On October 23, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that Christopher Haqq M.D., Ph.D. has joined Elicio as Executive Vice President, Head of Research and Development, and Chief Medical Officer (Press release, Elicio Therapeutics, OCT 23, 2019, View Source [SID1234542438]).

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"Chris is an accomplished physician-scientist who brings to Elicio over 20 years of translational drug development and leadership in large and small biotechnology companies across T cell immunotherapy, biologic, and small molecule modalities," commented Elicio CEO Robert Connelly. "We expect Chris’ knowledge of the impact of T-cell expansion, persistence and trafficking in immuno-oncology will dovetail with the unique lymph node targeting ability of Elicio’s Amphiphile platform."

Before joining Elicio, Dr. Haqq was the first employee and Chief Medical Officer of Atara Biotherapeutics, and later its Chief Scientific Officer, where he was the architect for an innovative pipeline including EBV specific T-cell product candidates for oncology and autoimmune disease, and a next generation off the shelf CAR-T cells for solid tumors. Earlier at Cougar Biotechnology and Janssen, Dr. Haqq was the lead clinician for a pivotal prostate cancer study leading to market approval for Zytiga (abiraterone acetate) and he led early development studies at Amgen.

Dr. Haqq has served as medical monitor for numerous oncology clinical trials working closely with global regulatory agencies. His teams have made successful filings for investigational new drug applications, breakthrough therapy, priority medicines, special protocol assessments and marketing approval and he has authored multiple patents and publications. Dr. Haqq initially practiced as a medical oncologist and led a translational science laboratory as an Assistant Professor in the Division of Hematology/Oncology at the University of California, San Francisco following post-graduate training as an Intern and Resident in Internal Medicine, Fellow in Medical Oncology and Fellow in Molecular Medicine. Dr. Haqq completed his M.D. and Ph.D. in Genetics at Harvard Medical School and his undergraduate training at Stanford University and the University of British Columbia.

"I am excited to lead Elicio’s strong R&D team during the transition from the lab bench to the bedside for its promising lymph node targeted immunotherapies where preclinical monotherapy and CAR-T combination show unique potential," said Dr. Haqq. "And as my family has experienced the unmet need for an effective mKRAS therapy, I am looking forward to evaluate ELI-002’s safety and efficacy in mKRAS bearing pancreatic, colorectal and lung cancers."

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.

On October 23, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract containing data from the Company’s Phase 2 clinical trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) has been selected for oral presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which will be held October 26-30, 2019 at the Hynes Convention Center in Boston (Press release, Kura Oncology, OCT 23, 2019, View Source [SID1234542439]).

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Nearly 500 abstracts were considered for this year’s program and just 10 were selected as short-talks by the Scientific Committee Cochairs. As a result of the selection, the previously announced poster presentation related to the Phase 2 clinical trial of tipifarnib in HRAS mutant HNSCC has been rescheduled to take place following the oral presentation. Details of the oral and poster presentations, entitled "Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations" (abstract A087), are as follows:

Oral Presentation
Session Title: Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers
Session Date: Tuesday, October 29, 2019
Session Start Time: 11:50 a.m. ET
Session End Time: 12:30 p.m. ET
Location: Level 3 – Ballroom AB

Poster Presentation
Session Title: Poster Session C: Clinical Trials 2
Session Date: Tuesday, October 29, 2019
Session Start Time: 12:30 p.m. ET
Session End Time: 4:00 p.m. ET
Location: Level 2 – Hall D

The data are embargoed until the beginning of the Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers session at 11:50 a.m. ET on Tuesday, October 29, 2019. A copy of the oral and poster presentations will be available at www.kuraoncology.com following presentation at the meeting.

On October 22, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported topline results from the second pre-specified interim overall survival (OS) analysis for the Phase 3 SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer who have previously been treated with anti-HER2-targeted therapies (Press release, MacroGenics, OCT 22, 2019, View Source [SID1234542407]). Margetuximab is an investigational, immune-enhancing monoclonal antibody derived from the Company’s proprietary Fc Optimization technology platform.

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The second interim OS analysis was based on 270 events. In the intent-to-treat (ITT) population, the median OS of patients treated with margetuximab and chemotherapy was prolonged by 1.8 months compared to that of patients who received trastuzumab and chemotherapy (21.6 months versus 19.8 months; hazard ratio [HR]=0.885; 95% CI: 0.693-1.130; p=0.326). A pre-specified exploratory objective was to evaluate the effect of CD16A allelic variation on margetuximab activity. Among the approximately 85% of patients carrying a CD16A 158F allele, the median OS was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm (23.7 months versus 19.4 months; HR=0.793; 95% CI: 0.607-1.035; p=0.087). Among the approximately 15% of patients who were homozygous for the CD16A 158V allele, the trastuzumab arm performed better than the margetuximab arm. The final pre-specified OS analysis is planned after 385 events have accrued, which is projected to occur in 2020. The first sequential primary endpoint of progression-free survival (PFS) in the ITT population was achieved, with statistical significance as previously reported.

Margetuximab plus chemotherapy had a generally comparable safety profile overall to that of trastuzumab plus chemotherapy, consistent with data previously reported from the study. Grade 3 or greater adverse events occurred in 145 (55%) patients on the margetuximab arm compared to 140 (53%) patients on the trastuzumab arm. Serious adverse events occurred in 45 (17%) patients on the margetuximab arm compared to 50 (19%) patients on the trastuzumab arm. Infusion-related reactions were more common with margetuximab treatment than with trastuzumab (13% versus 3%) and were mostly Grade 1 or 2 and associated with the first dose.

Detailed results from the second interim OS analysis from the SOPHIA study are scheduled to be presented during an oral session at the upcoming San Antonio Breast Cancer Symposium (SABCS) in December. MacroGenics expects to submit a Biologics License Application (BLA) to the FDA before the end of 2019.

About the SOPHIA Study

The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. To be eligible for the study, patients must have received at least two prior lines of anti-HER2-directed therapy in the metastatic setting, or in the case of having received (neo)adjuvant pertuzumab, at least one prior line of anti-HER2-directed therapy in the metastatic setting; and who have received at least one and no more than three prior lines of therapy overall in the metastatic setting. All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine, or T-DM1.

The study enrolled 536 patients who were randomized 1:1 to receive either margetuximab (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or

Exhbit 99.1
8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine) given at the standard dose. Patients were stratified by the number of metastatic sites (≤2 or >2), number of lines of prior therapy for metastatic disease (≤2 or >2) and choice of chemotherapy. Intent-to-treat analysis occurred after 265 PFS events.

Primary endpoints are sequentially-assessed PFS, determined by centrally-blinded radiological review, and OS. Key secondary endpoints are PFS by investigator assessment and objective response rate (ORR). PFS and ORR were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

About HER2-positive Breast Cancer

Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies (mAbs) targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an unmet need that eventually advances to the point where no currently approved HER2-targeting therapy continues to control the disease. Ongoing HER2 blockade is recommended for relapsed or refractory patients, but there is no approved therapy in the third line and beyond setting, or established standard of care after progression with trastuzumab, pertuzumab and ado-trastuzumab emtansine.

About Margetuximab

Margetuximab is an investigational monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered with MacroGenics’ Fc Optimization technology to enhance the engagement of the immune system. Margetuximab is also being evaluated in combination with anti-PD-1 therapy for the treatment of patients with HER2-positive gastroesophageal cancer and the registration-directed Phase 2/3 MAHOGANY trial (NCT04082364) has recently opened to patient enrollment.

About MacroGenics’ Fc Optimization Technology

MacroGenics’ Fc Optimization platform is designed to modulate an antibody’s interaction with immune effector cells. The Fc region of certain antibodies binds activating and inhibitory receptors, referred to as FcγRs, on immune cells found within the innate immune system. Such interactions affect killing of cancer cells through antibody dependent cellular cytotoxicity (ADCC), among other Fc-dependent functions.

The activating CD16A FcγR occurs in two variants, or alleles, with high (158V) or low (158F) affinity for the Fc domain of IgG1. A majority (approximately 85%) of the population carries the 158F allele, either in the homozygous form or as heterozygous with 158V. Patients that carry the 158F allele have been reported to show diminished clinical responses to certain therapeutic antibodies, including trastuzumab.

MacroGenics’ optimized Fc region binds with increased affinity to CD16A, including the 158F low-affinity allele, and, unique to MacroGenics’ technology, with reduced affinity to CD32B, the inhibitory FcγR. MacroGenics’ optimized Fc mediates improved effector functions, such as ADCC. To date, MacroGenics has incorporated its proprietary Fc Optimization technology in margetuximab, as well as enoblituzumab, an anti-B7-H3 monoclonal antibody currently in development in combination with anti-PD-1 therapy for cancer treatment.

On October 22, 2019 BERG, the clinical stage biopharmaceutical company that uses artificial intelligence (AI) to discover the biology of underlying disease, reported results from a preclinical study of its investigational drug BPM 31510 (novel ubidecarenone formulation) in glioblastoma models (Press release, Berg Pharma, OCT 22, 2019, View Source [SID1234542423]). The study, presented as a poster at the Society for Neuroscience (SfN) Annual Meeting in Chicago, demonstrated a novel oxidative stress dependent mechanism of action of BPM 31510 associated with anti-cancer responses in Glioblastoma Multiforme (GBM).

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"We are excited to observe independent validation by a team of researchers at Stanford University School of Medicine of novel mechanisms of redox regulation by BPM 31510 that seem largely cancer cell selective," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "The data are consistent with predictions by our proprietary Interrogative Biology platform that BPM 31510 affects mitochondrial-centric metabolism and can be applied to highly metabolic tumor types such as GBM. It is notable that this hallmark of cancer was awarded the 2019 Nobel Prize in Medicine1."

GBM is an aggressive type of brain cancer associated with very high morbidity and mortality rates. Currently, there are limited treatment options, thus there is an urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality specifically targeting cell metabolism, shifting the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation inducing oxidative stress and cell death specifically of cancer cells. GBM’s glycolytic dependency makes it a particularly relevant target indication for BPM 31510.

"These exciting findings support an entirely novel mechanism of cancer chemotherapy," said Eric J. Nestler, MD, PhD, Past President of SfN and the Nash Family Professor of Neuroscience at the Icahn School of Medicine at Mount Sinai in NYC. "BPM 31510 not only shows therapeutic promise for GBM in animal models, but has proven to be well tolerated in humans in a recent Phase 1 study. It will be important to establish its efficacy in human GBM patients." Dr. Nestler is a member of the Board of Directors of BERG.

The study was led by Lawrence Recht, MD, Professor of Neurology & Neurosurgery at Stanford University School of Medicine, with other Stanford researchers and in collaboration with BERG.

Details of the BERG presentation:
Date: Tuesday, October 22, 2019
Harnessing redox homeostasis as a therapeutic modality in glioblastoma
Session number 557 (Neuro-Oncology)
Location – Hall A, McCormick Place, Chicago, IL, USA
Time – 1:00 – 5:00 PM

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.

On October 22, 2019 SQZ Biotechnologies (SQZ), a cell therapy company developing innovative treatments for multiple therapeutic areas, reported that the company’s Investigational New Drug (IND) application for SQZ-PBMC-HPV, a novel cellular immunotherapy of antigen presenting cells (APCs) has been cleared after submission to the U.S. Food and Drug Administration (FDA) (Press release, SQZ Biotech, OCT 22, 2019, View Source [SID1234553405]). The trial is investigating the cell therapy comprised of SQZ-engineered APCs to treat HPV+ tumors, titled SQZ-PBMC-HPV. Marking the first program to enter the clinic for the company, SQZ-PBMC-HPV is also the first trial advancing into the clinic in the SQZ-Roche collaboration developing APCs for oncology.

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Armon Sharei, PhD, founder and chief executive officer of SQZ, noted, "The FDA’s clearance of our IND is a pivotal moment for the company. SQZ has potential to bring novel cell therapies to patients addressing high unmet medical needs, and this important milestone marks the first clinical translation of our platform."

"SQZ APCs have the potential for broad impact in the oncology space. A cell therapy targeting solid tumors without the need for immune or myeloablative pre-conditioning could possibly shift the paradigm for patients," said Oliver Rosen, MD, chief medical officer of SQZ. "The preclinical data underpinning this program have shown significant tumor reduction driven by high CD8 T cell infiltration into the tumor microenvironment, alongside a favorable preclinical safety profile. We are looking forward to translating this into potentially meaningful results for patients."

The Phase 1 multi-center trial (NCT04084951) is sponsored by SQZ and will enroll in multiple cohorts to assess SQZ-PBMC-HPV as both monotherapy and in combination with Roche’s checkpoint inhibitor, atezolizumab. HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ head & neck, cervical, anal, penile, vulval and vaginal cancers are all eligible for the study.

About SQZ-PBMC-HPV

SQZ-PBMC-HPV is an autologous cell therapy product precisely engineered via SQZ’s Cell Squeeze platform to target HPV+ cancers. It is the first product stemming from the 2018 collaboration expansion between Roche and SQZ to develop SQZ-APCs for oncology. The SQZ APC platform is designed to present tumor antigens to the body’s endogenous CD8 T cells. By enabling presentation of the appropriate target, this approach can potentially induce powerful CD8 T cell responses in patients to attack their tumors.