­ket. Block­ing the P2X3 re­cep­tor is a close­ly stud­ied method for re­duc­ing dis­or­ders around hy­per­sen­si­tiv­i­ty, in­clud­ing most promi­nent­ly chron­ic cough.

Mer­ck has al­ready brought their ver­sion — gefapix­ant, or MK-7264 — to Phase III tri­als for chron­ic cough treat­ment, with high hopes in cre­at­ing a ma­jor new fran­chise pro­gram. But Bel­lus points out in the S-1 fil­ing that in their Phase I tri­al for BLU-5937 they were able to pro­duce pos­i­tive re­sults with­out the taste-al­ter­ing side ef­fects that have marred Mer­ck’s tri­als. In Mer­ck’s lat­est tri­al, over 70% of pa­tients who re­ceived 50 mg ex­pe­ri­enced taste loss or al­ter­ation, com­pared to 5% of pa­tients in Bel­lus’s. In Ju­ly, Bel­lus be­gan its Phase II tri­al for chron­ic cough, which af­fects 26 mil­lion Amer­i­cans.

No ef­fec­tive treat­ment cur­rent­ly ex­ists.

Bel­lus al­so touts their P2X3 in­hibitor as po­ten­tial­ly use­ful against oth­er dis­or­ders re­lat­ed to hy­per­sen­si­tiv­i­ty. In 2020 they will be­gin a Phase II tri­al on eczema. The atopic der­mati­tis field is crowd­ed, but Bel­lus claims 40-50% of pa­tients are dis­sat­is­fied with their treat­ment.

In June Baird an­a­lyst Bri­an Sko­r­ney not­ed that he viewed BLU-5937 as a dif­fer­en­ti­at­ed as­set, say­ing it “may over time prove to be the best-in-class P2X3 an­tag­o­nist.”

Orig­i­nal­ly called Neu­rochem, the com­pa­ny was forced to re­struc­ture in 2008 af­ter their bid to launch their Alzheimer’s drug failed in a large clin­i­cal study. They changed their name and be­gan fo­cus­ing on or­phan drugs, al­though ALZ-801 was
li­censed by Alzheon in 2013.

This will be the sec­ond ma­jor fundrais­er in less than a year for Bel­lus, as it raised $35 mil­lion at $0.95 a share from an eq­ui­ty of­fer­ing in De­cem­ber.

As of June 30, the com­pa­ny had $42.4 mil­lion cash on hand. Bel­lus hopes to even­tu­al­ly sell BLU-5937 at $300-$600 per pa­tient, per month. List­ed in Cana­da, the com­pa­ny’s shares were trad­ing at $2.04.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

LAST UPDATED AUGUST 13

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

Does precision medicine work?

The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

No­var­tis’ CAR-T part­ner in Chi­na wraps $383M take-pri­vate deal en­gi­neered by CEO

After 13 years on Nasdaq, Cellular Biomedicine Group is returning to private hands.

CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.

No­vo gets PhI­II he­mo­phil­ia tri­als for a Roche ri­val back on track af­ter com­plet­ing work-around on blood clot threat

After abruptly shutting down three hemophilia studies back in March due to serious safety issues, Novo Nordisk is getting things going again.

The Danish pharma gave the go-ahead to resume Phase III trials for its concizumab candidate, which are investigating subcutaneous prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. Novo Nordisk had halted the studies after three patients experienced non-fatal blood clots.