On September 20, 2018: ENB Therapeutics Inc., a biopharmaceutical company pioneering pathways in endothelin-based oncologics, reported that it has closed its Series A private equity financing (Press release, ENB Therapeutics, SEP 21, 2018, View Source [SID1234634055]). Proceeds from the financing will be used to advance the company’s lead investigational drug compound, ENB-003,a first-in-class, selective inhibitor of the endothelin B receptor ("ETBR") through pre-clinical and early clinical development for the treatment of immunotherapy-resistant cancers.

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Remiges Ventures served as lead investor for the financing with participation from New York State Development, BioAdvance and Alexandria Ventures.

"We are extremely gratified to have attracted a leading group of investors to complete our Series A financing who recognize the potential of ENB-003 to overcome resistance to immunotherapy across multiple tumor types and indications," said Sumayah Jamal, Founder, President and Chief Scientific Officer of ENB. "We have already demonstrated robust pre-clinical efficacy in relevant mouse models across multiple resistant cancers and a favorable safety profile. We now have the capital necessary to advance ENB-003 into Phase 1 clinical trials during the second half of 2019."

Taro Inaba, Managing Partner at Remiges, added, "We believe that ENB Therapeutics’ novel compounds have the potential to enhance the efficacy of immunotherapies and potentially prolong patient survival and thereby address the high unmet medical need which still exists despite the successful development and widespread use of immunotherapies. Therefore, we are very pleased to have the opportunity to support the continued clinical development of ENB-003, which could improve the lives of patients with cancer."

On September 21, 2018 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (Press release, Oasmia, SEP 21, 2018, View Source [SID1234556569]). The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.

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The CHMP’s positive opinion will now be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.

The CHMP recommendation is based on clinical trials including the pivotal study OAS 07OVA. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after Cremophor EL (CrEL)-formulated paclitaxel in combination with carboplatin.

Key efficacy results in the per protocol population from the pivotal randomized clinical trial OAS-07OVA

Progression-free survival (PFS)
(N=644) Overall survival (OS)
(N=644)
Hazard ratio, HR1
(95% CI) 0.86
(0.72-1.03)
0.95

(0.78-1.16)

Apealea2 CrEL-paclitaxel2 Apealea2 CrEL-paclitaxel2
Median, months
(95% CI) 10.3
(10.1-10.7) 10.1
(9.9-10.2) 25.7
(22.9-28.1) 24.8
(21.7-27.1)

1A longer PFS or OS for Apealea compared to CrEL-formulated paclitaxel is indicated by a HR less than 1.0.
2In combination with carboplatin.

The most frequently reported adverse reactions after Apealea treatment in combination with carboplatin (≥10%) were neutropenia, anorexia, peripheral sensory neuropathy, neuropathy peripheral, diarrhea, nausea, vomiting, alopecia, arthralgia, myalgia, asthenia, fatigue and infusion site reaction.

About epithelial ovarian cancer

Ovarian cancer is the seventh most common cancer in women. Approximately 239,000 women are annually diagnosed with ovarian cancer globally and 152,000 dies from the disease. Epithelial ovarian cancer is the most common form and accounts for about 90% of ovarian cancers. The disease is often diagnosed at an advanced staged since it has no symptoms at early stages. The five-year survival rate (i.e. survival of patients with ovarian cancer compared to survival in the general population at the same age) for ovarian cancer has been estimated to 38% in Europe. During 2018, approximately 68,000 women will be diagnosed with ovarian cancer in Europe and 45,000 are predicted to die from the disease. Carboplatin and paclitaxel are common chemotherapy drugs for treatment of ovarian cancer, and are often used in combination.

About Apealea

Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion.

On September 21, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that XOSPATA Tablets 40 mg (generic name: gilteritinib), a FLT3 (FMS-like tyrosine kinase 3) inhibitor received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML) in Japan (Press release, Astellas, SEP 21, 2018, View Source [SID1234536692]).

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AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year1. XOSPATA has demonstrated inhibitory activity against both internal tandem duplication (ITD) and tyrosine kinase domain (TKD), FLT3 mutations that are seen in approximately one-third of patients with AML.

This approval is based on the CR/CRh2 rate results from the interim analysis of the multinational Phase 3 ADMIRAL study. In October 2015, gilteritinib was designated as one of the first products in Japan to be included in the SAKIGAKE3 designation system. A similar application for approval was filed in the United States in March, 2018 and is currently under review.

With this approval, Astellas hopes to further contribute to the health of patients suffering from AML and to support healthcare professionals involved in the treatment of AML by providing new treatment options.

Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.

On November 21, 2018 Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) reported that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab, a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy (Press release, Kyowa Hakko Kirin, NOV 21, 2018, View Source [SID1234531624]).
MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

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The CHMP’s opinion is now being referred to the European Commission (EC), for a final decision on the grant of a marketing authorisation. This decision is expected by the end of 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

"At Kyowa Kirin we are fully committed to contributing to the health and wellbeing of patients across Europe who are living with mycosis fungoides and Sézary syndrome," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "I am happy about the CHMP’s opinion which takes us one step closer to obtaining an EU marketing authorisation, launching mogamulizumab and to leaping forward to becoming a global specialty pharmaceutical company."

"Mycosis fungoides (MF) and Sézary syndrome (SS) can be disfiguring, debilitating, and even life-threatening, and there are limited treatment options for these rare lymphoma subtypes in Europe today," said Jeffrey S. Humphrey, MD, President of Kyowa Kirin Pharmaceutical Development, Inc. "MAVORIC, the pivotal Phase 3 trial of mogamulizumab, is the largest study of systemic therapy ever conducted in MF and SS. The study showed that mogamulizumab prolonged progression-free survival compared to vorinostat in patients with MF or SS. We will continue to work with the scientific community to advance the understanding of these complex diseases, and we look forward to working with health authorities to bring this important new option to Europe."

If mogamulizumab is approved, Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group company, will be responsible for commercializing mogamulizumab in Europe.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Mogamulizumab Regulatory Status in EU
The EMA’s scientific committee, CHMP adopted a Positive Opinion recommending the approval of the marketing authorisation of mogamulizumab for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. The CHMP’s recommendation is now being referred to the European Commission (EC), which is expected to render its final decision by the end of 2018. The EC typically adheres to the recommendation of the CHMP, but is not obligated to do so.

On October 21, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has commenced an underwritten public offering of its common stock (Press release, Fate Therapeutics, SEP 21, 2018, View Source [SID1234530292]). Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of clinical product candidates and the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock to be sold in the offering will be offered by Fate Therapeutics. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Jefferies, Piper Jaffray, and Wells Fargo Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as a co-manager for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-224680) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC").

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by e-mail at [email protected] or by telephone at (800) 747-3924; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, by email at [email protected] or by telephone at (800) 326-5897.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.