To investigate the expression of melanoma-associated antigen 1 (MAGE-1) in Chinese hepatocellular carcinoma (HCC) patients and to determine the existence and distribution of single nucleotide polymorphisms (SNP) of MAGE-1 gene.

METHODS:

Total RNA was extracted from cancer tissues and adjacent tissues from 19 HCC patients and the expression of MAGE-1 mRNA was examined by using RT-PCR. The PCR products were sequenced to analysis the gene variation. Genomic DNA was extracted from cancer tissues, adjacent tissues and peripheral blood cells of 19 HCC patients, as well as from peripheral blood cells of 23 healthy donors. The PCR product of MAGE-1 DNA was sequenced to determine the existence and distribution of SNPs of MAGE-1 gene.

RESULTS:

9 of 19 (47.4%) tumor tissues and none of adjacent tissue from HCC patients expressed MAGE-1 mRNA. There were three kinds of gene variations of cDNA in 9 MAGE-1 mRNA positive patients. One type was named type I including 1 patient, which sequence is as same as that of the GenBank M77481. The other was named TGA type including 5 patients, which involved three nucleotide changes (C159T, A272G and G393A) and result in two amino acid changes (T32A and R72Q). Another one was named GTG type including 3 patients, which involved three nucleotide changes (A272G, C991T, A1125G) and result in only one amino acid changes (T32A). According to the analysis of genomic DNA, above three types were not specific mutations of tumor tissue, but were SNPs. These SNPs types were distributed in HCC patients and normal donors with the frequencies of 26.3% (5/19) and 60.9% (14/23) for type I, 57.9% (11/19) and 47.8% (11/23) for TGA type, and 21.1% (4/19) and 21.7% (5/23) for GTG type, respectively. The sequences of two new SNPs had been deposited in GenBank with the accession numbers of AF463515 and AY148486. In male population, the distributions of SNPs were not correlated to HCC suffering or MAGE-1 expression. Several new HLA-restricted epitopes were probably resulted from SNPs existing. The three-dimensional models of MAGE-1 proteins of type I and TGA type was established by using computer software.

CONCLUSION:

The expression rate of MAGE-1 gene in Chinese HCC patients is high. Three SNP types of MAGE-1 gene exist in Chinese population. The three-dimensional models of MAGE-1 proteins were obtained by computer processing. These results will be helpful to developing MAGE-1 peptide-vaccine for HCC immunotherapy.

Frontiers in immunology

Arginase-1 targeting peptide vaccine in patients with metastatic solid tumors – A phase I trial

Article

作者: Andersen, Mads Hald ; Lorentzen, Cathrine Lund ; Ehrnrooth, Eva ; Pedersen, Ayako Wakatsuki ; Kjeldsen, Julie Westerlin ; Martinenaite, Evelina ; Holmstroem, Rikke Boedker ; Svane, Inge Marie ; Mørk, Sofie Kirial

Background:

Arginase-1-producing cells inhibit T cell-mediated anti-tumor responses by reducing L-arginine levels in the tumor microenvironment. T cell-facilitated elimination of arginase-1-expressing cells could potentially restore L-arginine levels and improve anti-tumor responses. The activation of arginase-1-specific T cells may convert the immunosuppressive tumor microenvironment and induce or strengthen local Th1 inflammation. In the current clinical study, we examined the safety and immunogenicity of arginase-1-based peptide vaccination.

Methods:

In this clinical phase I trial, ten patients with treatment-refractory progressive solid tumors were treated. The patients received an arginase-1 peptide vaccine comprising three 20-mer peptides from the ARG1 immunological “hot spot” region in combination with the adjuvant Montanide ISA-51. The vaccines were administered subcutaneously every third week (maximum 16 vaccines). The primary endpoint was to evaluate safety assessed by Common Terminology Criteria for Adverse Events 4.0 and laboratory monitoring. Vaccine-specific immune responses were evaluated using enzyme-linked immune absorbent spot assays and intracellular cytokine staining on peripheral blood mononuclear cells. Clinical responses were evaluated using Response Evaluation Criteria in Solid Tumors 1.1.

Results:

The vaccination was feasible, and no vaccine-related grade 3–4 adverse events were registered. Nine (90%) of ten patients exhibited peptide-specific immune responses in peripheral blood mononuclear cells. Six (86%) of the seven evaluable patients developed a reactive T cell response against at least one of the ARG1 peptides during treatment. A phenotypic classification revealed that arginase-1 vaccine-specific T cells were both CD4+ T cells and CD8+ T cells. Two (20%) of ten patients obtained stable disease for respectively four- and seven months on vaccination treatment.

Conclusion:

The peptide vaccine against arginase-1 was safe. Nine (90%) of ten patients had measurable peptide-specific responses in the periphery blood, and two (20%) of ten patients attained stable disease on protocol treatment.

Clinical trial registration:

https://clinicaltrials.gov/ct2/show/NCT03689192, identifier NCT03689192.

项与 IO-112 相关的新闻（医药）

2024-11-12

·GlobeNewswire-Health Care

IO Biotech Reports Third Quarter 2024 Financial Results and Provides Business Highlights

Pivotal Phase 3 trial (IOB-013/KN-D18) evaluating off-the-shelf therapeutic cancer vaccine IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma on track with primary endpoint of progression free survival (PFS) projected to be reached in first half of 2025Primary endpoint met in Phase 2 basket trial (IOB-022/KN-D38) cohort evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of advanced squamous cell carcinoma of the head and neck (SCCHN)Enrollment in Phase 2 basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable melanoma or SCCHN is proceeding ahead of scheduleEnded third quarter with approximately $80 million in cash and cash equivalents; the company continues to expect its cash position will support operations into the fourth quarter of 2025 NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the third quarter ended September 30, 2024. “We continue to add to the body of evidence that our novel investigational therapeutic cancer vaccine, IO102-IO103, has the potential to bring clinical benefit to patients with strong signals of activity now observed in patients with three types of metastatic solid tumors,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “As we look to the primary endpoint data readout from our Phase 3 pivotal trial in the first half of next year, we plan to be prepared to submit a Biologics License Application (BLA) to the FDA in 2025 and potentially make our first therapeutic cancer vaccine available for patients in the US with advanced melanoma in 2026.” Dr. Zocca continued, “Our T-win platform generates off-the-shelf therapeutic cancer vaccine candidates with a unique mechanism of action, capable of both targeting immune-suppressive cells and cancer cells. This dual action is what drives the strong activity we see when we combine IO102-IO103 with an anti-PD-1 therapy. In addition to IO102-IO103, the T-win platform has generated other novel candidates including IO112, targeting arginase 1 with a unique mechanism of action. We are excited about the strength of the data supporting the potential of IO112 and plan to submit an Investigational New Drug (IND) application to the FDA for this program in 2025.” Recent Business Highlights The per-protocol interim analysis in the pivotal Phase 3 trial (IOB-013/KN-D18), which is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma, was completed by the IDMC in the third quarter of 2024. Based on review of safety and efficacy data, the IDMC recommended the trial continue without modifications and noted that no new safety signals were observed. The outcome of the primary endpoint of PFS is projected to be available in the first half of 2025, potentially followed by a BLA submission in 2025 depending on the PFS outcome.Encouraging data for the fully enrolled squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC) cohorts of the Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of patients with metastatic disease were presented at the 2024 European Society of Medical Oncology (ESMO) Congress in September and the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting in November, respectively. [https://bit.ly/3zgzsoY; https://bit.ly/4fsVCno]The company continues to progress its perioperative Phase 2 basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab dosed before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN. Enrollment continues in both the single arm SCCHN cohort (cohort B) and the randomized melanoma cohort (cohort C), in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone. Third Quarter 2024 Financial Results Net loss for the three months ended September 30, 2024, was $24.0 million, compared to $21.7 million for the three months ended September 30, 2023.Research and development expenses were $20.2 million for the three months ended September 30, 2024, compared to $17.7 million for the three months ended September 30, 2023. The increase was primarily related to timing of clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s pivotal Phase 3 clinical trial. The company recognized $0.6 million in research and development equity-based compensation for the three months ended September 30, 2024, compared to $2.1 million for the three months ended September 30, 2023.General and administrative expenses were $6.3 million for the three months ended September 30, 2024, compared to $5.8 million for the three months ended September 30, 2023. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended September 30, 2024, compared to $0.9 million for the three months ended September 30, 2023.Cash and cash equivalents as of September 30, 2024 were $80.2 million, compared to $143.2 million at December 31, 2023. During the three months ended September 30, 2024, the company used cash, cash equivalents and restricted cash of $20.8 million. The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025. About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response rate (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study completed enrollment of 15 patients with melanoma in cohort A and continues to enroll 15 patients with SCCHN in cohort B as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C, melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiSalutem917-498-1967Julie.Funesti@salutemcomms.com IO BIOTECH, INC.Consolidated Statements of Operations and Comprehensive Loss(Unaudited in thousands, except share and per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses Research and development $20,178 $17,655 $50,337 $46,059 General and administrative 6,326 5,829 17,897 17,201 Total operating expenses 26,504 23,484 68,234 63,260 Loss from operations (26,504) (23,484) (68,234) (63,260)Other income (expense) Currency exchange gain (loss), net 1,630 (342) 1,078 (74)Interest income 1,068 1,708 3,996 3,932 Total other income (expense), net 2,698 1,366 5,074 3,858 Loss before income tax expense (benefit) (23,806) (22,118) (63,160) (59,402)Income tax expense (benefit) 209 (439) 998 499 Net loss (24,015) (21,679) (64,158) (59,901)Net loss attributable to common shareholders (24,015) (21,679) (64,158) (59,901)Net loss per common share, basic and diluted $(0.36) $(0.43) $(0.97) $(1.66)Weighted-average number of shares used in computing net loss per common share, basic and diluted 65,880,914 50,168,303 65,880,914 36,011,162 Other comprehensive loss Net loss $(24,015) $(21,679) $(64,158) $(59,901)Foreign currency translation (1,374) (108) (1,331) 268 Total comprehensive loss $(25,389) $(21,787) $(65,489) $(59,633) IO BIOTECH, INC.Consolidated Balance Sheets(Unaudited in thousands, except share and per share amounts) September 30,2024 December 31,2023 Assets Current assets Cash and cash equivalents $80,185 $143,193 Prepaid expenses and other current assets 6,059 4,062 Total current assets 86,244 147,255 Restricted cash 268 268 Property and equipment, net 695 847 Right of use lease asset 1,814 2,259 Other non-current assets 924 89 Total non-current assets 3,701 3,463 Total assets $89,945 $150,718 Liabilities and stockholders’ equity Current liabilities Accounts payable $5,256 $3,878 Lease liability - current 694 655 Accrued expenses and other current liabilities 10,105 11,184 Total current liabilities 16,055 15,717 Lease liability - non-current 1,325 1,839 Total non-current liabilities 1,325 1,839 Total liabilities 17,380 17,556 Commitments and contingencies Stockholders’ equity Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023 — — Common stock, par value of $0.001 per share; 300,000,000 shares authorized at September 30, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 66 66 Additional paid-in capital 411,479 406,587 Accumulated deficit (327,980) (263,822)Accumulated other comprehensive loss (11,000) (9,669)Total stockholders’ equity 72,565 133,162 Total liabilities and stockholders’ equity $89,945 $150,718

临床2期疫苗突破性疗法临床3期财报

2024-11-07

·GlobeNewswire-Health Care

IO Biotech Reports its Off-the-Shelf Therapeutic Cancer Vaccine, IO102-IO103, in Combination with KEYTRUDA® Demonstrates Promising Activity and Durability in First-line Treatment of Patients with Metastatic Lung Cancer in Phase 2 IOB-022 Study

-- Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached -- -- Safety profile consistent with prior studies with the combination, showing no unexpected toxicities compared to anti-PD1 monotherapy, and low-grade transient injection site reactions as the most common treatment related adverse event -- -- The data from this NSCLC cohort combined with the recent positive squamous cell carcinoma of the head and neck (SCCHN) cohort data presented at ESMO 2024 and previously reported positive Phase 1/2 study in melanoma demonstrate the potential of IO102-I0103 to be effective in broad patient populations -- -- Pre-clinical data for IO Biotech’s second T-win vaccine candidate, IO112 targeting arginase 1, demonstrates anti-tumor activity with dynamic changes in the tumor microenvironment (TME) driven by the vaccine-targeted modulation of immunosuppressive tumor-associated macrophages (TAMs) -- -- Data presented at the Society for Immunotherapy of Cancer’s Annual Meeting -- NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune modulating therapeutic cancer vaccines, announced data from the NSCLC cohort in the company’s Phase 2 basket trial of IO102-IO103, the company’s lead investigational candidate, given in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) (IOB-022/KN-D38). These data, as well as new pre-clinical data from IO Biotech’s second vaccine candidate, IO112, will be presented at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) in Houston on November 8-10, 2024. “These data build on the growing clinical evidence for IO102-IO103 in hard-to-treat cancers. These Phase 2 NSCLC data evaluating IO102-IO103 in combination with pembrolizumab demonstrated a positive trend in ORR compared to benchmark data in the evaluable patient population with no unexpected toxicity,” stated Jonathan Riess, MD, principal investigator of the trial and Director, Thoracic Oncology at the UC Davis Comprehensive Cancer Center. “We need new treatments that can extend the durability of response for lung cancer patients. No progression in nearly half of the patients in this study at 12 months is a positive signal.” The presentation contains clinical and biomarker data from the fully enrolled cohort of patients (n=37) with previously untreated metastatic stage NSCLC with PD-L1 high TPS ≥ 50. The data from 31 efficacy evaluable patients demonstrated: A 55% unconfirmed (16 partial responses, 1 complete response), 48% confirmed overall response rate (ORR) in a PD-L1 high population of patients with NSCLCAn 81% disease control rate (DCR)No disease progression at 12 months in approximately 50% of patientsAn encouraging 8.1-month median progression-free survival (PFS)Median duration of response (DOR) not yet reachedA safety profile consistent with previously reported data when combining IO102-IO103 with anti-PD-1 monotherapyVaccine-specific T cell responses to both IO102 (IDO1) and IO103 (PD-L1) were detected in patients on treatment “The results of the combination of IO102-IO103 with the anti-PD-1 therapy pembrolizumab in the NSCLC cohort, combined with the promising data presented at ESMO for the SCCHN cohort and the previous Phase 1/2 data in melanoma, add to the body of evidence that our dual-approach of targeting tumor cells and immune suppressive cells in the tumor microenvironment may drive a meaningful clinical benefit across a range of hard-to-treat cancers,” said Qasim Ahmad, MD, Chief Medical Officer of IO Biotech. “Importantly, we are observing promising activity with no unexpected toxicity and safety concerns, which addresses a high unmet medical need and an important gap in current treatment options for patients.” To date, the safety profile observed in this study (IOB-022/KN-D38) is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no unexpected systemic toxicity compared to anti-PD-1 monotherapy and low-grade transient injection site reactions reported as the most common treatment related adverse events. Data from the squamous cell carcinoma of the head and neck (SCCHN) cohort of this study were presented at the 2024 European Society for Medical Oncology congress in September that demonstrated the cohort met its primary endpoint of ORR with encouraging PFS data. Pre-clinical data from IO112, IO Biotech’s second therapeutic cancer vaccine candidate derived from the company’s T-win® platform, also presented at SITC 2024Arginase 1 (Arg1) plays a central role in immune suppression, and its overexpression has been reported in several cancers including renal cell carcinoma, pancreatic cancer, and head and neck cancer. Importantly, all immune suppressive myeloid cells in the TME express Arg1, and their key roles in cancer immune resistance mechanisms have been well described. The data presented in the poster showcase that IO112 vaccination leads to robust expansion of Arg1-specific T cells, which in turn directly target and reprogram immune suppressive TAMs, leading to tumor growth inhibition. “Our present data confirm the hypothesis that the primary and direct target of IO112 treatment are TAMs – and, what is striking, is how dynamically the vaccine-induced T cells are impacting TAMs,” said Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech. “Treatment with IO112 results in TAMs changing their phenotype completely, from immune suppressive to highly pro-inflammatory, driving the modulation of the TME, and facilitating the immune attack on tumor cells. These data give us further confidence in our T-win® platform, a unique approach to induce a proinflammatory and anti-tumorigenic TME via T cells that attack the primary drivers of immune suppression. This strong data adds to the rationale for IO112 clinical development, and we look forward to submitting an IND for IO112 in 2025.” The posters can be found on the “Posters & Publications” page of the IO Biotech website. Details for the presentations are below: Title: A phase 2 trial of the IO102-IO103 cancer vaccine plus pembrolizumab: results from the first-line (1L) cohort of PD-L1 high metastatic non-small cell lung cancer (NSCLC) Presenter: Jonathan W. Riess, MD, MS, UC Davis Comprehensive Cancer CenterAbstract/Poster number: 756Date: Saturday, November 9, 2024Location: Exhibit Halls AB - George R. Brown Convention CenterTimes: Poster hall: 9:00 a.m. - 8:30 p.m. CDT; Poster session 12:15 – 1:45 p.m.; Poster reception 7:00-8:30 p.m. Title: Immune modulating vaccine against arginase 1 controls tumor growth via modulation of tumor-associated macrophages Presenters: Evelina Martinenaite, PhD, Senior Scientist, Translational Research, and Inés Lecoq, PhD, Scientist, Translational Research, IO BiotechAbstract/Poster number: 1038Date: Saturday, November 9, 2024Location: Exhibit Halls AB - George R. Brown Convention CenterTimes: Poster hall: 9:00 a.m. - 8:30 p.m. CDT; Poster session 12:15 – 1:45 p.m.; Poster reception 7:00-8:30 p.m. About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiSalutem917-498-1967julie.funesti@salutemcomms.com

临床2期疫苗免疫疗法临床结果突破性疗法

2024-10-04

·GlobeNewswire-Health Care

IO Biotech Announces Two Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting

NEW YORK, Oct. 04, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced two abstracts accepted for poster presentation at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) taking place taking place in Houston, Texas on November 8-10, 2024. The first abstract accepted for poster presentation contains updated and expanded data from the complete cohort (n=31) from the first line (1L) cohort of patients with PD-L1 high metastatic non-small cell lung cancer (NSCLC) in the Company’s Phase 2 basket trial of investigational IO102-IO103 in combination with pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy (IOB-022/KN-D38). The second abstract accepted for poster presentation contains new pre-clinical data for the next candidate in the IO Biotech pipeline, IO112, which targets Arginase 1. Poster Presentations Title: A phase 2 trial of the IO102-IO103 cancer vaccine plus pembrolizumab: results from the first-line (1L) cohort of PD-L1 high metastatic non-small cell lung cancer (NSCLC) Presenter: Jonathan W. Riess, MD, MS, UC Davis Comprehensive Cancer CenterPoster presentation number: 756Date: Saturday, November 9, 2024Location: Exhibit Halls AB - George R. Brown Convention CenterTimes: Poster hall: 9:00 a.m. - 8:30 p.m. CDT; Poster session 12:00 – 1:30 p.m.; Poster reception 7:00-8:30 p.m. Title: Immune modulating vaccine against arginase 1 controls tumor growth via modulation of tumor-associated macrophages Presenters: Evelina Martinenaite, PhD, Senior Scientist, Translational Research, and Inés Lecoq, PhD, Scientist, Translational Research, IO BiotechPoster presentation number: 1038Date: Saturday, November 9, 2024Location: Exhibit Halls AB - George R. Brown Convention CenterTimes: Poster hall: 9:00 a.m. - 8:30 p.m. CDT; Poster session 12:00 – 1:30 p.m.; Poster reception 7:00-8:30 p.m. The posters will be available on the “Posters & Publications” page of the IO Biotech website at the start of the meeting. About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial IOB-022/KN-D38 (NCT05077709) is a non-comparative, open-label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiSalutem917-498-1967Julie.Funesti@salutemcomms.com

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