On March 26, 2018 – Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that results from multiple preclinical studies of its Lm-based antigen delivery technology will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 (AACR 2018), April 14-18, 2018 in Chicago (Press release, Advaxis, MAR 26, 2018, View Source [SID1234524983]).

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The following late-breaking research will be presented:

Poster Title:

Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform
Poster Number:

LB-150/17
Session Title:

Late-Breaking Research: Clinical Research
Session Date and Time:

Monday, April 16, 2018, 1:00 pm – 5:00 pm (CT)
Authored By:

Advaxis and Amgen

Poster Title:

Targeting frameshift mutations with a Listeria monocytogenes immunotherapy drives neoantigen-specific antitumor immunity in the MC38 and CT26 mouse tumor models

Poster Number:

LB-148/15
Session Title:

Late-Breaking Research: Clinical Research
Session Date and Time:

Monday, April 16, 2018, 1:00 pm – 5:00 pm (CT)
Authored By:

Advaxis and Amgen

Poster Title:

Targeting shared hotspot cancer mutations with a Listeria monocytogenes immunotherapy induces potent anti-tumor immunity

Poster Number:

LB-149/16
Session Title:

Late-Breaking Research: Clinical Research
Session Date and Time:

Monday, April 16, 2018, 1:00 pm – 5:00 pm (CT)
Authored By:

Advaxis

In addition, the following Investigator Sponsored Trial data will be presented:

Poster Title:

Changes in local and peripheral T cell diversity after HPV E7 antigen-expressing Listeria-based immunotherapy (ADXS11-001) prior to robotic surgery for HPV-positive oropharyngeal cancer
Poster Number:

5639/10
Session Title:

PO.CL06.11: Vaccines 2
Session Date and Time:

Wednesday, April 18, 2018, 8:00 am – 12:00 pm (CT)
Authored By:

Andrew Sikora, Ph.D., MD, co-director of the Head and Neck Cancer Program at Baylor College of Medicine

On March 24, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported encouraging efficacy and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (EOC) (Press release, ImmunoGen, MAR 24, 2018, View Source [SID1234525455]). These data are being presented at the Society of Gynecologic Oncology (SGO) Annual Meeting, March 24-27, 2018 in New Orleans, LA.

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Key findings in 14 heavily pre-treated patients are as follows:

In the subset of 8 patients with medium or high folate receptor alpha (FRα) expression levels, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median progression-free survival (PFS) of 8.6 months (95% CI 1.6, upper bound not yet reached).
For all patients, the confirmed ORR was 43 percent (95% CI 18, 71), with a median PFS of 5.2 months (95% CI 1.6, 9.5); patients in this cohort had received a median of 4.5 prior lines of systemic therapy, with 64% of patients receiving 4 or more prior lines.
As previously reported, at full dosing, the combination of mirvetuximab (6 mg/kg) and pembrolizumab (200 mg, supplied by Merck) demonstrates favorable tolerability, consistent with the known safety profiles of each agent, with primarily mild to moderate (≤ grade 2) adverse events observed.
Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study.

"We are encouraged by the early evidence of anti-tumor activity with durable responses and the tolerability profile of mirvetuximab in combination with pembrolizumab, particularly among the subset of patients with medium or high folate receptor alpha expression where we saw the greatest benefit," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "Across multiple combinations, we’ve demonstrated that our Phase 3 single agent dose level for mirvetuximab combines readily with other therapies. The consistency of these findings further underscore the potential of mirvetuximab for ovarian cancer – both as monotherapy, and in combination with other therapies in earlier lines of treatment."

Featured Poster Presentation Details

Title: "Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer (EOC) patients" (abstract #74)

Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

The findings will be presented during featured poster presentation discussion sessions:

Sunday, March 25 at 3:30pm CT
Monday, March 26 at 3:30pm CT
Additional information can be found at www.sgo.org

About FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), pegylated liposomal doxorubicin, or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant EOC, primary peritoneal, or fallopian tube tumors, as well as a doublet combination of mirvetuximab with carboplatin and a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On March 24, 2018 -ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported encouraging efficacy and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (EOC) (Press release, , 24 24, 2018, View Source [SID1234524978]). These data are being presented at the Society of Gynecologic Oncology (SGO) Annual Meeting, March 24-27, 2018 in New Orleans, LA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer (EOC) patients"

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Key findings in 14 heavily pre-treated patients are as follows:

In the subset of 8 patients with medium or high folate receptor alpha (FRα) expression levels, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median progression-free survival (PFS) of 8.6 months (95% CI 1.6, upper bound not yet reached).
For all patients, the confirmed ORR was 43 percent (95% CI 18, 71), with a median PFS of 5.2 months (95% CI 1.6, 9.5); patients in this cohort had received a median of 4.5 prior lines of systemic therapy, with 64% of patients receiving 4 or more prior lines.
As previously reported, at full dosing, the combination of mirvetuximab (6 mg/kg) and pembrolizumab (200 mg, supplied by Merck) demonstrates favorable tolerability, consistent with the known safety profiles of each agent, with primarily mild to moderate (≤ grade 2) adverse events observed.
Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study.

"We are encouraged by the early evidence of anti-tumor activity with durable responses and the tolerability profile of mirvetuximab in combination with pembrolizumab, particularly among the subset of patients with medium or high folate receptor alpha expression where we saw the greatest benefit," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "Across multiple combinations, we’ve demonstrated that our Phase 3 single agent dose level for mirvetuximab combines readily with other therapies. The consistency of these findings further underscore the potential of mirvetuximab for ovarian cancer – both as monotherapy, and in combination with other therapies in earlier lines of treatment."

Featured Poster Presentation Details

Title: "Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer (EOC) patients" (abstract #74)

Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

The findings will be presented during featured poster presentation discussion sessions:

Sunday, March 25 at 3:30pm CT
Monday, March 26 at 3:30pm CT
Additional information can be found at www.sgo.org

About FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), pegylated liposomal doxorubicin, or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant EOC, primary peritoneal, or fallopian tube tumors, as well as a doublet combination of mirvetuximab with carboplatin and a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On March 24, 2018 Barricade Therapeutics reported a study conducted at The Wistar Institute in collaboration with The University of Texas Southwestern Medical Center which has demonstrated the efficacy of targeting aberrantly active telomerase to treat therapy-resistant melanoma (Press release, Barricade Therapeutics, MAR 24, 2018, View Source [SID1234524977]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A hallmark of several cancer types, including melanoma, is increased telomerase activation. Telomerase is an enzyme responsible for elongating telomeres which protect the integrity of chromosome ends during cell replication. While absent in most normal cells, telomerase is highly active in cancer cells, driving continuous cell divisions.

"Telomerase is an almost universal oncology target. In the present study, we provide a scientific rationale for the development of new clinical cancer treatments based on targeting telomeres in cancer cells," said Jerry W. Shay, co-author of the study, and professor of Cell Biology at UT Southwestern Medical Center.

Meenhard Herlyn, D.V.M., D.Sc., Caspar Wistar Professor in Melanoma Research and director of The Wistar Institute Melanoma Research Center, and his collaborators used a modified telomerase substrate they had previously described, 6-thio-2’-deoxyguanosine or 6-thio-dG (THIO), to utilize telomerase to induce telomere dysfunction. They demonstrated that THIO induced cell death in melanoma cells harboring BRAF gene mutations and impaired tumor growth in several BRAF-mutant mouse melanoma models without affecting the viability of normal skin cells.

The team also studied the ability of THIO treatment to stop proliferation and tumor growth of therapy-resistant melanoma cells. They created a large panel of human melanoma cell lines with acquired resistance to targeted therapy and immunotherapy and showed a general sensitivity of these cells to THIO both in vitro and in vivo.

"These exciting results add to a substantial amount of scientific data on THIO supporting our development program," said Frank Perabo, CEO of Barricade Therapeutics. "The data suggest that THIO could be studied in future clinical trials in a first- and second-line therapy setting, or in combination with other agents to overcome intrinsic resistance."

This work was supported by grants from NIH, DoD, Dr. Miriam and Sheldon G. Adelson Medical Research Foundation and the Melanoma Research Foundation

On March 23, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that Keith Orford, M.D., Ph.D, the company’s Senior Vice President of Clinical Development, will present at the Needham & Company 17th Annual Healthcare Conference at 2:00 p.m. ET on Wednesday, March 28, 2018 in New York City (Press release, Calithera Biosciences, MAR 23, 2018, View Source [SID1234535243]). The presentation will be webcast live and available for replay for up to 30 days at www.calithera.com in the Investor Relations section

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!