CD47 x CD20

Expect to disclose initial SC262 clinical data in 2024SEATTLE, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed CAR T therapy. Engineered CAR T cell therapies for B-cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B-cell lymphoma and B-cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in approximately 60% of CD19 CAR T-treated patients. CD22, which is also a B-cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. SC262 expresses the same CAR, including the same CD22 binder, used in CD22-directed CAR T therapies tested in multiple academic clinical trials. To date, these trials have shown durable complete responses in a substantial number of patients in the relapse setting following treatment with a CD19-directed CAR T therapy. “Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies,” said Doug Williams, PhD, Sana’s President of Research and Development. “SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T therapy platform. Over the past twelve months, Sana has received three IND regulatory clearances, as well as supported the authorization of an investigator-sponsored CTA, to begin new studies utilizing our hypoimmune platform in seven different indications in oncology, B-cell mediated autoimmune diseases, and type 1 diabetes. We look forward to presenting data from all of these studies this year, including initial proof of concept data for SC262 later this year.” About SC262 in B-cell MalignanciesSC262 is a hypoimmune, CD22-directed allogeneic CAR T cell therapy derived from healthy donor CD4+ and CD8+ T cells. SC262 is developed with Sana’s hypoimmune platform, which is designed to overcome the immunologic rejection of allogeneic cells and may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell malignancies. CD22 is expressed on lymphoma and leukemia cells in most patients with these diseases, including those that have failed CD19- and/or a CD20-directed therapies. SC262 is initially being explored in patients that have failed a previous CD19-directed therapy. The hypoimmune technology includes disruption of major histocompatibility (MHC) class I and MHC class II expression to allow cells to evade the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to evade the innate immune cell system, in particular macrophages and natural killer (NK) cells. The company has presented data across multiple preclinical models highlighting the potential of this platform to cloak cells from immune recognition and the potential of SC262 as a therapeutic for patients with B-cell malignancies. About Hypoimmune PlatformSana’s hypoimmune platform is designed to create cells ex vivo that can “hide” from the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale, and pluripotent stem cells, which can then be differentiated into multiple cell types at scale. Preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program targeting CD22+ cancers, and stem-cell derived pancreatic islet cells for patients with type 1 diabetes. About Sana BiotechnologySana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester. For more information about Sana Biotechnology, please visit https://sana.com/. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical and regulatory development plans and timing expectations; the Company’s expectations regarding the timing and significance of data from its clinical trials; the potential of CD22-directed CAR T therapies to address failure to achieve durable complete responses; expectations regarding the growth of the potential patient population for SC262; the potential significance of the IND clearance for SC262; the ability to use the Company’s hypoimmune platform to evade immune recognition and overcome the immunologic rejection of allogeneic cells without immunosuppression and the potential benefits associated therewith; the potential of SC262 as a therapeutic for patients with B-cell malignancies; and the ability to apply the HIP technology to donor-derived allogeneic T cells to make potent and persistent CAR T cells at scale and pluripotent stem cells, which can then be differentiated into multiple cell types at scale. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Quarterly Report on Form 10-Q dated November 8, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media:Nicole [email protected]@sana.com

Bristol Myers Squibb is ending development of a handful of new assets, including an anti-TIGIT med in phase 2. As the TIGIT class gets closer to finally seeing clinical success, Bristol Myers Squibb is trimming one of its candidates. The company disclosed development of a phase 2 anti-TIGIT is ending as part of its annual R&D day on Thursday. BMS is also halting work on a phase 2 nonalcoholic steatohepatitis (NASH) candidate licensed in 2016 from Nitto Denko Corporation and a handful of other phase 1 assets.  "We regularly evaluate our pipeline to best prioritize resources where we see the potential for transformational effects on patients’ lives," a spokesperson said in a statement.  BMS terminated a phase 2 study of the anti-TIGIT in solid tumors in late January due to “safety reasons, adverse change in the risk/benefit,” according to the clinical trial record. The record for a phase 1/2 multiple myeloma trial, sponsored by the Multiple Myeloma Research Consortium, was last updated in July to indicate it was active and recruitment had been completed. The decision comes as the class is potentially on the precipice of a bit of momentum, led by Roche's tiragolumab. Data released last year found that the asset in combination with Tecentriq did not improve progression-free survival in first-line non-small cell lung cancer patients, throwing into question the potential of the class that had garnered investments from numerous Big Pharmas. But an inadvertent data drop last month showed that treated patients did live longer compared to patients on just Tecentriq, though not by a statistically significant amount. Nonetheless, Roche's shared jump on the news.  BMS is evidently pushing all of its TIGIT chips toward a bispecific candidate licensed from Agenus in May 2021 for $200 million upfront. Agenus also stands to earn $1.36 billion in milestone payments. The bispecific is in a phase 1 trial in patients with solid tumors as both a monotherapy and in combination with a PD-1 inhibitor.  The NASH med was a siRNA asset targeting heat shock protein 47 that cost BMS $100 million to license in 2016. A phase 2 trial testing BMS-986263 in patients with advanced hepatic fibrosis that had been cured of hepatitis C wrapped up in February 2022. Data published in April last year showed that the most significant improvement in fibrosis was in patients at the 90-mg dose level, the highest in the trial, and that all adverse events were mild to moderate.  The early-stage cuts include a cancer molecule aimed at an undisclosed target, a CD47 and CD20-targeting lymphoma med, a leukemia treatment and a RIPK1 inhibitor. Editor's note: This story was updated to include a statement from a BMS spokesperson.

– Presented complete data from Phase 1A clinical trial of SL-172154 as monotherapy in platinum-resistant ovarian cancer (PROC) at the American Society of Clinical Oncology (ASCO) 2023 annual meeting, including data supporting 3 mg/kg as the appropriate dose for each PROC combination cohort – – Completed enrollment in the dose-escalation portion of the Phase 1A/B clinical trial of SL-172154 in relapsed/refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS); and expect to complete enrollment in both frontline expansion cohorts in HR-MDS and TP53 mutant AML in the fourth quarter of 2023 – – Enrollment progressing in the Phase 1B clinical trial of SL-172154 in combination with liposomal doxorubicin in PROC, completion of enrollment and initial data expected in the fourth quarter of 2023 – – Enrollment progressing in the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC; initial data expected in the fourth quarter of 2023 – AUSTIN, TX and DURHAM, NC, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended June 30, 2023, and provided recent business highlights. “We are pleased with our continued progress in enrollment in our ongoing trials in the second quarter of 2023, and in particular to now have four different expansion cohorts well underway in our AML/HR-MDS and PROC trials,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We believe that data from our dose-escalation study in PROC presented at ASCO demonstrated that SL-172154 may be a differentiated CD47 inhibitor due to the integrated CD40 agonist function, and we look forward to sharing initial combination data across multiple tumors and lines of therapy by the end of the year.” 2023 Anticipated Milestones ARC Platform SL-172154 (SIRPα-Fc-CD40L) Complete enrollment and initial data from the ongoing Phase 1B clinical trial of SL-172154 in combination with liposomal doxorubicin in PROC expected in the fourth quarter of 2023. Initial data from the ongoing Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected in the fourth quarter of 2023. Complete dose-escalation data, as monotherapy and in combination with azacitidine, for Phase 1A clinical trial of SL-172154 in primarily relapsed/refractory AML and HR-MDS expected in the fourth quarter of 2023. Completion of enrollment in the frontline TP53 mutant AML dose-expansion cohort and frontline HR-MDS dose-expansion cohort from our ongoing Phase 1A/B clinical trial of SL-172154 and initial data expected in the fourth quarter of 2023. Second Quarter 2023 Recent Business Highlights and Other Recent Developments ARC Clinical-Stage Pipeline SL-172154 (SIRPα-Fc-CD40L) Presented Complete Dose-Escalation Data from Phase 1A Monotherapy Clinical Trial of SL-172154 in PROC at the 2023 ASCO Annual Meeting: This open-label, multi-center, dose-escalation clinical trial evaluated the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with PROC. SL-172154 had near-full CD47 and CD40 target engagement and CD40-dependent pharmacodynamic effects observed at the 3 mg/kg dose. SL-172154 had a favorable safety and tolerability pro doses. The best response per RECIST 1.1 was stable disease in six (22%) patients. Completed Enrollment in Dose-escalation Portion of Phase 1A/B Clinical Trial of SL-172154 in AML and HR-MDS: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 as both monotherapy and in combination with azacitidine. In the dose-escalation portion of this trial, enrollment is complete. We are now enrolling patients in the dose expansion cohorts, evaluating SL-172154 in combination with azacitidine in both frontline HR-MDS patients and in frontline TP53 mutant AML. We expect to complete enrollment for the two expansion cohorts in the fourth quarter of 2023. We expect to share complete data from the dose-escalation portion of the trial and initial data from the frontline expansion cohorts in the fourth quarter of 2023. Enrollment Progressing in Phase 1B Clinical Trial of SL-172154 in Combination with Liposomal Doxorubicin in PROC: Enrollment is continuing in this trial, which is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, using the selected dose of 3 mg/kg, in combination with liposomal doxorubicin in patients with PROC. We completed enrollment in the safety run in portion of this trial in the second quarter of 2023 and expect to complete enrollment in the expansion cohort and present initial data from the trial in the fourth quarter of 2023. Enrollment Progressing in Phase 1B Clinical Trial of SL-172154 in Combination with Mirvetuximab Soravtansine in PROC. This trial is evaluating the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with mirvetuximab soravtansine in patients with PROC. Mirvetuximab soravtansine is an antibody-drug conjugate targeting folate receptor alpha (FRα), which provides for both direct tumor cell killing as well as enhanced macrophage phagocytosis through binding with Fc gamma receptors and has received accelerated approval for PROC patients whose tumors are shown to be FRα positive, defined as ≥75%, as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Preclinical studies have shown that both of these killing mechanisms are complementary to the mechanism of SL-172154 by enhancing the activity of macrophages to phagocytose FRα- expressing ovarian cancer cells, and that SL-172154 may broaden the activity of mirvetuximab, particularly in patients with tumors that express lower levels of FRα. We intend to enroll patients with broader FRα expression, including those with “high” (greater than ≥75%), “medium” (≥50% to <75%), and “low” (≥25% to <50%) expression of FRα, as determined by the VENTANA FOLR1 (FOLR1-2.1). We expect to present initial data from the trial in the fourth quarter of 2023. Gamma Delta T Cell Engager (GADLEN) Platform GADLEN Preclinical Compounds In an initial non-human primate toxicology study, presented at the 2023 Annual Meeting of the American Association for Cancer Research, we observed dose-dependent B cell depletion following administration of a CD20-directed GADLEN. Subsequently, in the second quarter of 2023, we performed an additional toxicology study in non-human primates that was designed to expand upon the initial non-human primate study. In this second study, the depth and durability of B cell depletion were inferior to that reported in published studies with other B cell depleting agents. We are working to determine the underlying scientific cause for these differences in B cell response, and whether these are due to species differences between humans and cynomolgus macaques, or due to aspects inherent to gamma delta T cell biology. We do not currently plan to Investigational New Drug application for any GADLEN compounds until these data are better understood. Second-Quarter 2023 Financial Results Cash and Cash Equivalents and Investments: As of June 30, 2023, cash and cash equivalents and investments were $117.2 million, as compared to $214.2 million as of June 30, 2022. Research and Development (R&D) Expenses: R&D expenses were $18.2 million for the quarter ended June 30, 2023, as compared to $23.0 million for the quarter ended June 30, 2022. This decrease was primarily driven by a decrease in expense associated with the manufacture of clinical trial materials to support our ongoing clinical trials. General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the quarter ended June 30, 2023, as compared to $4.7 million for the quarter ended June 30, 2022. Net Loss: Net loss was $21.3 million for the quarter ended June 30, 2023, or $0.50 per basic and diluted share, as compared to a net loss of $27.4 million for the quarter ended June 30, 2022, or $0.65 per basic and diluted share. 2023 Financial Guidance Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations through year-end 2024, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken. About SL-172154 SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with PROC (NCT04406623, NCT05483933) and patients with AML and HR-MDS (NCT05275439). About Shattuck Labs, Inc. Shattuck Labs, Inc. (NASDAQ: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, (“ARC®”), platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations regarding plans for our preclinical studies, clinical trials and research and development programs, plans for clinical trial design, the anticipated timing of the results from our preclinical studies and clinical trials, anticipated timing of enrollment in our clinical trials, anticipated timing for preclinical development updates, potential safety and clinical benefit of our product candidates, and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (the “SEC”)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. Investor & Media Contact: Conor Richardson Vice President of Investor Relations Shattuck Labs, Inc. [email protected] SHATTUCK LABS, INC. CONDENSED BALANCE SHEETS (In thousands) June 30, 2023 December 31, (unaudited) Assets Current assets: Cash and cash equivalents 71,893 47,379 Investments 45,279 113,901 Prepaid expenses and other current assets 19,278 23,304 Total current assets 136,450 184,584 Property and equipment, net 16,015 17,671 Other assets 2,805 3,069 Total assets 155,270 205,324 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable 2,011 7,170 Accrued expenses and other current liabilities 10,983 17,795 Total current liabilities 12,994 24,965 Non-current operating lease liabilities 3,818 4,202 Total liabilities 16,812 29,167 Stockholders’ equity: Common stock Additional paid-in capital 399,609 396,041 Accumulated other comprehensive loss Accumulated deficit (261,082 (219,012 Total stockholders’ equity 138,458 176,157 Total liabilities and stockholders’ equity 155,270 205,324 SHATTUCK LABS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, Collaboration revenue Operating expenses: Research and development 18,205 22,963 34,872 42,150 General and administrative 4,742 4,745 9,793 9,724 Expense from operations 22,947 27,708 44,665 51,874 Loss from operations (22,747 (27,658 (44,408 (51,824 Other income (expense) 1,401 2,338 Net loss (21,346 (27,371 (42,070 (51,899 Unrealized gain (loss) on investments Comprehensive loss (21,081 (27,952 (41,267 (52,447 Net loss per share – basic and diluted (0.50 (0.65 (0.99 (1.22