On November 7, 2018 IRX Therapeutics, Inc. reported that the company’s assets have been acquired by the newly formed Brooklyn ImmunoTherapeutics LLC. This name reflects the company’s focus on advancing the science of cytokine-based immunotherapy for the treatment of a range of cancers (Press release, Brooklyn ImmunoTherapeutics, NOV 7, 2018, View Source [SID1234531266]).

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"Cytokine-based immunotherapy overcomes immune suppression to activate an immune attack on tumors by upregulating multiple checkpoints and represents an exciting new approach to treating cancer," said Charles Cherington, General Partner and Board Chair of Brooklyn ImmunoTherapeutics. "In a Phase 2A clinical trial, IRX-2, our clinical drug candidate, demonstrated an improvement in progression free survival and overall survival in patients with head and neck squamous cell carcinoma. We believe this unique injectable cytokine mixture amplified from normal donor lymphocytes has the potential to improve patient outcomes both as a single agent and in combination with other anti-cancer agents. We are committed to exploring this potential in a range of solid tumors including breast cancer, cervical and vulvar neoplasms, renal cell carcinoma, hepatocellular carcinoma, gastric and esophageal cancer as well as other solid tumor indications."

A global, multicenter, randomized, double-blind, placebo-controlled Phase 2B clinical trial of IRX-2 (INSPIRE trial, clinicaltrials.gov NCT02609386) in 105 patients with head and neck squamous cell carcinoma has completed enrollment with results expected in mid-2020 (CIN: NCT03267680, Breast: NCT02950259).

On November 7, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first nine months of 2018 on Tuesday, 13 November 2018 (Press release, Evotec, NOV 7, 2018, View Source;announcements/press-releases/p/evotec-ag-to-report-first-nine-month-2018-results-on-13-november-2018-5741 [SID1234530884]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 13 November 2018

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)

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On November 7, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported the appointment of Dr. Richard "Ric" Woodman as Chief Medical Officer and Senior Vice President of Research & Development. Dr. Woodman will report to Dr. Steve Fruchtman, President and former CMO of the Company (Press release, Onconova, NOV 7, 2018, View Source [SID1234530908]).

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Ric Woodman, M.D., served most recently as Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis. In his role, Ric provided strategic medical and scientific leadership for both marketed and development-stage compounds. Previously, Ric served as Franchise Head for Hematology in Global Medical Affairs at Novartis Oncology with global oversight of non-registration clinical programs and has worked on the development and life-cycle management of several compounds including Tasigna, Glivec, Farydak, Rydapt, Odomzo and Kymriah.

Before joining Novartis Oncology, Dr. Woodman was Senior Medical Director with Johnson & Johnson, leading the Oncology franchise at Ortho Biotech Products, LP. Prior to Ortho Biotech, Ric held academic appointments as Professor in the Departments of Medicine and Oncology at the University of Calgary in Canada where he joined the faculty in 1990.

Dr. Woodman completed his hematology/oncology clinical fellowship and postdoctoral research fellowship at Scripps Clinic and Research Institute in the Department of Experimental Medicine.

In his welcome statement, Dr. Steve Fruchtman said, "The addition of Ric to the Onconova leadership team is an exciting boost to our expertise in drug development in malignant hematology and oncology. Ric has a proven track record and expertise in the approval of novel agents that have changed the standard of care in hematology, including an erythropoietic stimulatory agent to promote red cell production by the marrow, a common issue in patients with MDS, as well as agents for CML that have transformed the life expectancy of these patients and the management of CML from a previously lethal disease to a chronic disorder. As a key part of the team, Ric’s expertise will help optimize the development of Rigosertib for patients with unmet medical needs in MDS and cancer."

"I am excited to join Onconova at this advanced stage of development of Rigosertib and other promising pipeline assets," said Dr. Woodman. "The anticipated completion of the INSPIRE trial in higher-risk MDS and advancing the design of a pivotal combination trial of oral rigosertib and azacitidine towards a Special Protocol Assessment (SPA) are positioning the Company for late stage development, which are areas within my experience and expertise. These trials have set a solid foundation for Rigosertib in patients with MDS. While focused on advancing Rigosertib towards regulatory approval for MDS, Onconova has also created additional opportunities for advancement. I am delighted to join my new colleagues at Onconova, and have the opportunity to work with Steve again in advancing new medicines for patients with unmet medical needs."

Onconova is also pleased to announce the hiring of Matthew Parris to the position of Senior Director, Clinical Operations. Matt joined us after leadership roles in Europe and the U.S. at several Biotechnology companies, including, most recently, Inovio, and at Clinical Research Organizations (CROs), including Orion and Pharm-Olam.
Onconova also welcomes David Evans, who joined recently as Associate Director, Regulatory Affairs, after a decade-long successful career at Celgene.

On November 7, 2018 Immunomic Therapeutics Inc. (ITI) Scientist Amit Adhikara reported that it will present at the Society for NeuroOncology 2018 Annual Meeting in New Orleans (Press release, Immunomic Therapeutics, NOV 7, 2018, View Source [SID1234530943]). The presentation will focus on Immunomic’s recently-expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM).

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Immunomic’s technology platform has 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 Immunomic’s platform technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

Details of Immunomic’s poster presentation are below:

Who: Amit Adhikara, Scientist at Immunomic Therapeutics

What: Development of Cytomegalovirus (CMV) Based DNA Vaccines for GBM Using the UNITE Platform

When: Friday, November 16 at 7:30 p.m. CST

Where: Marriott Hotel, 555 Canal Street, New Orleans, LA, 70130

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.

On November 7, 2018 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter ended September 30, 2018 (Press release, Immunomedics, NOV 7, 2018, View Source [SID1234530991]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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The Company has made significant progress in the first fiscal quarter with an ongoing focus on regulatory, clinical, manufacturing and launch preparatory efforts and will continue to work closely and collaboratively with the FDA to address outstanding review issues in connection with our Biologics License Application for sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC).

"Patients with mTNBC are in dire need of better treatment options," said Michael Pehl, President and Chief Executive Officer of Immunomedics. "Our entire team is dedicated to bringing sacituzumab govitecan, with its highly differentiated benefit/risk profile, to these patients and focused on a potential marketing approval by the PDUFA date of January 18, 2019. We are well underway with commercial launch preparations, including the official onboarding of the salesforce this week, while we continue to expand our manufacturing collaborations and clinical plans to reflect our long-term commitment to cover multiple underserved indications and expanded geographies in the future."

Highlights of Recent Progress

The Company has entered into a long-term manufacturing partnership with Samsung BioLogics Co., Ltd as our second source manufacturer of hRS7, the antibody used in sacituzumab govitecan, to further enhance our supply chain and prepare for future demand driven by additional indications and broadening of our geographic footprint.

The Company has recruited and is in the process of training fifty highly-qualified sales representatives, all of whom have experience in the breast cancer field. In addition, the commercial leadership team across marketing, sales, sales operations, and market access is now fully staffed.

The Company has broadened its ongoing clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, on the development of the combination of durvalumab and sacituzumab govitecan to include second-line metastatic non-small cell lung cancer (NSCLC), leveraging AstraZeneca’s existing development infrastructure.
First Quarter Fiscal 2019 Results
The Company had no revenues in the three-month period ended September 30, 2018 due primarily to the discontinued sale of LeukoScan during the third quarter of fiscal 2018 in order for the Company to focus on its ADC business. Revenues in the three-month period ended September 30, 2017 were approximately $0.7 million.

Total costs and expenses were $57.2 million for the three months ended September 30, 2018, compared to $22.3 million for the three months ended September 30, 2017, due primarily to a $20.9 million increase in research and development expenses, a $8.5 million increase in general and administrative expenses, and a $5.6 million increase in sales and marketing expenses. Most of these increases were attributable to activities related to preparations for the potential approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States.

The Company recognized $1.2 million in non-cash income for the three months ended September 30, 2018, compared to $86.4 million in non-cash expense for the three months ended September 30, 2017. The decrease in expense was due primarily to the exercise of warrants, partially offset by an increase in the fair market value of warrants outstanding. Interest expense was $10.1 million for the three months ended September 30, 2018, compared to $2.6 million for the three months ended September 30, 2017. The increase was due primarily to increased debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $64.2 million, or $0.34 per share, for the three months ended September 30, 2018, compared to $118.7 million, or $0.97 per share, for the same quarter in fiscal 2018.

As of September 30, 2018, the Company had $585.5 million in cash, cash equivalents, and marketable securities, which it believes is sufficient to support its next phase of growth; further build its clinical, medical affairs, commercial, and manufacturing infrastructure; begin its effort to commercialize sacituzumab govitecan globally; and fund its operations into 2021.

Balance Sheet
On October 5, 2018, Immunomedics completed the exchange of approximately $12.9 million in aggregate principal amount of its 4.75% Convertible Senior Notes due 2020 (Convertible Senior Notes) for newly issued shares of the Company’s common stock, pursuant to privately negotiated exchange agreements entered into between the Company and a limited number of holders of the Convertible Senior Notes. The remaining aggregate principal amount of the Convertible Senior Notes is approximately $7.1 million.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the first quarter fiscal 2019 and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1568527. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.