On September 14, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that a poster describing the design of the ongoing Phase I/II trial of BT8009 will be presented during an e-poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 on September 19-21, 2020 (Press release, Bicycle Therapeutics, SEP 14, 2020, View Source [SID1234565077]). BT8009 is a second-generation Bicycle Toxin Conjugate (BTC), which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload. BT8009 targets Nectin-4, a tumor antigen observed to be overexpressed in several common tumor types and associated with poor disease prognosis.

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"We believe BT8009 represents an important addition to the landscape of potential next-generation treatments for patients with Nectin-4-positive cancers, as it could improve on Nectin-4-targeted therapies that are based on conventional modalities," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "With our recent announcement that the first patient has been dosed in the Phase I/II trial of BT8009, we are pleased that the trial is progressing and look forward to providing an overview of its design at ESMO (Free ESMO Whitepaper)."

Details on Bicycle’s poster presentation at ESMO (Free ESMO Whitepaper) are as follows:

Poster Title: BT8009-100 Phase I/II Study of the Safety, Pharmacokinetics, & Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
Abstract #: 3716
Presentation #: 599TiP

The poster will be available on the ESMO (Free ESMO Whitepaper) website, as well as in the Publications section of bicycletherapeutics.com, beginning Thursday, September 17.

On September 14, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor for the treatment of myelofibrosis, reported that Dr. Stephen Dilly, President and CEO, will present an overview of the company at two investor conferences in September: the H.C. Wainwright 22nd Annual Global Investment Conference and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, Sierra Oncology, SEP 14, 2020, View Source [SID1234565093]).

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H.C. Wainwright Annual Global Investment Conference

Date:

Wednesday, Sept 16

Time:

11:00 am ET

Webcast link:

View Source

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date:

Monday, September 21

Time:

11:40 am ET

Webcast Link:

View Source

Replays of these presentations will be available on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

On September 14, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will participate at the World Vaccine Congress Washington being held virtually September 28-October 1, 2020 (Press release, Immunomic Therapeutics, SEP 14, 2020, View Source [SID1234565112]). Andrew Eisen, MD, Ph.D., Immunomic’s Vice President of Clinical Development, will present a talk titled, "Pharmacodynamic Imaging in a CMV Vaccine Trial for Glioblastoma."

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In addition, Immunomic Therapeutics, lead founder and supporter of Why We Vax, a non-profit whose mission is to help educate communities with research backed facts on vaccines, will be leading a Q&A panel titled, "What If They Gave a COVID-19 Vaccine and Nobody Came," at 3:50pm EST on October 1, 2020.

"Vaccines are one of the safest, most widely-adopted health care practices in the world. Why We Vax will spread the message that vaccines are rigorously tested and provide the best defense against diseases. One example is Measles, which can have a lasting impact on a child’s immune system," said Dr. William Hearl, Why We Vax Chairman, Immunomic Therapeutics CEO, and experienced vaccinologist.

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speakers, exclusive interviews, world leading presentations, live panel debates, and virtual face to face meetings.

Presentation details are as follows:

Dr. Andrew Eisen Presentation
Title: Pharmacodynamic Imaging In A CMV Vaccine Trial For GBM
Panel Category: Cancer and Immunotherapy Track
Panel Date and Time: Wednesday, September 30, 2020 2:30PM

Why We Vax Q&A Panel
Title: What If They Gave a COVID-19 Vaccine and Nobody Came
Category: Vaccine Safety track: Risk Assessment & Communication of Safety
Date and Time: Thursday, October 1, 2020 3:50PM

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

On September 14, 2020 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H and SSEA-4) and chemotherapeutics targeting AKR1C3, reported a scientific presentation will be held for OBI-999 (anti-Globo H targeted ADC) at the World ADC Digital Scientific meeting on Sept 16, 2020 (Press release, OBI Pharma, SEP 14, 2020, View Source [SID1234565130]).

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The scientific presentation titled, "A Novel Globo H-targeting Antibody-drug Conjugate: OBI 999" with a follow-up live discussion and question session will be led by Ming-Tain Lai, PhD. Chief Scientific Officer at OBI Pharma. The presentation will highlight the results from pre-clinical studies of OBI Pharma’s first-in-class anti-Globo H antibody drug conjugate (OBI-999), including animal efficacy and safety data, supporting the ongoing Phase 1/2 human study ongoing at the MD Anderson Cancer Center in Houston, TX (USA).

"OBI Pharma is proud to present at the prestigious 2020 World ADC Digital conference for OBI-999, our novel anti-Globo H first-in-class ADC cancer therapeutic. We look forward to providing future updates of our ongoing clinical studies, which could provide an important cancer ADC therapeutic option to patients suffering from cancer worldwide," stated Ming-Tain Lai, PhD.

Title: A Novel Globo H-targeting Antibody-drug Conjugate: OBI-999
Presenter: Ming-Tain Lai, PhD. Chief Scientific Officer at OBI Pharma, Inc. Taipei, Taiwan.
Presentation Date and Time: Wednesday, Sept. 16, 2020. 11:30 a.m. – 11:50 a.m. Eastern Time
Live Discussion & Question Session: Wednesday, Sept. 16, 2020. 12:30 p.m. Eastern Time

On September 14, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the hosting of a Key Opinion Leader (KOL) Event to discuss the medical need in pancreatic cancer and the potential role of eryaspase in this setting (Press release, ERYtech Pharma, SEP 14, 2020, View Source [SID1234565150]).

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TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has randomized more than 450 of the approximately 500 patients to be enrolled in the trial. The interim superiority analysis, to be conducted by the Independent Data Monitoring Committee when two-thirds of the events have occurred, is currently expected to take place around year-end 2020. Since the interim analysis does not include a test for futility, there will be two possible outcomes: (1) the trial will either continue toward a final analysis, expected in the second half of 2021, or (2) the trial will be stopped for superiority if the primary endpoint is met by demonstrating a significant improvement in overall survival (OS). In April 2020, the U.S. Food and Drug Administration (FDA) granted eryaspase Fast Track Designation as a potential second-line treatment of patients with metastatic pancreatic cancer.

On September 29, 2020 at 10:00 am ET, ERYTECH will host a call that will include a presentation by KOL Dr. Manuel Hidalgo, MD, Ph.D. (Weill Cornell Medicine/New York Presbyterian Hospital), who will discuss the current treatment landscape and unmet medical need in treating patients with pancreatic cancer, and an update by Erytech’s management on eryaspase and the TRYbeCA-1 trial. Dr. Hidalgo and management will be available to answer questions at the conclusion of the call.