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.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Eye­ing quick ap­proval, Ab­b­Vie of­fers a close-up on their pres­by­opia drug da­ta

AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.

AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.

Prahlad Singh, PerkinElmer CEO

Shelling out $5B+, PerkinElmer pays the big bucks for an­ti­body and reagent play­er

PerkinElmer has been busy on the acquisition front throughout the Covid-19 pandemic, and on Monday, the Massachusetts-based diagnostics and life sciences company added the biggest feather to its cap.

PerkinElmer will acquire antibody and reagents provider BioLegend for nearly $5.25 billion, the entities announced Monday morning. The deal is PerkinElmer’s third acquisition since November 2020 as it kicked development of Covid-19 testing into high gear, as well as the company’s biggest buyout ever.

The clock is tick­ing for Iterum af­ter FDA hands down CRL for Pfiz­er castoff an­tibi­ot­ic

Iterum knew its odds were slim as it awaited an FDA ruling on a key urinary tract infection drug with its bank account running low. The FDA, however, wasn’t impressed, and Iterum’s days look numbered.

The FDA has sent the tiny biotech a complete response letter for the antibiotic sulopenem, shutting down hopes at getting the oral medication across the finish line, the drugmaker revealed Monday.

J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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An­oth­er one bites the dust: Bris­tol My­ers Squibb pulls 'dan­gling' ac­cel­er­at­ed ap­proval for Op­di­vo in liv­er can­cer

Bristol Myers Squibb has agreed to pull a second-line liver cancer indication for its blockbuster Opdivo as a monotherapy, becoming the second PD-(L)1 indication to bite the dust after the FDA’s oncology adcomm reviewed six “dangling” accelerated approvals in April.

The outside experts voted against two of the six indications discussed at the meeting, including Opdivo as a monotherapy for hepatocellular carcinoma (HCC) patients who have previously been treated with sorafenib, and Merck’s Keytruda as a third-line treatment for stomach cancer. The adcomm voted 5 to 4 not to maintain Opdivo’s indication, after it failed to show clinical benefit in a confirmatory trial.

Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa via AP Images)

Covid-19 roundup: Fau­ci says multi­bil­lion dol­lar pro­gram could cub fu­ture pan­demics; Japan­ese drug­mak­er spices up race for Covid-19 pill

When the Covid-19 pandemic swept over the world, drugmakers were able to spin years worth of research into the fastest turnaround time for vaccine development the world has ever seen. In anticipation of the next potential global health threat, Anthony Fauci has been promoting a billion dollar plan that could create “prototype vaccines” in preparation of what comes next. And if the US can find funding, Fauci thinks that the research can start as early as next year.