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FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

On October 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI) reported that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer (Press release, Puma Biotechnology, OCT 2, 2019, View Source [SID1234540020]). With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

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In the ongoing CONTROL Trial, patients with HER2-positive early stage breast cancer who have completed trastuzumab-based adjuvant therapy receive neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles (56 days) of treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL Trial (NCT02400476) was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide. For the 64 patients who received the combination of loperamide plus budesonide, the incidence of grade 3 diarrhea was 28% compared to 32% in patients treated with loperamide alone. Diarrhea leading to treatment discontinuation declined to 11% in the loperamide plus budesonide cohort, compared to 18% in the loperamide alone cohort.

"We are pleased to be able to update the label for NERLYNX to include the data on the use of prophylactic loperamide plus budesonide," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We believe FDA approval of the labeling supplement will help us to ensure that physicians and patients are better informed in selecting prophylactic therapy that may improve the tolerability of the drug."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IGM Biosciences Initiates First-in-Human Phase 1 Clinical Trial of IGM-2323 for the Treatment of Relapsed/Refractory B Cell Non-Hodgkin’s Lymphoma

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]).

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.

Elicio Therapeutics Completes $33 Million Series B Financing

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]).

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.

Lilly Confirms Date and Conference Call for Third-Quarter 2019 Financial Results Announcement

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.

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.

Agilent Receives Approval for First PD-L1 Companion Diagnostic in China

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]).

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.

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