Nello Mainolfi, Kymera CEO (via YouTube)

Kymera, rais­ing $173M+, be­comes the 48th biotech IPO of the year as 2020 sur­pass­es 2019

Yet an­oth­er biotech will hit Nas­daq on Fri­day, and this one marks a mile­stone for 2020.

Cam­bridge, MA-based Kymera has priced its IPO, an­nounc­ing a pub­lic price of $20 per share and $173.7 mil­lion raise. That’s up­sized from an ini­tial range of $16 to $18 per share, and would give the com­pa­ny a mar­ket val­ue north of $900 mil­lion.

The an­nounce­ment marks the 48th biotech IPO to go pub­lic this year, sur­pass­ing the to­tal from all of 2019, ac­cord­ing to in­vest­ment an­a­lyst Brad Lon­car. Kymera’s tick­er will be $KYMR.

Launch­ing from stealth mode out of an At­las-backed in­cu­ba­tor in 2017, Kymera has been at or near the fore­front of pro­tein degra­da­tion R&D, join­ing oth­er pi­o­neers C4 Ther­a­peu­tics, Arv­inas and Nurix. Kymera has marched for­ward steadi­ly since then, nab­bing $102 mil­lion in a Se­ries C back in March and agree­ing to a col­lab­o­ra­tion with Sanofi in Ju­ly po­ten­tial­ly worth more than $2 bil­lion.

The biotech is fo­cus­ing re­search on a trio of lead pro­grams de­signed to de­grade IRAK4, IRAKIMiD and STAT3, re­spec­tive­ly. IRAK4 was the star of the Sanofi pact, a tar­get that sits down­stream of “one of the most val­i­dat­ed path­ways in in­nate im­mu­ni­ty,” Kymera CEO Nel­lo Main­olfi pre­vi­ous­ly told End­points News, re­fer­ring to where the IL-1 cy­tokine fam­i­ly and toll-like re­cep­tor sig­nal­ing con­verges.

Pro­ceeds from Fri­day’s IPO are ex­pect­ed to fund the de­vel­op­ment of not on­ly the IRAK4 pro­gram, dubbed KT-474, but the oth­er lead stud­ies through the end of Phase I. Kymera is ex­pect­ed to file its first IND for KT-474 some­time in the first half of 2021, with fil­ings for the oth­er two com­ing lat­er in the year.

Kymera is like­ly look­ing to be­come the sec­ond biotech to bring a pro­tein degra­da­tion pro­gram in­to the clin­ic, af­ter Arv­inas’ pro­tein de­grad­er, an an­dro­gen re­cep­tor-tar­get­ing drug for prostate can­cer, reached hu­man test­ing in 2019. Nurix and C4 Ther­a­peu­tics have not be­gun any clin­i­cal stud­ies yet ei­ther, though the duo have inked col­lab­o­ra­tions with Gilead and Roche, re­spec­tive­ly.

While its pro­tein degra­da­tion com­peti­tors have fo­cused main­ly on can­cers, Kymera has branched out in­to in­flam­ma­to­ry and au­toim­mune dis­eases, as well as fi­bro­sis. The com­pa­ny pro­filed about 600 E3 lig­as­es with its plat­form, at­tract­ing both Sanofi and Ver­tex to sign col­lab­o­ra­tion deals.

Sanofi is like­ly aim­ing to find a suc­ces­sor to its block­buster drug Dupix­ent, and hopes they have found an­oth­er di­a­mond in the rough in KT-474. As part of the agree­ment, the French phar­ma would take the lead on Phase II test­ing once Kymera fin­ish­es first-in-hu­man test­ing.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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