On November 22, 2018 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Commission has granted an approval of Apealea for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with Carboplatin (Press release, Oasmia, NOV 22, 2018, View Source [SID1234556568]). This approval marks the first approval for a systemic platinum-based paclitaxel combination therapy approved for first relapse of platinum-sensitive epithelial ovarian cancer.

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The European Commission has granted 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.

Today’s milestone for Apealea is an important one for patients in Europe experiencing a relapse of their ovarian cancer disease since this treatment allows a platinum-based treatment option with a high dose paclitaxel free from Cremophor EL (CrEL).

About the OAS-07OVA study

The European Commission decision is based on clinical trials including the pivotal study OAS 07OVA conducted on patients with disease relapse. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after comparator; CrEL-formulated paclitaxel in combination with carboplatin.

Median progression-free survival (PFS) was 10.3 months in the Apealea arm compared to 10.1 months in the comparator arm (HR:0.86; 95% CI: 0.72 – 1.03)
Median overall survival (OS) was 25.7 months in the Apealea arm compared to 24.8 months in the comparator arm (HR:0.95; 95% CI: 0.78 – 1.16)

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 November 22, 2018 CellProtect Nordic Pharmaceuticals AB reported that it has received a 1 MSEK grant from Vinnova, Sweden’s Innovation Agency (Press release, CellProtect Nordic Pharmaceuticals, NOV 22, 2018, View Source [SID1234533265]). The funds will be used to upscale the production of a novel drug candidate CellProtect, an advanced therapy medicinal product (ATMP), for the treatment of multiple myeloma. The project will be conducted in collaboration with Karolinska University Hospital.

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The grant has been provided to CellProtect Nordic Pharmaceuticals AB within the program "Competence Centers; Support for SMEs 2018″. Its aim is to stimulate active and sustainable participation of small and medium size enterprises facilitating growth of the Swedish biologics industry.

Moreover, CellProtect Nordic Pharmaceuticals AB and the Karolinska University Hospital, via the Karolinska Cell Therapy Center (KCC) and its production unit Vecura, are partners of the Vinnova Competence Centre for Advanced BioProduction by Continuous Processing (AdBIOPRO). This key competence centre, focusing on manufacturing of emerging potent therapeutic products, is coordinated by the Royal Institute of Technology in Stockholm, and includes a number of industrial partners.

"We are very grateful for the grant for this important work. Upscaling of the production is an imperative step in order to initiate confirmatory clinical trials with CellProtect in patients with multiple myeloma which is a primary indication for our drug candidate" says Karin Mellström, CEO of CellProtect Nordic Pharmaceuticals AB.

On November 21, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies with the goal of activating a patient’s immune system against cancer through T-cell activation, reported the pricing of an underwritten public offering consisting of 8,000,000 shares of Common Stock together with Warrants to purchase 4,000,000 shares of Common Stock at a combined price to the public of $1.50 (Press release, Heat Biologics, NOV 21, 2018, View Source [SID1234531543]). The gross proceeds to the Company from this offering are expected to be approximately $12,000,000 before deducting underwriting discounts, commissions and other offering expenses. The Warrants will have an exercise price of $1.65, will be exercisable upon issuance and will expire five years from the date of issuance. Heat Biologics, Inc. has granted the underwriter a 45-day option to purchase additional shares of Common Stock and/or additional Warrants to cover over-allotments, if any. The offering is expected to close on November 26, 2018, subject to customary closing conditions.

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A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

CIM Securities, LLC is acting as a financial advisor to Heat Biologics in connection with the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-221201) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the y prospectus supplement and accompanying prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Heat Biologics, Inc. has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Heat Biologics, Inc. and such offering.

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.

On November 21, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the 30th Annual Piper Jaffray Healthcare Conference (Press release, Bicycle Therapeutics, NOV 21, 2018, View Source [SID1234531544]). The presentation will take place at 8:10 a.m. ET on Tuesday, November 27, 2018.

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On November 21, 2018 PellePharm, a late clinical-stage biopharmaceutical company committed to targeting rare dermatologic conditions at their source, reported that Sanuj K. Ravindran, M.D., chief executive officer and president, will present at the Piper Jaffray Healthcare Conference on Tuesday, November 27, at 12:30 p.m. EST in New York (Press release, PellePharm, NOV 21, 2018, View Source [SID1234531545]).

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A live webcast of the presentation can be accessed on the company’s website at www.pellepharm.com. A replay of the webcast will be archived on the PellePharm website for at least two weeks following the presentation.