Malignant melanoma, metastatic

All patients in the trial who were alive at 3 years remain alive at 4 years (69.5%) with a minimum follow-up period of 4 years (median 53.0 months) The expected next key milestone for UV1 is the readout of the FOCUS trial during Q3 2024, in which the treatment combination is the same as in the UV1-103 trial June 11, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced encouraging overall survival (OS) data from both cohorts in the UV1-103 Phase I clinical trial in malignant melanoma. The UV1-103 study evaluates Ultimovacs’ universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma. The study enrolled 30 patients in the U.S. in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant. With a minimum follow-up of 4 years (median 53.0 months), the updated OS results show that all patients who were alive at the 3-year mark remain alive at 4 years, with an OS rate of 69.5% Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (complete or partial disappearance of tumors). Biomarker analyses reported in October 2022 showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is comparable to that of pembrolizumab alone. “We are encouraged by the strong overall survival rate observed in this Phase I study,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The data show a high survival rate among patients enrolled in the UV1-103 trial, even after a minimum of 4 years of follow-up. We look forward to the read-out of the FOCUS trial in head and neck cancer, where the same treatment combination has been used”. This US-based Phase I clinical trial evaluates the Company’s lead candidate, UV1, combined with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with unresectable metastatic malignant melanoma. The trial evaluates safety, tolerability, and initial signs of clinical response. Thirty patients in the U.S. were treated in the study in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant. The 20 patients in the first cohort received a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received the standard 75 mcg GM-CSF adjuvant dose per UV1 vaccination. The study has completed the enrollment of 30 patients, as announced on August 18, 2020. All included patients received the drugs as first-line treatment for advanced and metastatic malignant melanoma. Compiled clinical results for the 30 patients enrolled are: Objective response rate (ORR): 57%. Complete response rate (CR): 33% Median Progression Free Survival (mPFS): 18.9 months (as measured by iRECIST) Overall survival (OS) after 12 months: 87% after 24 months: 73% after 36 months: 69.5% after 48 months: 69.5% Out of the 9 deaths, 4 happened during the first year, 4 during the second year, and one during the third year across both cohorts. Three patients in cohort 1 chose not to be followed beyond 24 months. The trial had previously reached its primary endpoint of safety and tolerability, and no unexpected safety issues related to UV1 have been observed in this trial. As a historical reference (not head-to-head comparison since dosing and the patient population are different), the registrational study for pembrolizumab, Keynote-006, showed an overall survival rate of 42% at 48 months (Long GV et al, ASCO 2018). The U.S. Food and Drug Administration (FDA) granted a dual Fast Track designation for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines. The lead cancer vaccine candidate UV1 is an off-the-shelf vaccine directed against human telomerase (hTERT), an antigen present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to investigate UV1’s impact in combination with other immunotherapies in multiple cancer types. UV1 is a patented technology owned by Ultimovacs. In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-Epitope-Targeting (TET) technology, combines tumor-specific antigens and adjuvant in the same molecule and is in Phase I clinical development. The Company is listed on the Euronext Oslo Stock Exchange (ULTI). UV1 is a therapeutic cancer vaccine designed to induce a specific T-cell response against telomerase. UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T-cells. These CD4+ T-cells have the potential to provide inflammatory signals, and T-cell support is believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated vaccine-specific T-cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules. The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is, therefore, not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months with eight intradermal injections and the immune-modulator GM-CSF. The content above comes from the network. if any infringement, please contact us to modify.

May 01, 2024 -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that the first patient has been enrolled in an investigator-initiated Phase 2 trial to evaluate GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, at the Earle A. Chiles Research Institute (EACRI), a division of Providence Cancer Institute in Portland, Oregon, USA. Under the direction of Providence investigators Dr. Brendan Curti and Dr. William Redmond, the study aims to evaluate the safety and efficacy of GB1211 at a dose of 100mg twice daily in combination with pembrolizumab for the treatment of metastatic malignant melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). Drs. Curti and Redmond received an R01 Research Project Grant award from the National Cancer Institute, National Institutes of Health, for their investigator-initiated Phase 2 trial. Galecto has committed to supply GB1211 for the trial. Galectin-3 is overexpressed in many cancers, including melanoma and HNSCC. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment can cause checkpoint inhibitor resistance by blocking the binding of the checkpoint inhibitor antibodies, pembrolizumab and atezolizumab (Tecentriq®), to their respective targets. Preclinical data has shown that GB1211 has the ability to reduce galectin-3 associated interference with immune checkpoint inhibition (ICI), thus alleviating galectin-3-specific ICI resistance. In the fourth quarter of 2023, Galecto reported topline results from its Phase 1b/2a GALLANT-1 clinical trial evaluating GB1211 twice daily in combination with atezolizumab for the first-line treatment of non-small cell lung cancer (NSCLC). Galecto reported that investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received the recommended Phase 2 dose level of GB1211 100 mg for at least three weeks. Historically, response rates of only 22–38% have been observed with atezolizumab monotherapy in the first-line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to ICI. Dr. Brendan Curti, Medical Director, Providence Melanoma Program, and EACRI Member and Robert W. Franz Endowed Chair for Clinical Research, said, “Our ability to perform bench-bedside research is a great strength of the Providence Cancer Institute. The insights from Dr. Redmond’s lab about how to use galectin inhibitors to alter the tumor microenvironment and promote anti-tumor activity, as well as our initial observations in patients, provide a robust rationale for our phase II clinical trial in patients with melanoma and HNSCC.” Dr. William Redmond, Member and Director, EACRI Immune Monitoring Lab, and co-principal investigator for the trial, stated, “We have published a significant amount of data on the important role of galectin-3 in creating immune suppression within the tumor microenvironment. We are excited to start this study in melanoma and HNSCC patients to potentially counteract ICI resistance and increase the efficacy of ICI by combining GB1211 and pembrolizumab.” “We are excited that the Providence Cancer Institute and Drs. William Redmond and Brendan Curti have initiated this trial. Dr. Redmond is a world-leading expert on the role of galectin-3 in cancer and ICI resistance and has demonstrated how galectin inhibition can be used to enhance tumor treatment,” stated Dr. Hans Schambye, CEO of Galecto. “Following the encouraging topline results from the GALLANT-1 trial that we reported in the fourth quarter of 2023, we look forward to exploring potential synergies with another leading ICI, pembrolizumab. This new trial marks a significant stride towards exploring GB1211's potential to enhance the effectiveness of ICI in various cancer indications.” The randomized, double-blind placebo-controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will employ a fixed dose of GB1211 in conjunction with the standard therapeutic dose of pembrolizumab in patients with unresectable or metastatic MM or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. In addition to monitoring for toxicity and clinical response, biospecimens will be obtained to assess immunologic measures relevant to galectin biology and T-cell checkpoint inhibition. Tumor volume will be assessed by immune response RECIST criteria (iRECIST criteria 1.1). It is anticipated that early data from this trial could be available as early as 2025. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness, and metastatic potential. In the tumor tissue, galectin-3 supports the creation of fibrosis, tumor proliferation, metastasis, and immune avoidance. Preclinical data announced at the 2022 ASCO Annual Meeting furthermore suggest that galectin-3 can enhance PD-1 and PD-L1 binding and avert the interference of anti-PD-1/anti-PD-L1 therapies by blocking the binding of the antibodies to their respective targets. GB1211 is specifically designed to counter these anti-checkpoint inhibitor effects of galectin-3. GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and exhibited dose-dependent pharmacokinetics. Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple Phase 2 clinical opportunities in fibrosis and cancer, including (i) an orally active LOXL2 inhibitor (GB2064) for the treatment of myelofibrosis; (ii) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis; and (iii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications. Providence Cancer Institute of Oregon, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Learn more at www.providence.org/ORcancer. The content above comes from the network. if any infringement, please contact us to modify.

– On track to dose 15-20 patients with higher dose cNeT by year-end 2023 – – Clinical and translational science data update from the ongoing Phase I/IIa trials in NSCLC and melanoma expected in Q1 2024 with additional data available in mid-2024 – – Strong cash position of $140 million supports operations through 2025 – LONDON, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the quarter ended September 30, 2023, and recent business highlights. “We are pleased with progress across the scientific field that continues to demonstrate the importance of neoantigens as the most attractive targets in solid-tumor oncology. We believe that our proprietary capability to identify the most immunogenic clonal neoantigens, recently shared at ESGCT and SITC, puts us in a strong position with our clonal neoantigen-reactive T cell (cNeT) therapy and potentially other neoantigen targeting approaches,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “Our Phase I/IIa clinical trials evaluating cNeT therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS) continue to progress and we are on track to dose patients in line with our previous guidance. We look forward to sharing our next clinical and translational data update in Q1 2024.” Recent Highlights Presented posters (Abstract 437, Abstract 1312) at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting highlighting a significant dose boost of reactive CD8 and CD4 cNeT from the optimized VELOSTM manufacturing platform and the use of the PELEUS™ AI-powered bioinformatics platform for the identification and validation of immunogenic clonal tumor neoantigens.Presented posters (P459, P485, P507) at the European Society of Gene & Cell Therapy (ESGCT) 30th Annual Congress highlighting the favorable cNeT phenotypic properties and polyfunctionality critical for precision adoptive cell therapies and the expansion of cNeT from the blood of patients with cancer.Delivered an oral presentation at the mRNA Cancer Vaccines Summit highlighting neoRanker™, a new AI-based tool for the selection of immunogenic clonal tumor neoantigens for personalized therapies.Delivered oral presentations at the 5th Annual TIL Therapies Summit highlighting optimized manufacturing of AI-powered precision TIL therapies for solid cancer, and the potency and fitness of cNeT.Presented posters (P319, P407, P518) at the Seventh International Cancer Immunotherapy Conference (CICON23) highlighting a precision adoptive cell therapy process based on expansion of cNeT from blood of cancer patients. Financial Highlights Cash and cash equivalents: Cash and cash equivalents were $140.1 million as of September 30, 2023, as compared to $173.3 million as of December 31, 2022. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations through 2025.Research and development (R&D) expenses: R&D expenses were $14.7 million for the third quarter ended September 30, 2023, an increase of $4.1 million compared to $10.6 million for the third quarter ended September 30, 2022. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D.General and administrative (G&A) expenses: G&A expenses were $4.4 million for the third quarter ended September 30, 2023, a decrease of $1.0 million compared to $5.4 million for the third quarter ended September 30, 2022. This decrease was primarily driven by lower professional fees, personnel costs and facilities spend. Net loss: Net loss for the third quarter ended September 30, 2023, was $16.7 million or $0.42 per share compared to $12.5 million or $0.32 per share for the third quarter ended September 30, 2022. About Achilles Therapeutics Achilles is a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens. Forward Looking Statements This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing of the Company’s clinical and translational data updates and the Company’s beliefs about recent data updates, and expectations related to the Company’s operating expenses and capital expense requirements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. For further information, please contact: Investors:Meru AdvisorsLee M. Sternlstern@meruadvisors.com Media:ICR ConsiliumSukaina Virji, Tracy Cheung, Emmalee Hoppe+44 (0) 203 709 5000achillestx@consilium-comms.com ACHILLES THERAPEUTICS PLC Condensed Consolidated Balance Sheets (Unaudited)(in thousands, except share and per share amounts)(expressed in U.S. Dollars, unless otherwise stated) September 30, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $140,138 $173,338 Prepaid expenses and other current assets 15,354 23,242 Total current assets 155,492 196,580 Non-current assets: Property and equipment, net 9,648 12,399 Operating lease right of use assets 7,013 8,081 Deferred tax assets 185 251 Restricted cash 33 33 Other assets 2,967 3,014 Total non-current assets 19,846 23,778 TOTAL ASSETS $175,338 $220,358 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $5,352 $5,187 Income taxes payable - 326 Accrued expenses and other liabilities 8,209 8,292 Operating lease liabilities-current 4,620 4,188 Total current liabilities 18,181 17,993 Non-current liabilities: Operating lease liabilities-non-current 2,731 4,388 Other long-term liability 941 933 Total non-current liabilities 3,672 5,321 Total liabilities 21,853 23,314 Commitments and contingencies (Note 12) Shareholders’ equity: Ordinary shares, £0.001 par value; 40,782,948 and 40,932,727 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022, respectively 54 54 Deferred shares, £92,451.851 par value, one share authorized, issued and outstanding at September 30, 2023 and December 31, 2022 128 128 Additional paid in capital 413,815 408,844 Accumulated other comprehensive loss (19,190) (21,695)Accumulated deficit (241,322) (190,287)Total shareholders’ equity 153,485 197,044 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $175,338 $220,358 ACHILLES THERAPEUTICS PLC Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)(in thousands, except share and per share amounts)(expressed in U.S. Dollars, unless otherwise stated) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 OPERATING EXPENSES: Research and development $14,712 $10,597 $42,354 $38,387 General and administrative 4,384 5,437 13,387 17,162 Total operating expenses 19,096 16,034 55,741 55,549 Loss from operations (19,096) (16,034) (55,741) (55,549)OTHER INCOME, NET: Other income 2,389 3,599 4,692 8,499 Total other income, net 2,389 3,599 4,692 8,499 Loss before provision for income taxes (16,707) (12,435) (51,049) (47,050)Benefit (Provision) for income taxes 24 (41) 14 (70)Net loss (16,683) (12,476) (51,035) (47,120)Other comprehensive income: Foreign exchange translation adjustment (5,289) (18,147) 2,505 (45,126)Comprehensive loss $(21,972) $(30,623) $(48,530) $(92,246)Net loss per share attributable to ordinary shareholders—basic and diluted $(0.42) $(0.32) $(1.28) $(1.20)Weighted average ordinary shares outstanding—basic and diluted 40,066,922 39,313,764 39,900,910 39,104,866