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Forbius Announces First Patient Dosed in Phase 2a EGFR-Overexpressing Triple Negative Breast Cancer (TNBC) Trial of AVID100, a Novel, Tumor-Specific Anti-EGFR ADC

On April 22, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-specific anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) (Press release, Forbius, APR 22, 2019, View Source [SID1234535319]).

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Approximately 20% of patients with TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion, Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing, TNBC (IHC 2+/3+). This is the third cohort launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

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.

A recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.

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).

Aura Biosciences to Present Two Year Phase 1b/2 Clinical Data for AU-011 at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting

On April 22, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that two year clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting being held April 28-May 2, 2019, in Vancouver, British Columbia (Press release, Aura Biosciences, APR 22, 2019, View Source [SID1234535318]).

Poster presentation details are as follows:

Title: Two Year Results of a Phase 1/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Poster Number: B0197
Poster Presenter: Tara McCannel, M.D., Ph.D, Director of the Ophthalmic Oncology Center, Jules Stein Eye Institute, UCLA School of Medicine
Session: Clinical Melanoma – Therapy and Complications
Date and time: Sunday, April 28, 2019; 1:00-2:45pm PT
Location: Vancouver Convention Centre, Western Exhibition Hall

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

Moleculin Announces Conference Call to Discuss Significant Discovery For Lung Cancer and FDA Activity on Wednesday, April 24, 2019

On April 22, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it will host a conference call to discuss its significant discovery for lung cancer, FDA Fast Track Designation and recent corporate events (Press release, Moleculin, APR 22, 2019, View Source [SID1234535317]). The call will be at 4:30 p.m. ET on Wednesday, April 24, 2019.

Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live webcast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. The Company will field live questions from equity analysts in a Q&A segment of this call. Participants may submit questions in advance for the Company to address in the Q&A segment by sending them to [email protected]. A webcast replay will be available in the Investors section of the Company’s website at www.moleculin.com for 90 days. A teleconference replay will be available at (877) 344-7529 or (412) 317-0088, confirmation code 10130980, through May 1, 2019.

Forbius Announces First Patient Dosed in Phase 2a Triple Negative Breast Cancer (TNBC) Trial of AVID100, a Novel, Tumor-Specific Anti-EGFR ADC

On April 22, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-selective anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) (Press release, Forbius, APR 22, 2019, View Source [SID1234535316]).

Approximately 20% of TNBC patients have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing TNBC (IHC 2+/3+). This is the third cohort that has been launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting ADC engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity in skin or 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.

A recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment-related adverse events in the Phase 1 trial at the RP2D were well-tolerated and grade 1 or 2 in severity.

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).

GlycoMimetics Announces Publication of Nature Cell Biology Paper Supporting Recently Announced Clinical Trial of GMI-1359

On April 22, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported the publication of a paper in Nature Cell Biology that describes how tumor cells engage specific stromal components, most notably E-selectin, for propagation and outgrowth (Press release, GlycoMimetics, APR 22, 2019, View Source [SID1234535315]).1 The paper provides further scientific support for the clinical trial in breast cancer patients with bone metastasis that was recently announced by GlycoMimetics.

Specifically, Esposito et. al. identify an E-selectin ligand expressed on tumor cells that is necessary for inducing mesenchymal-epithelial transition (MET) and that drives metastatic progression within the bone marrow microenvironment. Of note, in preclinical animal models of human breast cancer, inhibition of E-selectin with GlycoMimetics’ compound uproleselan (GMI-1271) prevented bone metastases progression and significantly attenuated bone metastases-associated bone degradation, resulting in a significant survival advantage in treated tumor-bearing mice. Previously published work also demonstrates a complimentary role for CXCR4. Together these observations support the testing of GMI-1359, GlycoMimetics’ dual-function antagonist, which targets both mechanisms.

"The scientific rationale for potential uses of GMI-1359 in oncology indications continues to build," said John L. Magnani, PhD, Chief Scientific Officer of GlycoMimetics. "This most recent paper contributes additional understanding to the critical role of E-selectin and to the potential uses of compounds that target this mechanism in cancer, in particular in cancers that metastasize to bone."

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers.