On March 25, 2019 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a type II variation application to add efficacy data to the Apealea product information (Press release, Oasmia, MAR 25, 2019, View Source [SID1234556567]).

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The marketing authorisation approval for Apealea in the EEA was based on the phase III pivotal study OAS‑07OVA. The study was conducted on 789 randomized patients with relapse of ovarian cancer disease that were treated with paclitaxel in combination with carboplatin. The results of the subpopulation analysis of the patients corresponding to the approved indication, i.e patients experiencing their first relapse, were based on 301 patients (Apealea arm) and 298 patients (Comparator arm).

The positive opinion of the application allows the product information to present all available efficacy data for Apealea for the approved indication in addition to the data describing the entire population. This change may be implemented after completion of the review process of the translation into all EU languages (and Norwegian and Icelandic) by the end of April 2019.

– This provides complete transparency to the physicians, as well as patients, regarding differences in efficacy between Apealea and solvent-based paclitaxel, says Mikael Asp, CEO

Information on subgroup analysis by relapse:

Subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the per protocol (PP) and the intention-to-treat (ITT) populations. Progression free survival (PFS) and overall survival (OS) results in the PP population are presented in the tables below. In the intention-to-treat population, the hazard ratios (HR) for PFS in the subgroups of patients with first relapse and second relapse were 0.80 (95% confidence interval (CI): 0.66;0.97) and 1.04 (95% CI: 0.74;1.47), respectively. The hazard ratios for OS in patients with first and second relapse were 0.98 (95% CI: 0.79;1.21) and 1.18 (95% CI: 0.79;1.75), respectively. Thus, the results in the subgroup of patients with first relapse are consistent with the results in the overall population and in addition, there was an indication of PFS benefit for Apealea.

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 March 25, 2019 ExCellThera Inc., a clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that its lead technology, ECT-001, will be used as part of two new clinical trials in patients with high-risk leukemia (Press release, ExCellThera, MAR 25, 2019, View Source [SID1234535179]). The announcement follows the recent clearance of the company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and of a clinical trial application by Health Canada, in each case for the use of ECT-001 to treat patients with high-risk leukemia and myelodysplasia. The US-based study will be conducted at the Fred Hutchinson Cancer Centre in Seattle, Washington, with the Canadian study principally taking place at the Hôpital Maisonneuve-Rosemont in Montreal, Quebec.

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Leukemia is a cancer that begins in blood stem cells and can develop very quickly. It results in the over-production of abnormal cells, which crowd out healthy blood cells and leave the patient tired, short of breath and prone to bleeding, bruising and infection. Current treatment may include chemotherapy, radiation and a hematopoietic (blood) stem cell transplant.

"Blood stem cell transplants present a life-saving option for some patients; however, they can lead to life-threatening complications," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "ECT-001 expanded blood transplants are reengineered grafts with higher quantities of stem and immune cells. Our clinical data thus far show the grafts greatly reduce the risks of post-transplant complications, including chronic graft-versus-host-disease, infection and disease relapse, resulting in better overall well-being for patients."

The two new studies are designed to be complementary and will each enrol up to 20 patients, representing geographically distinct populations. Primary endpoints include relapse free survival and incidence of transplant related mortality. Secondary endpoints include graft-versus-host disease and other infectious complications.

ExCellThera plans to initiate additional trials, including a Phase III pivotal trial in the United States and Canada, in the coming months. In December 2018, ECT-001 received FDA orphan drug designation for the prevention of graft-versus-host disease.

About ECT-001
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative blood transplant therapies for patients with blood cancers, allowing more rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.

On March 25, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, reported that details on the presentation of data from five studies supporting the company’s lead drug candidate, AsiDNA, in poster sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019, in Atlanta, GA, USA (Press release, Onxeo, MAR 25, 2019, View Source [SID1234534652]).

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Françoise Bono, PhD, Chief Scientific Officer, commented: "We are very pleased to have five studies accepted and presented at the prominent AACR (Free AACR Whitepaper) meeting as it reflects the interest, the quality and the diversity of our current translational research on AsiDNA. Through these data, we further demonstrate the uniqueness of our lead compound in terms of mechanism of action and its related unique properties, especially on preventing the occurrence of resistance to treatment, one of the major issues in oncology today. All these data complement and reinforce our rationale for the continued clinical development of AsiDNA expected to start in the coming weeks, now that we have identified the active doses that trigger target engagement and confirmed the favorable safety profile in our phase I DRIIV study. We look forward to presenting and discussing our very exciting findings during the conference."

On March 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the closing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 25, 2019, View Source [SID1234534633]).

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Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering.

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

Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter exercised its option to purchase the short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock effective as of the closing.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016, and additional registration statement filed pursuant to Rule 462(b) (File No. 333-230422). A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained 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 any of the Company’s securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction

On March 25, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into an agreement with funds managed by Oberland Capital Management, LLC ("Oberland Capital") for up to $135.7 million in exchange for selling rights to a portion of royalty revenues on worldwide net sales of Erivedge (Press release, Curis, MAR 25, 2019, View Source [SID1234534632]).

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Under the terms of the agreement, Curis received $65.0 million in an upfront cash payment, plus Curis is entitled to receive up to an additional $70.7 million in milestone payments if future net royalties exceed pre-defined annual and cumulative thresholds. Oberland Capital will receive 100% of the first $13.2 million and 35% thereafter of annual net royalties due to Curis from worldwide net sales of Erivedge, excluding a portion of non-US royalties retained by Curis. At the closing of the transaction, Curis used a portion of the sale proceeds to retire existing debt, with remaining proceeds of approximately $30 million, excluding closing costs and related transaction fees, to be used to fund its operations.

James Dentzer, President & CEO of Curis, commented, "We are pleased to announce this agreement with Oberland Capital. We believe this structure provides Curis with substantial non-dilutive capital today, while retaining significant participation in the future upside potential of Erivedge. The proceeds of this transaction further strengthen our cash position as we fund our three lead therapeutic candidates to reach their near term development catalysts and beyond."

"Erivedge is an attractive asset commercialized by a world-class marketer and we are pleased to partner with Curis as it advances its clinical pipeline" said Andrew Rubinstein, Managing Partner of Oberland Capital. "Acquiring a participation in Erivedge royalties reflects our strategy of investing in commercial stage or near-commercial stage biopharmaceutical products that address serious diseases or areas of high unmet medical need."

About Erivedge
Erivedge (vismodegib) is a first-in-class orally-administered small molecule which is designed to selectively inhibit the Hedgehog signaling pathway by targeting a protein called Smoothened. Genetic mutations that lead to unregulated activation of Hedgehog signaling are found in basal cell carcinoma (BCC) and medulloblastomas. Aberrant signaling in the Hedgehog pathway is implicated in over 90% of BCC cases. Erivedge is being developed and commercialized by Roche and Genentech under a 2003 collaboration agreement between Curis and Genentech whereby Genentech obtained an exclusive, global, royalty-bearing license with the right to sublicense, to make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy. Erivedge is approved for use in patients with advanced basal cell carcinoma in the U.S. and over 60 foreign countries. It is also under regulatory review for commercialization in a number of additional territories.