On October 2, 2019 Agilent Technologies Inc. (NYSE: A) reported that the National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) has approved its PD-L1 IHC 22C3 pharmDx assay for use in China (Press release, Agilent, OCT 2, 2019, https://www.agilent.com/about/newsroom/presrel/2019/02oct-ca19027.html [SID1234540016]).

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!

The assay is now approved as a companion diagnostic to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) for first-line treatment with single-agent KEYTRUDA, an anti-PD-1 therapy manufactured by Merck & Co., Inc. Kenilworth, NJ, U.S.A.

Lung cancer accounts for 20% of all cancer deaths in China and is the leading cause of cancer death there1. NMPA approved the assay to identify advanced NSCLC patients whose tumors express PD-L1 Tumor Proportion Score (TPS) ≥ 1% for first-line treatment with KEYTRUDA monotherapy. KEYTRUDA, as monotherapy, recently received NMPA approval for first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 TPS ≥ 1% as determined by a validated test.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1, and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated in NSCLC.

"Pathologists in China recognize the need for validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression for metastatic NSCLC patients," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "With this approval, Agilent is excited to be able to offer the first PD-L1 CDx in the Chinese market."

PD-L1 IHC 22C3 pharmDx is the first and only NMPA-approved companion diagnostic that has been clinically validated to aid in the identification of NSCLC patients for treatment with KEYTRUDA.

Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalized medicine, which is where assays such as PD-L1 IHC 22C3 pharmDx come into play.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in collaboration with Merck & Co.

1 View Source

On October 2, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will announce its third-quarter 2019 financial results on Wednesday, October 23, 2019 (Press release, Eli Lilly, OCT 2, 2019, View Source [SID1234540017]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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!

The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On October 2, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has closed its $33 million Series B financing (Press release, Elicio Therapeutics, OCT 2, 2019, View Source [SID1234540018]).

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!

Proceeds from the financing will be used to advance Elicio’s pipeline of novel lymph node targeted immuno-therapies, including ELI-002, an Amphiphile mKRAS vaccine (AMP KRAS). ELI-002 targets all seven KRAS mutations that drive 99% of all mKRAS-driven cancers, estimated to be 25% of all human solid tumors.

"We believe ELI-002 can become a universal mKRAS vaccine with the potential to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer," said Robert Connelly, CEO of Elicio. "This new funding is a strong endorsement of this program, the Amphiphile platform, and our progress."

Elicio has established an international investor base, including Clal Biotechnology Industries, Livzon Pharmaceutical Group and Efung Capital. "We are gratified to be able to expand our investor base and strengthen our balance sheet as we advance multiple Amphiphile immuno-therapies towards initial patient studies," Connelly said.

Elicio’s AMP KRAS vaccine ELI-002 has completed preclinical validation, IND-enabling GLP toxicology studies, GMP manufacturing, and a pre-IND meeting with the FDA and Elicio intends to begin an initial patient study in pancreatic cancer patients in the first half of 2020. These trials will be multi-site, randomized, controlled studies. Initial ELI-002 pancreatic cancer patient data is expected in the second half of 2020.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On October 2, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-2323, the Company’s CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) (Press release, IGM Biosciences, OCT 2, 2019, View Source [SID1234540019]).

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!

This Phase 1 clinical trial represents the first in-human application of IGM Biosciences’ engineered IgM antibody technology. The Phase 1 multi-center, open label trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL. IGM-2323 will initially be administered at a planned fixed-dose, as part of a dose escalation protocol.

On October 2, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported the publication of an article titled "Preliminary observations on soluble programmed death-1 protein as a prognostic and predictive biomarker in patients with metastatic melanoma treated with patient-specific autologous vaccines" in the oncology journal Oncotarget (Press release, AIVITA Biomedical, OCT 2, 2019, View Source [SID1234540003]). Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, and other key members of the AIVITA team authored the article.

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!

The publication suggests that because of its role as an immune checkpoint, levels of soluble programmed cell death protein-1 (sPD-1) could be useful as a prognostic biomarker or predictive biomarker in cancer patients treated with vaccines. The authors theorized that very low blood levels of sPD-1 may indicate lack of an existing anti-cancer immune response, while very high levels may indicate an active immune response that is suppressed. In between these extremes, a decrease in PD-1 following cancer vaccine injections may indicate an enhanced immune response that has not been suppressed.

Blood samples were obtained at baseline and four weeks later during a randomized trial in which patients with metastatic melanoma were treated with either AIVITA’s immunotherapy, or an active control article. Median survival was more than twice as long in patients treated with AIVITA’s immunotherapy. The combination of a very low baseline sPD-1, or absence of a very high PD-1, at baseline followed by a decline in sPD-1 at week-4 of the study was predictive of surviving 3 or more years in patients treated with AIVITA’s immunotherapy, but not with the control article. Among patients treated with AIVITA’s immunotherapy, these sPD-1 criteria appropriately classified 80% of 3-year survivors, and 86% of patients who did not survive three years.

"These observations suggest that sPD-1 may be a useful biomarker for melanoma patients being treated with our platform immunotherapy, and/or to predict efficacy after only three injections," said Dr. Robert O. Dillman, Chief Medical Officer at AIVITA. "We look forward to confirming these results in larger studies and investigating whether it can predict response in other cancers."

AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298