Andrew Hirsch, C4 Therapeutics CEO

C4's An­drew Hirsch blows up IPO to $182M, while on­colyt­ic virus up­start nabs $87M of­fer­ing

On Fri­day, Mass­a­chu­setts-based biotechs C4 Ther­a­peu­tics and On­corus be­came the lat­est to jump on­to Nas­daq.

Less than a month af­ter be­ing tapped as C4 Ther­a­peu­tics’ new CEO, Bind and Agios vet An­drew Hirsch is march­ing the biotech to Wall Street with an up­sized IPO.

C4, which ini­tial­ly filed for $100 mil­lion, priced 9.6 mil­lion shares at $19 mil­lion apiece, net­ting $182.4 mil­lion. The pro­ceeds will be used to push the com­pa­ny’s first pro­tein degra­da­tion can­di­dates in­to the clin­ic, ac­cord­ing to an S-1/A fil­ing.

C4 is work­ing on small mol­e­cule pro­tein de­graders that se­lec­tive­ly de­stroy dis­ease-caus­ing pro­teins, in­clud­ing some that it calls “un­drug­gable.” The Wa­ter­town, MA-based pre­clin­i­cal com­pa­ny has burned through $140 mil­lion. It’s eye­ing a clin­i­cal de­but for its can­di­date CFT7455 — which tar­gets IKZF1/3 in mul­ti­ple myelo­ma (MM), pe­riph­er­al T-cell lym­phoma and man­tle cell lym­phoma pa­tients — in the first half of 2021.

“We ex­pect to sub­mit an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion, or IND, for this prod­uct can­di­date to the U.S. Food and Drug Ad­min­is­tra­tion, or the FDA, in the fourth quar­ter of 2020 and be­gin a first-in-hu­man Phase 1/2 clin­i­cal tri­al for this prod­uct in the first half of 2021,” the S-1/A states.

The com­pa­ny said it be­lieves the can­di­date “could even­tu­al­ly re­place ther­a­pies based in the class of mol­e­cules known as IMiDs as the as the stan­dard of care in mul­ti­ple in­di­ca­tions, in­clud­ing MM.”

C4’s sec­ond pre­clin­i­cal can­di­date, CFT8634 for syn­ovial sar­co­ma and SMAR­CB1-delet­ed sol­id tu­mors, is ex­pect­ed to en­ter a Phase I/II tri­al by the end of next year. Its BRAF V600E and RET pro­grams, which are still in dis­cov­ery, could be “in the clin­ic by the end of 2022,” ac­cord­ing to the fil­ing.

Hirsch has an op­tion on 3.5% of the com­pa­ny’s stock with “an ex­er­cise price per share equal to the pub­lic of­fer­ing price in the IPO.” That’s on top of a $560,000 base salary and bonus plan. He hails from Agios, where he served as CFO for 4 years. And be­fore that, he wrapped the Bind bank­rupt­cy.

Back in June, C4 raised $170 mil­lion, in the form of a $150 mil­lion B round and $20 mil­lion in ven­ture debt from Per­cep­tive. Co­bro, which co-led the B round, holds 6.1% of stock af­ter the of­fer­ing. Per­cep­tive has 6.3%.

C4 hit Nas­daq on Fri­day un­der the tick­er $CC­CC.

On­corus priced 5.8 mil­lion shares at $15 apiece, the mid­point of a $14 to $16 range, pulling in $87 mil­lion. The biotech had ini­tial­ly filed for an $86 mil­lion IPO in Sep­tem­ber.

The biotech’s lead can­di­date, ON­CR-177, is cur­rent­ly in Phase I de­vel­op­ment for mul­ti­ple sol­id tu­mor can­cers, in­clud­ing squa­mous cell car­ci­no­ma of the head and neck, breast can­cer and melanoma. About $32 mil­lion of IPO pro­ceeds will be used to push the can­di­date, an on­colyt­ic Her­pes Sim­plex Virus (oHSV) vi­ral im­munother­a­py, through Phase I, ac­cord­ing to the com­pa­ny’s S-1/A fil­ing.

“We ex­pect to re­port pre­lim­i­nary da­ta from this tri­al in mul­ti­ple da­ta read­outs be­gin­ning in the sec­ond half of 2021 through the sec­ond half of 2022,” the fil­ing states.

On­corus land­ed a $79.5 mil­lion Se­ries B led by Cowen and Per­cep­tive Ad­vi­sors last year for its work in the on­colyt­ic virus space. So far, the biotech has spent $96.3 mil­lion.

“Not all on­colyt­ic virus­es are the same and I think the in­vestors that came in­to this round clear­ly saw that we were much dif­fer­ent than oth­ers that are out there,” CEO Ted Ash­burn told End­points.

Cowen holds 5.5% of the biotech’s shares af­ter the of­fer­ing, ac­cord­ing to the S-1/A. “En­ti­ties af­fil­i­at­ed with MPM Cap­i­tal” have 12.4%.

On­corus will be list­ed un­der the tick­er $ON­CR.

Last week, Nas­daq count­ed $11.3 bil­lion in biotech IPOs this year. A num­ber of fac­tors, in­clud­ing the Covid-19 pan­dem­ic, con­tributed to a “per­fect storm” for an IPO boom, Nas­daq head of health­care list­ings Jor­dan Saxe told End­points News. He es­ti­mat­ed there will be 65-70 biotech IPOs by the end of the year, on the low end.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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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 are 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 are 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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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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Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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