The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy.

Start Date13 Oct 2020

Sponsor / Collaborator

Candel Therapeutics, Inc.

[+1]

NCT03603405 / RecruitingPhase 1/2IIT

Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination with Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

Start Date28 Feb 2018

Sponsor / Collaborator

The Methodist Hospital Research Institute

100 Clinical Results associated with Aglatimagene besadenovec

100 Translational Medicine associated with Aglatimagene besadenovec

100 Patents (Medical) associated with Aglatimagene besadenovec

195

Literatures (Medical) associated with Aglatimagene besadenovec

03 Oct 2023·Expert opinion on biological therapy

Oncolytic virotherapies for pediatric tumors

Review

Author: Atchley, Travis J ; Johnston, James M ; Laskay, Nicholas Mb ; Estevez-Ordonez, Dagoberto ; Gross, Evan G ; Markert, James M ; Hamo, Mohammad A

INTRODUCTION:

Many pediatric patients with malignant tumors continue to suffer poor outcomes. The current standard of care includes maximum safe surgical resection followed by chemotherapy and radiation which may be associated with considerable long-term morbidity. The emergence of oncolytic virotherapy (OVT) may provide an alternative or adjuvant treatment for pediatric oncology patients.

AREAS COVERED:

We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). For each virus, we discuss the mechanism of tumor-specific replication and cytotoxicity as well as key findings of preclinical and clinical studies.

EXPERT OPINION:

Substantial progress has been made in the past 10 years regarding the clinical use of OVT. From our review, OVT has favorable safety profiles compared to chemotherapy and radiation treatment. However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future.

01 Oct 2023·Human gene therapy

Clinical Efficacy and Safety of AdV-tk Gene Therapy for Patients with Cervical Squamous Intraepithelial Lesion: A Prospective Study.

Article

Author: Tang, Huadong ; Li, Yanmei ; Liu, Xin ; Liu, Qing ; Hou, Ying ; Zhou, Yuxiang ; Li, Ning ; Li, Xiulan ; Xu, Fuqiang ; Bian, Meina ; Wang, Nan

Cervical cancer is the fourth most common type of cancer for women in 2020, and many more women have cervical precancerous lesion-squamous intraepithelial lesion (SIL). Early treatment of cervical SIL to reverse or delay its progression is an important approach to reduce the incidence of cervical cancer. The efficacy and safety of adenovirus-based vectors expressing the thymidine kinase gene (AdV-tk) in the treatment of multiple types of cancers shows promise for its use in gynecology. We aim to provide relevant clinical efficacy and safety data after introducing AdV-tk for the treatment of cervical SIL for the first time through this prospective study. We conducted a maximum of 6 sessions to administer AdV-tk gene therapy to 23 patients (mean age: 35 years old) with cervical low-/high-grade SIL (LSIL/HSIL) who were enrolled from August 2015 to April 2018 and analyzed the clinical characteristics and follow-up outcomes (mean follow-up period: 7.3 months). The present study consisted of 17 patients (73.9%) with cervical HSIL and 6 patients with LSIL confirmed by colposcopy-directed biopsy. We observed an overall histological remission and regression rate of 87.0% (20/23, 95% confidence interval [95% CI]: 73.2-100, p < 0.001) after AdV-tk gene therapy. Eight patients (34.8%) were detected with human papillomavirus (HPV) 16/18 subtypes and 13 patients were found to be positive with at least one of the other 13 high-risk HPV (HR-HPV) subtypes, while 2 patients did not have any of the 15 HR-HPV subtypes. The overall clearance rate of HR-HPV was 76.2% (16/21, 95% CI: 58.0-94.4, p = 0.016) after AdV-tk gene therapy. For safety evaluation, no severe complications were reported in any of the 23 patients. The most commonly reported symptom was fever in 52.2% (12/23) of patients and all symptoms were fully resolved after symptomatic treatment. Our data indicate that AdV-tk gene therapy has high efficacy and safety in the treatment of cervical SIL among gynecological patients. Our findings provide clinical evidence on the potential promotion and application of AdV-tk in the treatment of cervical SIL, and potentially for cervical cancer, among gynecological patients.

01 Jan 2023·Frontiers in medicine

Uncovering transcriptomic landscape alterations of CAN-2409 in in vitro and in vivo glioma models.

Article

Author: Zdioruk, Mykola ; Hoetker, Michael S ; Nowicki, Michal O ; Barone, Francesca ; Tabatabai, Ghazaleh ; Lawler, Sean E ; Koch, Marilin S ; Tak, Paul P ; Herbert, Zachary T ; Chiocca, E Antonio

Rationale:

CAN-2409 is a locally delivered oncolytic therapy, which results in vaccination against the injected tumor. CAN-2409 consists of a non-replicating adenovirus armed with the Herpes virus thymidine kinase, which metabolizes ganciclovir into a phosphorylated nucleotide that is incorporated into the tumor cell's genome, thereby inflicting immunogenic cancer cell death. While CAN-2409's immunological impact has been well characterized, its effects on the tumor cells transcriptome remains unknown. We compared the transcriptomic landscape after treatment of glioblastoma models with CAN-2409 in vitro and in vivo to assess how the interplay with the tumor microenvironment influences CAN-2409-mediated transcriptome alterations.

Methods:

We performed RNA-Seq with CAN-2409 treated patient-derived glioma stem-like cells and tumors of C57/BL6 mice and compared KEGG pathway usage and differential gene expression focusing on immune cell and cytokine profiles. T-cell -killing assays were performed to assess candidate effectors.

Results:

PCA analysis showed distinct clustering of control and CAN-2409 samples under both conditions. KEGG pathway analysis revealed significant enrichment for p53 signaling and cell cycle pathway, with similar dynamics for key regulators of both pathways in vitro and in vivo, including MYC, CCNB1, PLK1 and CDC20. Selected alterations (PLK1 and CCNB1) were validated at the protein level. Cytokine expression analysis revealed upregulation of pro-inflammatory IL12a under both conditions; immune cell gene profiling showed reduction of myeloid associated genes. T-cell-killing assays showed increased killing in the presence of IL-12.

Conclusion:

CAN-2409 significantly alters the transcriptome both in vitro and in vivo. Comparison of pathway enrichment revealed mutual and differential utilization of pathways under both conditions, suggesting a modulating influence on the cell cycle in tumor cells, and of the tumor microenvironment on the transcriptome in vivo. IL-12 synthesis likely depends on interactions with the tumor microenvironment, and it facilitates CAN-2409 cell killing. This dataset provides potential to understand resistance mechanisms and identify potential biomarkers for future studies.

News (Medical) associated with Aglatimagene besadenovec

16 Dec 2024

·www.globenewswire.com

Candel Therapeutics Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares

NEEDHAM, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the closing of its previously announced underwritten public offering of 12,000,001 shares of its common stock at a price to the public of $6.00 per share and pre-funded warrants to purchase up to an aggregate of 3,333,333 shares of its common stock at a price to the public of $5.99 per pre-funded warrant to purchase one share of the common stock, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The 12,000,001 shares of common stock sold in the offering include 2,000,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase up to 2,000,000 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Candel are approximately $92 million, before deducting underwriting discounts and commissions and other offering expenses. Candel intends to use the net proceeds from the offering to continue the development of its product candidates, including preparing submission of a Biologics License Application for CAN-2409 in prostate cancer and for general corporate purposes. Citigroup, BofA Securities and Canaccord Genuity acted as joint bookrunning managers for the offering. H.C. Wainwright & Co. acted as lead manager for the offering. A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the “SEC”) on August 5, 2022 and declared effective by the SEC on August 12, 2022. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or telephone: 1-800-831-9146; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, email: dg.prospectus_requests@bofa.com; or Canaccord Genuity LLC, Attention: Syndication Department, 1 Post Office Square, 30th Floor, Boston, MA 02109, or by email at prospectus@cgf.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2) and borderline resectable pancreatic ductal adenocarcinoma (PDAC) (phase 2), and recently completed phase 2b and phase 3 clinical trials in localized, non-metastatic prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma (rHGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. Forward-Looking Statements Various statements in this release concerning the use of proceeds from the public offering constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of substantial risks and uncertainties, many of which are outside Candel’s control, that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Candel’s stock price and changes in market conditions, as well as those risks more fully discussed in the section entitled “Risk Factors” in the prospectus supplement and registration statement referenced above, Candel’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 28, 2024 with the SEC and subsequent filings with the SEC including Candel’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Candel undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, Inc.tjenkins@candeltx.com Media Contact:Ben ShannonVice PresidentICR HealthcareCandelPR@icrhealthcare.com

Phase 2Immunotherapy

13 Dec 2024

·www.globenewswire.com

Candel Therapeutics Announces Pricing of Public Offering

NEEDHAM, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the pricing of an underwritten public offering of 10,000,001 shares of its common stock at a price to the public of $6.00 per share and pre-funded warrants to purchase up to an aggregate of 3,333,333 shares of its common stock at a price to the public of $5.99 per pre-funded warrant to purchase one share of the common stock, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The gross proceeds from the offering to Candel are expected to be approximately $80 million, before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about December 16, 2024, subject to customary closing conditions. In addition, Candel has granted the underwriters a 30-day option to purchase up to 2,000,000 additional shares of common stock at the public offering price, less the underwriting discount. Candel intends to use the net proceeds from the offering to continue the development of its product candidates, including preparing submission of a Biologics License Application for CAN-2409 in prostate cancer and for general corporate purposes. Citigroup, BofA Securities and Canaccord Genuity are acting as joint bookrunning managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering. A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the “SEC”) on August 5, 2022 and declared effective by the SEC on August 12, 2022. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or telephone: 1-800-831-9146; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, email: dg.prospectus_requests@bofa.com; or Canaccord Genuity LLC, Attention: Syndication Department, 1 Post Office Square, 30th Floor, Boston, MA 02109, or by email at prospectus@cgf.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2) and borderline resectable pancreatic ductal adenocarcinoma (PDAC) (phase 2), and recently completed phase 2b and phase 3 clinical trials in localized, non-metastatic prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma (rHGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. Forward-Looking Statements Various statements in this release concerning the timing and completion of the public offering on the anticipated terms or at all may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of substantial risks and uncertainties, many of which are outside Candel’s control, that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Candel’s stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering, as well as those risks more fully discussed in the section entitled “Risk Factors” in the prospectus supplement and registration statement referenced above, Candel’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 28, 2024 with the SEC and subsequent filings with the SEC including Candel’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that Candel will be able to complete the public offering on the anticipated terms. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Candel undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, Inc.tjenkins@candeltx.com Media Contact:Ben ShannonVice PresidentICR HealthcareCandelPR@icrhealthcare.com

Phase 2ImmunotherapyPhase 1

12 Dec 2024

·www.globenewswire.com

Candel Therapeutics Announces $80 Million Proposed Public Offering

NEEDHAM, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the launch of an underwritten public offering of $80 million of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Candel. Candel also intends to grant the underwriters a 30-day option to purchase up to an additional $12 million of the shares of its common stock offered in the public offering under the same terms and conditions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Candel intends to use the net proceeds from the offering to continue the development of our product candidates, including preparing the submission of a Biologics License Application for CAN-2409 in prostate cancer and for general corporate purposes. Citigroup, BofA Securities and Canaccord Genuity are acting as joint bookrunning managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering. A shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the “SEC”) on August 5, 2022 and declared effective by the SEC on August 12, 2022. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-800-831-9146; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, email: dg.prospectus_requests@bofa.com; or Canaccord Genuity LLC, Attention: Syndication Department, 1 Post Office Square, 30th Floor, Boston, MA 02109, or by email at prospectus@cgf.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2) and borderline resectable pancreatic ductal adenocarcinoma (PDAC) (phase 2), and recently completed phase 2b and phase 3 clinical trials in localized, non-metastatic prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma (rHGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. Forward-Looking Statements Various statements in this release concerning the timing, size, structure and completion of the proposed public offering on the anticipated terms or at all may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of substantial risks and uncertainties, many of which are outside Candel’s control, that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Candel’s stock price, changes in market conditions, the final terms of the public offering and satisfaction of customary closing conditions related to the public offering, as well as those risks more fully discussed in the section entitled “Risk Factors” in the prospectus supplement and registration statement referenced above, Candel’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 28, 2024 with the SEC and subsequent filings with the SEC including Candel’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that Candel will be able to complete the public offering on the anticipated terms. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Candel undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, Inc.tjenkins@candeltx.com Media Contact:Ben ShannonVice PresidentICR HealthcareCandelPR@icrhealthcare.com

Phase 2Immunotherapy

100 Deals associated with Aglatimagene besadenovec

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15074

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	US	Candel Therapeutics, Inc.	01 Sep 2011
Localized Prostate Carcinoma	Phase 3	PR	Candel Therapeutics, Inc.	01 Sep 2011
metastatic non-small cell lung cancer	Phase 2	US	NYU Langone Health	13 Oct 2020
metastatic non-small cell lung cancer	Phase 2	US	Candel Therapeutics, Inc.	13 Oct 2020
Recurrent Prostate Carcinoma	Phase 2	US	Candel Therapeutics, Inc.	01 May 2016
Recurrent Prostate Carcinoma	Phase 2	MX	Candel Therapeutics, Inc.	01 May 2016
Pancreatic adenocarcinoma	Phase 2	US	Candel Therapeutics, Inc.	01 Oct 2015
Pancreatic adenocarcinoma	Phase 2	MX	Candel Therapeutics, Inc.	01 Oct 2015
Glioblastoma Multiforme	Phase 2	US	Candel Therapeutics, Inc.	01 Mar 2007
Malignant glioma of brain	Phase 2	US	Candel Therapeutics, Inc.	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PipelineReview Manual	Phase 3	Prostatic Cancer	745	CAN-2409 plus Standard of care external beam radiation therapy	bzgfgqfmnz(wgjnqalgzp): HR = 0.7, P-Value = 0.0155 Met View more	Positive	11 Dec 2024
				Standard of care external beam radiation therapy
NCT04495153 (ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer	73	CAN-2409 + valacyclovir	ozzcrlfwhj(oavbatvhgh) = yzbnyglawm kuzjgwotgo (zxscrsmfig, 14.3 - NA) View more	Positive	24 May 2024
				CAN-2409 + valacyclovir (C1, stable disease)	ozzcrlfwhj(oavbatvhgh) = rwgxpeleof kuzjgwotgo (zxscrsmfig )
NCT02446093 (PaTK02, Biospace) Manual	Phase 2	Pancreatic Cancer	13	CAN-2409+valacylovir or acyclovir+chemoradiation or SBRT	yrnnmlpgxx(uufaipvcuu) = none thxkfkwvae (btohrajcuo )	Positive	04 Apr 2024
				chemoradiation or SBRT
NCT00589875 (BrTK02, CTgov)	Phase 2	Glioblastoma Multiforme \| Malignant glioma of brain	52	Radiation therapy+Temozolomide+Valacyclovir+CAN-2409	xghxgxxhuw(sevwtdjkjy) = prlagotxwb cfsknkqagm (pgmbfvipfw, jkmhtivvkd - mdsoznewon) View more	-	03 Apr 2024
PaTK02 (SITC2023)	Phase 2	Locally Advanced Pancreatic Adenocarcinoma Neoadjuvant soluble granzymes B \| IL-10 \| IFNÎ³	19	CAN-2409+prodrug	yhgmuovqzp(sigpibqaak) = thrikjhooz ybgtkpeiqr (giliupczmm ) View more	Positive	02 Nov 2023
				CAN-2409+Prodrug (Standard of care (SOC) chemoradiation (CR) and surgery)	yhgmuovqzp(sigpibqaak) = mlvqydfusv ybgtkpeiqr (giliupczmm ) View more
NCT04495153 (Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	40	CAN-2409+valacyclovir+immune checkpoint inhibitor	mbdsqkdtop(vjhytwzata) = apmahqmqtw ooxmzkacvf (gllogrggjl ) View more	Positive	26 Sep 2023
NCT03576612 (SITC 12022 \| SITC 22022) Manual	Phase 1	High grade glioma First line	41	valacyclovir+CAN-2409+nivolumab (patients with methylated MGMT promoter undergoing gross total resection (GTR))	xucipkmwye(ockhpputxb) = ozsdwisrft ptwvnbjmec (xhccctrhlt )	Positive	01 Nov 2022
				valacyclovir+CAN-2409+nivolumab (patients with methylated MGMT promoter undergoing sub-total resection (STR))	xucipkmwye(ockhpputxb) = ybixbanaof ptwvnbjmec (xhccctrhlt )
NCT04495153 (ASCO2022) Manual	Phase 2	Non-Small Cell Lung Cancer	28	ICI+Aglatimagene besadenovec (stable disease)	ymsbxfwrtd(qacamntyqm) = Of the 14 RECIST evaluable patients who received 2 doses of CAN-2409, clinical response was seen in 4 patients fdrrfodqwn (eavnhyhlxg ) View more	Positive	02 Jun 2022
				ICI+Aglatimagene besadenovec (progressive disease after ≥18 weeks)
SNO2021	Phase 1	High grade glioma MGMT-methylation positive \| IDH-wildtype \| IDH-mutant	41	CAN-2409 + Valacyclovir + Nivolumab + Standard of Care	gvqntdznjd(wfajxmdfrn) = nausea, fatigue, fever, headache, and increased ALT vhrnnhxsyi (dxdryysmem )	Positive	12 Nov 2021
NCT03131037 (ASCO 12020 \| ASCO 22020) Manual	Phase 1	Non-Small Cell Lung Cancer Neoadjuvant	12	Valacyclovir+aglatimagene besadenovec	kjtbgtblqp(pbwfqqlhfn) = CTC grade 1 fever (n = 1), flu-like symptoms (n = 1) and nausea/vomiting/diarrhea (n = 1). The only > grade 2 lab abnormality was transient grade 3 lymphopenia (n = 2) zmryqmqxlm (hjeqkrcxaa )	Positive	29 May 2020

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