On January 17, 2019 RhoVac AB ("RhoVac") reported today, 17th January 2019, positive interim immune-results on 3- and 6-month’s follow-up testing in their phase I/II clinical study RhoVac-001 in prostate cancer patients (Press release, RhoVac, JAN 17, 2019, View Source [SID1234532778]).

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In the clinical study RhoVac-001 all patients treated are monitored for duration of immune response over a 12-month period following completion of treatment. At this time RhoVac can present interim results after 3- and 6-month’s follow-up analysis. The result show that 18 of 21 of the patients (86%) still have a robust immune response to RV001. In other words, all 18 patients measured as Confirmed Immune Responders following completion of treatment, still show comparable response after 3- and 6-month’s follow-up.

The clinical study RhoVac-001
The study RhoVac-001 (ClinicalTrials.gov identifier: NCT03199872) is a first-in-man trial studying the cancer vaccine RV001. Twenty-two prostatectomised patients were enrolled in the study. The primary endpoint of the study was to evaluate the safety and tolerability of the RV001 cancer vaccine. The primary end-point was met and the results reported in August 2018 confirmed that treatment with RV001 is safe and well tolerated by the prostate cancer patients.

The secondary endpoint was to investigate the RV001-specific immunological response to treatment. The immune response was analysed before -, two time during – and once, one month after completion of treatment. The result reported in August 2018 was that 86% (18 of 21 of the eligible patients) showed a significant immune response to RV001 in the three samples taken during or after treatment. All 18 responding patients also qualified as Confirmed Immune Responders as they showed a significant response in two of the three samples taken during or after treatment. The conclusion on the immune monitoring during treatment was that a vaccine mediated immune response was established following treatment with RV001 and the dose administered in the study was biologically active.

Final results, including 9- and 12 month’s follow-up immunological analysis, is expected to be reported mid-2019.

Comments from RhoVac´s CEO, Anders Ljungqvist
-The interim results at 3- and 6 month’s follow-ups are exciting data and the results confirm that the RV001 mediated immune response is maintained in the patients. Again, the data shows that the response is very consistent over time as already indicated at completion of treatment. The T-cell monitoring group, Department of Immunology at the University of Tübingen, has again performed a timely and dedicated work enabling us to report the interim results as planned. We are now looking forward to completing the follow-up phase and after this, focus on the phase IIb clinical study.

For more information, please contact:
Anders Ljungqvist – CEO, RhoVac AB
Phone: +45 4083 2365
E-mail: [email protected]

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 17th January 2019.

On January 17, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its President and CEO, Peter L. Hoang, will present a corporate overview at the upcoming Phacilitate Leaders World & World Stem Cell Summit 2019 on Wednesday, January 23, 2019 (Press release, Marker Therapeutics, JAN 17, 2019, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=Marker+Therapeutics+to+Present+at+the+Phacilitate+Leaders+World+%26+World+Stem+Cell+Summit+2019 [SID1234532705]).

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Presentation Details

Title: Efficacy without Toxicity: A Multi-Antigen, Non Gene-Modified Therapy That May Address Current CAR-T Limitations
Date: Wednesday, January 23, 2019
Time: 2:20 p.m. EST
Location: Hyatt Regency, Miami, FL

On January 17, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) reported that it has entered into a definitive agreement to sell its portfolio of seven FDA-approved hematology/oncology products to Acrotech Biopharma L.L.C. Acrotech Biopharma is a New Jersey-based wholly-owned subsidiary of Aurobindo Pharma USA Inc (Press release, Spectrum Pharmaceuticals, JAN 17, 2019, View Source [SID1234532706]).

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"This divestiture marks a major strategic shift for Spectrum to ensure laser-focus on novel, oncology drug development and commercialization," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The proceeds generated by the sale will significantly strengthen the financial position of the company, providing the capital to develop and commercialize our two late-stage pipeline assets, and placing us in a solid position to evaluate additional growth opportunities."

The seven products included in the sale are: FUSILEV (levoleucovorin), FOLOTYN (pralatrexate injection), ZEVALIN (ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection), BELEODAQ (belinostat) for injection, EVOMELA (melphalan) for injection, and KHAPZORY (levoleucovorin). The products generated combined sales of $76.4 million during the first nine months of 2018.

"Along with this divestiture, the majority of impacted staff will transition to Acrotech thereby right sizing Spectrum for our development efforts. Additionally, we are retaining a core group of commercial talent to lead the launch of ROLONTIS and poziotinib," added Joe Turgeon.

The Boards of Directors of Spectrum Pharmaceuticals and Aurobindo have both approved the transaction, which is subject to regulatory approvals and expected to close within 90 days. Jefferies LLC is acting as exclusive financial advisor to Spectrum. Paul Hastings LLP is acting as exclusive legal counsel to Spectrum.

Conference call details:

Thursday, January 17, 2019 at 8:30 a.m. Eastern/5:30 a.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2890988
International: (973) 796-5077, Conference ID# 2890988

The conference call will also be webcast live. To access the webcast, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from January 17, 2019 @ 11:30 p.m. ET/8:30 p.m. PT through January 24, 2019, until 11:30 p.m. ET/8:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 2890988
International Replay Dial-In: (404) 537-3406, Conference ID# 2890988

Terms of Purchase and Sale Agreement

Under the terms of the deal, Acrotech will make a $160 million up-front cash payment and up to $140 million in milestones listed below:

Marqibo Milestones

$30 million for FDA Product Approval for MARQIBOwith label indicated for diffuse large B-cell lymphoma
$10 million for FDA Product Approval for MARQIBO for any indication other than the B-Cell Lymphoma Indication, single vial or pediatric ALL
$30 million for Net Sales of MARQIBOduring any trailing twelve (12) month period during the Milestone Period are equal to or greater than $300,000,000
$10 million for Net Sales of MARQIBO during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $400,000,000
Khapzory Milestones

$5 million for Net Sales of KHAPZORY during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $50,000,000
$5 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $150,000,000 at any time during the Milestone Period
$10 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $200,000,000 at any time during the Milestone Period
$15 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $300,000,000 at any time during the Milestone Period
$25 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $400,000,000 at any time during the Milestone Period
The milestone period lasts for five years post the closing of the transaction. KHAPZORY milestones only payable in the event KHAPZORY is assigned a unique J-code

On January 17, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host its 15th annual International Symposium on Melanoma and Other Cutaneous Malignancies Saturday, Feb. 9, at the InterContinental New York Times Square in New York City. This educational conference will be co-chaired by Omid Hamid, M.D., chief of translational research and immunotherapy and director of melanoma therapeutics at The Angeles Clinic and Research Institute and Jeffrey S. Weber, M.D., Ph.D., deputy director of the Perlmutter Cancer Center at New York University Langone Health.

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"We are looking forward to hosting our International Symposium on Melanoma and Other Cutaneous Malignancies once again in New York City," said Phil Talamo, president of PER. "Now in its 15th year, the symposium continues to provide physicians with the tools they need to personalize care for every patient they treat with skin and other cutaneous including some very exciting data in the adjuvant setting."

Throughout the international conference, world-renowned melanoma experts Hamid and Weber, along with distinguished skin cancer specialists, will host several sessions covering topics such as current advances in immunotherapy and targeted therapies, the benefits of regional therapy, how to use predictive and prognostic modeling and how to manage treatment-related adverse events associated with emerging strategies. This symposium will also feature a Medical Crossfire, in which the expert panel will address attendees’ questions and participate in a rigorous debate on pressing issues faced by the skin cancer treatment community.

This highly interactive symposium will also feature a special presentation, "We Are What We Eat: How the Microbiome Influences Responses to Immunotherapy in Cancer," by Thomas F. Gajewski, M.D., Ph.D., AbbVie Foundation professor of cancer immunotherapy at University of Chicago Medicine. Gajewski investigates and develops new treatments for patients with melanoma. He also serves as an editor for Cancer Research and the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

The 15th annual International Symposium on Melanoma and Other Cutaneous Malignancies is a one-day conference, revolutionizing the presentation of emerging therapies and evolving standards of care in the management of patients with melanoma and other skin cancers. Attendees who attend this educational conference will gain insight on the latest strategies for the use of checkpoint inhibitors, current and emerging treatments for the BRAF gene as it affects mutant melanoma, and mitigating treatment-related toxicities with targeted therapy and immunotherapies.

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.

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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.