CEO Markus Renschler (Cyteir Therapeutics)

With crossover round in its pock­et, syn­thet­ic lethal­i­ty-fo­cused Cyteir Ther­a­peu­tics eyes a jump on­to Nas­daq

Cyteir Ther­a­peu­tics CEO Markus Ren­schler has his eye on the mar­ket. The Cel­gene vet pulled in an $80 mil­lion crossover round on Thurs­day to fu­el Cyteir’s lead syn­thet­ic lethal­i­ty pro­gram, and when the time is right, he’ll have the S-1 ready.

“We’re con­sid­er­ing an IPO in 2021,” Ren­schler said, adding that the tim­ing isn’t set in stone.

Un­til then, the Se­ries C should give Cyteir the flex­i­bil­i­ty to grow its team, and ad­vance its lead can­di­date — an in­hibitor of RAD51-me­di­at­ed DNA re­pair dubbed CYT-0851 — to Phase II as a monother­a­py. The small biotech is al­so plan­ning com­bi­na­tion tri­als that pair CYT-0851 with oth­er can­cer treat­ments, like chemother­a­pies and po­ten­tial­ly PARP in­hibitors.

The idea be­hind syn­thet­ic lethal­i­ty is to in­hib­it the DNA dam­age re­pair that can­cer cells need to sur­vive and grow, Ren­schler ex­plained. Much like Covid is mu­tat­ing, can­cers mu­tate to be­come more ag­gres­sive, avoid chemother­a­py and so forth, he said. That ge­nom­ic in­sta­bil­i­ty cre­ates “breaks” that must be re­paired.

Kevin Mills

What sets Cyteir apart from oth­ers pur­su­ing syn­thet­ic lethal­i­ty, Ren­schler said, is that CYT-0851 tar­gets RAD51, a crit­i­cal en­zyme in dou­ble-strand­ed DNA re­pair. Jack­son Lab­o­ra­to­ry re­searcher Kevin Mills, Cyteir’s for­mer CSO, dis­cov­ered RAD51 plays a vi­tal sup­port­ing role in cell re­pair in cells that high­ly ex­press a mol­e­cule called ac­ti­va­tion-in­duced cy­ti­dine deam­i­nase — a be­nign en­zyme in nor­mal cells that be­comes hy­per­ac­tive and dam­ages DNA in can­cer cells.

“It is ab­solute­ly es­sen­tial to re­pair that dam­age, and we have shown by se­lect­ing can­cers, or pa­tients that have can­cers that have high de­grees of these dou­ble strand­ed breaks, we can have an im­pact on their can­cer growth,” Ren­schler said.

CYT-0851 is cur­rent­ly in the dose-es­ca­la­tion por­tion of a Phase I/II study for sol­id tu­mors and hema­to­log­i­cal ma­lig­nan­cies, and is slat­ed to en­ter Phase II in the sec­ond half of this year.

In com­bi­na­tion with oth­er chemother­a­pies or PARP in­hibitors, it could act as a “syn­er­gis­tic dou­ble punch,” Ren­schler said. The oth­er drug would in­duce DNA dam­age, while the RAD51 in­hibitor would in­hib­it the re­pair.

Some of the Se­ries C mon­ey will fi­nance IND-en­abling stud­ies for CYT-1853, what Ren­schler called the com­pa­ny’s “sec­ond-gen­er­a­tion” RAD51 in­hibitor. Cyteir al­so has an undis­closed com­pound for sol­id tu­mors up its sleeve, for which it plans to launch IND-en­abling stud­ies in 2023.

In ad­di­tion, the 25-per­son com­pa­ny says it’s look­ing to dou­ble its head count this year.

The syn­thet­ic lethal­i­ty space has been heat­ing up. An­ti­cancer Bio­science launched ear­li­er this week with $21 mil­lion from pri­vate Chi­nese in­vestors to stand shoul­der to shoul­der with US syn­thet­ic lethal­i­ty play­ers like Re­pare, Ar­tios, Ideaya and Cyteir. Back in June, Glax­o­SmithK­line R&D chief Hal Bar­ron front­ed $120 mil­lion cash to part­ner with Ideaya, promis­ing an­oth­er $940 mil­lion to $960 mil­lion in com­bined de­vel­op­ment and reg­u­la­to­ry mile­stones for each prod­uct to suc­cess­ful­ly emerge on­to the mar­ket.

RA Cap­i­tal Man­age­ment led Cyteir’s Se­ries C with Janus Hen­der­son In­vestors, Acu­ta Cap­i­tal Part­ners, Al­ly Bridge Group, Avid­i­ty Part­ners, Am­ple Plus Fund, and CaaS Cap­i­tal Man­age­ment. No­vo Hold­ings, Ven­rock, Light­stone Ven­tures, DROIA Ven­tures, Os­age Uni­ver­si­ty Part­ners (OUP), and oth­er undis­closed in­vestors chipped in.

A cor­rec­tion has been made to Kevin Mills’ ti­tle, and the spelling of CYT-0851 on sec­ond ref­er­ence.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.