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Pathfinders in Biopharma

Cidara’s pursuit of universal flu protection with a single dose

12 min episode · 2 min read
·
A Single Dose

Episode

12 min

Read time

2 min

Topics

Relationships, Fundraising & VC, Leadership

AI-Generated Summary

Key Takeaways

  • Universal flu protection gap: Over 50 million high-risk or immunocompromised Americans fail to mount adequate responses to flu vaccines, creating a population entirely unserved by current prevention tools. CD388 bypasses immune response requirements by functioning as a direct antiviral, not a vaccine.
  • Neuraminidase targeting strategy: CD388 targets a universally conserved active site on neuraminidase that remains identical across all influenza strains year after year. This eliminates the annual strain-guessing problem that caused vaccine mismatch during the most severe flu season in 17 years.
  • Phase 2b enrollment execution: Cidara fully enrolled a 5,000-subject Phase 2b trial within 10 weeks, running September through December 2024 with a 40-person team. The trial coincided with a historically severe flu season, increasing the statistical likelihood of generating meaningful efficacy data.
  • Reclaiming partnership rights: After J&J exited infectious disease in 2023, Cidara raised a $240 million PIPE financing to outcompete large pharma companies and reacquire full global rights to CD388 with zero royalty obligations, shifting from partner-dependent to fully independent development.

What It Covers

Cidara Therapeutics CEO Jeff Stein discusses CD388, a single-dose antifungal-to-antiviral platform molecule targeting neuraminidase to deliver universal influenza protection across all strains, including for 50 million immunocompromised Americans who cannot respond to conventional vaccines.

Key Questions Answered

  • Universal flu protection gap: Over 50 million high-risk or immunocompromised Americans fail to mount adequate responses to flu vaccines, creating a population entirely unserved by current prevention tools. CD388 bypasses immune response requirements by functioning as a direct antiviral, not a vaccine.
  • Neuraminidase targeting strategy: CD388 targets a universally conserved active site on neuraminidase that remains identical across all influenza strains year after year. This eliminates the annual strain-guessing problem that caused vaccine mismatch during the most severe flu season in 17 years.
  • Phase 2b enrollment execution: Cidara fully enrolled a 5,000-subject Phase 2b trial within 10 weeks, running September through December 2024 with a 40-person team. The trial coincided with a historically severe flu season, increasing the statistical likelihood of generating meaningful efficacy data.
  • Reclaiming partnership rights: After J&J exited infectious disease in 2023, Cidara raised a $240 million PIPE financing to outcompete large pharma companies and reacquire full global rights to CD388 with zero royalty obligations, shifting from partner-dependent to fully independent development.

Notable Moment

Stein revealed that despite widespread concern about FDA leadership disruptions, Cidara has experienced no regulatory delays and has actually seen faster-than-expected agency interactions, contradicting the prevailing anxiety across the biopharma sector.

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Episode Transcript

Welcome back to Pathfinders, a podcast series from RBC Capital Markets where we uncover the key trends and catalysts shaping the fast moving world of biopharma and health care. I'm your host, Joe Colletti. Today, I'm joined by doctor Jeff Stein, president and CEO of Saidara Therapeutics, a clinical stage company developing long acting immunotherapies through its Cloudbreak platform. We'll talk to him about the company's lead antiviral program, its expansion into oncology, and how the company's navigating the fast changing landscape of biotech. Doctor Stein, thanks for joining us. Joe, thanks a bunch. I'm really excited about this. So I wanted to start off for those that may not be as familiar with Sadara and maybe talk a little little about your mission. How do you define the company's core purpose, and what unmet needs are you aiming to address? Yeah. So Sidara has been around since 2014 when we founded, and we were founded on the concept of applying bispecific immunotherapy to infectious disease. That was obviously early days. We got public pretty quickly. Went public, in 2015. That was based on our lead program in antifungal, which was not in immuno therapy, but it was a very compelling opportunity for us to advance something in infectious disease. And back then, this was a tremendous unmet need. We took that molecule, resifungent, from preclinical to approval in 2023 in The US and in Europe. Along the way, this immunotherapy platform evolved up into the point in 2018 when we discovered our current lead molecule, CD three eighty eight, which is potentially transformational, is the truly first opportunity to have universal protection against influenza. And I use that term in its broadest sense. The term universal influenza vaccine has been around for over twenty years. It has been a kind of a holy grail of big pharma companies trying to make something that's broadly protective that can protect year after year against a changing flu virus, including pandemic strains. It has never come to fruition. But let's assume that miraculously some company comes up with a universal vaccine. It's not gonna work in all people. As we learned during COVID, you have to have a robust immune response to respond to a vaccine. And as it turns out in The US, there are over fifty million people in high risk or immune compromised populations that simply don't respond to vaccines, or if they get a flu infection, it results in hospitalization or death. So this is an enormous population in The US. Sidera, our mission is to address this population with this first molecule, c d three eighty eight, which is designed to offer single dose universal protection against all strains of influenza in all people. I wanna stay on the CD three eighty h just for a second. You talked a little bit about maybe what it could mean for flu prevention in the future. I'd love if you have if you want to expand that a little …

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