TIL

Achilles Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, April 4, 2024
Research, Virtual, NSCLC, Immunotherapy, TIL, Patient, G&A, Allele, ACHL, HLA, Neoplasm, Therapy, Event, Safety, Melanoma, Patent, Escape Room, Cryptocurrency

LONDON, April 04, 2024 (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 fourth quarter and year-ended December 31, 2023, and recent business highlights.

Key Points: 
  • These learnings will inform the development of cNeT and related neoantigen vaccine and TCR-T therapies,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics.
  • Research and development (R&D) expenses: R&D expenses were $15.9 million for the fourth quarter ended December 31, 2023, a decrease of $3.0 million compared to $18.9 million for the fourth quarter ended December 31, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $3.6 million for the fourth quarter ended December 31, 2023, a decrease of $0.4 million compared to $4.0 million for December 31, 2022.
  • Net loss: Net loss for the fourth quarter ended December 31, 2023 was $18.6 million or $0.46 per share compared to $24.1 million or $0.61 per share for the fourth quarter ended December 31, 2022.

Achilles Therapeutics Provides Interim Phase I/IIa Update on Clonal Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma Including First Patients Dosed with Enhanced Host Conditioning

Retrieved on: 
Thursday, April 4, 2024
Lymphocytopenia, Neutropenia, NSCLC, TIL, Patient, ACHL, Therapy, Safety, Melanoma, Blood, Escape Room

LONDON, April 04, 2024 (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 interim Phase I/IIa data on the use of clonal neoantigen reactive T cells (cNeT) from the CHIRON study in advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and the THETIS study in recurrent or metastatic malignant melanoma. The update includes data from 18 patients across CHIRON (n=12) and THETIS (n=6) dosed since the previous interim update in December 2022, with two CHIRON patients and one THETIS patient having received enhanced chemo-conditioning and IL-2 dosing aligned to standard tumor infiltrating lymphocyte (TIL) therapy (enhanced host conditioning) in a new Cohort C. This new Cohort C will allow the impact of enhanced host conditioning on cNeT engraftment and persistence beyond 28 days to be evaluated.

Key Points: 
  • All trial participants were late-stage, checkpoint refractory patients with progressive disease at the time of lymphodepletion.
  • The observed tolerability profiles remain favorable and similar to standard TIL therapy.
  • These learnings will inform the development of cNeT and related neoantigen vaccine and TCR-T therapies,” said Dr Iraj Ali, CEO of Achilles Therapeutics.
  • “We have made important progress in the optimization of our VELOS manufacturing process with a significant improvement in cNeT doses delivered and are developing our understanding of the relationship between host conditioning and the engraftment of infused cNeT.

Phio Pharmaceuticals Reports 2023 Year End Financial Results and Provides Business Update

Retrieved on: 
Tuesday, April 2, 2024
Skin care, Research, Lung cancer, Ovarian cancer, DP, Head, Conference, Face, Cell, Skin cancer, Immunotherapy, TIL, Clinical, Cancer, Cervical cancer, HNSCC, George Washington University, Patient, Gene, American Academy, D&O, IND, Centricity, AACR, Glioblastoma, Skin, Breast cancer, Scalp, Melanoma, Patent, SITC, Private law, FDA, BRD4, Food, Pharmaceutical industry

MARLBOROUGH, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today reported its financial results for the year ended December 31, 2023 and provided a business update.

Key Points: 
  • The latter clearance was significant since there are no drugs specifically approved to treat early stages I and II of cSCC.
  • As of February, the first two patients in our first cohort have completed treatment with PH-762 with no reported adverse events.
  • In 2023 we implemented a cost rationalization program driven by our transition from discovery research to product development.
  • At December 31, 2023 we had cash of $8.5 million as compared with $11.8 million at December 31, 2022.

Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Toxicity, NSCLC, TIL, Disease, Patient, University, MD Anderson Cancer Center, AACR, IL2, ICI, Therapy, Safety, Poster, PFS, Capillary leak syndrome, Cytokine release syndrome, Pharmaceutical industry

, professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.

Key Points: 
  • , professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.
  • The single-center study ( NCT05470283 ) is evaluating the safety, tolerability, dosing, and efficacy of OBX-115 in patients with ICI-resistant metastatic melanoma.
  • All 6 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 2.5 (range, 1–5) lines of prior therapy.
  • In addition to the first-in-human study, Obsidian is actively enrolling patients with metastatic melanoma and NSCLC at multiple sites in its ongoing Phase 1/2 multicenter study.

Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 22, 2024
Date, Patient, SAN, Cancer, Employment, TIL

SAN CARLOS, Calif., March 22, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on March 22, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 97,700 shares of Iovance’s common stock to twenty new, non-executive employees.

Key Points: 
  • SAN CARLOS, Calif., March 22, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on March 22, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 97,700 shares of Iovance’s common stock to twenty new, non-executive employees.
  • The awards were granted under Iovance’s 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022 and May 10, 2023, and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Each of the stock options granted as referenced in this press release has an exercise price of $15.02, the closing price of Iovance’s common stock on the Date of Grant.
  • Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.

Turnstone Biologics Corp. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Recent Business Highlights

Retrieved on: 
Thursday, March 21, 2024
Administration, Head, TIL, Colorectal cancer, Immunotherapy, HNSCC, Takeda Oncology, Selection, Patient, G&A, Melanoma, TILS, Investment, CRC, Breast cancer, SITC, Research and development, Research institute, Turnstone, Uveal melanoma

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent business highlights.

Key Points: 
  • “2023 marked a transformative year for Turnstone Biologics in which we transitioned into a publicly traded company and continued to advance our pipeline through clinical development.
  • Recently, Turnstone expanded their trials to evaluate additional solid tumor types in addition to the existing indications of breast cancer and uveal melanoma.
  • Preclinical Data Presentations at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting Support Ongoing Clinical and Preclinical Efforts.
  • Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2023, cash, cash equivalents and short-term investments were $94.8 million.

Obsidian Therapeutics Announces Oversubscribed $160.5 Million Series C Financing to Drive OBX-115 Clinical Development

Retrieved on: 
Wednesday, April 3, 2024
Biotechnology, Health, Genetics, Clinical Trials, Oncology, Janus, Growth, Novo Holdings A/S, NSCLC, TIL, Patient, Wellington Management Company, Paradigm, Foresite Capital, Bristol Myers Squibb, Lung cancer, Doctor of Philosophy, Therapy, Melanoma, Investment, Atlas Venture, Pharmaceutical industry

Obsidian Therapeutics, Inc. , a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced it has closed a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management.

Key Points: 
  • Obsidian Therapeutics, Inc. , a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced it has closed a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management.
  • Proceeds from the financing will advance Obsidian’s lead engineered tumor-infiltrating lymphocyte (TIL) program, OBX-115, in its ongoing trials for patients with melanoma and non-small cell lung cancer (NSCLC).
  • The Company is focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.
  • “This financing provides funding through key clinical readouts in melanoma and is the catalyst to continue expanding OBX-115 into NSCLC, where there is significant potential and high unmet need.”

Trialbee's Jamie Goldfarb to Lead Discussion on Defining Success and Enhancing Collaboration in Clinical Trials at Patients as Partners in Clinical Research Conference

Retrieved on: 
Thursday, March 14, 2024
Honey, Goldfarb, Patient, Success, Partner, Food and Drug Administration, ROI, Digital, TIL, Pharmacy, GSK, Research, Participation, National Cancer Institute, Cancer, Medidata Solutions, Ecosystem, Melanoma, Food, FDA, Process optimization, Fireside chats, Pharmaceutical industry

CHAPEL HILL, N.C. and MALMÖ, Sweden, March 14, 2024 /PRNewswire-PRWeb/ -- Trialbee, the global leader in technology-driven patient recruitment for clinical trials, is honored that Director of Patient Recruitment Strategy Jamie Goldfarb will take center stage at the Patients as Partners in Clinical Research on March 20-22, in Philadelphia, PA.

Key Points: 
  • The session aims to strengthen relationships among sites, sponsors, and patients to deepen understanding and engagement.
  • "Many patients aren't aware that clinical trials present viable treatment opportunities, and if they do, their needs are often overlooked," Goldfarb said.
  • "By actively listening to patients, sponsors can gain invaluable insights and perspectives that lead to medical advances and improve countless lives."
  • The Patients as Partners in Clinical Research conference offers a unique opportunity to hear from pharmaceutical research and development leaders, Food and Drug Administration (FDA) representatives, and patient advocates on how patient involvement drives greater efficiencies in clinical research.

Lyell Immunopharma Announces the Acceptance of Three Abstracts for Presentation at 2024 AACR Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024
SAN, TIL, AACR, Memory, Abstract, Tumor microenvironment, Patient, Poster, Lyell, Lymphocyte, Vaccine

One oral and two poster presentations will highlight data from Lyell’s product pipeline and research programs, including:

Key Points: 
  • One oral and two poster presentations will highlight data from Lyell’s product pipeline and research programs, including:
    A poster presentation of nonclinical data on LYL119, Lyell’s second-generation ROR1-targeted CAR T-cell product candidate
    Details on the presentations are below.
  • Previously published studies have demonstrated the decline in T-cell function as a person ages.
  • IL-12 is an immune-stimulatory cytokine that can induce potent anti-tumor activity, but unregulated systemic delivery of IL-12 has been shown to have a limited therapeutic window.
  • trIL-12 is being advanced under a collaboration between Lyell and Outpace with the goal of improving efficacy for T-cell therapies by harnessing the therapeutic potential of IL-12.

Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer

Retrieved on: 
Monday, March 4, 2024
IOV, NSCLC, SAN, EGFR, TIL, FDA, Food, Lung cancer, Safety, Patient, ROS, ALK, Cancer, Pharmaceutical industry

In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring.

Key Points: 
  • In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring.
  • Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202.
  • Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025.
  • Preliminary data from the IOV-LUN-202 trial support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies.