Steven Kafka (Section 32)

Deer­field and ARCH back a new $200M SPAC run by Cal­i­for­nia VC firm

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Two promi­nent life sci­ences firms have teamed up to spon­sor a new SPAC that made its way to Nas­daq on Tues­day evening.

Deer­field Man­age­ment and ARCH Ven­ture Part­ners are back­ing the blank check com­pa­ny known as DA32 Life Sci­ence Tech Ac­qui­si­tion Corp., which priced at $200 mil­lion Mon­day, the firms an­nounced. The pair is team­ing up with Cal­i­for­nia-based VC firm Sec­tion 32, whose man­ag­ing part­ner Steven Kaf­ka will run the SPAC.

Ax­ios had first re­port­ed a SPAC might be in the works back in ear­ly June.

Though ARCH pre­vi­ous­ly launched a blank check com­pa­ny when Bob Nelsen and for­mer Ver­tex CEO Jeff Lei­den got a $500 mil­lion SPAC off the ground in March, Nelsen won’t be in­volved in this ef­fort. The high-pro­file in­vestor was not men­tioned in the blank check com­pa­ny’s S-1.

In­stead, it will be ARCH co-founder Kei­th Cran­dell run­ning point for the firm, as Cran­dell nabs a seat on the SPAC’s board of di­rec­tors. He’ll join Deer­field part­ner An­drew El­Bardis­si and SPAC CFO Christo­pher Wolfe, who the S-1 said has man­aged fi­nan­cials for at least three pre­vi­ous blank check com­pa­nies for Deer­field pri­or to their merg­ers.

Wolfe is the on­ly di­rec­tor with any per­son­al shares in the blank check com­pa­ny, tak­ing home a 2.5% stake.

Kaf­ka, mean­while, has com­plet­ed his meta­mor­pho­sis from his pre­vi­ous stint as a biotech CEO. Be­gin­ning in April 2019, Kaf­ka worked as founder and CEO of can­cer blood test com­pa­ny Thrive Ear­li­er De­tec­tion, be­fore Ex­act Sci­ences bought it out in an Oc­to­ber 2020 cash and stock deal for up to $2.15 bil­lion.

Pri­or to join­ing Thrive, Kaf­ka had served as COO of Foun­da­tion Med­i­cine for about five years be­fore Roche ac­quired it for $2.4 bil­lion back in 2018.

Un­like the pre­vi­ous ARCH SPAC, which hint­ed to­ward a fo­cus on “tech­nolo­gies like wear­able sen­sors, re­mote con­tin­u­ous da­ta cap­ture, point of care di­ag­nos­tics, tele­health ca­pa­bil­i­ties and ar­ti­fi­cial in­tel­li­gence/ma­chine learn­ing tools,” the new blank check out­fit is pro­vid­ing few­er de­tails on po­ten­tial tar­gets.

The S-1 al­so in­clud­ed much of the boil­er­plate lan­guage that’s be­come com­mon through­out the SPAC boom of the last 12 to 18 months, in­clud­ing sev­er­al men­tions that the SPAC is “not pro­hib­it­ed” from pur­su­ing a merg­er with any of the di­rec­tors’ af­fil­i­at­ed com­pa­nies.

The mar­ket saw a mas­sive in­flux of SPACs at the be­gin­ning of the year, with more than 300 across all sec­tors be­ing filed or priced in the first quar­ter alone. But with that ac­tiv­i­ty came big­ger scruti­ny from reg­u­la­tors, with the SEC be­gin­ning to ask fi­nan­cial in­sti­tu­tions to vol­un­tar­i­ly pro­vide doc­u­ments over how they were in­ter­nal­ly polic­ing such blank check ef­forts.

Ac­tiv­i­ty has ramped back up since then, though not to the mar­ket’s pre­vi­ous heights. And the glut of SPACs has brought an uptick in merg­ers over the last few months, with near­ly a dozen life sci­ences re­verse merg­ers oc­cur­ring in the sec­ond quar­ter, per the End­points News tal­ly. Over­all, SPACs have brought more than $17 bil­lion to the biotech sec­tor in 2021.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Wen Wang, IASO CEO

Chi­nese CAR-T play­er books a megaround to dri­ve bustling cell ther­a­py port­fo­lio through the clin­ic

China has quickly emerged as a major driver of oncology R&D in recent years, particularly in cell therapies where the potential for cheaper development has investors drooling. Now, one player, with a handful of early data, is swimming in a new round of investor cash.

IASO Bio has closed a $108 million Series C that the Chinese and California-based biotech said it will use to advance its slate of cell therapy lead programs, while also propping up a roster of next-gen allogeneic cell therapies for the future, according to a release.