Stimulator of interferon genes

OncoNano Medicine Announces First Patient Dosed in Phase 1 Study Evaluating ONM-501 in Patients with Advanced Solid Tumors and Lymphomas

Retrieved on: 
Monday, November 27, 2023

The ONM-501 trial ( NCT06022029 ) is a multicenter Phase 1, dose escalation and dose expansion study in patients with advanced solid tumors and lymphomas.

Key Points: 
  • The ONM-501 trial ( NCT06022029 ) is a multicenter Phase 1, dose escalation and dose expansion study in patients with advanced solid tumors and lymphomas.
  • ONM-501 features dual STING activation, with the polymers used to construct the micelles binding to and activating STING alongside the payload critical to activation.
  • During the combinatorial dose escalation and expansion cohort segments of the trial, ONM-501 will be dosed in combination with Regeneron’s Libtayo® (cemiplimab-rwlc), an anti-PD-1 monoclonal antibody.
  • OncoNano and Regeneron have entered into a clinical trial supply agreement for this ONM-501 study.

Medicenna Presents Preclinical MDNA223 BiSKIT Data at the AACR Special Conference on Tumor Immunology and Immunotherapy

Retrieved on: 
Tuesday, October 3, 2023

TORONTO and HOUSTON, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ, TSX: MDNA), a clinical-stage immunotherapy company focused on the development of novel Superkines, today announced that new preclinical data characterizing MDNA223, an anti-PD1-IL-2 BiSKIT (Bifunctional SuperKine for ImmunoTherapy), were presented at the 2023 AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy held from October 1 - 4, 2023, in Toronto, Canada.

Key Points: 
  • TORONTO and HOUSTON, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ, TSX: MDNA), a clinical-stage immunotherapy company focused on the development of novel Superkines, today announced that new preclinical data characterizing MDNA223, an anti-PD1-IL-2 BiSKIT (Bifunctional SuperKine for ImmunoTherapy), were presented at the 2023 AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy held from October 1 - 4, 2023, in Toronto, Canada.
  • “We believe that our dual-functioning BiSKIT candidates, such as MDNA223, are more potent and selective and may have an increased capacity to induce superior CD8+ T cell responses against tumor cells.
  • The sum of encouraging preclinical data on MDNA223 highlights the potential of Medicenna’s BiSKIT platform to broadly delivery effective therapy to otherwise challenging-to-treat ‘cold’ tumors.
  • Copies of the poster will be posted to the “ Events and Presentations ” page of Medicenna’s website following the conclusion of the meeting.

OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo® (cemiplimab) in ONM-501 Study

Retrieved on: 
Wednesday, September 6, 2023

OncoNano Medicine, Inc. today announced a clinical trial supply agreement with Regeneron for the use of Libtayo® (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate.

Key Points: 
  • OncoNano Medicine, Inc. today announced a clinical trial supply agreement with Regeneron for the use of Libtayo® (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate.
  • The ONM-501 first-in-human trial ( NCT06022029 ) is a multicenter Phase 1a/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas.
  • OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab.
  • “We are thrilled to collaborate with a leading company such as Regeneron as we continue working toward our mission of delivering targeted therapeutics to cancer patients.”

OncoNano Presents Compelling Data for ONM-501 and a Novel Tumor Specific Delivery Technology at AACR Annual Meeting 2023

Retrieved on: 
Tuesday, April 18, 2023

OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023.

Key Points: 
  • OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023.
  • The posters detail positive nonclinical data for ONM-501, the Company’s dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate, formulated with the company’s OMNI™ polymer technology as well as positive data for encapsulated bispecific antibody and cytokine using ON-BOARD™ tumor specific delivery technology.
  • This novel mechanism provides potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both “hot” and “cold” tumor microenvironments.
  • The promising data that we presented at AACR 2023 suggest our technology may provide a solution to overcome the clinical application limitations of these highly potent protein therapeutics.”

Fresh Tracks Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 30, 2023

BOULDER, Colo., March 30, 2023 (GLOBE NEWSWIRE) -- Fresh Tracks Therapeutics, Inc. (the “Company” or “Fresh Tracks”) (Nasdaq: FRTX), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • Revenue was $2.1 million for the fourth quarter of 2022, compared to $0.1 million for the fourth quarter of 2021.
  • Research and development expenses were $2.6 million for the fourth quarter of 2022, compared to $3.1 million for the fourth quarter of 2021.
  • General and administrative expenses were $4.0 million for the fourth quarter of 2022, compared to $3.3 million for the fourth quarter of 2021.
  • The Company’s net loss was $4.5 million for the fourth quarter of 2022 compared to $6.1 million for the fourth quarter of 2021.

Fresh Tracks Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022

BOULDER, Colo., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Fresh Tracks Therapeutics, Inc. (the “Company” or “Fresh Tracks”) (Nasdaq: FRTX), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.

Key Points: 
  • To better align with our new strategic vision and plans, we recently rebranded the Company to Fresh Tracks Therapeutics, commented Robert Brown, Chief Executive Officer of Fresh Tracks.
  • In the second quarter of 2022, Fresh Tracks entered into an asset purchase agreement (APA) with Botanix SB Inc. (Botanix).
  • Fresh Tracks management will host a conference call today at 4:30 p.m. EDT to discuss the financial results and recent corporate developments.
  • Fresh Tracks Therapeutics is a clinical-stage pharmaceutical company striving to transform patient lives through the development of innovative and differentiated prescription therapeutics.

OncoNano Medicine Announces Pre-Clinical Data for Dual-Activating STING agonist at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Thursday, November 10, 2022

OncoNano Medicine, Inc. today announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts.

Key Points: 
  • OncoNano Medicine, Inc. today announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts.
  • ONM-501, OncoNanos lead therapeutic program in development, is a dual-activating STING (Stimulator of Interferon Genes) agonist advancing towards a first in human trial planned to be initiated in the first half of 2023.
  • Previously published data has demonstrated the differentiated mechanism of ONM-501 with dual burst and sustained STING activation, enhanced cytosolic delivery and tumor retention through encapsulation of an endogenous STING agonist - cGAMP with OnocoNanos proprietary STING-activating OMNI polymeric micelles.
  • The results presented here confirm many of our hypotheses regarding the potential of ONM-501 to provide a robust therapeutic index of immune activating STING activity that may be differentiated from other STING agonists.

Exelixis Announces Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 1, 2022

In the third quarter of 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners were almost $500 million.

Key Points: 
  • In the third quarter of 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners were almost $500 million.
  • Exelixis earned $30.3 million in royalty revenues during the quarter ended September 30, 2022, pursuant to collaboration agreements with its partners, Ipsen and Takeda.
  • Previously, in July, Exelixis announced that COSMIC-313 met its primary endpoint, demonstrating significant improvement in PFS at the primary analysis.
  • Exelixis management will discuss the companys financial results for the third quarter of 2022 and provide a general business update during a conference call beginning at 5:00 p.m.

OncoNano Medicine to Present Data on Novel Development Candidates at the Society for Immunology of Cancer (SITC) Annual Meeting

Retrieved on: 
Wednesday, October 5, 2022

Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the bodys immune system to target cancer.

Key Points: 
  • Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the bodys immune system to target cancer.
  • OncoNanos lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries.
  • ONM-501, OncoNanos second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023.
  • Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas.

OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis

Retrieved on: 
Thursday, September 29, 2022

OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS).

Key Points: 
  • OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS).
  • The Phase 2 study ( NCT04950166 ) remains open to enrollment and is designed to evaluate the ability of pegsitacianine, a micellar fluorescence agent, to detect residual malignancies following CRS, an operation to completely resect peritoneal metastases.
  • The data presented revealed that 15 patients (55%) have demonstrated a clinically significant detection of pathology-confirmed residual disease following the completion of intended surgery.
  • Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing surgical resection.