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]):

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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]).

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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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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]).

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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).

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.

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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 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the full enrollment of cohort 2 (N = 87) for previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, MAY 28, 2019, http://investor.sppirx.com/news-releases/news-release-details/spectrum-announces-poziotinib-zenith20-trial-her2-cohort-cohort [SID1234536606]). Topline results from this cohort are expected by mid 2020. This is the second cohort that has met enrollment target in Spectrum’s ZENITH20 trial – an open-label, multi-center, global phase 2 trial evaluating NSCLC patients with EGFR or HER2 exon 20 insertion mutations.

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"Our global poziotinib development program is multifaceted and progressing rapidly, which speaks to the high unmet need for patients with this type of lung cancer," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Topline results from cohort 1 in EGFR patients are expected to be available later this year, and are intended to provide the data for regulatory submission. Our goal at Spectrum is to develop novel therapies to serve patients with high unmet medical need, and we are diligently pursuing this goal with our poziotinib program."

The ZENITH20 trial consists of four cohorts of NSCLC patients with EGFR or HER2 exon 20 insertion mutations, with each cohort independently powered for a pre-specified statistical hypothesis. There are two cohorts in the previously-treated NSCLC setting, cohorts 1 (EGFR) and 2 (HER2), and two in the first-line setting, cohorts 3 (EGFR) and 4 (HER2). The primary endpoint is objective response rate (ORR). Additional endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and safety.

"The ZENITH20 trial is a critically important investigation for NSCLC patients harboring exon 20 insertion mutations as these patients have a poor prognosis and very limited treatment options," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "A new and targeted treatment is urgently needed. Our brisk enrollment rates are very encouraging for such rare mutations and a strong testimony to the strength of our team."

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.