On September 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported it has enrolled 158 patients in its Phase 2 trial of AG013 for the treatment of severe oral mucositis (Press release, Oragenics, SEP 25, 2019, View Source [SID1234539778]).

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In addition, the Data and Safety Monitoring Board (DSMB) for the trial, recently met and reviewed safety data to date and has determined that the trial may continue with no adjustments or further review. The company is currently enrolling approximately 200 patients in 59 study sites in the United States and Europe.

"Having reached more than three quarters enrollment is an important milestone for this trial, and we remain on track to complete enrollment by the end of the fourth quarter of 2019. In the meantime, we are grateful to our DSMB for their continued support in reviewing our incremental safety data and clearing the trial to continue uninterrupted. Finally, we look forward to providing additional updates on the progress and data from the trial as it becomes available," stated Alan Joslyn, CEO of Oragenics, Inc.

AG013, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an ActoBiotics therapeutic candidate formulated to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. The compound was designed by the company’s strategic partner, ActoBio Therapeutics, Inc., a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON).

On September 25, 2019 Innate Pharma SA (the "Company" or "Innate" – Euronext Paris: FR0010331421 – IPH), reported that AstraZeneca (LSE/STO/NYSE: AZN) will advance monalizumab into a Phase III randomized clinical trial evaluating monalizumab in combination with cetuximab in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and the companies will co-fund the trial (Press release, Innate Pharma, SEP 25, 2019, View Source [SID1234539800]). The trial initiation is expected in 2020, subject to regulatory and compliance approvals.

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"This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Together with AstraZeneca, we are working diligently to progress this potential novel treatment for head and neck cancer patients, a population with a high unmet medical need."

About the Innate-AstraZeneca monalizumab agreement:

On April 24 2015, the Company signed a co‑development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments of up to $1.275 billion to Innate Pharma. The Company has already received $350 million, and the next payment due by AstraZeneca is $100 million upon dosing of the first patient in a first Phase III clinical trial. AstraZeneca will book all sales and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase III development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Hence, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing Phase II development for monalizumab is focused on investigating monalizumab in combination strategies.

About Cetuximab:

Cetuximab is an anti-EGFR monoclonal antibody. NK cells mediate cetuximab-induced antibody dependent cellular cytotoxicity (ADCC) against SCCHN, and genetic and preclinical experiments suggest that ADCC can be enhanced by NK-stimulators.

The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 months (Vermorken et al, JCO 2007).

On September 25, 2019 ImaginAb Inc., a clinical-stage immuno-oncology imaging company, reported it has enrolled its first patient for the Phase II clinical trial of its lead product CD8 tracer, 89Zr-Df-IAB22M2C, at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) (Press release, ImaginAb, SEP 25, 2019, View Source [SID1234539761]). This study is a collaboration between UAB’s Division of Hematology and Oncology and Division of Molecular Imaging and Therapeutics, reflecting UAB’s commitment to world-class research and clinical care.

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89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, enabling treatment to be tailored quickly and specifically to the needs of that patient.

UAB is one of ImaginAb’s active clinical sites conducting Phase II baseline/on-treatment clinical trials investigating the utility of ImaginAb’s CD8 tracer, 89Zr-Df-IAB22M2C, to image CD8 T cells before (baseline) and after (on-treatment) cancer patients receive immunotherapy-based treatment.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to predict, inform, monitor and enable the treatment of cancer more effectively. We are delighted to have enrolled and imaged our first patient in this ongoing clinical study at UAB, a world-renowned research center in Nuclear Medicine and Molecular Imaging."

The trial will enroll advanced and metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8+ T cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

The ImaginAb team will be at the European Society for Medical Oncology ESMO (Free ESMO Whitepaper) Congress 2019 at Fira Gran Via, Barcelona from September 27 to October 1, 2019. Dr. Anna Wu, Chief Scientific Advisor, and Board member and Dr. Toni Ribas, Ph.D., ImaginAb Science Advisory Board Member and President-Elect for The American Association for Cancer Research (AACR) (Free AACR Whitepaper), will be attending and hosting meetings. In addition, ImaginAb’s commercial team led by Ivan Plavec, Chief Business Officer (CBO), will be hosting meetings and available at the ImaginAb Booth #477.

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144

On September 25, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported its participation in the following upcoming investor conferences (Press release, Moderna Therapeutics, SEP 25, 2019, View Source [SID1234539779]):

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2019 Cantor Fitzgerald Global Healthcare Conference in New York City on Thursday, October 3, 2019 at 10:05 a.m. ET.
Chardan’s 3rd Annual Genetic Medicines Conference in New York City on Tuesday, October 8, 2019 at 11:30 a.m. ET.
A live webcast of each presentation will be available under "Events & Presentations" in the Investors section of the Moderna website at View Source A replay of each webcast will be archived on Moderna’s website for 30 days following the presentations.

On September 25, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Ron Cohen, M.D., Acorda’s President and Chief Executive Officer, will present at the 2019 Cantor Global Healthcare Conference on Friday, October 4 at 11:15AM ET (Press release, Acorda Therapeutics, SEP 25, 2019, View Source [SID1234539762]). A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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