On May 28, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported positive final results from the DRIIV-1 phase 1 study assessing the safety and the activity of AsiDNA, the Company’s first-in-class DNA repair inhibitor, when administered intravenously in patients with advanced solid tumors (Press release, Onxeo, MAY 28, 2019, View Source [SID1234536604]).

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!

Olivier de Beaumont, Medical Director of Onxeo, commented: "DRIIV-1 successfully achieved each of its core objectives, including further demonstrating the favorable safety profile of AsiDNA, confirming its ability to be combined with other agents and validating its mechanism of action in patients’ tumor cells through the marked activation of its targets. Importantly, the optimal active dose of AsiDNA has been determined and is being utilized in our ongoing DRIIV-1b study combining AsiDNA with chemotherapy. We intend to present the full results of the DRIIV-1 study at future scientific meetings."

AsiDNA is the first compound of a novel class of anti-tumor products. By simulating a DNA break (decoy effect), it binds to the DNA-repairing proteins, thereby preventing the recruitment of these proteins to the damaged genomic site, leading to tumor cells death.

DRIIV-1, a phase 1 dose-escalation study of AsiDNA administered intravenously, was designed to evaluate its toxicity profile as well as its pharmacokinetics and pharmacodynamics parameters via intratumoral activity biomarkers. The study was conducted in four centers in France and Belgium and enrolled twenty-two adult patients. All patients had metastatic cancers and were failing or progressing after one or more standard treatments with no further therapeutic options.

Five dose levels have been tested (from 200 to 1,300mg) out of the six planned. It was deemed unnecessary to test the sixth dose (1,800mg) since the therapeutic window between the optimal dose of 600mg and the highest tested dose of 1,300mg is considered sufficient.

Overall, the tolerance profile of AsiDNA was considered favorable by the DSMB experts, with 90% of all product-related adverse events being non-specific grade 1 and 2 events. The maximum tolerated dose (MTD) was not reached.

Most importantly, AsiDNA demonstrated systemic activity in DRIIV-1 through the strong activation of its targets, as evidenced by the significant increase, of two intratumoral biomarkers of DNA-PK and the decrease of a tumor proliferation biomarker. At the dose of 600mg, among the 3 patients included in the cohort, 2 patients with relapsed multi-treated metastatic colorectal cancer were controlled without progression at medical imaging at the end of the second cycle of treatment with AsiDNA, with maintenance of treatment for 3 months.

This dose was considered optimal for the further development of AsiDNA in combination with chemotherapy (carboplatin and carboplatin plus paclitaxel) which started early May 2019 with the first patient treated in the phase 1b trial, DRIIV-1b.

Judith Greciet, Chief Executive Officer of Onxeo, concluded: "The successful completion of DRIIV-1 is a major milestone for Onxeo as this study validates both the systemic activity of AsiDNA and its tolerance profile well-suited for combination treatments. We expect to maintain a strong development momentum and have already started the evaluation of AsiDNA in combination with chemotherapy in the DRIIV-1b study. Our teams are already actively working on other clinical development pathways in combination, notably with PARP inhibitors. We would like to warmly thank our investigators and their teams for their support and valuable contributions to this trial and the upcoming ones."

On May 28, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, reported that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (Press release, Sermonix Pharmaceuticals, MAY 28, 2019, View Source [SID1234536622]). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

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!

Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s 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 with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

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 May 28, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that the company will participate in the following conferences in June (Press release, Axial Biotech, MAY 28, 2019, View Source [SID1234537218]):

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!

BIO International Convention 2019 on Monday, June 3, 2019 at 3:00 p.m. ET in Philadelphia, PA
Panel Presentation: What’s Next: The Landscape of Innovation in 2019 and Beyond
Session ID: 537703
CNS Targets and Translational Strategies on Wednesday, June 19, 2019 at 8:05 a.m. ET in
Boston, MA
Presentation: Harnessing the Gut-Brain Axis to Discover Novel CNS Therapeutics
JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 11:30 a.m. ET in New
York, NY

On May 28, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company and updates concerning its clinical stage drug candidates, momelotinib and SRA737, at 8:00 am ET on Wednesday, June 5 at the Jefferies Global Healthcare Conference being held in New York (Press release, Sierra Oncology, MAY 28, 2019, View Source [SID1234536605]).

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!

During the presentation, Dr. Glover will discuss:

updated progress in the development program for momelotinib, the company’s Phase 3 JAK1, JAK2 and ACVR1 inhibitor for the treatment of myelofibrosis.
preliminary clinical efficacy data for Sierra’s Chk1 inhibitor, SRA737, which will have been presented on June 1st at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

On May 28, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody drug conjugate (ADC), in EGFR-overexpressing squamous cell carcinoma of the head and neck (SCCHN), squamous non-small cell lung cancer (sqNSCLC) and triple negative breast cancer (TNBC) (Press release, Forbius, MAY 28, 2019, View Source [SID1234536623]).

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!

AVID100-01 (NCT03094169) is a Phase 2, open label, multicenter study to evaluate the safety and efficacy of AVID100 in up to 100 SCCHN, sqNSCLC and TNBC patients with confirmed EGFR-overexpression. The trial is currently enrolling patients at centers in the U.S. and will be expanding to additional clinical sites in Canada.

Preclinical data demonstrated AVID100 to be highly potent and selectively cytotoxic against EGFR-expressing cancer cells while sparing normal keratinocytes. A Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin confirmed that AVID100 was well tolerated and established an RP2D of 220 mg/m2 (~6 mg/kg), which is expected to be in the therapeutically active range and is one of the highest RP2Ds reported for ADCs with maytansinoid payload.

Approximately 20–25% of patients with SCCHN, sqNSCLC and TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for these indications with confirmed EGFR-overexpression.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+) and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).