Presage has created a method for evaluating the effectiveness of drugs or RNA interference agents on tumors without the constraints associated with traditional systemic administration. This approach allows pharmaceutical companies to discontinue development of ineffective compounds and identify drug targets using RNA interference without worrying about the distribution of systemically administered RNAi agents. Additionally, Presage's technology can help identify successful drug combinations by providing a more direct measurement of their efficacy.

Tags

Skin and Musculoskeletal Diseases

Neoplasms

Respiratory Diseases

Small molecule drug

Chemical drugs

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	2

Top 5 Drug Type	Count

Small molecule drug	1
Chemical drugs	1

Top 5 Target	Count

ROR1(Inactive tyrosine-protein kinase transmembrane receptor ROR1)	1
STING(Stimulator of interferon genes)	1

Drugs associated with Presage Biosciences, Inc.

Relatlimab

Target

LAG3

Mechanism

LAG3 inhibitors [+2]

Active Org.

Bristol Myers Squibb Co. [+2]

Originator Org.

Bristol Myers Squibb Co.

Active Indication

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma [+27]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

TAK-676

Target

STING

Mechanism

STING agonists

Active Org.

Takeda Development Center Americas, Inc. [+4]

Originator Org.

Takeda Development Center Americas, Inc.

Active Indication

Solid tumor [+4]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Motolimod

Target

TLR8

Mechanism

TLR8 agonists

Active Org.

Array BioPharma, Inc.

Originator Org.

Array BioPharma, Inc.

Active Indication

Head and Neck Neoplasms [+2]

Inactive Indication

Advanced cancer [+9]

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Presage Biosciences, Inc.

NCT06273852 / RecruitingEarly Phase 1

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors

This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.

Start Date29 Apr 2024

Sponsor / Collaborator

Pure Biologics SA

[+1]

NCT06019390 / Not yet recruitingNot Applicable

eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Observational Study

Introduction: Due to the worldwide ageing population and the increasing prevalence of chronic illnesses and cognitive deficits, appropriate instruments for frailty early screening and assessment of geriatric syndromes are required. Digital tools based on artificial intelligence can help improve the evaluation and screening of health risks in the older adults.
Objectives: This study aims to evaluate the effectiveness of the PRESAGE CARE questionnaire in screening geriatric syndromes among older adults and to assess its correlation with standardized test scores of the comprehensive geriatric assessment (CGA).
Methods: A monocentric prospective observational study will be conducted between October 2023 and July 2024, on seniors who are in the day hospitalization service of Charles-Foix hospital in France. During the consultation with older adults, the investigators will ask the patient's home caregiver to use the PRESAGE CARE application to fill in the PRESAGE CARE questionnaire. Once the questionnaire will be completed on the application, the PRESAGE platform will automatically recorde specific risks for each senior. Subsequently, the investigators will retrieve the data from standardized tests conduct on the same day and enter the results for each patient into the platform.
The primary outcome will be the correlation between standardized test scores and the risks computed by the Presage Care system for the risk of depression, the risk of undernutrition, the risk of cognitive impairment and the risk of loss of autonomy in activities of daily living.
Secondary outcome will be the comparison of the Area Under the Median Curve (AUC), and the sensitivity, specificity and positive predictive values of artificial intelligence (AI)-based models on the Présage Care questionnaire.

Start Date01 Oct 2023

Sponsor / Collaborator

Presage Biosciences, Inc.

[+1]

NCT06413095 / CompletedEarly Phase 1

Pembrolizumab Alone and in Combination(s) With MK-0482 and MK-4830 Via Intratumoral Injection in Patients With Head and Neck Squamous Cell Carcinoma or Soft Tissue Sarcoma Prior to Planned Surgical Intervention

This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native tumor microenvironment (TME) following intratumoral microdosing via the CIVO device in patients with surface accessible Head and Neck Squamous Cell Carcinoma (HNSCC) or Soft Tissue Sarcoma (STS) lesion(s) who are scheduled for tumor and/or regional node dissection as part of their standard treatment.

Start Date01 Jun 2022

Sponsor / Collaborator

Presage Biosciences, Inc.

[+1]

100 Clinical Results associated with Presage Biosciences, Inc.

0 Patents (Medical) associated with Presage Biosciences, Inc.

Literatures (Medical) associated with Presage Biosciences, Inc.

01 Jun 2023·Journal of Clinical Oncology

Multiplexed trackable intratumor microdosing of the investigational STING agonist TAK-676 alone and in combination in the native tumor microenvironment of patients with head and neck cancer: A phase 0 trial.

Author: Schauer, Nathan J ; Mehta, Vikas ; Lineberry, Neil ; Burns, Connor ; Beirne, Emily ; Ow, Thomas J ; Rajasekaran, Karthik ; Klinghoffer, Richard ; Jenkins, Wendy ; Turner, Atticus ; Pang, John ; Tang, Alice L ; Merrell, Angela ; Frazier, Jason ; Derry, Jonathan ; Nathan, Cherie-Ann ; Grenley, Marc O ; Gregory, Richard C. ; Van Zante, Annemieke ; Schiff, Bradley A

2579 Background: TAK-676 is a novel synthetic STING agonist developed to induce an inflammatory state through release of interferon (IFN), production of proinflammatory chemokines and cytokines, and activation of innate and adaptive immune cells in the tumor microenvironment (TME). To gain early mechanistic insights on the effects of TAK-676 in the native TME alone and in combination with standard-of-care chemotherapies, we completed a Phase 0 intratumoral microdosing trial in head and neck squamous cell carcinoma patients using the Comparative In Vivo Oncology (CIVO) platform. CIVO enables direct evaluation of biomarker response in trackable, distinct regions of drug exposure upon resection. These studies were designed to identify rational combinations that could be evaluated in future clinical trials with therapeutic intent. Methods: This IRB-approved study was conducted at four centers within the United States. Fifteen subjects provided Informed Consent and enrolled in the trial. Microdoses (≤1/100th systemic dose) of TAK-676, carboplatin, 5-FU, paclitaxel, and combinations thereof, were simultaneously injected via CIVO to eligible patients presenting with a surface-accessible primary or metastatic lesion ≥ 2 cm and planned surgical resection of the target lesion at 24 (n=8) or 72–96 (n=7) hours. Injection sites were identified via co-injection of fluorescent tracking markers (CIVO GLO). Multiplexed ISH, IHC, and spatial molecular profiling via GeoMx and CosMx were used to resolve molecular responses at each injection site. Patients were monitored for adverse events (AEs) for 28 days following injection. Results: TAK-676 exposure was associated with increased IFN signaling in all samples analyzed at the 24-hour cohort. This was accompanied by increased expression of pro-inflammatory cytokines and chemokines, “M1-like” macrophages, NK cells, and CD8+ T cells. Spatial profiling with GeoMx and CosMx revealed an IFN signature and elevated pro-inflammatory markers across multiple cell types throughout the TME. In addition, exposure to TAK-676 plus chemotherapy resulted in localized enhancement of apoptosis vs. chemotherapy alone across multiple tumors. The responses observed at 24 hours were transient and not detected in the 72–96-hour cohort. No AEs related to injection procedure or contents were reported. Conclusions: Intratumor microdosing via CIVO of TAK-676 alone and in combination with chemotherapy was shown to promote an early pro-inflammatory response, providing evidence of an on-target mechanism of action. The absence of effect at the late timepoints could be due to pharmacokinetics of drug exposure or compensatory signaling within the TME. In this Phase 0 clinical trial we safely demonstrated precise, mechanistic effects of TAK-676 on the native TME of intact human tumors. Clinical trial information: NCT04541108 .

15 Jun 2022·Cancer Research

Abstract 3424: Deep mechanistic profiling of immune oncology (I-O) drug combinations in cancer patients with CIVO® intratumoral microdosing and NanoString GeoMx DSP

Author: Sottero, Kimberly ; Klinghoffer, Richard ; Anderson, Kirsten ; Kung, Gloria ; Frazier, Jason P. ; Derry, Jonathan M. ; Gundle, Kenneth R. ; Grenley, Marc

AbstractDespite over four thousand clinical trials investigating combinations of various anti-cancer agents with immune checkpoint inhibitors (CPI), few have demonstrated significant clinical improvement over CPI alone. This indicates a need for approaches that can guide development of complex (≥ 3 drug) I-O combination treatments by enabling far greater mechanistic understanding of response to drug exposure by components of the authentic tumor microenvironment (TME). Here we show how an approach based on two technologies, the Presage Comparative In Vivo Oncology (CIVO) Platform and the NanoString GeoMx Digital Spatial Profiler (GeoMx DSP), highlights drug synergies as well as mechanisms of resistance to drug exposure in the native and intact TME of cancer patients, providing a path to rapid identification of effective drug combinations. The CIVO platform enables trackable multiplexed intratumoral delivery of microdosed drugs, either as single agents or in combinations, allowing evaluation of the localized tumor response to drug candidates in the TME while capturing tumor heterogeneity and patient diversity. GeoMx DSP is a method for high-plex spatial profiling of mRNAs with rare-cell sensitivity. Combining these technologies in Phase 0 clinical studies in human soft tissue sarcoma patients we evaluated distinct tumor sites microdosed with either nivolumab (anti-PD1), aldesleukin (recombinant IL-2), the combination of nivolumab and aldesleukin, vehicle (no drug), or chemotherapy controls. Using the Nanostring Cancer Transcriptome Atlas we evaluated the effect of drug exposure on expression of over 1,800 genes simultaneously with spatial resolution across individual patient tumors. Synergistic elevation of multiple transcripts was observed at tumor sites exposed to the combination of aldesleukin and nivolumab. This included T-cell specific elevation of granzyme B, a classic biomarker of T-cell activation. Importantly, we show how events such as T-cell activation may be dampened by feedback loops involving immune suppressive responses including, but not limited to, elevation of IDO-1 in non-T-cell components of the TME. Results were observed across multiple patient tumors and were verified by conventional immuno-histochemistry or in situ hybridization. Performing these studies across different patients allows us to explore the inter-individual variation in drug responses. We believe this is an efficient and biologically relevant approach to better understanding feedback loops activated within the authentic TME and ultimately prioritizing drug combinations for clinical development.Citation Format: Jason P. Frazier, Kenneth R. Gundle, Marc Grenley, Gloria Kung, Kimberly Sottero, Kirsten Anderson, Richard Klinghoffer, Jonathan M. Derry. Deep mechanistic profiling of immune oncology (I-O) drug combinations in cancer patients with CIVO® intratumoral microdosing and NanoString GeoMx DSP [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3424.

15 Jun 2022·Cancer Research

Abstract 620: Intratumoral microdosing via the CIVO® Platform reveals anti-tumor immune responses induced by the STING Agonist TAK-676 alone and in combination with chemotherapies

Author: Lineberry, Neil B. ; Ditzler, Sally ; Gregory, Richard C. ; Grenley, Marc ; Klinghoffer, Richard A. ; Hatton, Beryl A. ; Berger, Allison J. ; Malek, Karim S.

AbstractPurpose/Objectives: Individual tumor complexity and the emergence of treatment resistance mechanisms have proven challenging for oncology drug development, and methods for prioritizing combination therapy approaches are needed. The CIVO (Comparative In Vivo Oncology) platform can simultaneously deliver up to 8 drugs and combinations in microdose amounts to distinct, trackable regions within a single intact tumor, enabling studies that can assess multiple drugs and combinations directly in patients during early drug development. This study employed CIVO to assess two combination strategies incorporating the STING (Stimulator of Interferon Genes) agonist TAK-676 and chemotherapies capable of inducing immunogenic cell death. We evaluated TAK-676’s ability to elicit pharmacodynamic (PD) changes suggestive of anti-tumor immune activation within the tumor microenvironment (TME) in a syngeneic mouse model, both as monotherapy and in combination with cisplatin and 5-FU or cisplatin and paclitaxel chemotherapy doublets.Materials/Methods: TAK-676 and chemotherapy combinations were simultaneously microdosed via CIVO in a syngeneic mouse melanoma model (YUMM1.7). Successful injections were visualized after administration, during sample processing, and in biomarker-stained tissue sections via a fluorescent tracking marker co-injected through each needle, and PD responses were assessed via immunohistochemistry and in situ hybridization following tumor resection.Results: Drug mechanism of action-specific biomarker activity was evident as early as 4 hours after injection. TAK-676 induced robust elevation of pIRF3 and CXCL10 along with IFNγ from both T and NK cell compartments, indicating STING pathway activation. Phospho-histone H3 accumulation was noted in response to paclitaxel-induced mitotic arrest. 5-FU and cisplatin induced localized DNA damage, visible via elevated phospho-histone H2AX-positive nuclei. Cytotoxic T lymphocyte (CTL) accumulation was detected around TAK-676 injection sites, likely recruited from the local TME via induction of chemokines such as CXCL10. Early tumor cell apoptosis and induction of pro-inflammatory cytokines such as CXCL10 were detected in response to both triplet combinations. CTL activation was enhanced in response to both triplet combinations by 24 hours, whereas CTL enrichment at levels greater than induced by TAK-676 alone was noted specifically in response to the triplet combination with cisplatin and paclitaxel by 72 hours.Conclusion: These studies highlight TAK-676’s potential to promote anti-tumor immunity and the utility of the CIVO platform to reveal and characterize combination-specific responses. This application of CIVO is being further evaluated in an ongoing Phase 0 trial in patients with head and neck squamous cell carcinoma (NCT04541108).Citation Format: Beryl A. Hatton, Marc Grenley, Sally Ditzler, Richard A. Klinghoffer, Allison J. Berger, Karim S. Malek, Richard C. Gregory, Neil B. Lineberry. Intratumoral microdosing via the CIVO® Platform reveals anti-tumor immune responses induced by the STING Agonist TAK-676 alone and in combination with chemotherapies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 620.

News (Medical) associated with Presage Biosciences, Inc.

25 Jul 2024

·www.prnewswire.com

Presage Biosciences Announces First Patient Dosing of Pure Biologics' ROR1 Targeting Antibody For Treatment of Cancer

SEATTLE, July 25, 2024 /PRNewswire/ -- Presage Biosciences, a biotechnology company that directly measures activity of oncology drugs within human tumors, announced the Phase 0 dosing of the first cancer patient with Pure Biologics' PBA-0405, an antibody that targets ROR1. PBA-0405 has been engineered to induce tumor cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment. In January, Presage and Pure Biologics announced the U.S. Food and Drug Administration issued a Study May Proceed notification for Phase 0 testing of a pre-GMP first-in-human drug candidate with Presage's Comparative In Vivo Oncology (CIVO®) platform. CIVO enables microdosing directly in a human tumor that is planned for surgical removal. Extensive molecular profiling technologies determine drug effectiveness in the tumor microenvironment by analysis of the expression of thousands of genes. "With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound with a unique mode of action to enter studies in patients. We're encouraged by the preclinical data we've seen so far and are eager to evaluate its pharmacodynamic activity in human studies", said Dr. John Weinberg, Chief Medical Officer of Pure Biologics. ROR1 is a tumor-associated antigen expressed on many solid tumors and B cell malignancies. "We are very excited to partner with Pure Biologics to evaluate their pre-GMP oncology drug in a first-in-human Phase 0 CIVO study" said Dr. Patrick Gray, Presage CEO. "Testing of pre-GMP compounds in human tumors in situ simplifies and speeds up the drug development process. Our Phase 0 studies can determine tumor killing activity, synergism with approved or investigational drugs, and immuno-oncology activity." About CIVO Comparative In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with immunohistochemistry, in situ hybridization, and molecular profiling technologies in both preclinical and Phase 0 trials to inform and de-risk oncology drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . For more information: [email protected] SOURCE Presage Biosciences Inc

Phase 1ImmunotherapyIND

30 Nov 2023

·www.prnewswire.com

Presage Biosciences Announces New Pharma Partnership to Evaluate Novel Immuno-Oncology Drug Combinations with CIVO® Technology

SEATTLE, Nov. 30, 2023 /PRNewswire/ -- Presage Biosciences, a pioneering translational oncology company whose mission is to use CIVO and spatial molecular profiling to understand the complexity of drug response in the tumor microenvironment (TME), has entered into an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), a global biopharmaceutical company. According to the agreement, Presage's platform will be used by AstraZeneca in translational analysis to evaluate several investigational bispecific antibody combinations in samples taken from head and neck cancer patients. The work will contribute to advancing AstraZeneca's growing portfolio of immuno-oncology agents looking to harness the immune system against cancer. Rich Klinghoffer, PhD, Chief Executive Officer of Presage, said: "Prior studies have demonstrated that the CIVO platform provides accurate guidance about the therapeutic potential of novel agents in the only context that matters: Fully intact patient tumors. We are very pleased to be working with an innovator like AstraZeneca and supporting their quest to discover, develop, and deliver transformative medicines to patients." Earlier this month, Presage presented results from a completed Phase 0 study evaluating Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) alone and in combination with other immune-oncology agents at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting. The study enrolled patients across six US-based cancer centers in both soft tissue sarcoma and head and neck cancer. Study data highlight the importance of evaluating novel therapies in patient tumors and revealed a contradiction between results from in-vivo animal studies versus results in the intact TME. "For too long, we have put our trust in laboratory models of cancer that do not capture the complexity of the intact TME," said Klinghoffer. "The CIVO technology was developed to address this fundamental issue in cancer drug development and the results from this study demonstrate the true power of our platform - the ability to know, early in development, how a drug impacts patient tumors." KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About CIVO Clinical In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. The platform enables evaluation of up to eight distinct and trackable drugs and drug combinations simultaneously. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in Phase 0 trials in order to inform and de-risk drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . SOURCE Presage Biosciences Inc

ImmunotherapyPhase 1ASCOClinical Result

18 Apr 2023

·www.prnewswire.com

Presage to Present at AACR 2023 - Core CIVO Technology Reveals Unexpected Effects of an Investigational Ubiquitination Inhibitor on Checkpoint Blockade

SEATTLE, April 17, 2023 /PRNewswire/ -- Presage Biosciences, a pioneer in translational oncology whose mission is understanding the complexity of drug response in the tumor microenvironment (TME), will present at the Immunology, TME Minisymposium at the American Association for Cancer Research (AACR) 2023 Annual Meeting. In an independent study, Presage's innovative multiplexed trackable microdosing platform (CIVO®) was used to introduce an investigational ubiquitin inhibitor (TAK-243) alone and in combination with anti-PD1. The resulting data demonstrated that TAK-243 has potential to increase anti-tumor immunogenicity and prime tumors for response to immune checkpoint inhibition. The Session (MS.IM01.03 – Immune Checkpoints at Tumor Beds, #3476) is titled "TAK-243 increases tumor immunogenicity enhancing systemic anti-tumor immune response and tumor regression in combination with immune checkpoint inhibition in a syngeneic model of lymphoma" and will be presented live on April 17, 2023 from 3:52pm-4:07pm EST. "We are excited to showcase these novel findings on the TME and how we have paired CIVO with sophisticated spatial profiling to translate preclinical findings to human disease" said Richard Klinghoffer, Presage's Chief Executive Officer. "We continue our work with fellow innovators in oncology to deliver key translational data early in the clinical development process." After AACR 2023, Presage Biosciences' CIVO technology will be further showcased at two events: The 4th Annual International Phase-0/Microdosing Stakeholder Meeting in Boston, MA on April 24th. Presage is featured speaker, panel moderator and sponsor at this year's event; Life Science Innovation Northwest (LSINW) in Seattle, WA on April 25. LSINW is the Pacific Northwest's largest annual life science conference. About CIVO Comparative In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . Media Contact: Julie Rathbun Rathbun Communications (206) 769-9219 [email protected] SOURCE Presage Biosciences

AACRImmunotherapy

100 Deals associated with Presage Biosciences, Inc.

100 Translational Medicine associated with Presage Biosciences, Inc.

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Drug(Targets)	Indications	Global Highest Phase

PBA-0405 ( ROR1 )	Squamous Cell Carcinoma of Head and Neck More	Phase 1 Clinical
TAK-676 ( STING )	Squamous Cell Carcinoma of Head and Neck More	Phase 1 Clinical
Subasumstat ( SAE )	Head and Neck Neoplasms More	Discontinued
Motolimod ( TLR8 )	Squamous Cell Carcinoma of Head and Neck More	Pending
MVC-101 ( CD3 x EGFR )	Solid tumor More	Pending

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