In a first, HKEX re­ceives IPO pitch from lo­cal biotech look­ing to make it big in crowd­ed an­ti­bod­ies field

A Hong Kong-based an­ti­body mak­er has filed for an IPO on the HKEX, mark­ing the first tru­ly home­grown com­pa­ny to take ad­van­tage of new rules that al­low pre-rev­enue biotechs to list on the stock ex­change.

Shawn Le­ung HK­IB

Founder and CEO Shawn Le­ung calls SinoMab an in­dus­try pi­o­neer in the re­gion, hav­ing start­ed out in 2002 with sup­port from Morn­ing­side — at a time the city’s lead­ers ap­peared more in­ter­est­ed in “ra­tio­nal­iza­tion” of Chi­nese med­i­cine. Le­ung, an Ox­ford-ed­u­cat­ed lo­cal who trained in the US first as a post­doc then at Im­munomedics, came up with his own frame­work for hu­man­iz­ing an­ti­bod­ies. That formed the ba­sis of SinoMab’s cur­rent pipeline, which com­pris­es a lead an­ti-CD22 drug, a BTK in­hibitor, and four oth­er pre­clin­i­cal mAbs.

With SM03, SinoMab is tar­get­ing some of the biggest in­di­ca­tions in im­munol­o­gy: rheuma­toid arthri­tis (PhI­II), sys­temic lu­pus ery­the­mato­sus (PhI) and Sjö­gren’s syn­drome (IND), in ad­di­tion to non-Hodgkin’s lym­phoma (PhII).

While Le­ung has kept the com­pa­ny’s head­quar­ters in Hong Kong’s Sci­ence Park, he’s al­so ex­pand­ed SinoMab’s foot­print, with an of­fice in Shen­zhen, a pro­duc­tion plant in Hainan and a sub­sidiary in Aus­tralia to fa­cil­i­tate clin­i­cal tri­als.

“In fu­ture, we ex­pect to lean more to­wards Chi­na be­cause we are in­creas­ing­ly see­ing that that is where the tal­ent, the mar­ket and the mon­ey are,” he said in a 2017 in­ter­view with Phar­ma Board­room. “As we are look­ing to po­si­tion our­selves for mar­ket ap­proval, we are cur­rent­ly in­vest­ing in a new man­u­fac­tur­ing plant in Chi­na and we need chan­nels to source the mon­ey for that. An ex­pand­ed pres­ence in Chi­na will al­so help us ex­pand our port­fo­lio and gain more col­lab­o­ra­tion, both lo­cal­ly and glob­al­ly.”

Le­ung, who’s al­so a mem­ber of the HKEX’s biotech ad­vi­so­ry board, adds that Hong Kong, nev­er­the­less, re­tains a cru­cial edge with re­gards to in­tel­lec­tu­al prop­er­ty:

This is not some­thing that com­pa­nies nec­es­sar­i­ly want to do in Chi­na; if an em­ploy­ee de­cides to leave with valu­able da­ta, the sheer phys­i­cal size and pop­u­la­tion den­si­ty of Chi­na mean that he can eas­i­ly dis­ap­pear with­out a trace. In Hong Kong, the in­fra­struc­ture is trust­wor­thy and ro­bust. The biotech com­mu­ni­ty is al­so rather close-knit. This is why no mat­ter how SinoMab grows in the fu­ture, pro­to­type R&D will al­ways be done here and we will on­ly go to Chi­na for the scale-up.

Those would be key sell­ing points for Hong Kong to con­tin­ue com­pet­ing with oth­er biotech hubs in Chi­na — most no­tably Shang­hai, which re­cent­ly opened up its own biotech board.

SinoMab has ac­cu­mu­lat­ed a num­ber of Chi­nese in­vestors af­ter five ven­ture rounds. Aside from the 21.7% Le­ung holds via Skytech Tech­nol­o­gy, there are three oth­er big share­hold­ers: Forbes Cap­i­tal So­lu­tions claims 24.21%, Hainan Haiyao con­trols 18.45%, and Apri­cot has a 25.83% stake pri­or to the IPO.

So­cial im­age: Shut­ter­stock

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.