On June 3, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, yesterday reported a poster on the preclinical performance of its lead investigational drug, lasofoxifene, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sermonix Pharmaceuticals, JUN 3, 2019, View Source [SID1234536854]). The new abstract showed that lasofoxifene, in combination with palbociclib, was more effective than the combination of fulvestrant and palbociclib at reducing primary tumor growth in a mouse intraductal model.

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The results of the abstract titled "Lasofoxifene as a Potential Treatment for ER+ Metastatic Breast Cancer" also demonstrated that:

Lasofoxifene alone was significantly more effective than fulvestrant at inhibiting metastasis of both MCF7-Y537S and D538G tumors to the lungs and liver.
Lasofoxifene + palbociclib was more effective at inhibiting liver metastasis than either drug alone and was more effective than fulvestrant + palbociclib at reducing metastasis to the liver and lungs.
For patients with estrogen receptor-positive (ER+) metastatic breast cancer, fulvestrant is a current approved first line treatment alone and in combination with ribiciclib, and in combination with palbociclib and abemaciclib with disease progression after endocrine therapy. ER+ metastatic breast cancers that express constitutively active somatic ESR1 mutations at Y537S and D538G appear to allow many tumors to progress rapidly, even on currently available endocrine therapies.

Sermonix, which is currently enrolling patients in a Phase 2 clinical study of lasofoxifene in ER+ metastatic breast cancer, last month was granted a Fast Track designation by the U.S. Food and Drug Administration for lasofoxifene in advanced breast cancer with ESR1 mutations. The designation allows for the expedited development and review of drugs that treat serious conditions and fill an unmet medical need.

"The data, from Dr. Geoffrey Greene’s lab at the University of Chicago, demonstrate that lasofoxifene, alone and in combination with a CDK4/6 inhibitor, has potential promise for treating endocrine therapy resistant ER+ metastatic breast cancer in patients whose tumors express activating ESR1 mutations," said Dr. Barry Komm, Sermonix chief scientific officer.

Sermonix’s Phase 2 open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women who have locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation identified by a liquid biopsy.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On June 3, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has launched FoundationOne CDx Cancer Genomic Profile, (hereafter "the Program") a next-generation sequencing based gene mutation analysis program (Press release, Chugai, JUN 3, 2019, View Source [SID1234536853]). Also, SRL Inc. has started providing testing services for the Program today.

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FoundationOne CDx is the first cancer genomic test in Japan which obtained regulatory approval for the two functions of gene mutation analysis program (for use in cancer genome profiling) for solid tumors, and somatic gene mutation analysis program (for use in assessing anticancer drug indications). The approval was granted by the Ministry of Health, Labour and Welfare on December 27, 2018.

"FoundationOne CDx Cancer Genomic Profile will open up a new horizon for personalized cancer care. I am delighted that the program is now available for patients and healthcare providers in Japan," said Tatsuro Kosaka, Chugai’s President and CEO. "Through this program, Chugai will further strive to realize advanced and sustainable patient-centric healthcare by promoting access to treatments optimized to each patient."

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection and analysis of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from patient’s tumor tissues. As a comprehensive companion diagnostic function, it can be also used as a companion diagnostic for certain molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare providers through comprehensive genomic profiling.

[Notes]
A press release issued on March 19, 2019: Miraca and Chugai Enter into Business Partnership Agreement for "FoundationOne CDx Cancer Genome Profile"
View Source

Approval information

Brand name FoundationOne CDx Cancer Genomic Profile
Nonproprietary name
Gene mutation analysis program (for use in cancer genome profiling)
Somatic gene mutation analysis program (for use in assessing anticancer drug indications)
Approval date December 27, 2018
Intended uses or indications
The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
EGFR exon 19 deletions and EGFR exon 21 L858R alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Conditions for approval
The necessary measures must be taken to ensure that the product is used by a physician with adequate knowledge and experience of cancer genomic medicine at a medical institution with a cancer genome profiling-based medical system pursuant to the "Guidelines for the Development of Core Hospitals and Other Facilities for Cancer Genomic Medicine," and in compliance with the scope and timing of testing stipulated in the most recent guidelines, etc., of relevant academic societies.
Appropriate procedures and controls to protect personal information and up-to-date security and privacy protection measures to prevent unauthorized access must be implemented for tumor tissue specimens sent to the laboratory and for information obtained from these specimens.
Quality control of input data must be performed as described in the Remarks column of the attached Application Form. Any changes to the quality control of input data as described in the Remarks column of the Application Form (excluding minor changes specified by Order of the MHLW in Article 23-2-5, paragraph (11) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices ["the Act"]) must be approved by the MHLW Minister pursuant to Article 23-2-5, paragraph (11) of the Act. Note that this approval applies mutatis mutandis to the provisions of Article 23-2-5 paragraph (13), Article 23-2-6, and Article 23-2-7 of the Act.

On June 3, 2019 Iovance Biotherapeutics, Inc presented the corporate presentation (Presentation, Iovance Biotherapeutics, JUN 3, 2019, View Source [SID1234536851]).

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On June 3, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), reported that Ryan Spencer, Senior Vice President, Commercial, and Interim Co-President, will present at the William Blair & Co. Annual Growth Stock Conference on Thursday, June 6, at 9:20 a.m. C.T (Press release, Dynavax Technologies, JUN 3, 2019, View Source [SID1234536850]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source

On June 3, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that Chief Medical Officer Dr. Robert O. Dillman presented clinical data on melanoma patients treated with patient-specific vaccines on June 1 at the 55th Annual Meeting of ASCO (Free ASCO Whitepaper) in Chicago, Illinois (Press release, AIVITA Biomedical, JUN 3, 2019, View Source [SID1234536849]). The data is being published concurrently in the journal Melanoma Management.

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The abstract and publication describe survival data for 72 patients pooled from two Phase 2 trials. In the first trial conducted in 54 patients, the projected median overall survival was 54% at a time when median follow up was 4.5 years (Dillman et al. Cancer Biother Radiopahrm 2009;24:311-319.). Actual 5-year survival was 50% once all patients had been followed a minimum of five years. In the second Phase 2 trial patients were randomized for treatment with either their patient-specific dendritic cell vaccine (DCV) or patient-specific tumor cell vaccine (TCV). In both treatment arms the source of antigen was autologous tumor cells that were self-renewing in cell culture. Median overall survival was better in the DCV-treated patients: median survival 40.3 vs 20.5 months, 3-year actual survival of 61% vs 25% (p=0.018), and a 70% reduction in the risk of death (p=0.0053) [Dillman et al. J Immunother Cancer 2018;6:19.] The data for DCV-treated patients was pooled in order to address questions related to survival of specific subsets of patients [Dillman et al. Melanoma Manag 2019]. All patients had been followed for five years. The data showed that for melanoma patients who had recurrent Stage III disease that was not measurable at the time DCV-treatment was initiated, the 5-year survival rate was 72%. In melanoma patients who had previous Stage IV melanoma but did not have measurable disease at the time of treatment, the 5-year survival rate was 53%. Patients with measurable Stage IV melanoma had a median survival of 18.5 months with a two-year survival rate of 46%, which compares favorably to results achieved with anti-PD-1 checkpoint inhibitors in similar patients.

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy 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.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

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 the 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