Pre-rev­enue vac­cine de­vel­op­er CanSi­no lines up at a buzzing HKEX

On the same day As­cle­tis start­ed pub­licly pitch­ing its his­toric IPO on the Hong Kong stock ex­change, an­oth­er home­grown drug­mak­er is tak­ing its own shot at a pub­lic list­ing.

Xue­feng Yu

Prob­a­bly best known for its Ebo­la vac­cine — which got ap­proved and ac­cept­ed in­to Chi­na’s na­tion­al stock­pile last Oc­to­ber — CanSi­no Bi­o­log­ics is de­vel­op­ing 15 vac­cine can­di­dates for 12 dis­ease ar­eas in to­tal. The lead pro­grams fo­cus on meningo­coc­cal con­ju­gate vac­cines, fol­lowed by ver­sions of the com­mon DTP vac­cine, both of which would be boost­ed by the raise.

As its name (quite sub­tly) sug­gests, CanSi­no has its roots in the Cana­di­an/Chi­nese con­nec­tion the founders shared. It all start­ed, CEO Xue­feng Yu writes in an open­ing let­ter, on a sum­mer day about 10 years ago, when He­len Hui­hua Mao, Dongxu Qiu, Tao Zhu and him­self gath­ered for a bar­beque in Toron­to.

He­len Hui­hua Mao

As se­nior ex­ecs at Sanofi Pas­teur, As­traZeneca and Wyeth, they saw all too well the glar­ing gap in vac­cine de­vel­op­ment as il­lus­trat­ed by Yu’s sto­ries from his trips to Chi­na. Then they made a de­ci­sion that sur­prised even them­selves: to start a com­pa­ny that would not on­ly pro­duce bet­ter al­ter­na­tives to cur­rent or im­port­ed vac­cines, but al­so come up with “glob­al­ly in­no­v­a­tive” vac­cines based on Chi­na’s un­met med­ical needs.

Dongxu Qiu

That was 2009. Nine years lat­er, they have at­tract­ed top-notch in­vestors at Lil­ly Asia Ven­tures (18.75%) and Qim­ing Ven­tures (8.10%) as well as the state-owned Fu­ture In­dus­try De­vel­op­ment Fund (5.50%) to back their vi­sion. The founders, who are now joined by for­mer As­traZeneca top ex­ec Shou-Bai Chao in run­ning the com­pa­ny, each hold around 10% of the stock.

Tao Zhu

As CanSi­no moves for­ward with two Phase III MCV pro­grams, two Phase I DTP vac­cines, an ear­ly-stage tu­ber­cu­lo­sis boost­er and a slate of oth­er pre­clin­i­cal projects, they’ve al­so start­ed build­ing up a com­mer­cial plan. The plan, they write in the ap­pli­ca­tion, is to have 100 staffers ded­i­cat­ed to sell­ing the vac­cines to lo­cal cen­ters for dis­ease con­trol, ini­tial­ly in 30 eco­nom­i­cal­ly-de­vel­oped cities and grad­u­al­ly ex­pand­ing to oth­er lo­ca­tions.

If As­cle­tis’ progress is any in­di­ca­tion, the HKEX reg­u­la­tors — as­sist­ed by a pan­el of es­teemed biotech pro­fes­sion­als — will have no prob­lem by keep­ing the vet­ting process with­in the promised 12 weeks.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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