On October 23, 2018 AstraZeneca, and its global biologics research and development arm MedImmune, reported a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly (Press release, AstraZeneca, OCT 23, 2018, View Source [SID1234530224]). The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines.

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AstraZeneca will obtain full oncology rights to the first-in-class humanised anti-NKG2A antibody, monalizumab, expanding its partnership with Innate from the initial collaboration announced in 2015. AstraZeneca also gains option rights to IPH5201, an antibody targeting CD39, as well as four preclinical molecules from Innate’s pipeline. Innate is licensing the US and EU commercial rights to recently FDA-approved Lumoxiti (moxetumomab pasudotox) for hairy cell leukaemia (HCL).

Pascal Soriot, Chief Executive Officer, said: "Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate. Today’s agreement also secures the long-term commercialisation of the recently FDA approved rare disease medicine, Lumoxiti, through dedicated focus and investment by Innate Pharma."

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said: "Today is a defining moment for Innate Pharma as we transition to become a fully-integrated oncology-focused biotech. Lumoxiti is a major therapeutic innovation for patients who suffer from relapsed/refractory hairy cell leukaemia, and we are proud to be in a position to address a significant unmet medical need. Our commercial team will be focused on rare cancers and generate more value as our own haemato-oncology proprietary pipeline develops."

Monalizumab

Building on a 2015 collaboration with Innate, AstraZeneca is exercising its option to obtain full oncology rights to monalizumab, a first-in-class humanised anti-NKG2A antibody. NKG2A is a checkpoint receptor expressed on tumour-infiltrating cytotoxic T-cells and natural killer (NK) cells that inhibits their anti-cancer functions. The companies currently share Phase II development for monalizumab in combination trials in both head and neck and colorectal cancer, with additional trials underway in other solid tumours.

Results from a single-arm Phase II trial of monalizumab in combination with cetuximab in head and neck cancer patients were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society of Medical Oncology), showing deep and durable responses in 40 patients with ORR of 27.5%, progression free survival of 5.0 and overall survival of 10.3 months, respectively. Among the 40 patients enrolled in the cohort expansion, the safety findings were consistent with previously-presented data at AACR (Free AACR Whitepaper) 2017 and 2018 (Abstract #1049PD).

CD39 and additional molecules

AstraZeneca is entering into a development collaboration and option for further co-development and co-commercialisation with Innate for its CD39 monoclonal antibody, IPH5201.

CD39 is a membrane-bound extracellular enzyme overexpressed on both regulatory T-cells and tumour cells in several cancer types. CD39 plays an important role in promoting immunosuppression through the pathway that degrades adenosine triphosphate (ATP) into adenosine. It is increasingly recognised that the adenosine pathway is critical in tumour immunosuppression and will complement AstraZeneca’s current portfolio in this area.

In addition, Innate grants AstraZeneca an option to exclusively license four molecules to be agreed upon from Innate’s preclinical portfolio, increasing the breadth and depth of AstraZeneca’s immuno-oncology portfolio.

Lumoxiti

Innate is licensing the US commercial rights of AstraZeneca’s recently FDA-approved treatment for HCL, Lumoxiti. Innate, with support from AstraZeneca, will continue EU development and commercialisation, pending regulatory submission and approval.

Lumoxiti is a CD22-directed cytotoxin and a first-in-class medicine in the US for adult patients with relapsed or refractory HCL who have received at least two prior systemic therapies, including treatment with a purine nucleoside analogue. Approximately 1,000 people are diagnosed with HCL in the US each year, a subset of which would be eligible for Lumoxiti. Innate will recognise revenues and co-commercialise Lumoxiti with AstraZeneca in the US and will take full responsibility by mid-2020.

Financial considerations

Innate will pay AstraZeneca $50 million upfront for Lumoxiti, and $25 million for future commercial and regulatory milestones, in consideration for its intellectual property and clinical and manufacturing development of the medicine. This income will be recorded as Other Operating Income by AstraZeneca.

AstraZeneca will pay Innate $100 million in the first quarter of 2019 for the expansion of the monalizumab collaboration. Additional financial arrangements related to monalizumab are detailed and available in the 2015 collaboration announcement.

Further, AstraZeneca will pay Innate $50 million upfront for the development collaboration and option for further co-development and co-commercialisation of Innate’s CD39 monoclonal antibody, IPH5201, plus an option exercise fee, milestones and royalties. Innate will have the potential for co-promotion and profit sharing in the EU.

AstraZeneca will also pay Innate $20 million upfront for an exclusive license option on four to-be-agreed molecules from Innate’s preclinical portfolio. These options can be exercised before the molecules reach clinical development, triggering an option exercise fee in addition to milestones and royalties. Innate will have the potential for co-promotion and profit sharing in the EU, dependent on future progress.

Given the long-term collaboration between the two companies, AstraZeneca will acquire a 9.8% equity stake in Innate Pharma through the issuance of 6,260,500 new shares to AstraZeneca at €10/share. Issuance of the new shares is expected to take place on or about 25 October 2018.

On October 23, 2018 Cerus Corporation (Nasdaq:CERS) reported that its third quarter results will be released on Thursday, November 1, 2018, after the close of the stock market Cerus Corporation (Nasdaq:CERS) announced today that its third quarter results will be released on Thursday, November 1, 2018, after the close of the stock market. The company will host a conference call and webcast at 4:15 P.M. EDT that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 7095077. The replay will be available approximately three hours after the call through November 15, 2018.. The company will host a conference call and webcast at 4:15 P.M. EDT that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 7095077. The replay will be available approximately three hours after the call through November 15, 2018.

On October 23, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will report its third quarter 2018 financial results on Tuesday, November 6, 2018 (Press release, BioCryst Pharmaceuticals, OCT 23, 2018, View Source [SID1234530138]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9090479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9090479.

On October 23, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported data from its Phase 2b clinical trial evaluating avasopasem manganese (GC4419), a highly selective and potent small molecule dismutase mimetic, in patients with locally advanced squamous cell head and neck cancer were presented today during a scientific session at the American Society for Radiation Oncology Annual Meeting in San Antonio, Texas (Press release, Galera Therapeutics, OCT 23, 2018, View Source [SID1234530124]).

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Avasopasem manganese demonstrated statistically significant reductions in the duration, incidence and severity of severe oral mucositis (SOM) in patients with head and neck cancer, its lead indication. The presentation, "A Randomized, Placebo (PBO) Controlled, Double-blind Phase 2b Trial of GC4419 (avasopasem manganese) to Reduce Severe Radiation-related Oral Mucositis (SOM) in Patients (pts) with Locally Advanced Squamous Cell Cancer of the Oral Cavity (OC) or Oropharynx (OP)," was given by trial investigator Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics.

"Approximately 70 percent of patients receiving chemoradiotherapy for head and neck cancer develop severe oral mucositis, and there is currently no drug approved to prevent or treat it. These positive Phase 2b data have been presented at multiple scientific meetings, which reinforces both the strength of the results and the urgency for a treatment to address this pervasive and unmet need," said Mel Sorensen, M.D., President and CEO of Galera. "We are pleased to have initiated our pivotal ROMAN trial of avasopasem manganese in patients with head and neck cancer earlier this month, which seeks to confirm the efficacy seen in this Phase 2b trial."

Additional non-clinical data were presented in a poster discussion, "The Radioprotector GC4419 Ameliorates Radiation Induced Lung Fibrosis While Enhancing the Response of Non-Small Cell Lung Cancer Tumors to High Dose per Fraction Radiation Exposures," by Michael Story, Ph.D., UT Southwestern Medical Center, on October 22. These data highlighted a reduction in normal organ damage and a significant increase in tumor response to radiation therapy with avasopasem managanese. Galera sponsored this research.

For more information and to view the abstracts, please visit View Source

About the Avasopasem Manganese Phase 2b Data

The 223-patient, double blind, randomized, placebo-controlled trial evaluated the safety of avasopasem manganese and its ability to reduce the duration of radiation-induced SOM in patients with locally advanced squamous cell head and neck cancer receiving seven weeks of radiation therapy plus cisplatin.

Patients in the trial were treated with either 30 mg or 90 mg of avasopasem manganese or placebo by infusion on the days they received their radiation treatment. Patients were randomized to one of the three treatment groups (1:1:1) and the trial recruited patients in both the United States and Canada. Avasopasem manganese exhibited a safety profile comparable to placebo in the two treatment groups, and was well tolerated. In the trial’s intent-to-treat population, the 90 mg dose of avasopasem manganese met the primary endpoint, demonstrating a statistically significant (p = 0.024) 92 percent reduction in the median duration of SOM from 19 days to 1.5 days.

In the 90 mg arm, avasopasem manganese also demonstrated a clinically meaningful effect in pre-specified secondary endpoints (incidence and severity of SOM). Avasopasem manganese achieved a 34 percent reduction through completion of radiation (p = 0.009), and a 36 percent reduction through 60 Gy of radiation (p = 0.010), in the overall incidence of SOM, and reduced the severity of patients’ OM by 47 percent (p = 0.045).

About Avasopasem Manganese

Avasopasem manganese (GC4419) is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. It works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

Avasopasem manganese is being studied in the Phase 3 ROMAN trial of patients with head and neck cancer, its lead indication, for its ability to reduce the incidence and severity of radiation-induced severe oral mucositis. In Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial, avasopasem manganese demonstrated the ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. Avasopasem manganese is also currently being studied in combination with SBRT for its anti-tumor effect in a Phase 1/2 trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, it demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy and Fast Track designations to avasopasem manganese for the reduction of SOM in patients with head and neck cancer.

About Oral Mucositis

Oral mucositis (OM) is a painful and problematic complication during cancer treatment, especially radiation therapy, caused by excessive superoxide generated during treatment that breaks down epithelial cells that line the mouth. Patients suffering from OM experience severe pain, inflammation, ulceration and bleeding of the mouth.

In the United States, more than 50 percent of patients with cancer receive radiotherapy at some time in their treatment. In patients with head and neck cancer, radiotherapy is a mainstay of treatment and approximately 70 percent of patients receiving radiotherapy develop SOM as defined by the World Health Organization as Grade 3 or 4, which is the most debilitating side effect of the radiotherapy.

SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. SOM may also inhibit patients’ ability to eat solid food or even drink liquids, and can cause serious infections. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. There is currently no drug approved to prevent or treat SOM in patients with head and neck cancer.

On October 23, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, reported that the company will present at the NYC Oncology Investor Conference. Immunomic’s Founder and Chief Executive Officer (CEO) William Hearl, Ph.D., will discuss Immunomic’s recently-expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) (Press release, Immunomics, OCT 23, 2018, View Source [SID1234530091]). The uniquely-comprehensive design features of the UNITE platform allow vaccines to broadly activate adaptive immunity, resulting in both humoral and cellular responses. UNITE aims to provide a solution to direct and enhance antigen processing and presentation, which in turn, increases the immunogenicity of nucleic acid vaccines. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics

What: Presentation on UNITE Technology as applied to Oncology

When: Tuesday, October 30 at 3:30 p.m. EDT

Where: Rockefeller Center, 1270 6th Avenue, New York, NY, 10020

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.