On October 10, 2018 Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan1 (rituximab) for the treatment of adult patients in three proposed indications (Press release, Celltrion, OCT 10, 2018, View Source [SID1234529850]). The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

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The FDA will take the Committee’s recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed Rituxan biosimilar.

The Committee based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development program for CT-P10 demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications.

"We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications," said Woosung Kee, Chief Executive Officer of Celltrion. "The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients."

"If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience," said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. "We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems."

Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize CT-P10 in the U.S. and Canada.

1 Rituxan is a registered trademark of Biogen and Genentech USA, Inc.

About CT-P10

Celltrion’s CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.’s Rituxan, is currently approved in 47 countries across the globe. CT-P10 is the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and was first launched in Europe in 2017. The active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells.

On October 10, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that China’s State Medical Insurance Administration (SMIA) has included VIDAZA (azacitidine for injection) on its national reimbursement drug list (NRDL) (Press release, BeiGene, OCT 10, 2018, View Source;p=RssLanding&cat=news&id=2370979 [SID1234530257]). VIDAZA is a nucleoside metabolic inhibitor and was approved in China for patients with intermediate-2 / high-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML). It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

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"VIDAZA became commercially available in China in February and is the only approved hypomethylating agent shown to prolong survival for patients with MDS. With this national reimbursement coverage, we expect more patients to have an opportunity to benefit from VIDAZA in China," commented Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd. "BeiGene is committed to improving patient access to high-quality, innovative cancer treatments."

VIDAZA is recommended by National Comprehensive Cancer Network (NCCN) Guidelines in the US as a front-line treatment. In a global Phase 3 trial (AZA-001) involving intermediate-2 and high-risk MDS patients, VIDAZA significantly prolonged the median overall survival to 24.5 months compared with 15 months for the conventional care regimens (CCR- best supportive care, low-dose cytarabine or intensive chemotherapy) group. In the VIDAZA group, 45% of patients who were dependent on red blood cell transfusions at baseline became transfusion independent compared with 11% in the CCR group.There was a higher objective response rate among patients treated with VIDAZA (49%) as compared to the CCR arm (29%). VIDAZA also delayed the onset of AML for these patients (17.8 months vs.11.5 months). The most common grade 3-4 events were peripheral blood cytopenias for all treatments.

"We are pleased that patients in China will have improved access to VIDAZA and other cancer treatments listed on the 2018 NRDL," said Professor Wang Jianxiang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences. "VIDAZA is an important treatment for MDS with demonstrated survival benefit. The broadening access to new treatments like VIDAZA could significantly improve the care of our patients."

About Myelodysplastic Syndrome, Acute Myeloid Leukemia and Chronic Myelomonocyte Leukemia

MDS is a group of conditions that can occur when the bloodforming cells in the bone marrow become abnormal. This leads to low numbers of one or more types of blood cells. In about one-third of patients with MDS, the disease can progress to a rapidly growing cancer of bone marrow cells called AML.i CMML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood; it affects mainly older adults. CMML has features of both MDS and myeloproliferative disorder and is considered the most common disease among myelodysplastic/myeloproliferative diseases.ii

About VIDAZA (Azacitidine for Injection)

VIDAZA is a nucleoside metabolic inhibitor indicated in China for the treatment of patients with intermediate-2 / high-risk MDS, AML with 20-30% bone marrow blasts and CMML. It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

In the US, VIDAZA is indicated for the treatment of patients with the following FAB MDS subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML.

Important Safety Information

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.

In Study 1 (a randomized, open-label, controlled trial carried out in 53 U.S. sites compared the safety and efficacy of subcutaneous VIDAZA plus supportive care with supportive care alone ("observation") in patients with any of the five FAB subtypes of myelodysplastic syndromes (MDS)) and Study 2 (a multi-center, open-label, single-arm study of 72 patients with RAEB, RAEB-T, CMMoL, or AML), most frequently observed adverse reactions occurring in at least 5% of patients by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).

In Study 4 (the AZA-001 survival trial, an international, multicenter, open-label, randomized trial in MDS patients with RAEB, RAEB-T or modified CMMoL according to FAB classification and Intermediate-2 and High risk according to IPSS classification), most frequently observed adverse reactions occurring in at least 5% of patients were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most frequently observed adverse reactions in the percentage with NCI CTC Grade 3/4 reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%), and febrile neutropenia (12.6%).

Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and/or toxicity, but at a minimum, prior to each dosing cycle.

Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

VIDAZA may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to avoid pregnancy during treatment with VIDAZA. Males with female sexual partners of reproductive potential should not father a child and should use effective contraception during treatment with VIDAZA.

The importance of the drug to the mother should be taken into consideration before the breastfeeding mothers decide to discontinue breastfeeding or the drug.

On October 10, 2018 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T(AlloCAR T) therapies for cancer, reported the pricing of its initial public offering of 18,000,000 shares of its common stock at a price to the public of $18.00 per share (Press release, Allogene, OCT 10, 2018, View Source [SID1234529851]). The gross proceeds to Allogene Therapeutics from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $324.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 11, 2018 under the symbol "ALLO." The offering is expected to close on October 15, 2018, subject to customary closing conditions. In addition, Allogene Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 2,700,000 shares of common stock.

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Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC are acting as the joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or via telephone: 1-866-471-2526, or via email: [email protected]; or
J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or via telephone: 1-866-803-9204; or
Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or via email: [email protected]; or
Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or via telephone: 1-877-547-6340, or via email: [email protected].
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 10, 2018. This press release shall not constitute an offer to sell or a 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.

On October 9, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its PCT patent application covering a targeted therapy to treat solid cancerous tumors was published on September 27, 2018 (Publication No. WO 2018/175576) (Press release, PharmaCyte Biotech, OCT 9, 2018, View Source [SID1234529817]). It was titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof." This PCT application allows PharmaCyte to file patent applications and seek protection in most major market countries throughout the world. These patent applications, if granted, will provide protection for PharmaCyte’s technology for 20 years without a gap in patent protection – until March 2038.

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Kenneth L. Waggoner, PharmaCyte Biotech’s Chief Executive Officer, commented "The publication of this PCT patent application is a significant step in being able to protect our unique cancer therapy for many years to come. It is particularly important now as we get closer to beginning our clinical trial in patients with locally advanced pancreatic cancer (LAPC). However, in addition to pancreatic cancer, the Cell-in-a-Box live cell encapsulation technology also gives us opportunities to develop unique therapies for other forms of cancer where new treatment modalities are needed."

The PCT application also specifically includes methods of treating other cancerous tumors, such as those of the liver, breast and colon, using the live-cell encapsulation of genetically modified human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver. These cells are encapsulated using the proprietary Cell-in-a-Box technology. Together with low doses of a drug of the oxazaphosphorine class, ifosfamide, the encapsulated cells comprise PharmaCyte’s therapy for pancreatic cancer. The patent application also includes using PharmaCyte’s platform technology with cyclophosphamide, another chemotherapy drug of the oxazaphosphorine class that is activated by the cytochrome P450 enzyme system. In the case of pancreatic cancer, it is hoped that the Cell-in-a-Box plus low dose ifosfamide combination will be beneficial to patients whose pancreatic tumors become resistant to standard chemotherapies such as the combination of the anticancer drugs gemcitabine and Abraxane or FOLFIRINOX. The use of Cell-in-a-Box encapsulation with other drugs against other forms of cancer remains to be investigated.

The PCT patent application originated from a provisional patent application by the same title that was filed with the U.S. Patent and Trademark Office (USPTO) on March 21, 2017 and a patent application by the same title that was filed with the USPTO on March 21, 2018.

On October 9, 2018 BerGenBio ASA (OSE:BGBIO) reported that the company and its collaborators will present interim clinical and biomarker data from its Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich (19 – 23 October 2018) (Press release, BerGenBio, OCT 9, 2018, View Source [SID1234529835]).

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Pre-clinical data on the role of AXL inhibition in Myelodysplastic Syndrome (MDS) will also be presented. Details of the presentations are below.

The posters will be made available at www.bergenbio.com in the Investors / Presentations section at the time of presentation and full abstracts will be made available online according to ESMO (Free ESMO Whitepaper)’s embargo schedule: View Source

Poster presentations at ESMO (Free ESMO Whitepaper):
Sunday 21 October, 11:15 – 12:15, Hall B3 – Room 21

Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials
Robert Holt, PhD et al
Poster Discussion session – Translational research 2
Invited discussant: 11:15 – 11:45
Presentation number: 63PD
Sunday 21 October, 12:45 – 13:45, Hall A3 – Poster Area

Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma
Cornelia Schuster, MD, PhD et al
Poster display session – Melanoma and other skin tumours
Presentation number: 1266P
Sunday 21 October, 16:30 – 17:45, Hall B3 – Room 21

The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS
Hind Medyouf, PhD et al
Poster Discussion session – Haematological malignancies
Invited discussant: 16:30 – 16:55
Presentation number: 1009PD
END

About the ESMO (Free ESMO Whitepaper) Congress
The ESMO (Free ESMO Whitepaper) Congress is the leading European meeting for medical oncology convening over 20,000 international delegates from the field. ESMO (Free ESMO Whitepaper) 2018 will be held in Munich, Germany 19-23 October 2018.