Seek­ing an edge in the glob­al I/O race, Al­pham­ab On­col­o­gy loads up $100M-plus from mar­quee back­ers

Al­pham­ab On­col­o­gy be­lieves it has what it takes to stand out from the del­uge of check­point in­hibitors cur­rent­ly in de­vel­op­ment — not just in Chi­na but glob­al­ly. A syn­di­cate of well-heeled in­vestors now shares that con­fi­dence, in­fus­ing more than $100 mil­lion to fu­el an am­bi­tious dri­ve through the clin­ic.

Ting Xu

Ad­van­tech, PAG and Chi­na Ven­ture Cap­i­tal Fund led the Se­ries A, which is ex­pect­ed to sup­port Al­pham­ab’s lead as­set, KN035, all the way up to reg­is­tra­tional tri­als and fund late-stage pro­grams for three oth­er clin­i­cal drug can­di­dates. Or­biMed, Her­itage Provider Net­work and Jan­chor Part­ners al­so chipped in.

Spun out of Suzhou Al­pham­ab, Al­pham­ab On­col­o­gy in­her­it­ed all can­cer-re­lat­ed work done over the last nine years at the par­ent com­pa­ny un­der CEO Ting Xu, the founder of both en­ti­ties and a for­mer se­nior re­searcher at Bio­gen and Serono.

Back when the team start­ed its pro­grams sev­er­al years ago, Xu tells me in an email, they en­vi­sioned a high­ly com­pet­i­tive PD-(L)1 field. Their strat­e­gy in re­sponse fea­tures plays in both “I/O 1.0” — a sub­cu­ta­neous­ly ad­min­is­tered PD-L1 an­ti­body — and “I/O 2.0” with a bis­pe­cif­ic tar­get­ing both PD-L1 and CT­LA-4.

KN035, or en­vafolimab, the PD-L1 an­ti­body cur­rent­ly in piv­otal tri­als, rep­re­sents the most ad­vanced pro­gram in Al­pham­ab On­col­o­gy’s pipeline. Giv­en that fre­quent in­tra­venous ad­min­is­tra­tion is a ma­jor draw­back to com­pli­ance and con­ve­nience, Xu says, the “user-friend­li­ness” of a sub­cu­ta­neous prod­uct, with a short­er ad­min­is­tra­tion time and po­ten­tial for home-use, can make it at­trac­tive in the ad­ju­vant/neoad­ju­vant set­ting and as a main­te­nance ther­a­py.

It’s a com­pet­i­tive ad­van­tage al­so be­ing pur­sued by Bris­tol-My­ers Squibb through a pact with San Diego-based Halozyme, which is pro­vid­ing its hyaluronidase en­zyme-based tech to see if the check­point leader can de­liv­er its I/O drugs with a sub­cu­ta­neous jab.

Al­pham­ab is part­ner­ing with 3D Med­i­cines, a Chi­na-based pre­ci­sion med­i­cine com­pa­ny, on the clin­i­cal de­vel­op­ment while build­ing a com­mer­cial man­u­fac­tur­ing site to pre­pare for po­ten­tial ap­proval.

The PD-L1/CT­LA-4 bis­pe­cif­ic dubbed KN046, on the oth­er hand, is aimed at over­com­ing the safe­ty lim­i­ta­tions of cur­rent CT­LA-4 an­ti­bod­ies.

“We will ex­plore the op­por­tu­ni­ties in two fronts: In­crease the re­sponse rate in large in­di­ca­tions like NSCLC, HCC etc. while ad­dress­ing some PD-(L)1 non-re­sponse tu­mor types,” Xu adds.

Both pro­grams, like the rest of the pipeline, are be­ing po­si­tioned for the US, EU and Japan mar­kets in ad­di­tion to Chi­na. Some ear­ly-stage clin­i­cal tri­als will be con­duct­ed in Aus­tralia through an Al­pham­ab sub­sidiary there.

The new funds will al­so go to­ward an ag­gres­sive re­cruit­ment plan: At 100 staffers now, the com­pa­ny plans to dou­ble its size by the end of 2019.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.