Can you introduce Arcellx and the firm’s pipeline?

Our mission is to pioneer transformative technologies. Central to our approach is our proprietary D-Domain, a synthetic binding domain that serves as the foundation for our innovative therapies.

Our leading drug candidate, anitocabtagene autoleucel (anito-cel), represents a significant advancement in CAR-T therapy for relapsed or refractory multiple myeloma (rrMM). At the American Society of Hematology (ASH) conference last year, we presented new data from our Phase 1 expansion trial of anito-cel, with the data demonstrating continued long-term responses. Of the 38 evaluable patients with a median follow-up of 26.5 months following treatment, we observed a 100% overall response rate and a complete response or a stringent complete response rate of 76%. Additionally, 92% of evaluable patients had a very good partial response or higher, indicating the potential for anito-cel to be a best-in-class autologous CAR-T therapy. Importantly, our therapy demonstrated a unique safety profile with no instances of delayed neurotoxicity or Parkinsonian symptoms, setting it apart from existing CAR-T therapies on the market.

In addition to anito-cel, we are excited about our ARC-SparX program. ARC-SparX offers a modular approach to cell therapy, enhancing controllability and adaptability as a dosable CAR-T therapy. We have ongoing clinical programs, including ACLX-001 for rrMM and ACLX-002 for relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome. These programs hold promise for addressing disease heterogeneity and expanding therapeutic options for patients.

From a business perspective, we are listed under the NASDAQ ticker symbol “ACLX” and in December 2022, we entered a strategic partnership with Kite, a Gilead Company, to co-develop and co-commercialize anito-cel in the US. This past November, we were excited to announce an expansion in that partnership. Can you elaborate on the D-Domain technology and its potential to revolutionize cell therapy?

It is a novel synthetic binding domain scaffold, distinct from traditional ScFv used in CAR-T therapies. The D-Domain is smaller and more stable, offering unique advantages in both manufacturing and clinical efficacy. In manufacturing, we observe high CAR positivity, leading to potentially improved efficacy and safety profiles. Additionally, there is remarkable consistency across all patients, which is critical for scaling autologous cell therapies. Our Phase 1 data confirm this advantage, supporting our collaboration with Kite to scale therapy for multiple myeloma. Can you discuss the future of your lead drug candidate?

Looking ahead in 2024, we are focused on completing enrollment in iMMagine-1, our pivotal Phase 2 study of anito-cel. Our plans include presenting preliminary clinical data from iMMagine-1 by year-end.

We are also collaborating closely with Kite on designing earlier-stage trials for rrMM and preparing for commercialization to address an underserved market for patients with multiple myeloma. How do you assess the attractiveness of the oncology space for investors?

Oncology remains a high priority, as evidenced by recent financing trends, where approximately a quarter of recent funding has been directed towards oncology. This influx of capital is likely to bolster funding opportunities not only for oncology but also for the broader biotech sector. What is your analysis of the current funding environment for biotechs in the US?

The current funding landscape for biotechs in the US is heavily reliant on the ability to showcase data and upcoming clinical milestones. Beyond just presenting data, having a robust leadership team is paramount. When we took Arcellx public in 2022, we prioritized assembling a diverse and experienced leadership team. A diverse team not only enhances decision-making but also demonstrates our commitment to inclusivity, which is increasingly valued by investors.

Artificial intelligence is also undeniably significant in the current market landscape. We are particularly seeing its potential in target identification, especially concerning synthetic domains and optimized targets. The key is to judiciously integrate AI where it adds value. How do you view the current state of the life sciences industry, and what excites you about its future?

I believe the market has significantly picked up with increased financing and M&A activity, particularly in promising oncology and life sciences innovation. At Arcellx, we are thrilled about advancing our programs and transitioning into the commercialization phase alongside our partners at Kite. Our collaboration positions us well for scaling our business, especially in autologous cell therapy, where reliability and scalability are paramount.