Iso­Plex­is aims to steer its 'bar­codes' to Nas­daq as Asia-fo­cused SPAC launch­es merg­er ef­forts

The biotech IPO train con­tin­ues steadi­ly chug­ging along, with a new pas­sen­ger punch­ing their tick­et late Tues­day.

Bran­ford, CT-based Iso­Plex­is is jump­ing aboard, sub­mit­ting its SEC pa­per­work with a $100 mil­lion ask pen­ciled in and aim­ing to bring its per­son­al­ized pro­tein “bar­codes” to Nas­daq. Tues­day’s S-1 comes a lit­tle over six months af­ter Iso­Plex­is nabbed a $135 mil­lion Se­ries D led by Per­cep­tive.

The fil­ing marks the lat­est in a long string of biotechs that joined the Nas­daq par­ty this year, and one Nas­daq of­fi­cial Jor­dan Saxe ex­pects to con­tin­ue. In a con­ver­sa­tion with End­points News ear­li­er this month, Saxe said the in­dex is in dis­cus­sions with about 250 biotechs aim­ing to list over the next year and a half.

Iso­Plex­is is charg­ing ahead with its plan to per­son­al­ize can­cer treat­ment us­ing its sin­gle-cell analy­sis tool to re­fine im­munother­a­pies. That tool has helped re­searchers cre­ate what the com­pa­ny calls “pro­teom­ic bar­code chips,” al­low­ing clos­er ex­am­i­na­tion of a pa­tient’s com­ple­ment of pro­teins with­in cells.

Though Iso­Plex­is is fo­cus­ing on can­cer right now, they have am­bi­tions to ex­pand in­to in­fec­tious dis­eases, in­flam­ma­to­ry con­di­tions and neu­ro­log­i­cal dis­eases, the S-1 said. The com­pa­ny be­lieves the sin­gle-cell ap­proach is key here, as it ar­gues pre­vi­ous pro­teomics ap­proach­es fo­cus on­ly on av­er­age cell ac­tiv­i­ty in the ag­gre­gate.

Sean Mack­ay

Re­searchers uti­lize Iso­Plex­is’ sys­tems for the analy­sis of func­tion­al pro­teins from sin­gle cells on “pro­teom­i­cal­ly bar­cod­ed” chips. Af­ter the chip is run on the Iso­Plex­is in­stru­ment, the com­pa­ny runs it through a soft­ware it de­vel­oped to an­a­lyze how a per­son’s im­mune sys­tem might re­spond to dif­fer­ent treat­ments, in a process CEO Sean Mack­ay termed “sin­gle-cell im­mune land­scap­ing” in an in­ter­view with End­points in Jan­u­ary.

Iso­Plex­is did not re­veal its plans on how it ex­pects to use IPO funds, say­ing on­ly in the S-1, “At this time we can­not spec­i­fy with cer­tain­ty the par­tic­u­lar us­es for the net pro­ceeds from this of­fer­ing.” The biotech fur­ther didn’t re­veal how much of the com­pa­ny each stake­hold­er owns, though it did say Mack­ay is the high­est-paid di­rec­tor af­ter he took home near­ly $1 mil­lion last year.

$50M Asia-fo­cused SPAC files for Nas­daq list­ing

Tues­day al­so saw the for­ma­tion of a new blank check com­pa­ny tar­get­ing the biotech sec­tor.

The SPAC comes from the CEO of phar­ma VC firm The Bal­loch Group, Ed­ward Wang. Wang plans to fo­cus ac­qui­si­tion ef­forts on a com­pa­ny based in Asia, and is pen­cil­ing in $50 mil­lion for the blank check raise.

In ad­di­tion to biotech, Wang not­ed he is al­so ex­plor­ing a merg­er with a com­pa­ny in the new en­er­gy and ed­u­ca­tion sec­tors. Cur­rent plans will cen­ter around a com­pa­ny val­ued be­tween $150 mil­lion and $300 mil­lion.

Ac­cord­ing to the S-1, the SPAC has con­nec­tions to a for­mer Chi­nese youth trav­el di­rec­tor, as CFO Yi Zhong served in this ca­pac­i­ty for 16 months be­tween 2016 and 2017. An­oth­er di­rec­tor, Ray­mond Gibbs, al­so spent time in the con­sumer goods in­dus­try.

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.

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.

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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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

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