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ISA Pharmaceuticals´ Chief Scientific Officer Prof. Cornelis Melief to Present at Keystone Cancer Vaccines Conference

On January 16, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Cornelis Melief will give a talk at the upcoming Keystone Cancer Vaccines Conference in Vancouver, BC, Canada, January 20-24, 2019 (Press release, ISA Pharmaceuticals, JAN 16, 2019, View Source [SID1234532675]).

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The talk titled "Therapeutic HPV16 Vaccination Is Effective as Monotherapy in Pre-Malignant Disease, but Requires Combination Treatment in HPV16-Induced Cancers" is scheduled for Thursday, January 24, 2019, at 17:00 as part of the session "Immune Monitoring of T Cells" (17:00-18-45, Pacific Ballroom).

The data will outline the T cell response to ISA Pharmaceuticals´ therapeutic vaccine ISA101 and the resulting clinical activity. ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer.

Alpine Immune Sciences Announces $25 Million Private Placement

On January 16, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company dedicated to developing innovative treatments for patients suffering from cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to the Company of approximately $25.3 million, before deducting placement agent commissions and other offering expenses (Press release, Alpine Immune Sciences, JAN 16, 2019, View Source [SID1234532670]). The private placement is being led by Decheng Capital with participation from existing investors OrbiMed Advisors, Frazier Healthcare Partners, Alpine BioVentures, and BVF Partners L.P. Effective on the closing of the private placement, the Company expects to appoint Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, to the Alpine Board of Directors.

Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue units representing an aggregate of approximately 4.7 million shares of common stock and warrants to purchase an aggregate of approximately 1.8 million shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock plus a warrant to purchase 0.39 shares of common stock, is $5.37. The warrants to purchase common stock will have a per share exercise price of $12.74 and will be exercisable at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market.

The private placement is expected to close on or about January 18, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to fund development of lead programs ALPN-101 in autoimmune and inflammatory indications and ALPN-202 in cancer.

Piper Jaffray & Co. acted as sole placement agent in the transaction.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Anixa Biosciences to Hold Conference Call to Discuss Outlook for 2019

On January 16, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will hold a conference call on January 24, 2019 at 1:30 p.m. Pacific / 4:30 p.m. Eastern to discuss its plan for 2019, including the commercialization path and timeline for Cchek, its artificial intelligence based cancer diagnostic test, and the clinical path of its CAR-T based ovarian cancer therapeutic program (Press release, Anixa Biosciences, JAN 16, 2019, View Source [SID1234532668]).

"We are pleased with the advances made with both of our programs to date, and are excited about where these programs are headed this year. We believe 2019 will be a transformative year for Anixa and we look forward to sharing our plans on this conference call," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences.

To access the call, please dial (866) 342-8591 five minutes prior to the start time.

European Medicines Agency validates Oasmia Pharmaceutical AB’s application to add efficacy data to the approved Apealea® product information

On January 15, 2019 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Medicines Agency (EMA) has validated a type II variation application to add efficacy data to the Apealea product information (Press release, Oasmia, JAN 15, 2019, View Source [SID1234556566]). Validation of the application confirms that the submission is complete and that the EMA assessment process begins. Based on the EMAs procedural timelines, Oasmia anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of Q1 or beginning of Q2 2019.

The application is based on subpopulation data (n=599) from the OAS-07OVA study and aims to provide treating physicians with efficacy data for Apealea in combination with carboplatin for the approved indication; adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The current efficacy data describes the population in OAS-07OVA that also included patients with several disease relapses (n=789).

About the subpopulation analysis submitted as a type II variation:

The marketing authorisation approval for Apealea in the EEA was based on study OAS 07OVA conducted on 789 randomized patients with disease relapse. The results of the subpopulation analysis of patients experiencing their first relapse were based on 301 patients (Apealea arm) and 298 patients (Comparator arm) being part of the OAS-07OVA study. The results show that there is a statistically significant advantage for Apealea with regards to progression-free survival.

Key efficacy results in patients with their first relapse in the intention-to-treat population from the pivotal randomized clinical trial OAS-07OVA

Progression-free survival (PFS)
(N=301) Overall survival (OS)
(N=298)
Hazard ratio, HR1
(95% CI) 0.80
(0.66-0.97) 0.98
(0.79-1.21)

Apealea2 CrEL-paclitaxel2 Apealea2 CrEL-paclitaxel2
Median, months
(95% CI) 10.3
(10.1-11.1) 10.0
(9.6-10.2) 24.7
(21.9-28.0) 23.4
(20.5-26.7)
1A longer PFS or OS for Apealea compared to Cremophor-EL (CrEL)-formulated paclitaxel is indicated by a HR less than 1.0.
2In combination with carboplatin.

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.

Biomunex Pharmaceuticals signs a licensing agreement with Sanofi for the development of bi- and multi-specific antibodies

On January 15, 2019 Biomunex Pharmaceuticals, a biopharmaceutical company focused on providing immuno-therapeutics through the discovery and development of bi- and multi-specific antibodies, reported that it has entered into a licensing agreement with Sanofi (Press release, BIOMUNEX Pharmaceuticals, JAN 15, 2019, View Source [SID1234554044]). Under the terms of the agreement, Sanofi will have access to Biomunex’ proprietary technology to generate and optimize bi- and multi-specific antibody therapeutics. Sanofi will be solely responsible for the research, development, manufacturing and global commercialization activities. This agreement, the first of its kind for Biomunex, is in line with the company’s business model, which is to establish licensing or collaboration agreements and to become a clinical-stage company in the short term.

Biomunex will receive an initial upfront payment and will be eligible to receive further clinical, regulatory and commercial milestone payments. Further financial details were not disclosed.

"This licensing agreement is a major milestone for Biomunex. It demonstrates the high value of the BiXAb technology and is the starting point for our collaboration strategy with pharmaceutical companies to discover and develop cutting-edge bi- and multi-specific antibodies, giving patients new treatment options," said Pierre-Emmanuel Gerard, MD, founder and CEO of Biomunex. "We believe that the proceeds from this deal, together with the funding round that we expect to finalize in the near future, will help us accelerate the development of Biomunex’ proprietary BiXAb bi- and multi-specific antibody programs in immuno-oncology and other therapeutic areas towards clinical development."

About the BiXAb Platform
Biomunex’ Plug-and-Play BiXAb platform generates next-generation bi- and multi-specific antibodies. This universal modular bi- and multi-specific format enables turnkey formatting of BiXAb from any pair of monospecific monoclonal antibodies as building blocks, with minimal engineering, in a timely and cost-effective manner. BiXAb possesses all the key properties expected of an ideal bi-specific antibody technology (modularity, excellent drug-like properties and manufacturability, multi-specificity potential). This enables Biomunex to develop immuno-oncology drug candidates with high anti-tumor activity demonstrating true synergy on their targets. The BiXAb platform is also suitable to generate innovative bi- and multi-specific antibodies in other therapeutic areas, such as immune-mediated inflammatory and infectious diseases.