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Last update 24 May 2025

CRS-207

Last update 24 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Live attenuated vaccine, Therapeutic vaccine

Synonyms

Listeria monocytogenes-expressing mesothelin, ANZ-207, CRS 207

Target

MSLN

Action

modulators

Mechanism

MSLN modulators(Mesothelin modulators)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Pancreatic adenocarcinoma metastaticOvarian CancerPancreatic Cancer+ [1]

Inactive Indication

Adenocarcinoma of EsophagusAdvanced Malignant Solid NeoplasmEpithelioid mesothelioma, malignant+ [9]

Originator Organization

Johns Hopkins Bloomberg School of Public Health

Active Organization

Chugai Pharmaceutical Co., Ltd.

Johns Hopkins Bloomberg School of Public Health

Cerus Corp.

+ [1]

Inactive Organization

Anza Therapeutics, Inc.

License Organization

ANI Pharmaceuticals, Inc.

Aduro BioTech, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Clinical Trials associated with CRS-207

NCT05014776

/ Active, not recruitingPhase 2IIT

A Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and clinical activity of tadalafil, pembrolizumab, ipilimumab, and CRS-207 in subjects with metastatic pancreatic adenocarcinoma who have progressed after at least 1 prior chemotherapy regimen.

Start Date22 Aug 2022

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT03006302

/ CompletedPhase 2IIT

Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer

This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.

Start Date31 Jan 2018

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+3]

NCT03190265

/ CompletedPhase 2IIT

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.

Start Date14 Dec 2017

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+3]

100 Clinical Results associated with CRS-207

100 Translational Medicine associated with CRS-207

100 Patents (Medical) associated with CRS-207

Literatures (Medical) associated with CRS-207

15 Jul 2020·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Reiss, Kim ; Vonderheide, Robert H. ; Coussens, Lisa M. ; Tsujikawa, Takahiro ; Le, Dung T. ; Durham, Jennifer N. ; Laheru, Daniel A. ; Tempero, Margaret A. ; Jaffee, Elizabeth M. ; Sugar, Elizabeth A. ; Danilova, Ludmila ; Nauroth, Julie M. ; Considine, Michael ; Onners, Beth ; Anders, Robert A. ; Fisher, George A. ; Ko, Andrew H. ; Wu, Annie A. ; Crocenzi, Todd ; Brockstedt, Dirk G. ; Fertig, Elana J.

Abstract:

Purpose::

Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF–secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes–expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).

Patients and Methods::

Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates.

Results::

Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7–8.6] and 6.1 (95% CI, 3.5–7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55–1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8+ T cells and a decrease in CD68+ myeloid cells, were observed in long-term survivors in Arm A only.

Conclusions::

Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.

01 May 2020·Cancer immunology researchQ1 · MEDICINE

Single-Cell Immune Competency Signatures Associate with Survival in Phase II GVAX and CRS-207 Randomized Studies in Patients with Metastatic Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Müller, Thomas ; Lemmens, Ed ; Nair, Nitya ; Jaffee, Elizabeth M. ; Brockstedt, Dirk G. ; Chang, Serena ; Whiting, Chan ; Chen, Shih-Yu ; Le, Dung T. ; Murphy, Aimee

Abstract:

The identification of biomarkers for patient stratification is fundamental to precision medicine efforts in oncology. Here, we identified two baseline, circulating immune cell subsets associated with overall survival in patients with metastatic pancreatic cancer who were enrolled in two phase II randomized studies of GVAX pancreas and CRS-207 immunotherapy. Single-cell mass cytometry was used to simultaneously measure 38 cell surface or intracellular markers in peripheral blood mononuclear cells obtained from a phase IIa patient subcohort (N = 38). CITRUS, an algorithm for identification of stratifying subpopulations in multidimensional cytometry datasets, was used to identify single-cell signatures associated with clinical outcome. Patients with a higher abundance of CD8+CD45RO−CCR7−CD57+ cells and a lower abundance of CD14+CD33+CD85j+ cells had improved overall survival [median overall survival, range (days) 271, 43–1,247] compared with patients with a lower abundance of CD8+CD45RO−CCR7−CD57+ cells and higher abundance of CD14+CD33+CD85j+ cells (77, 24–1,247 days; P = 0.0442). The results from this prospective–retrospective biomarker analysis were validated by flow cytometry in 200 patients with pancreatic cancer enrolled in a phase IIb study (P = 0.0047). The identified immune correlates provide potential prognostic or predictive signatures that could be employed for patient stratification.

01 Oct 2019·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Clinical Response of Live-Attenuated, Listeria monocytogenes Expressing Mesothelin (CRS-207) with Chemotherapy in Patients with Malignant Pleural Mesothelioma

Q1 · MEDICINE

Article

Author: Whiting, Chan C. ; Enstrom, Amanda ; Brockstedt, Dirk G. ; Murphy, Aimee L. ; Hassan, Raffit ; Kumar, Sushil ; McDougall, Katherine ; Coussens, Lisa M. ; Jaffee, Elizabeth ; Lemmens, Ed ; Tsujikawa, Takahiro ; Jahan, Thierry ; Nair, Nitya ; Honarmand, Somayeh ; Antonia, Scott ; Alley, Evan ; Choe, Gina ; Thomas, Anish ; Kindler, Hedy

Abstract:

Purpose::

Malignant pleural mesothelioma (MPM) is an aggressive cancer associated with poor prognosis. CRS-207 is a live-attenuated Listeria monocytogenes engineered to express mesothelin, a tumor-associated antigen highly expressed in MPM. CRS-207 induces antitumor immune responses and increases susceptibility of neoplastic cells to immune-mediated killing.

Patients and Methods::

Patients with unresectable MPM, ECOG 0 or 1, and adequate organ and pulmonary function were enrolled in this multicenter, open-label phase Ib study. They received two priming infusions of 1 × 109 CFU CRS-207, followed by pemetrexed/cisplatin chemotherapy, and CRS-207 booster infusions. Primary objectives were safety and induction of immune response. Secondary/exploratory objectives included tumor response, progression-free survival (PFS), overall survival (OS), immune subset analysis, and gene-expression profiling of tumor.

Results::

Of 35 evaluable patients, 89% (31/35) had disease control with one complete response (3%), 19 partial responses (54%), and 10 stable disease (29%). The estimated median duration of response was 5.0 months (95% CI, 3.9–11.5). The median PFS and OS were 7.5 (95% CI, 7.0–9.9) and 14.7 (95% CI, 11.2–21.9) months, respectively. Tumor size reduction was observed post–CRS-207 infusion prior to chemotherapy in 11 of 35 (31%) patients. No unexpected treatment-related serious adverse events or deaths were observed. IHC analysis of pre- and post–CRS-207 treatment tumor biopsies revealed possible reinvigoration and proliferation of T cells, increased infiltration of dendritic and natural killer cells, increased CD8:Treg ratio, and a shift from immunosuppressive M2-like to proinflammatory M1-like macrophages following CRS-207 administration.

Conclusions::

Combination of CRS-207 and chemotherapy induced significant changes in the local tumor microenvironment and objective tumor responses in a majority of treated patients.

News (Medical) associated with CRS-207

17 Jun 2022

·www.prnewswire.com

Biologic Therapy Market Information: By Product and Geography - Global Forecast till 2025

NEW YORK, June 17, 2022 /PRNewswire/ -- One of the key factors driving the Biologic Therapy Market growth is the strong R&D pipeline. The efficiency of biologics in the treatment of severe infections, malignancies, and immunological and hormonal disorders is encouraging manufacturers to invest in R&D for the development of biologics. For instance, monoclonal antibodies constitute one of the fastest-growing segments amongst biological therapies. To date, 88 monoclonal antibodies have been approved for different indications. Some of the examples are ICT-107 for glioblastoma, VGX-3100 for cervical cancer, NeuVax for breast cancer, NexVax2 for celiac disease, CRS-207 for pancreatic cancer, PEV7 for recurrent vulvovaginal candidiasis, and GI-4000 for pancreatic cancer. Similar is the case of biologics meant to be used as vaccines and therapeutic proteins, the pipeline of vendors like AbbVie, Amgen, Johnson & Johnson, and F. Hoffmann-La Roche clearly indicate huge investments in R&D. Apart from manufacturers that are actively involved in research on biologics, many research institutes are also engaged in developing novel biologics through industrial collaborations. Technavio has announced its latest market research report titled Biologic Therapeutics Market by Product and Geography - Forecast and Analysis 2021-2025 Get more information on Macro & Micro Economic Factor Analysis, Statistical Tools, and Trend Projection at Affordable Pricing options. Learn More The Biologic Therapy Market value is set to grow by USD 226.61 billion, progressing at a CAGR of 11% from 2020 to 2025, as per the latest report by Technavio. Moreover, the market is segmented by product (antibody therapeutics, vaccines, cell therapy, gene therapy, and other therapies) and geography (North America, Europe, Asia, and ROW). Biologic Therapy Market 2021-2025: Segmentation Product Antibody Therapeutics Vaccines Cell Therapy Gene Therapy Other Therapies The biologic therapy market share growth by antibody therapeutics will be significant during the forecast period. Monoclonal antibodies are amongst the most widely sold biologics and are even referred to as the future of medicine. Monoclonal antibodies are cloned from single-parent cells and are designed to recognize and bind to specific receptors on the surface of the cells. This specificity in action makes monoclonal antibodies more effective than conventional treatments for immunological and chronic ailments like cancer. Owing to these factors, it is expected that the global biologic therapy market will grow during the forecast period. Geography North America Europe Asia ROW 57% of the market's growth will originate from North America during the forecast period. The US is the key market for biologic therapy in North America. Market growth in this region will be slower than the growth of the market in the Asia region. One of the reasons for market growth in the Americas is the increased incidence of chronic diseases. The rise in the prevalence of major health disorders is mainly due to lifestyle changes and increased consumption of alcohol and tobacco in the US. However, market growth is expected to be only gradual due to the patent expiry of major biologics present in the market. Biologic Therapy Market 2021-2025: Scope Biologic Therapy Market size Biologic Therapy Market trends Biologic Therapy Market analysis High cost of biologics is one of the key challenges hindering the biologic therapy market growth. Biologics can be used for the treatment of several types of malignancies, hormonal imbalances, and autoimmune conditions, but they are expensive, which makes them beyond the reach of the economically underprivileged. The total manufacturing costs, which include the costs related to the clinical trials associated with biologics, account for vendors offering these products at high costs. The development of a biological molecule requires a separate living organism. Though bacterial production is not that costly, the production of therapeutic agents like monoclonal antibodies and vaccines becomes costly as they involve animal handling. The immunization of the animal and other procedures related to the production of antibodies and vaccines increases the cost of that product. Due to the high price of biologic therapy, many patients are unable to access this effective therapy, and this will remain a major challenge for the market during the forecast period. Biologic Therapy Market 2021-2025: Vendor Analysis The report analyzes the market's competitive landscape and offers information on several market vendors, including: AbbVie Inc. AstraZeneca Plc Bristol-Myers Squibb Co. F. Hoffmann-La Roche Ltd. GlaxoSmithKline Plc Johnson and Johnson Inc. Merck and Co. Inc. Novartis AG Pfizer Inc. Sanofi SA The biologic therapy market is concentrated and the vendors are deploying growth strategies such as partnering with research organizations and hospitals for R&D to compete in the market. Biologic Therapy Market 2021-2025: Key Highlights CAGR of the market during the forecast period 2021-2025 Detailed information on factors that will assist biologic therapy market growth during the next five years Estimation of the biologic therapy market size and its contribution to the parent market Predictions on upcoming trends and changes in consumer behavior The growth of the biologic therapy market Analysis of the market's competitive landscape and detailed information on vendors Comprehensive details of factors that will challenge the growth of biologic therapy market vendors Related Reports: Head and Neck Cancer Diagnostics Market by Diagnostic Methods and Geography - Forecast and Analysis 2020-2024: The head and neck cancer diagnostics market size has the potential to grow by USD 3.41 billion during 2020-2024. The market's growth momentum will accelerate throughout the forecast period. Latest Exclusive Research Insights Here Global Spine Biologics Market 2018-2022: The global spine biologics market size will grow by USD 418.72 million during 2018-2022. This industry research report provides a detailed analysis of the market based on product (bone grafts, BMP, BMAC, and others) and geography (the Americas, APAC, and EMEA). Latest Exclusive Research Insights Here Table of Contents: 1 Executive Summary 2 Market Landscape 2.1 Market ecosystem Exhibit 01: Parent market Exhibit 02: Market characteristics 2.2 Value chain analysis 3 Market Sizing 3.1 Market definition Exhibit 03: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 04: Market segments 3.3 Market size 2020 3.4 Market outlook: Forecast for 2020 - 2025 Exhibit 05: Global - Market size and forecast 2020 - 2025 ($ billion) Exhibit 06: Global market: Year-over-year growth 2020 - 2025 (%) 3.5 Market by application 4 Five Forces Analysis 4.1 Five forces summary Exhibit 07: Five forces analysis 2020 & 2025 4.2 Bargaining power of buyers Exhibit 08: Bargaining power of buyers 4.3 Bargaining power of suppliers Exhibit 09: Bargaining power of suppliers 4.4 Threat of new entrants Exhibit 10: Threat of new entrants 4.5 Threat of substitutes Exhibit 11: Threat of substitutes 4.6 Threat of rivalry Exhibit 12: Threat of rivalry 4.7 Market condition Exhibit 13: Market condition - Five forces 2020 5 Market Segmentation by Product 5.1 Market segments Exhibit 14: Product - Market share 2020-2025 (%) 5.2 Comparison by Product Exhibit 15: Comparison by Product 5.3 Antibody therapeutics - Market size and forecast 2020-2025 Exhibit 16: Antibody therapeutics - Market size and forecast 2020-2025 ($ billion) Exhibit 17: Sales of major monoclonal antibodies 2018-2020 ($ million) Exhibit 18: Antibody therapeutics - Year-over-year growth 2020-2025 (%) 5.4 Vaccines - Market size and forecast 2020-2025 Exhibit 19: Vaccines - Market size and forecast 2020-2025 ($ billion) Exhibit 20: Vendors offering vaccines Exhibit 21: Vaccines - Year-over-year growth 2020-2025 (%) 5.5 Cell therapy - Market size and forecast 2020-2025 Exhibit 22: Cell therapy - Market size and forecast 2020-2025 ($ billion) Exhibit 23: Cell therapy - Year-over-year growth 2020-2025 (%) 5.6 Gene therapy - Market size and forecast 2020-2025 Exhibit 24: Gene therapy - Market size and forecast 2020-2025 ($ billion) Exhibit 25: Gene therapy - Year-over-year growth 2020-2025 (%) 5.7 Other therapies - Market size and forecast 2020-2025 Exhibit 26: Other therapies - Market size and forecast 2020-2025 ($ billion) Exhibit 27: Other therapies - Year-over-year growth 2020-2025 (%) 5.8 Market opportunity by Product Exhibit 28: Market opportunity by Product 6 Customer landscape 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 30: Market share by geography 2020-2025 (%) 7.2 Geographic comparison Exhibit 31: Geographic comparison 7.3 North America - Market size and forecast 2020-2025 Exhibit 32: North America - Market size and forecast 2020-2025 ($ billion) Exhibit 33: North America - Year-over-year growth 2020-2025 (%) 7.4 Europe - Market size and forecast 2020-2025 Exhibit 34: Europe - Market size and forecast 2020-2025 ($ billion) Exhibit 35: Europe - Year-over-year growth 2020-2025 (%) 7.5 Asia - Market size and forecast 2020-2025 Exhibit 36: Asia - Market size and forecast 2020-2025 ($ billion) Exhibit 37: Asia - Year-over-year growth 2020-2025 (%) 7.6 ROW - Market size and forecast 2020-2025 Exhibit 38: ROW - Market size and forecast 2020-2025 ($ billion) Exhibit 39: ROW - Year-over-year growth 2020-2025 (%) 7.7 Key leading countries Exhibit 40: Key leading countries 7.8 Market opportunity by geography Exhibit 41: Market opportunity by geography ($ billion) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges Exhibit 43: Impact of drivers and challenges 8.3 Market trends 9 Vendor Landscape 9.1 Overview Exhibit 44: Vendor landscape 9.2 Landscape disruption Exhibit 45: Landscape disruption Exhibit 46: Industry risks 10 Vendor Analysis 10.1 Vendors covered Exhibit 47: Vendors covered 10.2 Market positioning of vendors Exhibit 48: Market positioning of vendors 10.3 AbbVie Inc. Exhibit 49: AbbVie Inc. - Overview Exhibit 50: AbbVie Inc. - Product and service Exhibit 51: AbbVie Inc. – Key news Exhibit 52: AbbVie Inc. - Key offerings 10.4 AstraZeneca Plc Exhibit 53: AstraZeneca Plc - Overview Exhibit 54: AstraZeneca Plc - Product and service Exhibit 55: AstraZeneca Plc – Key news Exhibit 56: AstraZeneca Plc - Key offerings 10.5 Bristol-Myers Squibb Co. Exhibit 57: Bristol-Myers Squibb Co. - Overview Exhibit 58: Bristol-Myers Squibb Co. - Product and service Exhibit 59: Bristol-Myers Squibb Co. – Key news Exhibit 60: Bristol-Myers Squibb Co. - Key offerings 10.6 F. Hoffmann-La Roche Ltd. Exhibit 61: F. Hoffmann-La Roche Ltd. - Overview Exhibit 62: F. Hoffmann-La Roche Ltd. - Business segments Exhibit 63: F. Hoffmann-La Roche Ltd. – Key news Exhibit 64: F. Hoffmann-La Roche Ltd. - Key offerings Exhibit 65: F. Hoffmann-La Roche Ltd. - Segment focus 10.7 GlaxoSmithKline Plc Exhibit 66: GlaxoSmithKline Plc - Overview Exhibit 67: GlaxoSmithKline Plc - Business segments Exhibit 68: GlaxoSmithKline Plc – Key news Exhibit 69: GlaxoSmithKline Plc - Key offerings Exhibit 70: GlaxoSmithKline Plc - Segment focus 10.8 Johnson and Johnson Inc. Exhibit 71: Johnson and Johnson Inc. - Overview Exhibit 72: Johnson and Johnson Inc. - Business segments Exhibit 73: Johnson and Johnson Inc. – Key news Exhibit 74: Johnson and Johnson Inc. - Key offerings Exhibit 75: Johnson and Johnson Inc. - Segment focus 10.9 Merck and Co. Inc. Exhibit 76: Merck and Co. Inc. - Overview Exhibit 77: Merck and Co. Inc. - Business segments Exhibit 78: Merck and Co. Inc. – Key news Exhibit 79: Merck and Co. Inc. - Key offerings Exhibit 80: Merck and Co. Inc. - Segment focus 10.10 Novartis AG Exhibit 81: Novartis AG - Overview Exhibit 82: Novartis AG - Business segments Exhibit 83: Novartis AG – Key news Exhibit 84: Novartis AG - Key offerings Exhibit 85: Novartis AG - Segment focus 10.11 Pfizer Inc. Exhibit 86: Pfizer Inc. - Overview Exhibit 87: Pfizer Inc. - Business segments Exhibit 88: Pfizer Inc. – Key news Exhibit 89: Pfizer Inc. - Key offerings 10.12 Sanofi SA Exhibit 90: Sanofi SA - Overview Exhibit 91: Sanofi SA - Business segments Exhibit 92: Sanofi SA – Key news Exhibit 93: Sanofi SA - Key offerings Exhibit 94: Sanofi SA - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Currency conversion rates for US$ Exhibit 95: Currency conversion rates for US$ 11.3 Research methodology Exhibit 96: Research Methodology Exhibit 97: Validation techniques employed for market sizing Exhibit 98: Information sources 11.4 List of abbreviations Exhibit 99: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

VaccineGene TherapyAntibodyCell TherapyCollaborate

24 Oct 2016

·www.biospace.com

FDA Slaps Partial Hold on Bay Area Firm Aduro Biotech’s Cancer Vaccine Trial

October 24, 2016 By Mark Terry , BioSpace.com Breaking News Staff The U.S. Food and Drug Administration (FDA) placed a partial hold on Berkeley, Calif.-based Aduro Biotech ’s LADD trials. Aduro’s LADD technology is a method of engineering the bacteria Lysteria monocytogenes into therapeutics that stimulate targeted immune response to specific tumor antigens. The FDA didn’t specifically halt the trial, but paused new patient enrollment. The FDA hold was initiated after a blood culture sample on an indwelling port of a metastatic pancreatic cancer patient tested positive Listeria. The positive Listeria is suspected of being CRS-207. The patient presented with gastrointestinal symptoms, and was treated with intravenous antibiotics. As a result, subsequent blood cultures didn’t show signs of Listeria and the patient is recovering. All patients in the trial are continuing to receive treatment except one, who is on a pacemaker. The company stated, “Aduro is working with the FDA to lift the partial hold so as to resume new patient enrollment in its LADD clinical trials. The company is revising study protocols in accordance with feedback from the agency, including the modification of antibiotic administration following treatment, extended patient surveillance, and, as a pre-emptive measure, exclusion of patients who are on or will receive certain immune-suppressive treatments or who have certain prosthetic devices.” The LADD program uses live, attenuated double-deleted strains of Listeria monocytogenes that have been engineered to stimulate an innate immune response. They have also been engineered to express tumor-associated antigens, which causes the T-cells to attack specific tumors. CRS-207 is one of a group of product candidates in the LADD program that expressed the tumor-associated antigen mesothelin, which is over-expressed in various cancers, including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers. The company has two other separate platform technologies, STING pathway activators and B-select monoclonal antibodies. The partial hold does not affect either of those platform programs. Aduro recently presented two posters at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in New York. The first provided preclinical data in its LADD program showing positive changes in the tumor microenvironment and induction of a tumor-specific immune response. The second poster discussed its STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy program. Both presentations indicated that the addition of a PD-1 blockade demonstrated significant antitumor efficacy. “These preclinical data demonstrate the underlying mechanisms by which our LADD and STING immunotherapy platforms activate the immune system and induce robust innate immunity, facilitating a change in the tumor microenvironment which results in effective destruction of cancer cells in several preclinical models,” said Thomas Dubensky, Jr. , Aduro’s chief scientific officer, in a statement. “Importantly, the combination data are even more impressive, showing increased efficacy when our LADD and STING platforms are combined with an anti-PD1 checkpoint inhibitor to combat the tumor’s ability to hide from the immune system. These data support our strategy to combine our immunotherapy regimens with checkpoint inhibitors for greater anti-tumor activity, looking toward the ultimate goal of better, more effective patient care.”

VaccineImmunotherapyAACRClinical Study

02 Sep 2016

·www.biospace.com

Aduro Biotech Opens New HQ in the Bay Area, Eventually to House 400 Workers

September 2, 2016 By Mark Terry , BioSpace.com Breaking News Staff If finding and developing drugs have long timelines for biotech companies, that can sometimes seem short and simple compared to finding biotech real estate space in the Bay Area. Berkley-based Aduro Biotech recently announced it had opened new corporate offices and laboratory facilities, a process that took almost two decades. The company’s LADD tech platform uses modified strains of the bacteria Listeria that have been engineered to express tumor-associated antigens that stimulate the immune system. It also has a STING Pathway Activator platform that activates, appropriately enough, the intracellular STING receptor, which also stimulates a tumor-specific immune response. In May, Aduro announced that its Phase IIb ECLIPSE trial for CRS-207 in pancreatic cancer patients failed to meet its primary endpoint. Despite that setback, the company in June presented data from an ongoing Phase Ib trial of CRS-207 in combination with pemetrexed and cisplatin in unresectable malignant pleural mesothelioma (PMP), which showed promise. Last year the company made an initial public offering that brought in $119 million. The company’s new headquarters are 110,853 square feet at 740 Heinz Avenue in West Berkeley. The San Francisco Business Times reported that it took the developer, Wareham Development, about 17 years to “win all the approvals for the West Berkeley building, on the site of a landmark former dried coconut warehouse.” “Over the course of the last two years, we have grown significantly, both in the number of programs and in our employee base, and we have outgrown our former location,” said Stephen Isaacs , Aduro’s chairman, president and chief executive officer, in a statement. “We are extremely pleased to remain in Berkeley, maintaining our roots and our key connections with both the University of California, Berkeley and this extraordinary community. Our new facility also provides room to grow as we continue to advance our three technology platforms focused on the development of immunotherapies that transform the treatment of challenging diseases.” The facility is the Aquatic Park Center, which is a development by Wareham Development. It is dubbed the largest research building in the East Bay since Wareham built the EmeryStation Greenway four years ago. So far, Aduro has built out three floors of the building for 110 staffers. By the end of the year it will host 200 employees, and ultimately have room for 400. “We really needed the space,” Isaacs told the San Francisco Business Times. In addition to its various internal projects, Aduro has partnerships with Johnson & Johnson , and with Incyte Corp. . Novartis (NVS) is utilizing its STING program. Currently the company has five preclinical drugs. The company had an open house on September 1, joined by Congresswoman Barbara Lee , Assemblymember Tony Thurmond , Councilmember Darryl Moore , Mayor Tom Bates and the Honorable Nancy Skinner . “Technology and innovation are helping to drive our economy forward,” Lee said in a statement. “As these new technologies are applied to healthcare, they are helping people live longer, healthier lives. I am pleased to know Aduro Biotech, a cutting-edge leader in immunotherapy, will remain in Berkeley and continue the East Bay’s tradition of world-leading innovation in healthcare and biotech.”

Phase 2ImmunotherapyPhase 1Clinical Result

100 Deals associated with CRS-207

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Esophagus	Phase 2	United States	Aduro BioTech, Inc.	14 Aug 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 2	United States	Aduro BioTech, Inc.	14 Aug 2017
stomach adenocarcinoma	Phase 2	United States	Aduro BioTech, Inc.	14 Aug 2017
Malignant Pleural Mesothelioma	Phase 2	United States	Aduro BioTech, Inc.	31 May 2017
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	United States	Aduro BioTech, Inc.	08 Mar 2016
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	Canada	Aduro BioTech, Inc.	08 Mar 2016
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	Aduro BioTech, Inc.	08 Mar 2016
Platinum-Resistant Ovarian Carcinoma	Phase 2	Canada	Aduro BioTech, Inc.	08 Mar 2016
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	United States	Aduro BioTech, Inc.	08 Mar 2016
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	Canada	Aduro BioTech, Inc.	08 Mar 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03190265 (CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic	61	CRS-207+ipilimumab+Nivolumab	yknyqmhuuq = rffucvobyz tbjrdskjcg (xpixcbjpbk, dqkphqvtis - sqsoowbqwg) View more	-	10 Jul 2023
NCT02243371 (CTgov)	Phase 2	Adenocarcinoma \| Pancreatic adenocarcinoma metastatic	93	CRS-207+nivolumab+CY+GVAX (Arm A: CY/ GVAX/ CRS-207/ Nivolumab)	oukepgknyz(guuuukqfxo) = bbcaxgpvyz odxlhyjzxx (xxohyruaza, hlqpwhvacs - elbrlgvywa) View more	-	08 Oct 2019
NCT02243371 (CTgov)	Phase 2	Adenocarcinoma \| Pancreatic adenocarcinoma metastatic	93	CRS-207+CY+GVAX (Arm B: CY/ GVAX/ CRS-207)	oukepgknyz(guuuukqfxo) = rnqxkzwdbf odxlhyjzxx (xxohyruaza, dlvjyglzfl - jwrxukcpbt) View more	-	08 Oct 2019
NCT02575807 (SEASCAPE, CTgov)	Phase 1/2	Platinum-Resistant Fallopian Tube Carcinoma \| Platinum-Resistant Primary Peritoneal Carcinoma \| Platinum-Resistant Ovarian Carcinoma	35	CRS-207 (Phase 1: CRS-207)	fkwizeemuo = nldcimlllq iipkrrujie (arkshmbjxq, jvapckxqot - xdgpuqeucs) View more	-	04 Apr 2019
NCT02575807 (SEASCAPE, CTgov)	Phase 1/2		35	CRS-207+Epacadostat (Phase 1: CRS-207/IDO 100 mg)	fkwizeemuo = gwcwpmwsrn iipkrrujie (arkshmbjxq, wzhyuggeyr - mjxeqbalul) View more	-	04 Apr 2019
NCT03175172 (ASCO_SITC 12019 \| ASCO_SITC 22019) Manual	Phase 2	Malignant Pleural Mesothelioma	10	pembrolizumab+CRS-207	tfgbhpkjan(abwdlntpab) = umclgdtuzu vwgnuelrxm (nbeexzvyyj ) View more	Negative	28 Feb 2019
NCT03122548 (CTgov)	Phase 2	Adenocarcinoma of Esophagus \| stomach adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	5	CRS-207+pembrolizumab	olwkmyuhad = phmttrjrih mfvcwxrduw (yjgzmqtxbv, slrbmobzyi - qaxncgpzwt) View more	-	20 Feb 2019
NCT03175172 (NCT03175172 \| ###DELETE, CTgov)	Phase 2	Malignant Pleural Mesothelioma	10	CRS-207+pembrolizumab	shxpgbfxtb(dhtzystwoz) = opjncvjsfs ffekfphalb (ubiyuwbaeu, keshndriau - jnmrssufbe) View more	-	19 Feb 2019
NCT01417000 (Phase IIa, CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Cancer	93	CRS-207+cyclophosphamide+GVAX Pancreas (Cy/GVAX + CRS-207)	ibwinxahfv(fksrqzzpal) = ivxtmiawzv zryknalgdp (mxadjerovi, pgysvfbocw - trolxaljft) View more	-	08 May 2018
NCT01417000 (Phase IIa, CTgov)	Phase 2		93	cyclophosphamide+GVAX Pancreas (Cy/GVAX)	ibwinxahfv(fksrqzzpal) = ofsjhllnsg zryknalgdp (mxadjerovi, xfkljryfwo - npiarnylap) View more	-	08 May 2018
NCT02004262 (ECLIPSE, CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Cancer	303	CRS-207+cyclophosphamide+GVAX Pancreas Vaccine (Primary Cohort: Cy/GVAX + CRS-207)	naotqljtji(veyascatoj) = xrmqxmqvfd wkilevjleh (tzifbcoljq, oipcwwptfd - xjdcbjjerf) View more	-	03 May 2018
NCT02004262 (ECLIPSE, CTgov)	Phase 2		303	CRS-207 (Primary Cohort: CRS-207)	naotqljtji(veyascatoj) = rafvzkoguc wkilevjleh (tzifbcoljq, htwmntkfzh - frudfmpvih) View more	-	03 May 2018
SITC2015	Not Applicable	Malignant Pleural Mesothelioma mesothelin	60	CRS-207 with pemetrexed/cisplatin	rqqotjwnzk(ajsyasilpf) = hnfwpwrkkj cqutkklrhp (zjcxhrfsem ) View more	-	04 Nov 2015

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