What does a post-pan­dem­ic IPO fil­ing look like? Hong Kong biotech ap­pli­ca­tion of­fers clues

As Covid-19 be­comes a per­ma­nent fix­ture on se­cu­ri­ties doc­u­ments, a new biotech IPO fil­ing in Hong Kong has of­fered a glimpse of what the out­look is like on the oth­er end of the tun­nel.

Oc­u­men­sion had just start­ed a Phase III tri­al for its lead drug, a cor­ti­cos­teroid-re­leas­ing in­trav­it­re­al im­plant in-li­censed from Eye­Point Phar­ma­ceu­ti­cals, when the first cas­es of a mys­te­ri­ous pneu­mo­nia were re­port­ed in Chi­na.

But even as the coun­try went in­to lock­down, the biotech went on to seal a prod­uct trans­fer and co­op­er­a­tion deal on an eye drop, sub­mit an ab­bre­vi­at­ed NDA to the Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion, open up a new sub­sidiary in Suzhou, and launch two new prod­ucts in the past two months.

To sum­ma­rize:

Al­though we ex­pe­ri­enced a de­lay in screen­ing pa­tients for the on­go­ing Phase III clin­i­cal tri­al of OT-401 due to trav­el re­stric­tions im­ple­ment­ed to con­tain the spread of COVID-19, we had not ex­pe­ri­enced any ear­ly or ex­pect­ed ter­mi­na­tion of treat­ment or ne­ces­si­tat­ed re­moval of any en­rolled pa­tients un­der the tri­al.

Sev­er­al tri­al sites have al­ready re­sumed en­roll­ment; in oth­er words, there shouldn’t be long-term dam­age to ei­ther the clin­i­cal pro­gram or the busi­ness in gen­er­al.

Oc­u­men­sion’s ex­pe­ri­ence could be re­flec­tive of what hap­pens to some of the most well-fund­ed teams in Chi­na. In­cu­bat­ed at 6 Di­men­sions, the com­pa­ny en­joys the back­ing of a mar­quee syn­di­cate — fea­tur­ing Temasek, Boyu, Gen­er­al At­lantic, Eight Roads, 3W Part­ners and Cor­morant As­set Man­age­ment — that has col­lec­tive­ly put $200 mil­lion in the banks. The Se­ries B came in at a whop­ping $180 mil­lion.

The vi­sion, laid out bare­ly two years ago, was to bring a suite of spe­cial­ty oph­thalmic drugs un­der the same roof with world-class ex­e­cu­tion chops to de­vel­op, man­u­fac­ture and sell them.

“In Chi­na, eye dis­eases are com­mon, yet treat­ment rates are low, lag­ging sig­nif­i­cant­ly be­hind the Unit­ed States,” the first few lines of the IPO fil­ing read.

That leaves plen­ty of room for in-li­cens­ing — per­haps more so than hot­ter ar­eas such as on­col­o­gy — while con­duct­ing orig­i­nal re­search and dis­cov­ery. Oc­u­men­sion’s pipeline fea­tures three of the 10 oph­thalmic drugs ap­proved by the FDA since 2015 that are still not avail­able do­mes­ti­cal­ly.

The most ad­vanced of them is OT-401 or Yu­tiq, which treats chron­ic non-in­fec­tious uveitis af­fect­ing the pos­te­ri­or seg­ment of the eye. Oth­er part­nered drugs tar­get dis­eases like glau­co­ma, al­ler­gic con­junc­tivi­tis, wet AMD and post­op­er­a­tive in­flam­ma­tion. Mean­while Oc­u­men­sion’s in-house R&D group is al­so work­ing on their own so­lu­tions to bac­te­r­i­al con­junc­tivi­tis, dry eye and oth­ers.

More re­cent­ly — this Jan­u­ary to be pre­cise — Oc­u­men­sion broke ground on its own man­u­fac­tur­ing fa­cil­i­ty.

At the helm of the com­pa­ny is Ye Liu, an Ei­sai vet­er­an who, while serv­ing as the gen­er­al man­ag­er of Japan’s San­ten, was cred­it­ed for lead­ing the con­struc­tion of what was then the largest man­u­fac­tur­ing plant in Chi­na. Oth­ers on the man­age­ment team, from CSO Chang­dong Liu to CMO Dong­hong Chen, have al­so held po­si­tions in a range of lo­cal and multi­na­tion­al drug­mak­ers.

De­spite the rosy out­look, though, Oc­u­men­sion felt the oblig­a­tion to in­clude this pre­cau­tion: “We can­not guar­an­tee you, how­ev­er, that the COVID-19 out­break will not fur­ther es­ca­late or have a ma­te­r­i­al ad­verse ef­fect on our re­sults of op­er­a­tions.”

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.