Presentation materials to be provided at Heat Biologics, Inc. presentations

On November 29, 2019 Heat Biologics presented materials to be provided at Heat Biologics, Inc. presentations (Presentation, Heat Biologics, NOV 29, 2019, View Source [SID1234551782]).

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GlycoMimetics to Present at the Piper Jaffrey 31st Annual Healthcare Conference 2019

On November 29, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at the Piper Jaffrey 31st Annual Healthcare Conference in New York, New York, which takes place on December 3, 2019. Ms. King’s presentation is scheduled for 1:30 p.m. ET (Press release, GlycoMimetics, NOV 29, 2019, View Source [SID1234551781]).

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To access the live webcast and subsequent archived recordings for this presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

New Micro-Simulation Study in Cancer Medicine Finds Epi proColon® Provides Clinically Meaningful Reductions in Incidence and Mortality of Colorectal Cancer

On November 29, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company"), reported on micro-simulation model results indicating that Epi proColon, a colorectal cancer (CRC) screening test approved for patients who are unwilling or unable to be screened by the United States Preventive Services Task Force (USPSTF) recommended methods, provides clinically meaningful reductions in the incidence and mortality of CRC comparable to those of USPSTF currently recommended methods (Press release, Epigenomics, NOV 29, 2019, View Source [SID1234551780]). The micro-simulation model, developed and validated at Harvard Medical School, evaluated the impact of adherence rates, testing intervals and clinical performance of different screening strategies on CRC incidence and mortality. Results show that adherence rates and screening intervals can have a profound impact on the effectiveness of screening strategies as compared to one-time sensitivity and/or specificity. The study has been published in Cancer Medicine.1

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"While colonoscopy-based screening for CRC offers the highest sensitivity of all available screening strategies, the results of this micro-simulation model demonstrate that patient adherence and prescribed screening intervals heavily influence the long-term clinical effectiveness for all CRC screening strategies," said Daniel Sussman, MD, University of Miami Miller School of Medicine and an author on the publication. "Evaluating an environment where realistic colonoscopy adherence rates are less than 70% and the recommendation exists for ten-year intervals between colonoscopy screenings for individuals with average CRC risk, the findings of this study suggest that stool- and blood-based CRC screening strategies with higher adherence and considerably shorter intervals offer competing options to patients and clinicians in an effort to reduce CRC incidence and mortality. CRC is a disease that is largely preventable when detected and treated early."

The study was conducted using an individual-level model to simulate the natural history of CRC and enables comparison of clinical benefits, harms, and burden of alternative strategies for CRC screening. The model was validated by comparison of predicted CRC incidence and mortality, adenoma dwell times, overall dwell times and lifetime risk of developing CRC with results from two large randomized controlled trials2,3 and those of the National Cancer Institute’s Cancer Intervention and Surveillance Modeling Network (CISNET) models.4

The model used a hypothetical cohort of individuals aged 50 years or older and emulated the distribution of baseline characteristics for subjects in the landmark clinical studies. Identical cohorts were then created and assigned to different screening strategies in order to compare intervention-related differences in outcomes. The strategies and intervals summarized in the table below were analyzed under two scenarios: 1) adherence fixed at 100%; 2) adherence based on published rates. Sensitivity analyses based on varying initial and resulting overall adherence rates were also conducted.

Key findings from the study include:
• Assuming an adherence rate of 100%:
o FIT-DNA, FIT, HS-gFOBT, and SEPT9 averted 42-45 CRC cases and 25-26 CRC deaths
o COL averted 46 cases and 26 deaths
o CTC averted 39 cases and 23 deaths and FS averted 32 cases and 19 deaths per 1,000 individuals screened
o Estimated LYG were similar across FIT-DNA, FIT, HS-gFOBT, SEPT9, CTC, and COL strategies

• Based on reported adherence of eligible individuals to CRC screening, per 1000 individuals screened, colonoscopy produced the best outcomes unless a non-invasive method achieves a 65% – 70% or greater adherence rate

• Screening individuals with COL every ten years or SEPT9 every year (assuming reported adherence rates) resulted in more favorable outcomes compared to all other strategies (see figure below)

• The impact of analytic performance on screening outcomes is heavily influenced by adherence rates and screening interval

"The key take away from this study is that Epi proColon done annually can serve as an effective non-invasive CRC screening strategy that can provide long-term benefits similar to those of other currently recommended CRC screening methods with harms lower than those reported for colonoscopy. Most importantly, however, as stated by the authors, even for tests with the highest accuracy, such as colonoscopy, the benefit of screening could be muted by a suboptimal uptake and therefore we agree with many experts in the field in saying that the best test is the one that gets done," said Dr. Jorge Garces, President and Chief Scientific officer at Epigenomics AG.
"We hope that this study will spur discussion within the gastroenterology community and between physicians and their patients about how to best deploy all available screening strategies to reduce CRC incidence and deaths and improve patient outcomes," said Greg Hamilton, CEO at Epigenomics AG.

About Colorectal Cancer (CRC)
Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.

Ennovabio Closes $14 Million Series A Round for Novel Drug Development

On November, 29 2019 Shanghai Ennovabio Pharma, a novel drug startup, closed a $14 Series A financing led by Matrix Partners China and joined by existing shareholder Highlight Capital (Press release, EnnovaBio, NOV 29, 2019, View Source [SID1234551779]). Established in 2016 in Shanghai’s Zhangjiang Park, Ennovabio uses bioinformatics to develop Class 1.1 novel drugs. The company expects to file INDs in China and the US next year for its lead candidate, a treatment for diabetic eye disease. Ennovabio, which plans to combine internal research with in-licensed candidates to build its pipeline, has six novel drugs in preclinical development.

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Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer

On November 29, 2019 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC) (Press release, AstraZeneca, NOV 29, 2019, View Source [SID1234551777]).

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SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.1 A Prescription Drug User Fee Act date is set for the first quarter of 2020.

The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet, showing Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) vs. SoC. The risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed an estimated 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 54 countries, including the US, Japan and the EU, based on the Phase III PACIFIC trial.

About CASPIAN

CASPIAN is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of patients with extensive-stage SCLC. The trial compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and prophylactic cranial irradiation. The trial will continue to the final analysis of OS for the combination of Imfinzi, tremelimumab and chemotherapy. The trial is being conducted in more than 200 centres across 23 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint is OS.

About small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.3 About three quarters of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body. Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.4

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in 11 countries, including the US.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso (osimertinib), and ongoing Phase III trials ADAURA, LAURA, and FLAURA2 as well as the Phase II combination trials SAVANNAH and ORCHARD.5-7

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents approximately three-quarters of all patients with lung cancer.8 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON, PEARL, and CASPIAN) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy.

About AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the majority of patients.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.