ADC Therapeutics CEO Chris Martin (L) and Overland COO/CBO Ed Zhang

Go­ing to Chi­na? ADC Ther­a­peu­tics spot­lights a new way to do it with Hill­house-backed Over­land

Chris Mar­tin and his crew at ADC Ther­a­peu­tics went in­to the JP Mor­gan Health­care con­fer­ence this Jan­u­ary armed with pos­i­tive piv­otal da­ta for its lead an­ti­body-drug con­ju­gate, lon­cas­tux­imab tesirine. Hav­ing fo­cused its de­vel­op­ment pro­gram ex­clu­sive­ly in the US and Eu­rope, it was time to find a Chi­nese part­ner.

The search, which stretched out over the next few months, cul­mi­nat­ed in six term sheets, from large phar­ma, on­col­o­gy spe­cial­ists and all. But one bid­der stood out: Over­land Phar­ma, the fledg­ling plat­form play co-found­ed by ven­ture part­ners at Hill­house Cap­i­tal, a mar­quee VC firm Mar­tin has come to re­spect.

“It was a com­plete­ly dif­fer­ent struc­ture,” he told End­points News.

In­stead of sim­ply li­cens­ing lon­ca, Over­land pro­posed start­ing a joint ven­ture — one AD­CT would own 49% of — to house the Greater Chi­na and Sin­ga­pore rights to a to­tal of four AD­Cs in the Swiss biotech’s port­fo­lio, with $50 mil­lion in up­front in­vest­ment from Hill­house. The team of 30-plus Over­land staffers would ini­tial­ly shoul­der much of the lo­cal de­vel­op­ment and reg­u­la­to­ry work, both start­ing bridg­ing stud­ies de­signed specif­i­cal­ly for the li­censed ter­ri­to­ries and loop­ing them in­to glob­al tri­als. ADC will send the same num­ber of reps to the board of di­rec­tors as Over­land.

As the bio­phar­ma world learned last week with Over­land’s de­but, the start­up is pitch­ing it­self as a spring­board for West­ern drug de­vel­op­ers to bring not just prod­ucts, but their cut­ting-edge tech­nolo­gies to Chi­na through plat­form plays.

To be sure, joint ven­tures in Chi­na are noth­ing new. In the most promi­nent ex­am­ple, CAR-T pi­o­neers Kite, Juno and the less­er known Sin­ga­pore­an cell ther­a­py biotech Tes­sa have all set up JVs with lo­cal com­pa­nies — al­beit go­ing with hefty, es­tab­lished play­ers in the phar­ma scene.

On the sur­face, Over­land is more like Zai Lab, Ever­est Med­i­cines or even Per­cep­tive’s Lian­Bio in that it’s small­er and built ex­plic­it­ly to source for­eign in­no­va­tion in­to Chi­na. But be­hind it is an ex­ten­sive ecosyt­sem, from a net­work of CROs and man­u­fac­tur­ers to a com­mer­cial sales force, that Hill­house has as­sem­bled over the years.

Both part­ners have am­bi­tious goals for Over­land AD­CT Bio­phar­ma, which Mar­tin en­vi­sions grow­ing in­to a stand­alone com­pa­ny with multi­bil­lion mar­ket cap that can file for an IPO on the Hong Kong stock ex­change in a few years’ time.

Hua Mu

“We’ve been fol­low­ing in on the land­scape of ADC close­ly,” Over­land CMO and in­ter­im CEO Hua Mu said. “We know it’s an evolv­ing tech­nol­o­gy par­tic­u­lar­ly over the re­cent 2 years.”

But the over­whelm­ing ma­jor­i­ty of pro­grams are fo­cused on sol­id tu­mors, added Ed Zhang, the COO and CBO. You can find 10 or 12 dif­fer­ent AD­Cs tar­get­ed at HER2, but lon­ca and oth­er drugs from AD­CT (name­ly AD­CT-602, AD­CT-601 and AD­CT-901) would be the first com­pounds tagged with a pyrroloben­zo­di­azepine-based pay­load aimed at hema­to­log­i­cal in­di­ca­tions.

In the lead in­di­ca­tion of third-line re­lapsed/re­frac­to­ry dif­fuse large B cell lym­phoma, lon­ca spurred an over­all re­sponse rate of 48.3%. Giv­en that the 5-year sur­vival for DL­B­CL in Chi­na is 38% com­pared to 68% in the US and Eu­rope, Mu added, the drug would fill a huge gap.

While AD­CT is sup­ply­ing the ini­tial tri­al ma­te­r­i­al so that they can move as fast as pos­si­ble, there are tech trans­fer plans to even­tu­al­ly en­able man­u­fac­tur­ing in Chi­na — both for do­mes­tic use and be­yond.

“It’s more like a step­wise or two-step ap­proach,” Mu said.

From Lau­sanne, Switzer­land, Mar­tin not­ed he’s been com­mu­ni­cat­ing with Boston-based Zhang, Seat­tle-based Mu and the team in Chi­na via “hun­dreds of Zoom calls and Teams calls” as well as pho­tos.

It helped that he’s met the founders as well as the broad­er Hill­house team, he said. In fact, they were so keen not to lose time that AD­CT start­ed work­ing with Over­land be­fore for­mal­ly putting the JV to­geth­er.

“I think you learn to trust peo­ple by see­ing whether they do what they say. I think that’s a two-way street,” he said. “I must say I’ve been ex­treme­ly im­pressed by the Over­land team, not just the lead­er­ship team but the 30 peo­ple that they have work­ing with them. They’ve been very re­spon­sive, they’ve got on well with our — well, we have quite de­mand­ing clin­i­cal de­vel­op­ment and CMC teams, they’ve got on well and been re­spon­sive and they’ve moved for­ward, ef­fec­tive­ly done what they say they would do.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

James Garner, Kazia CEO (PR Newswire)

Kazia swipes an ex-Sanofi mol­e­cule for £1M up­front as they look to repli­cate their Genen­tech snag

Kazia has spent most of its young life trying to develop a single Genentech castoff it swiped for $5 million into a brain cancer drug. Now, with that molecule in a pivotal trial, the Aussie biotech is adding another old Big Pharma asset to its reserves.

Kazia announced Monday they in-licensed a small molecule called EVT801 from Evotec for a nominal upfront fee – $1.4 million — and $428 million in potential milestones. The company said they plan to launch a Phase I trial for the drug, a new VEGFR inhibitor, later this year.

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.