Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the wind­fall of cash drop­ping biotech’s way on Wall Street is abat­ing. Three more bio­phar­mas priced IPOs on Thurs­day and Fri­day morn­ing, rid­ing a his­toric boom with a $364 mil­lion pay­off.

Lon­don-based biotech Free­line Ther­a­peu­tics took home the li­on’s share of the cash with $159 mil­lion af­ter pric­ing 8,823,529 shares at $18 a pop. Check­mate Phar­ma­ceu­ti­cals, of Cam­bridge, MA, raised $75 mil­lion with an of­fer of 5 mil­lion shares at $15 — right at the mid­point of its range. And Arya Sci­ences Ac­qui­si­tion Corp III, the third in a se­ries from Per­cep­tive, priced 13,000,000 shares at $10 per share.

Drug­mak­ers are se­cur­ing big sums amid the pan­dem­ic boom, in­clud­ing AlloVir, which bagged $276 mil­lion from 16.3 mil­lion shares last week. Ini­tial­ly, the com­pa­ny had filed for a $100 mil­lion IPO. By June, all 23 new­ly pub­lic com­pa­nies had priced above their mid­point or up­sized their of­fer­ing.

And there’s more com­ing: Kymera Ther­a­peu­tics an­nounced plans to go pub­lic on Mon­day, when it filed for a $100 mil­lion IPO.

Check­mate ini­tial­ly filed for an IPO on Ju­ly 17, then raised its max­i­mum of­fer­ing price to $92 mil­lion in an amend­ed S-1 fil­ing. The im­muno-on­col­o­gy biotech is in­ves­ti­gat­ing its drug CMP-001 across mul­ti­ple can­cers, in­clud­ing melanoma and head and neck squa­mous cell car­ci­no­ma (HN­SCC), and says it will use the funds to ad­vance clin­i­cal tri­als. Bo­fA Se­cu­ri­ties, Jef­feries Group and BMO Cap­i­tal Mar­kets are man­ag­ing the deal.

CMP-001 us­es the im­mune sys­tem to its ad­van­tage, di­rect­ing ac­ti­vat­ed an­ti-tu­mor T cells to at­tack both the in­ject­ed tu­mor and tu­mors through­out the body. It’s been test­ed on more than 200 melanoma pa­tients to date, and based on clin­i­cal da­ta, the com­pa­ny be­lieves “there is an op­por­tu­ni­ty for CMP-001 to be de­vel­oped as a dif­fer­en­ti­at­ed im­muno-on­col­o­gy ther­a­py,” ac­cord­ing to the S-1 fil­ing.

Free­line ini­tial­ly filed for a $100 mil­lion IPO, with JP Mor­gan Se­cu­ri­ties LLC, Mor­gan Stan­ley & Co. and Ever­core Group as joint bookrun­ners. Its AAV gene-ther­a­py treat­ments tar­get he­mo­phil­ia A and B, Fab­ry dis­ease, and Type 1 Gauch­er dis­ease.

The biotech’s lead can­di­date, FLT180a, is cur­rent­ly in a Phase I/II tri­al for he­mo­phil­ia B. IPO funds will pro­pel the com­pa­ny’s pipeline, in­clud­ing Phase I/II tri­als for FLT180a and FLT190, a po­ten­tial drug to treat Fab­ry dis­ease.

SPACs (spe­cial pur­pose ac­qui­si­tion com­pa­nies) are ben­e­fit­ing from the boom, too. Once rare in the biotech world, they now rep­re­sent near­ly 35% of list­ings, Nas­daq’s Jay Heller told End­points last month.

Per­cep­tive Ad­vi­sors’ blank check com­pa­ny Arya III filed for a $143.7 mil­lion IPO on Ju­ly 21, and in­vestors are bet­ting on a prof­itable merg­er. In March, Arya I merged with biotech Im­mat­ics in a $252 mil­lion deal. Cerev­el Ther­a­peu­tics merged with Arya II in Ju­ly, ex­pect­ing to raise about $445 mil­lion to de­vel­op its pipeline.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.