Thanks for sharing @LifeSciVC insightful background that is often left unknown. Persistence and resilence. Well done to Denali for getting this asset via the shuttle tech to patients
Congrats to Denali for their FDA Approval of AVLAYAH!
Fun bit of biotech history. The bi-specific shuttle technology used in Avlayah came from F-star, a European biotech we helped seed in 2006 (thx Regina Hodits). They were advancing a bi-specific mAb format for a range of uses. Image below is from their 2006 pitch to us.
F-star did a collaboration with Denali to use their "Fcab" technology for BBB shuttles in 2016, when the now 10-year old biotech was figuring out what programs to advance internally vs in collaboration https://t.co/C6jhGr6e6N
In 2018, seeing momentum in their BBB programs, Denali acquired the subsidiary housing the BBB technology, called F-star Gamma. https://t.co/PSF9MOOUnS
With the approval of Avlayah, F-star's original technology thesis finally made it to market for one of the many postulated uses... 20 years later... Atlas Fund VII, a 2005 vintage fund, will be getting a small but fun milestone payment for approval...
Biotech is a long game, played by teams across the ecosystem collaborating in different ways over decades. Huge kudos to Ryan Watts, @rtnarch, and the team at Denali for their persistence in pushing Avlayah forward to patients.
Reverend Jesse Jackson called on each of us to be heralds of change, to be messengers of hope; to step forward and say “Send me” wherever we have a chance to make an impact.
How fortunate we were that Jesse Jackson answered that call. What a great debt we owe to him.
Novartis Chief Strategy Officer Ronny Gal wrote that the US is at "risk of losing its edge" in early clinical trials to China. He explains some of China's advantages incl: "Chinese hospitals have stronger incentives to participate in trials. They are ranked & evaluated on participation in trials, notably early trials." A link to his Linked In post is in the reply:
A dozen years old, but curious how many of these little lies are still told around the #JPM26 conference....
"Top 10 Little White Lies Told At The JP Morgan Healthcare Conference"
https://t.co/0er4Beffn3
#Myeloma Paper of the Day: Genomically smoldering myeloma is not a distinct entity but an amalgam of patients w/ either #MGUS (lower mutational load & absence of copy number alterations on chromosome 8) or myeloma w/ already existing driver lesions: https://t.co/sBXh3isks4. #mmsm
Mark your calendars! #BiotechHangout & @BiotechTV are back again for our annual IRL networking event at #JPM26! Join us at Persona on Tuesday, January 13th from 7-10pm for a chance to meet up with biotech friends.
Interested in sponsoring the event? Reach out to [email protected] for more information. Additional registration information to come.
Great M&A slides from Lifesci Capital.
Interesting to see acquirers are mostly interested in "unique" programs in term of biology (new mechanisms, platforms and modalities) or stage (first in class) with limited appetite for more incremental improvements or less differentiated assets that are very popular with investors (bispecifics, ADCs, radiopharma, half life extended biologics etc)
Bullish biotech report from Stifel. Rates, risk on, M&A picking up & pharma desperate to fill patent cliff w/ $1.2 trillion of firepower, “biotech cleanse” (eg more quality names with late stage data after multi-year purge), specialist funds recovered, generalists coming back $XBI $IBB
Kappa Myeloma antigen (KMA) is found on the cell surface of abnormal plasma cells and uniquely not on normal plasma cells, preserving the immune response to fight cancer and infections. Learn more about our first in class clinical phase immunotherapy. @theMMRF@Myeloma_Society@IrenemGhobrial@PeterMacCC@DrSidMukherjee@HiraSMian
What do you think about the new FDA and its initiatives?
@daphnezohar and @KendalleOC discuss regulatory stability, making CRLs public, and more on Biotech Direct, BiotechTV's new policy discussion show.
Watch the full discussion: https://t.co/7jZU1bf0Ar
Primary immunodeficiencies like CVID & APDS can share similar clinical presentations such as recurrent, severe infections. Patients with a CVID diagnosis & non-infectious complications may benefit from genetic testing for APDS. US clinicians learn more: https://t.co/DlFuugt7rT
Researchers from the Ghobrial Lab have developed a blood test that could transform the diagnosis and monitoring of multiple myeloma and its precursor conditions. The new method, known as SWIFT-seq, utilizes single-cell sequencing to profile circulating tumor cells in the blood, offering a non-invasive alternative to traditional bone marrow biopsies.
Read more about this groundbreaking research: https://t.co/ncWPV6ExO9
Next-Gen CAR-T: Which Tech Hits the Clinic First?
Not all “next-generation” CAR-T ideas are equally close to human use.
Looking at current clinical pipelines, regulatory precedents, and what’s quietly moving through IND-enabling work, here’s how we see the race:
1️⃣ Cytokine Secreting (“Armored” CAR-T)
Already in multiple Ph1/2 trials (IL-15, IL-18). Adds a cytokine cassette to a standard CAR, so the regulatory lift is lighter. IL-18 is emerging as the safest, most effective way to boost infiltration into “cold” tumors without the severe CRS risk of IL-12.
2️⃣ Genetic Modifications (TET2, NR4A, PD-1 KO)
CRISPR/TALEN-edited CAR-Ts are in the clinic now. These “passive” edits avoid new receptor biology, making translation easier. Expect early use in allogeneic CAR-Ts, where persistence is critical.
3️⃣ Tandem CARs (Dual scFv)
Clinically active in BCMA+GPRC5D myeloma programs. Solid tumor adoption hinges on picking targets with strong co-expression and minimal off-tumor hits. Mesothelin+Claudin18.2 is one to watch.
*This is next up in the clinic - super exciting, particularly in solid tumor + logic gates etc.
4️⃣ Bispecific Secreting
Like cytokine-secreting CAR-Ts but secreting checkpoint-blocking antibodies. Complexity of in vivo antibody dosing slows development, but could take off if it replaces separate checkpoint therapy.
**coming soon
5️⃣ SynNotch / SNIPRs
Elegant but bespoke, needs a priming antigen plus payload antigen. First likely success will be in GBM with EGFRvIII priming, where normal tissue overlap is low.
***a bit further of
6️⃣ Orthogonal Cytokine Receptors
Mostly preclinical. Novel receptor-cytokine pairs will face extra scrutiny. Likely to debut in allo CAR-T manufacturing, where ex vivo “arming” avoids systemic dosing risks.
The big takeaway: The first wins will be incremental, not radical, building on known CAR backbones with minimal extra complexity. The truly novel control systems will follow once regulators and manufacturers have more comfort with the risk profile.