On January 9, 2019 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 target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule (Press release, Athenex, JAN 9, 2019, View Source;p=RssLanding&cat=news&id=2382773 [SID1234532606]). Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.

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About Oraxol Phase III Study

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol Phase III study is an open-label, randomized, multicenter study to determine the safety, tolerability, and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer, with a target enrollment of 360 adult female patients. Secondary endpoints will measure progression-free survival and overall survival. More information about this study is available at www.clinicaltrials.gov.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi

On January 9, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported that its Board of Directors has appointed Brian Barnett, M.D., as Chief Executive Officer (Press release, Oncbiomune, JAN 9, 2019, View Source [SID1234532611]).

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Prior to joining the Company, Dr. Barnett served at Puma Biotechnology, Inc. since August 2016 ("Puma") most recently as a Vice President and Head of Medical Affairs. Prior to his time with Puma, Dr. Barnett was with Genentech, Inc., a subsidiary of Roche, from October 2012 to August 2016 and served as Medical Director, Kadcyla (T-DM1), Global Product Development Oncology and U.S. Medical Affairs. Prior to his appointment as CEO, Dr. Barnett was a member of the Company’s Scientific Advisory Board. Dr. Barnett received his B.S. from Millsaps College, M.D. from the University of Mississippi Medical Center, and completed his Medical Oncology Fellowship at Tulane University in New Orleans.

Dr. Barnett succeeds Dr. Jonathan Head as Chief Executive Officer at OncBioMune. Dr. Head will continue to serve the Company as the Chairman of the Board of Directors and now as its Chief Scientific Officer.

"It has long been our strategy to advance ProscaVax into mid-stage clinical trials for prostate cancer and find my successor from big pharma to lead our continued growth and pipeline development," commented Dr. Head. "Dr. Barnett was a natural choice given his experience at Puma and Genentech and understanding of our pipeline through his time as an advisor to the Company. I am confident that the Company is going to benefit from Dr. Barnett’s passion for drug development, business savvy and industry connections and I am thrilled to introduce him as our new CEO."

"I am excited and honored to take this opportunity to lead OncBioMune and spearhead development of our pipeline of exceptional drug candidates," said Dr. Barnett. "As an oncologist and as I’ve gotten to know the company more intimately, I see the opportunities that are presented with ProscaVax, the platform vaccine technology and our patented targeted transferrin transport technology. As we move forward with the Phase 2 trials of ProscaVax, I intend to focus on and expedite development of the transferrin technology simultaneously. This is an underappreciated part of our pipeline that I believe can possibly help cancer patients by addressing an unmet need and will resonate potentially as a tumor-agnostic, biomarker-directed and targeted approach to cancer therapy."

As previously announced, OncBioMune intended to host a shareholder call in December. With change in leadership, the company is rescheduling the call for later this quarter to give Dr. Barnett some time to get acclimated to his new position.

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On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $0.225 per share (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532612]). Cancer Genetics also granted the underwriter a 45-day option to purchase up to an additional 2,000,000 shares of its common stock at the public offering price of $0.225 per share, less underwriting discounts and commissions. Cancer Genetics expects to receive aggregate gross proceeds of approximately $3.0 million from the offering, assuming no exercise of the underwriter’s option to purchase additional shares. The offering is expected to close on or about January 14, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from the offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements it is negotiating with its banks, to pay certain costs previously incurred by it in connection with its terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 8, 2019 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, requesting conditional approval for the treatment of patients with relapsed or refractory multiple myeloma (MM) who have received at least three prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody (mAb), and to their most recent treatment regimen (penta-refractory MM) (Press release, Karyopharm, JAN 8, 2019, View Source [SID1234532591]). Karyopharm also announced that the selinexor MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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"The MAA submission for selinexor is an important milestone for Karyopharm and the CHMP’s granting of accelerated assessment further underscores the urgent need to improve outcomes for patients with highly refractory multiple myeloma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The results from the pivotal Phase 2b STORM study provide compelling evidence that selinexor in combination with low-dose dexamethasone has the potential to be an effective new treatment option for patients with this difficult to treat disease. With the filing of the MAA and an accelerated assessment designation from the EMA, we hope to make oral selinexor available as quickly as possible to patients throughout Europe."

An accelerated assessment is granted to products deemed by the CHMP to be of major interest for public health and represent therapeutic innovation. Accelerated assessments can reduce the active review time of an MAA from the standard 210 days down to 150 days once it has been validated by the EMA. Selinexor has also previously received orphan designation in multiple myeloma from the EMA.

A New Drug Application (NDA) seeking accelerated approval for oral selinexor with low dose dexamethasone as a treatment for patients with penta-refractory multiple myeloma is under Priority Review by the U.S. Food and Drug Administration (FDA) with an action date of April 6, 2019, under the Prescription Drug User-Fee Act (PDUFA).

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. In 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with penta-refractory multiple myeloma. The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval and was granted accelerated assessment. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On January 8, 2019 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it received a manufacturing and marketing approval of Demser (metyrosine) Capsule 250 mg ("Demser"), a tyrosine hydroxylase inhibitor, in Japan for the improvement of status of catecholamine excess secretion in patients with pheochromocytoma (Press release, Ono, JAN 8, 2019, View Source [SID1234605553]). Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan*. Catecholamine excessively secreted from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation, including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there are many cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia. Demser inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely secreted from PC, and alleviates symptoms due to catecholamine excess secretion. Demser is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs. Demser is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW), and ONO has been developing this product. In May 2015, the product was designated for the orphan drug by the MHLW. ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the treatment of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC, an affiliate of Valeant Pharmaceuticals International, Inc. (In July 2018, the company name was changed to Bausch Health Companies Inc., "Bausch Health"). In the US, Bausch Health markets the product under the tradename of "Demser" in the indication of PC. *: "Actual condition survey and preparation of medical guideline of pheochromocytoma" Research Report 2009, Research Project on Overcoming Intractable Diseases Project being conducted by the Ministry of Health, Labour and Welfare Overview of Demser Capsule 250 mg Product Name Demser Capsule 250 mg Generic name (JAN) Metyrosine Indication Improvement of status of catecholamine excess secretion in patients with pheochromocytoma Dosage and administration Usually, for adults and children 12 years of age and older, start to administer 500 mg of metyrosine orally daily. When the effect is insufficient, titrate the dose by 250 mg or 500 mg daily at intervals of 3 days or more by monitoring the clinical course closely, and dosage should be adjusted under adequate observation of urinary catecholamine amount and symptoms of the patient. However, the maximum daily dose is 4,000 mg with the highest dose of 1,000 mg per dose at intervals of 4 hours or longer. The daily dose of 500 mg is divided twice a day, 750 mg three times a day and 1,000 mg four times a day. Manufacturer/distributor Ono Pharmaceutical Co., Ltd. Approval date January 8, 2019 Conditions for approval 1. Risk Management Plan should be designed appropriately implemented. 2. Because of the very limited number of patients treated with the product in Japanese clinical trials, a post-marketing use-results survey covering all cases should be performed until data on a certain minimum number of patients have been accumulated. Through these activities, actions necessary to ensure the proper use of the product should be taken by identifying the characteristics of patients to be treated with the product and collecting safety and efficacy data as soon as possible.

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