Damian Clarke-Bruce

Global Healthcare Executive, Biotech, Pharmaceuticals, CEO/Board-member/GAICD

[Damian Clarke-Bruce @DCB_BioPharma]

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

[Bruce Booth @LifeSciVC]

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.

[Barack Obama @BarackObama]

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.

[Pearl Freier @PearlF]

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:

[Bruce Booth @LifeSciVC]

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

[Robert Z. Orlowski @Myeloma_Doc]

#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

[Brad Loncar @bradloncar]

In vivo CAR-T is looking good!

[Brad Loncar @bradloncar]

The #JPM26 schedule is already out.

[Biotech Hangout @BiotechCH]

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.

[Brad Loncar @bradloncar]

Be sure to follow @BiotechTV’s social channels here on X and beyond to catch my coverage of ASH this week.

[BiotechTV @BiotechTV]

𝐉𝐞𝐟𝐟𝐞𝐫𝐢𝐞𝐬 𝐋𝐨𝐧𝐝𝐨𝐧: @Jefferies M&A Banker Chris Roop shares his take on the environment for deals in biotech.

Full video: https://t.co/5Qaxo7y7VT

[Oncology Brothers @OncBrothers]

We now have more data on adj CDK4/6i at #ESMO25 + we’ll continue to use these Rx in metastatic settings as well. This is the table we’ve used (AEs + doses) for #Ribociclib #Abemaciclib, + #Palbociclib w/ @DrSGraff for our #ToxCheck 🗣️

#bcsm #OncTwitter @OncoAlert @OncUpdates

[Ohad Hammer @ohadhammer]

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)

[Daphne Zohar @daphnezohar]

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

[Daphne Zohar @daphnezohar]

Re China, BIOSECURE Act is back in play. Potential Impact on the Biotech Industry: https://t.co/X2ySthqcy8 ht @SamDavisEsq $XBI $IBB

[HaemaLogiX Ltd @HaemaLogiX]

We’re pleased to share CEO Damian Clarke-Bruce’s (@DCB_BioPharma) presentation from the 19th @Bioshares Biotech Summit, highlighting progress on our next-gen immunotherapies targeting malignant plasma cells while preserving healthy immune function.

https://t.co/hiDxp3AwGl

[Damian Clarke-Bruce @DCB_BioPharma]

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

[Damian Clarke-Bruce @DCB_BioPharma]

Excellent insights for all global biotech’s seeking understanding of the U.S. Biopharma political and regulatory environment. Full discussion a must see Thank you @bradloncar @KendalleOC @daphnezohar @AusBiotech @HaemaLogiX @PeterMacCC

[BiotechTV @BiotechTV]

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

[AllaboutAPDS @AllaboutAPDS]

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

[Dana-Farber @DanaFarber]

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

[BowTiedBiotech 🧪🔬🧬 @BowTiedBiotech]

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.