Athenex to Present Positive Data of Oraxol Clinical Trial in Breast Cancer at the ESMO 2018 Congress

On October 16, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that results of the Oraxol (oral paclitaxel and HM30181A) pharmacokinetics and phase II clinical trial in the treatment of breast cancer patients who failed previous chemotherapies will be presented on October 21, 2018 at a Poster Discussion in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich, Germany (Press release, Athenex, OCT 16, 2018, View Source;p=RssLanding&cat=news&id=2371846 [SID1234529936]).

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This study has completed patient recruitment and encouraging positive efficacy and safety data will be reported. Oraxol was granted the Promising Innovative Medicine Designation by the United Kingdom Medicines and Healthcare Products Regulatory Agency in December 2017.

Details on the Poster Discussion session are listed below.

Title: Oral paclitaxel and HM30181A demonstrate clinical activity in metastatic breast cancer (MBC) patients
Presentation Number: 287PD
Presenter: Ming-Shen Dai (Taipei, TW)
Session Name: Poster Discussion session – Breast cancer, metastatic
Date / Time / Location: October 21, 2018; 9:15 AM – 10:30 AM (local time); ICM – Room 1, ICM München
The Poster presentation at ESMO (Free ESMO Whitepaper) will be available on the ESMO (Free ESMO Whitepaper) website at 12:00 CEST on Friday, October 19, 2018.

Diplomat to Release Third-Quarter 2018 Operating Results, Host Conference Call on Nov. 6

On October 16, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will release its third-quarter 2018 operating results after market close Tuesday, Nov. 6, with a conference call to follow at 5 p.m. ET (Press release, Diplomat Speciality Pharmacy, OCT 16, 2018, View Source [SID1234529937]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participation code 7553049, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.

ICYMI…Immunomic Therapeutics Presents at the 2018 BIO Investor Forum…Watch webcast here

On October 16, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company reported that it will presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18 (Press release, Immunomics, OCT 16, 2018, View Source [SID1234530090]). William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18. William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). 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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A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

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

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

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.. 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.

A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

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

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

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.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2018

On October 16, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 498 million in the third quarter of 2018 compared to USD 317 million in the third quarter of 2017, an increase of 57% (Press release, Genmab, OCT 16, 2018, View Source [SID1234530344]). The 2018 third quarter net sales were USD 318 million in the U.S. and USD 180 million in the rest of the world.

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Johnson & Johnson reported worldwide operational growth (excluding the impact of foreign currency movements) between the two third quarter periods of 60%.The growth was partially offset by a one-time adjustment outside the U.S. related to accruals for retroactive pricing adjustments which negatively impacted this worldwide operational growth by 16 percentage points.

Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer (Press release, US FDA, OCT 16, 2018, View Source,advanced%20or%20metastatic%20breast%20cancer [SID1234613394]). Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

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Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The primary efficacy outcome was progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively (HR 0.54; 95% CI: 0.41, 0.71; p<0.0001).

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.

FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.

The recommended talazoparib dose is 1 mg taken as a single oral daily dose, with or without food.

View full prescribing information for TALZENNA.

FDA granted this application priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.).