On January 11, 2022 2seventy bio, Inc. (Nasdaq: TSVT), an emerging immuno-oncology cell therapy company, reported an update on the company’s outlook for 2022 (Press release, 2seventy bio, JAN 11, 2022, View Source [SID1234598573]).
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"It has been a privilege to launch 2seventy bio with such a strong foundation out of the gate including a first-in-class CAR-T for multiple myeloma with $1-2B late lines global peak sales potential, a highly differentiated product engine already delivering candidates to the clinic, strong financial health with a disciplined operating structure and a team that has extensive experience in the cell therapy field," said Nick Leschly, chief kairos officer. "As we double down on our goal of leading the future of oncology cell therapy, our vision is simple: design, learn and iterate to build the most powerful T-cell based solutions for patients with cancer. We are one of few companies that have the tools, infrastructure, experience and heart to deliver these new medicines with potential to create more time for our patients."
ABECMA
Since receiving FDA approval for ABECMA on March 26, 2021, ABECMA has generated approximately $150M in total U.S. revenue, which is shared equally by 2seventy bio and Bristol Myers Squibb (BMS). In response to significant demand, 2seventy bio and BMS are investing to increase capacity across the supply chain, with the goal to improve capacity and treat substantially more patients in the U.S. commercial setting. We anticipate U.S. revenue of $250-300M in 2022. We expect revenue to be driven by continued strong demand in 2022-2023 and to grow into 2023 and beyond. We continue to invest in earlier lines of therapy with data anticipated from the proof-of-concept KarMMa-2 study in second-line patients by the end of 2022, and potentially pivotal data, anticipated in 2023, from the registrational KarMMa-3 study in third-line patients. Based on the forecasted commercial ramp and the investment in earlier lines of therapy, we expect that ABECMA’s success will contribute cash back to fund the rest of the 2seventy bio pipeline starting in 2023.
Recently presented results from the ongoing CRB-402 clinical study of bb21217, a next-generation anti-BCMA CAR T, confirmed the hypothesis that bb21217 has more naïve T cell-phenotype and delivered encouraging durability of responses for patients achieving complete response. Based on the strength of the ABECMA clinical data and high commercial interest, 2seventy bio and BMS do not plan to pursue further development of bb21217. 2seventy bio will leverage the learnings from this program to further strengthen its oncology pipeline.
PIPELINE
"With the IND for our first regulatable CAR T cell program (SC-DARIC33 for the treatment of pediatric and young adult AML), in collaboration with Seattle Children’s Therapeutics, cleared earlier in 2021 and the recent clearance of the IND for our bbT369 program for the treatment of B-NHL, we have achieved our goal of delivering two INDs in 2021," said Philip Gregory, D.Phil., chief scientific officer. "More than just numbers, each of these programs is an example of the type of bold and innovative product candidates that will be the hallmark of 2seventy bio’s medicines. Of course, this is just the beginning of what we anticipate emerging from our research engine, which is fueled by a suite of tools and technologies that enable us to focus on the biology of cancer and create fit-for-purpose cell therapies with the goal of achieving deep and durable responses."
bbT369 IND Cleared – In December 2021, the FDA cleared the Investigational New Drug (IND) application for bbT369, an investigational dual-targeted CAR T cell therapy with a gene edit for patients with relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL). bbT369 has three layers of innovation. First, it targets a novel combination of antigens highly expressed in B cell lymphomas (CD79a and CD20) in an effort to achieve improved anti-tumor efficacy and to address antigen escape, a known mechanism of resistance to CD19-targeted CAR T cell therapy. Second, we provide split co-stimulation to drive robust T cell activation in response to either antigen. Third, the CAR T cell is also edited to remove CBLB, a negative regulator of T cell function, which we believe will drive increased expansion, resist anergy and maintain potency in sub-optimal conditions for T cell activation. Preclinical studies demonstrated bbT369 activity against single and low antigen tumors and achieved deep and durable responses. CRC-403 (NCT05169489), an open-label, multi-site Phase 1/2 dose-escalation study of bbT369, will begin enrollment in early 2022 and will serve as a proof-of-concept assessment of 2seventy bio’s proprietary gene editing platform, dual-targeting strategies and split co-stimulation signaling technology.
MUC-16 Program – Today, as part of a strategic collaboration between Regeneron and 2seventy bio, the companies named their first CAR-based solid tumor program utilizing bbT4015, an engineered CAR T cell therapy targeting MUC16. MUC16 is a large extracellular protein expressed on >80% of ovarian tumors. Preclinical data have shown robust single agent (CAR T alone) activity, including in stringent tumor rechallenge models. This program represents a platform for titratable pharmacologic combination approaches to enhance CAR T cell activity with the goal of developing a best-in-class cell therapy. The companies anticipate pursuing an IND in 2023.
FINANCIAL OUTLOOK
2seventy bio entered 2022 with approximately $360M in cash, cash equivalents and marketable securities. The company has done significant work and prioritization in order to reshape the cost structure and increase the proportion of investment on R&D while streamlining general and administrative costs. 2seventy bio anticipates a net cash spend of $220-250M for 2022 and a cash runway into the second half of 2023 based on existing cash, cash equivalents and marketable securities.
UPCOMING ANTICIPATED MILESTONES
ABECMA
Anticipate $250-300M total U.S. revenue in 2022
Increasing manufacturing capacity throughout 2022
KarMMa-2 study in 2L proof-of-concept data in 2022
KarMMa-3 study in 3L+ registrational data in 2023
Pipeline
Infusion of first patients in PLAT-08 study of SC-DARIC33 in AML in 2022
Initial assessment of feasibility of SC-DARIC33 drug product manufacturing and drug regulated anti-CD33 activity in 2H 2022
Infusion of first patients in CRC-403 study of bbT369 in B-NHL in 2022
Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety in 2H 2022
Investor Content Available on 2seventybio.com
An updated corporate presentation can be found on the investor relations section of our website, View Source For more detail on 2seventy bio’s pipeline, programs and strategic vision, please visit View Source to view video messages from our leadership team.
About ABECMA (idecabtagene vicleucel; ide-cel)
ABECMA is the first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy approved in the U.S. for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. ABECMA has also received approval in the European Union, Canada and Switzerland. ABECMA recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion and subsequent cytolytic killing of BCMA-expressing cells. ABECMA is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion and Profit Share Agreement with 2seventy bio and Bristol Myers Squibb. Bristol Myers Squibb continues to assume sole responsibility for ABECMA drug product manufacturing and commercialization outside of the U.S.
2seventy bio and Bristol Myers Squibb’s broad clinical development program for ABECMA includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4, KarMMa-7) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.