RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Mon­ey has nev­er been an is­sue for Ever­est Med­i­cines. With an es­sen­tial­ly open tab from their founders at C-Bridge Cap­i­tal, the biotech has gone two and a half years rack­ing up drug af­ter drug, bring­ing in top ex­ec af­ter top ex­ec, and is­su­ing clin­i­cal up­date af­ter up­date.

But now oth­er in­vestors want in — and they’re bet­ting big.

Ian Woo

Ever­est is clos­ing its Se­ries C at $310 mil­lion. The first $50 mil­lion comes from the Ji­ashan Na­tion­al Eco­nom­ic and Tech­no­log­i­cal De­vel­op­ment Zone; the re­main­ing C-2 tranche was led by Jan­chor Part­ners, with RA Cap­i­tal Man­age­ment and Hill­house Cap­i­tal as co-lead­ers. Decheng Cap­i­tal, GT Fund, Janus Hen­der­son In­vestors, Rock Springs Cap­i­tal, Oc­ta­gon In­vest­ments all joined.

The biotech might be best known for pay­ing $65 mil­lion up­front to grab Asian rights to Im­munomedics’ an­ti­body-drug con­ju­gate last April — a record for Chi­nese biotechs in-li­cens­ing West­ern drugs. But the oth­er as­sets in their pipeline would ring equal­ly, if not more, fa­mil­iar to a US au­di­ence: Are­na’s S1P re­cep­tor ag­o­nist etrasi­mod, Unit­ed Ther­a­peu­tics’ PAH drug ra­linepag, Tetraphase an­tibi­ot­ic Xer­a­va (er­ava­cy­cline), among oth­ers.

The idea, CFO Ian Woo pre­vi­ous­ly told End­points News, is to go for the crown jew­els of their biotech part­ners — and not the un­want­ed, shelved prod­ucts.

That ap­proach re­quires earn­ing the trust of part­ners, some­thing Ever­est has honed af­ter eight such deals.

Wende Chen

Pi­o­neered by the likes of Zai Lab and BeiGene, bridg­ing the med­ical gap be­tween the US and Chi­na has be­come a pop­u­lar strat­e­gy for do­mes­tic biotechs. Ever­est po­si­tioned it­self right up there with the lead­ers, in­clud­ing CStone and In­novent. The mar­ket’s big enough for al­most every­body with the ex­per­tise to iden­ti­fy the right in­di­ca­tions and pur­sue the op­ti­mal clin­i­cal de­vel­op­ment path, they con­tend.

“We are well-po­si­tioned to ad­vance the clin­i­cal de­vel­op­ment of our ro­bust ther­a­peu­tics pipeline, which spans a num­ber of im­por­tant dis­eases, and we look for­ward to build­ing a strong foun­da­tion on which we will grow our com­mer­cial busi­ness,” said Ker­ry Blan­chard, the Eli Lil­ly vet who was ap­point­ed CEO ear­li­er this year.

He is flanked in the C-suite by Ian Woo, pres­i­dent and CFO; and Wende Chen, chief com­mer­cial of­fi­cer.

Two of the drugs Ever­est holds rights to have been ap­proved in the US. Im­munomedics’ breast can­cer ther­a­py Trodelvy was OK’d in April, trig­ger­ing $60 mil­lion in mile­stone pay­ment, and Ever­est was cleared for Chi­na tri­als that month. Around the same time, they nabbed ap­proval for an­oth­er, Xer­a­va, in Sin­ga­pore for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions.

Here’s a brief overview of the rest:

  • etrasi­mod (Are­na): oral mod­u­la­tor of the sphin­go­sine 1-phos­phate re­cep­tor (S1PR). In Phase III for ul­cer­a­tive col­i­tis
  • tani­bor­bac­tam (Ve­na­torx): in­jectable broad-spec­trum be­ta-lac­ta­mase in­hibitor. In Phase III for com­pli­cat­ed uri­nary tract in­fec­tions
  • ra­linepag XR (Unit­ed): ex­tend­ed re­lease ag­o­nist of the IP re­cep­tor. In Phase III for pul­monary ar­te­r­i­al hy­per­ten­sion
  • Ne­fe­con (Cal­lid­i­tas): oral for­mu­la­tion of budes­onide. In Phase III for IgA nephropa­thy
  • FGF401 (No­var­tis): re­versible-co­va­lent in­hibitor of FGFR4. In Phase Ib/II for he­pa­to­cel­lu­lar car­ci­no­ma
  • SPR206 (Spero): polymyx­in de­riv­a­tive de­signed to re­duce the kid­ney tox­i­c­i­ty that is seen clin­i­cal­ly with polymyx­in B and col­istin

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Jude Samulski, AskBio

Bay­er and AskBio ex­pand grand gene ther­a­py am­bi­tions with new Parkin­son's pro­gram, top sci­en­tist

It only took 20 years, but Jude Samulski is finally turning AskBio into a gene therapy behemoth in the hills of North Carolina.

The now Bayer-owned biotech announced Friday they were bringing over the clinical team from Brain Neurotherapy Bio, completing a buyout announced in December and adding clinical programs in Parkinson’s and multiple system atrophy to an already large pipeline.

AskBio launched BrainNeuBio in 2018, a move consistent with Samulski’s long-running strategy of spinning out promising programs, which led to the Bamboo Therapeutics and Pfizer’s Duchenne Gene Therapy program, as well as a hemophilia program now owned by Takeda.

Delores Schendel, Medigene CEO (Vimeo via website)

Medi­gene cuts TCR-T ther­a­py in piv­ot to fo­cus on sol­id tu­mors

It’s been several months since Medigene AG laid out plans to devote itself to solid tumors. In keeping with that promise, the German biotech said Thursday that it’s cutting an early-stage TCR-T therapy for relapsed or refractory blood cancer patients — after researchers blamed the pandemic in part for their failure to dose any patients in the first seven months of a Phase I trial.

The candidate, MDG1021, was licensed from the Leiden University Medical Center at the end of 2018, about a year after Medigene out-licensed its AAV-like particle tech to focus on T cells and immunotherapy. It targets a specific, immunogenic form of the antigen HA-1, which is expressed on cells of the hematopoietic system. The idea is that if the patient’s blood cells, — and thus lymphoma or leukemic cells — carry the immunogenic version of the HA-1 antigen and the donor stem cells do not, MDG1021 TCR-T cells would fight the patient’s cancer cells while allowing the donor cells to repopulate the patient’s blood forming system.

Glax­o­SmithK­line moves malar­ia vac­cine pro­duc­tion to In­dia; Nevakar bags Eu­ro­pean part­ner and nine-fig­ure deal

GSK is shifting production of its malaria vaccine to a Covid-19 vaccine developer in India.

Wednesday’s move to Bharat Biotech was made as part of efforts to battle the deadly fever, as GSK’s vaccine is the first to prove effective in combating the disease. Bharat will take over manufacturing of the protein part of the vaccine while GSK continues developing the adjuvant portion of the shot.

The vaccine is currently being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Program. More than 500,000 children have received the first dose since the pilots were initiated by the three countries in 2019.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.