Tim Clackson, Theseus CEO

Or­biMed's TKI play makes its Nas­daq de­but as The­seus prices IPO

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A Boston biotech with a hefty back­ing from Or­biMed is mak­ing its Nas­daq de­but Thurs­day.

The­seus Phar­ma­ceu­ti­cals priced its IPO at $16 per share, the high end of its range, jump­ing to the pub­lic mar­ket rough­ly six months af­ter Or­biMed led the biotech’s nine-fig­ure Se­ries B. The­seus net­ted $160 mil­lion for the pub­lic of­fer­ing, bring­ing the sec­tor’s to­tal com­bined 2021 raise to $13.74 bil­lion across 86 dif­fer­ent com­pa­nies, per the End­points News tal­ly.

The IPO will make a big win­ner out of Or­biMed, which owned al­most 60% of shares pri­or to the pric­ing and has been in­volved in the com­pa­ny since it led a Se­ries A back in 2018, ac­cord­ing to the S-1. Once The­seus starts trad­ing un­der the tick­er $THRX, that slice will dwin­dle to about 45%.

Fore­site Cap­i­tal is al­so in­volved in the biotech, hav­ing joined on to the Se­ries B round in April. When The­seus com­pletes its of­fer­ing, Fore­site will own an 8.5% stake.

The­seus got start­ed by a group of col­leagues at Ari­ad Phar­ma­ceu­ti­cals fol­low­ing its $5.2 bil­lion buy­out from Take­da in 2018, strik­ing a deal with their for­mer com­pa­ny to li­cense some patents, com­pounds and a chem­i­cal li­brary to get start­ed. Ari­ad nabbed a 5.9% slice of the com­pa­ny in ex­change.

Af­ter get­ting off the ground with Or­biMed’s $20 mil­lion back­ing, the com­pa­ny laid low un­til the big Se­ries B ear­li­er this year when it un­veiled its lead pro­gram, but the biotech has still not test­ed any of its pro­grams in hu­mans. The­seus is de­vel­op­ing “pan-vari­ant” ty­ro­sine ki­nase in­hibitors to treat dif­fer­ent types of can­cer, with the hope that the can­di­dates can in­hib­it a het­ero­ge­neous mix of re­sis­tance mu­ta­tions.

Its lead pro­gram is dubbed THE-630 and tar­gets the KIT ki­nase, which re­searchers be­lieve can hit all ma­jor class­es of ac­ti­vat­ing and re­sis­tance mu­ta­tions re­lat­ed to that ki­nase in gas­troin­testi­nal stro­mal tu­mors. The­seus is plan­ning to launch the Phase I por­tion of a Phase I/II study some­time be­tween late in the fourth quar­ter this year and mid-first quar­ter in 2022. The biotech will aim to re­cruit pa­tients who have re­ceived at least four pri­or lines of ther­a­py.

The­seus al­so has an EGFR in­hibitor de­signed to beat C797S-me­di­at­ed re­sis­tance to first- or lat­er-line Tagris­so treat­ment for pa­tients with non-small cell lung can­cer. This pro­gram is well be­hind the lead, as The­seus is yet to nom­i­nate a can­di­date for the clin­ic. Cur­rent plans have that nom­i­na­tion pegged for the first half of next year.

Biotech re­mains on pace to top­ple last year’s record IPO sum of $16.5 bil­lion, but the tor­rent of cash seen ear­li­er this year slowed sig­nif­i­cant­ly in the third quar­ter. Even though things still look good for 2022 when tak­ing the last five years in­to ac­count, IPO fig­ures in the last three months were at their low­est lev­els since the start of 2020, per Deal­For­ma num­bers mae­stro Chris Doko­ma­ji­lar.

A new start for Nu­vec­tis

A small New Jer­sey biotech is look­ing to get in­to the IPO ac­tion as well, fil­ing on Wednes­day for a $30 mil­lion de­but.

Found­ed in 2020, Nu­vec­tis Phar­ma is work­ing on push­ing two in-li­censed can­cer pro­grams in­to the clin­ic, with a lead pro­gram that’s ready for Phase I. That can­di­date, brought in from Lon­don’s In­sti­tute for Can­cer Re­search, is an in­hibitor of the heat shock fac­tor 1 path­way. Nu­vec­tis is seek­ing to ini­ti­ate a Phase I study in ovar­i­an clear cell car­ci­no­ma by the end of the year.

The biotech’s sec­ond pro­gram comes from the Uni­ver­si­ty of Ed­in­burgh in Scot­land, with a deal signed this past Au­gust. It’s a can­di­date try­ing to in­hib­it the SRC and YES 1 ki­nas­es, and Nu­vec­tis is aim­ing to launch IND-en­abling stud­ies in the fourth quar­ter.

Nu­vec­tis was found­ed by a pair of ex­ec­u­tives from Stem­line Ther­a­peu­tics and a third biotech vet­er­an, Ron Bentsur, who used to be the CEO of Uro­Gen. Bentsur owns the biggest stake in the com­pa­ny at about 26%.

Once Nu­vec­tis goes pub­lic, it will trade un­der the tick­er $NVCT.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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