– Interim clinical data for SL-172154 in combination with azacitidine in TP53 mutant (TP53m) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) showed only modest improvement in median overall survival compared to azacitidine monotherapy benchmarks; further development of SL-172154 discontinued – – Prioritization to focus on SL-325, a first-in-class antagonist antibody to DR3, the receptor for TL1A, intended for clinical development in inflammatory bowel disease (IBD); IND filing expected in Q3 2025 – – SL-172154 associated restructuring expected to extend cash runway into 2027 – AUSTIN, TX and DURHAM, NC, USA I October 01, 2024 I Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with cancer and chronic immune-related diseases, today announced a strategic pipeline prioritization to include the discontinuation of its clinical program, SL-172154. The Company will turn its focus to SL-325, its DR3 antagonist antibody, and plans initial clinical development in patients with IBD, where TL1A/DR3 blocking antibodies have demonstrated compelling monotherapy efficacy. “We are disappointed that the promising complete remission rates we previously shared from our Phase 1 clinical trial did not translate to clinically meaningful improvements in median overall survival for TP53m AML and HR-MDS patients treated with SL-172154 in combination with azacitidine. We thank our clinical team and investigators for conducting an excellent clinical study, yet we must accept this result as it stands and move on to other opportunities with a higher probability of success,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. Dr. Schreiber continued, “We are announcing a strategic shift to focus on SL-325, a DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 signaling pathway. We believe SL-325 could be a first-in-class DR3 receptor blocking antibody, and that this approach will prove more potent than blocking TL1A, for many of the same reasons that blocking PD-1 has proven more potent than blocking PD-L1. This strategic shift in our clinical development plans and subsequent realignment of our organization with an approximate 40% reduction in workforce will allow us to use our resources most efficiently to position Shattuck for long-term success. I would like to express my gratitude to the patients who participated in our clinical trials to date as well as to the Shattuck team members who were impacted by this realignment.” Top-line Phase 1B SL-172154 Clinical Trial Results HR-MDS TP53m AML Corporate Updates Financial Guidance Update As of June 30, 2024, cash and cash equivalents and investments were $105.3 million. Shattuck has implemented a restructuring plan to prioritize the development of the Company’s DR3 program. The plan is intended to optimize the Company’s cost structure by aligning the size and structure of its workforce with the Company’s current goals and strategy, following the discontinuation of SL-172154. Approximately 40% of Shattuck’s workforce will be impacted by the changes. The Company expects to complete the reduction in force in the fourth quarter of 2024. Given the changes to Shattuck’s operations and cost structure, the Company believes its cash and cash equivalents and investments will be sufficient to fund its planned operations into 2027, beyond results from its planned Phase 1 clinical trial of SL-325. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from potential business development transactions, and/or additional costs associated with additional development activities that may be undertaken. Shattuck Labs Investor Call and Webcast Shattuck will host a conference call and webcast at 8:00 a.m. ET on Tuesday, October 1, 2024, to discuss clinical data from SL-172154 and outline a strategic pipeline prioritization to focus on SL-325, a first-in-class DR3 antagonist targeting the TL1A/DR3 signaling pathway. Participants are invited to listen by dialing (800) 715-9871 (domestic) or +1 (646) 307-1963 (international) five minutes prior to the start of the call and providing the passcode 6989140. A live webcast presentation will be available here or on the company’s website at www.ShattuckLabs.com under Events & Presentations . A replay of the webcast will be archived on the company’s website following the presentation. About Shattuck Labs, Inc. Shattuck Labs, Inc. (Nasdaq: STTK) is a biotechnology company specializing in the development of potential treatments for autoimmune/inflammatory diseases and cancer. Shattuck is developing a potentially first-in-class antibody for the treatment of IBD and other inflammatory autoimmune diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor agonist and antagonist therapeutics come together in its lead program, SL-325, a first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 pathway. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com . SOURCE: Shattuck Labs

临床1期财报

2024-10-02

·Pharmaceutical Technology

Shattuck Labs stock craters following pipeline and job cuts

Following the restructuring news, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. Shutterstock: paper cut design / Shutterstock. Shattuck Labs has dropped by nearly 45% after it announced plans to reduce its headcount and discontinue its lead cancer therapy programme, SL-172154. The restructuring decision was made after interim data from a Phase Ib trial (NCT05275439) showed a lack of a definitive overall survival (OS) benefit in patients receiving SL-172154. The company added that the ‘modest’ improvements in the OS seen in Phase I would likely erode in larger late-stage studies. Following the announcement, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. The company’s market cap currently stands at $81.6m. SL-172154 is a cluster of differentiation 47 (CD47) inhibitors, which were investigated as a treatment for myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). In February, Shattuck licensed out multiple potential drug candidates, including SL-172154, to Ono Pharmaceuticals in a deal worth more than $227m. As part of the restructuring, the companies have mutually terminated the agreement and Shattuck is “no longer required to satisfy any remaining performance obligations and will not receive any future research activity reimbursements or upfront, milestone, or royalty payments from Ono”. See Also: ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy The cost-saving measures also cull 40% of the workforce by the end of the year and will cost between $1.5m and $1.75m. Shattuck reported cash reserves of $105.3m as of 30 June, as per the latest SEC filing by the company. The company plans to funnel its remaining resources into developing its antibody therapy, SL-325. The DR3 antagonist acts by modulating adaptive immunity, as DR3 is expressed on the cell surface of various immune cells. Shattuck is developing SL-325 as a treatment for inflammatory autoimmune diseases, including inflammatory bowel disease (IBD). The company plans to file an investigational new drug application (IND) for SL-325 in Q3 2025. Shattuck noted that it has sufficient funds to finance beyond its planned Phase I clinical trial of SL-325 and into 2027. Following the recent round of lay-offs, Shattuck joins the list of pharmaceutical companies, including Atreca , Candel Therapeutics , Cidara Therapeutics , Kinnate Bio , and NexImmune , which have cut their workforces to reallocate funds into their clinical development pipelines in the last few months.

临床1期免疫疗法引进/卖出临床申请

2024-10-01

·FierceBiotech

Shattuck axes CD47 program over weak efficacy data, lays off 40% of staff and loses Ono deal

Shares in Shattuck fell 51% to $1.72 in premarket trading. Shattuck Labs has hammered another nail into the coffin of CD47. After seeing a “modest” effect on survival in blood cancer, the biotech axed its candidate, pivoted to a preclinical program and gave 40% of its employees pink slips.The dropped molecule is a dual-sided fusion protein with three functional domains, a design intended to enable macrophages to eat cancer cells while activating antigen-presenting cells and avoiding anemia. As other companies dropped out of the space, Shattuck’s SL-172154 became the leading CD47 candidate in acute myeloid leukemia (AML).However, hopes that the company could buck the trend in CD47 have faded throughout 2024. Shattuck’s share price fell after the publication of interim data in May and June, falling from above $10 to below $4. Now, a third look at the data has persuaded Shattuck to drop the program.The biotech said it saw “only modest improvement in median overall survival compared to azacitidine monotherapy benchmarks.” In AML, the current median overall survival (OS) in patients who received SL-172154 and the chemotherapy drug azacitidine is 10.5 months and, at best, could reach 11.7 months. The benchmark for TP53m AML patients treated with azacitidine alone is five to eight months. In TP53m higher-risk myelodysplastic syndromes, Shattuck reported a median OS of 10.6 months that won’t improve beyond 13.1 months in subsequent data cuts. The biotech’s benchmark in that setting is 9 to 12 months. The data prompted the biotech to move on to “opportunities with a higher probability of success,” Shattuck CEO Taylor Schreiber, M.D., Ph.D., said in a statement.Shattuck is now focused on SL-325, a DR3 antagonist antibody. The biotech has identified DR3 blockade as a way to treat inflammatory bowel disease. Shattuck is aiming to file to test the antibody in humans in the third quarter of 2025. SL-325 acts on the same pathway as TL1A, the target of a molecule Roche bought for $7.1 billion. Shattuck believes targeting DR3 rather than TL1A will improve potency.The company will need fewer employees to execute its revised strategy. Having ended last year with 75 full-time employees across two sites in Texas and North Carolina, Shattuck is now laying off 40% of its staffers. The change will result in restructuring charges of around $1.5 million but ultimately cut costs, extending the biotech’s cash runway into 2027 and beyond the delivery of phase 1 data on SL-325.Shattuck shared details of the changes alongside news of the end of its deal with Ono Pharmaceutical. Ono paid $2 million upfront in February to collaborate on bifunctional fusion proteins directed toward a pair of targets for the potential treatment of autoimmune and inflammatory diseases. The Japanese drug developer put up $3.4 million to fund the first six months of research. Rather than continue the collaboration, Shattuck and Ono have mutually agreed to terminate the license deal. The termination deprives Shattuck of the chance to pocket more payments from Ono, including up to $7 million tied to research milestones, but also frees the biotech from performance obligations.Shares in Shattuck fell 51% to $1.72 in premarket trading.