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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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