A Chi­nese I/O biotech look­ing to turn around an old No­var­tis pro­gram gets a new fundraise af­ter launch­ing PhI­II study

Close to a year af­ter pulling in its last pri­vate fundraise, Chi­nese im­muno-on­col­o­gy biotech Ad­lai Nortye is back with an­oth­er nine-fig­ure round. And it comes as it seeks to con­tin­ue push­ing for­ward a for­mer ex­per­i­men­tal No­var­tis ther­a­py.

Ad­lai Nortye raised $100 mil­lion in a Se­ries D, the biotech an­nounced Thurs­day, rough­ly 10 months af­ter a Se­ries C of the same amount. In ad­di­tion to ad­vanc­ing its pipeline and fur­ther­ing R&D, Ad­lai Nortye said some of the funds could be used for “merg­ers and ac­qui­si­tions and oth­er strate­gic col­lab­o­ra­tions.”

SDIC Fund Man­age­ment and Tigermed co-led Thurs­day’s round. Ad­lai Nortye is head­quar­tered in Hangzhou, Chi­na, with US op­er­a­tions run­ning out of North Brunswick, NJ. End­points News has reached out for com­ment.

“This round of fi­nanc­ing rep­re­sents an im­por­tant mile­stone for Ad­lai Nortye,” CEO Carsten Lu said in a state­ment.

Re­searchers have de­vel­oped two plat­forms, one for im­munol­o­gy drugs and one to help de­vel­op an­ti­bod­ies, Ad­lai Nortye says. The first is a screen­ing tool that rapid­ly runs po­ten­tial can­di­dates and tar­gets through po­ten­tial com­bi­na­tion ap­proach­es, os­ten­si­bly al­low­ing for bet­ter op­ti­miza­tion for can­cer drugs and de­sign­ing more ef­fi­cient clin­i­cal tri­als. The an­ti­body plat­form, mean­while, us­es a yeast dis­play sys­tem to fa­cil­i­tate drug dis­cov­ery.

Ad­lai Nortye cur­rent­ly has four drug can­di­dates in clin­i­cal tri­als, the most ad­vanced of which is an oral pan-P13K in­hibitor known as bu­parlis­ib. The com­pound is in the midst of a Phase III tri­al in com­bi­na­tion with chemother­a­py for re­cur­rent or metasta­t­ic neck squa­mous cell car­ci­no­ma. The biotech launched the study in April and plans to en­roll about 500 pa­tients.

It’s a can­di­date Ad­lai Nortye re­ceived from No­var­tis back in 2018. The Swiss phar­ma punt­ed on the pro­gram af­ter a re­port from their sci­en­tists con­clud­ed the safe­ty pro­file of the drug did not sup­port fur­ther de­vel­op­ment in breast can­cer. No fi­nan­cial terms were dis­closed at the time of the deal.

Though bu­parlis­ib had shown a mar­gin­al­ly sig­nif­i­cant sur­vival ben­e­fit for breast can­cer pa­tients in a No­var­tis-run Phase III sev­er­al years ago, Grade 3 or 4 ad­verse events were re­port­ed in near­ly two-thirds of pa­tients in the drug arm, com­pared to the con­trol group’s rate of 34%. Side ef­fects termed as se­ri­ous arose in 22% of pa­tients giv­en the com­bo, with 16% in the con­trol group. Re­searchers saw one treat­ment-re­lat­ed death in each arm.

There were al­so three sui­cide at­tempts in the bu­parlis­ib group, rais­ing con­cerns about sui­ci­dal ideation among pa­tients ex­posed to the drug.

In ad­di­tion to bu­parlis­ib, Ad­lai Nortye is re­search­ing an oral EP4 an­tag­o­nist in the neoad­ju­vant set­ting for lo­cal­ly ad­vanced rec­tal can­cer and an im­muno-on­colyt­ic virus for sol­id tu­mors and hema­to­log­i­cal ma­lig­nan­cies.

So­cial: Carsten Lu, Ad­lai Nortye CEO (Ad­lai Nortye)

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.

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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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 rather narrow 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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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.

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.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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