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.

Ting Xu

CEO Ting Xu told re­porters he ex­pects to file for ap­proval of their lead PD-L1 drug at Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion in H2 2020, and the de­ci­sion could come by the end of the year in the most ide­al sce­nario.

If ap­proved, the sub­cu­ta­neous in­jec­tion of KN035 (en­vafolimab) would be­come the sec­ond PD-L1 agent to fol­low five PD-1 drugs on the mar­ket: Mer­ck’s Keytru­da, Bris­tol-My­ers Squibb’s Op­di­vo, Jun­shi’s Tuoyi, In­novent’s Tyvyt and Jiang­su Hen­grui’s cam­re­lizum­ab. As­traZeneca has just clinched an OK for Imfinzi.

Among them, Tyvyt — which In­novent is part­nered with Eli Lil­ly on — re­cent­ly earned a cov­et­ed spot on the na­tion­al re­im­burse­ment list by slash­ing its price to $403 (RMB2843) per 100mg, down 64% from its orig­i­nal price, which is al­ready much low­er than its for­eign coun­ter­parts.

There are prof­its to be made even at a sim­i­lar price lev­el, Xu as­sured re­porters.

But even as the check­point agents pile on, Al­pham­ab’s re­al am­bi­tion lies in the bis­pecifics field, where Xu has plowed for six years.

Two of Al­pham­ab’s bis­pecifics are now in Phase II test­ing, in­clud­ing KN046 (PD-L1/CT­LA4) and KN026 (HER2). For the lat­ter, Xu is plot­ting three routes of at­tack: a head-to-head with Her­ceptin in front­line breast can­cer; tri­als in pa­tients with low ex­pres­sion or re­sis­tance to Her­ceptin; and a bio­mark­er-dri­ven ap­proach.

About half of the IPO funds will go to­ward clin­i­cal de­vel­op­ment and po­ten­tial com­mer­cial­iza­tion of KN046, with a BLA planned for 2021.

The new round of cash will al­so fund an on­go­ing Phase II study of CD80-tar­get­ing im­munomod­u­la­tor KN019 for au­toim­mune con­di­tions.

Matthews Funds, Or­biMed, Green­woods, MSAL, Lake Bleu Prime, Luye Phar­ma and Taikang Life chimed in as cor­ner­stone in­vestors.

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.

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

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

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.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

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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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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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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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.

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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.