Bioreg­num Opin­ion Col­umn by John Car­roll

Back when Vi­vid­ion put to­geth­er its $82 mil­lion B round more than a year ago, I spec­u­lat­ed that the start­up was prob­a­bly gear­ing up for an IPO. That still hasn’t hap­pened, but they may be a lot clos­er af­ter to­day.

The ARCH- and Ver­sant-backed com­pa­ny just nailed down a $135 mil­lion raise from a dream team of crossover in­vestors, with Lo­gos Cap­i­tal and Box­er Cap­i­tal lead­ing as Soft­Bank jumps in with Avoro Cap­i­tal Ad­vi­sors, Black­Rock, RA Cap­i­tal Man­age­ment, T. Rowe Price As­so­ci­ates, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Wood­line Part­ners LP, Acu­ta Cap­i­tal and Driehaus Cap­i­tal Man­age­ment. Ex­ist­ing in­vestors ARCH Ven­ture Part­ners, BVF Part­ners L.P., Cas­din Cap­i­tal, Mubadala Cap­i­tal, Nex­tech In­vest and Ver­sant Ven­tures all came back to chip in.

“There was a lot of en­thu­si­asm for this raise,” CEO Jeff Hat­field tells me about the pipeline-build­ing raise for a com­pa­ny that has big am­bi­tions in on­col­o­gy as well as im­munol­o­gy. “It came to­geth­er very quick­ly and we bumped it up a cou­ple of times.”

Hat­field isn’t ready to flag an IPO, though — “Who knows what the fu­ture holds?” — but he’s a lot more forth­com­ing about the pre­clin­i­cal work they have un­der­way.

In-house work in­cludes a fo­cus on the KEAP1-NRF2 ax­is, with work un­der­way on NRF2 mu­tant and ad­dict­ed can­cers. NRF2 mod­u­lates stress in cells, ex­plains Hat­field, and once “mu­tat­ed it leads to a form of can­cer that is cur­rent­ly” un­ad­dressed by any ex­ist­ing ther­a­peu­tics. That gets to the com­pa­ny’s fo­cus on the broad range of dis­ease tar­gets still in un­chart­ed drug ter­ri­to­ry.

The com­pa­ny has spe­cial­ized in iden­ti­fy­ing lig­ands for unique pock­ets, al­low­ing them to drug pre­vi­ous­ly un­drug­gable pro­teins. The chair­man is Rich Hey­man, who built and sold Aragon and Ser­agon.

There is al­so a tran­scrip­tion fac­tor pro­gram they’re work­ing on with Bris­tol My­ers that Hat­field de­scribes as “one of a hand­ful of Holy Grail tar­gets in on­col­o­gy and im­munol­o­gy.” But that’s as far as he’s will­ing to go at this stage.

James Sabry

So how about that IPO?

Just this morn­ing we wrote up a sto­ry about Soft­Bank’s plan to in­ject bil­lions more in pub­lic biotechs, help­ing to push the stock boom that’s dri­ven up the Nas­daq biotech in­dex by 35% over the past year — and adding more cash to crossovers would ap­pear to fit in neat­ly with that strat­e­gy.

Since that B round Vi­vid­ion has struck a deal with Roche — the Big Phar­ma every­one likes to have on their R&D side — that de­liv­ered $135 mil­lion in cash plus mul­ti­ple bil­lions on the back end. That gave Roche a shot at E3 lig­as­es — which plays a role in pro­tein degra­da­tion, one of BD chief James Sabry’s fa­vorite sub­jects — as well as new on­col­o­gy and im­munol­o­gy pro­grams.

That all adds up to some promi­nent play­ers, world-class part­ners, a lot of cash on hand and the first snap­shot of the pre­clin­i­cal strat­e­gy — all key in­gre­di­ents fu­el­ing the IPO boom of the past year.

So we’ll see.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.