On January 5, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD), a leading immuno-oncology company, reported that it has entered into a new collaboration agreement with Japan’s CYTLIMIC, a recent spin off from NEC Corporation (NEC), to test a cancer peptide vaccine in combination with IMP321 (Press release, Prima Biomed, JAN 5, 2017, View Source [SID1234517309]).

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Under the new Material Transfer Agreement (MTA) Prima will provide IMP321 for a formulation development targeting a new pre-clinical and clinical development study to be conducted by CYTLIMIC. The development will be funded by CYTLIMIC and the MTA will be revenue generating for Prima.

Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: "When IMP321 is used as an adjuvant to a cancer vaccine to boost tumour-specific CD8 T cells, it is used at a very low dose to get a local effect at the vaccine injection site. The use of IMP321 as an adjuvant to a vaccine is therefore different from Prima’s other combination approaches where higher doses are used to boost Antigen Presenting Cells (APCs) in the whole body. It is very encouraging that CYTLIMIC has committed further resources to this exciting research, based on several positive published studies using IMP321 as an adjuvant to cancer vaccines."

CYTLIMIC’s President and Chief Executive Officer, Dr Shun Doi, said: "I am pleased with the progress to enter into this collaboration with Prima BioMed, which follows the successful research collaboration among NEC Corporation, Yamaguchi University and Prima
BioMed, to realize an innovative peptide vaccine for cancer immunotherapy."

In May 2015 Prima entered into a collaboration agreement with NEC to supply IMP321 for a pre-clinical study investigating IMP321 in combination with a therapeutic vaccine for different carcinoma types, to be developed at Yamaguchi University. Pre-clinical work demonstrated that low dose IMP321 co-injected with a peptide vaccine is safe. This resulted in a decision to progress to clinical development and now the foundation of CYTLIMIC by NEC, together with leading Japan-based venture capital firms.

About CYTLIMIC
CYTLIMIC, a recent spin off from NEC Corporation (NEC), is a biotechnology company developing immunotherapy products for the treatment of cancer, including a cancer peptide vaccine in combination with IMP321. CYTLIMIC’s products aim to activate immune systems to attack cancer cells while enabling patients to maintain a high quality-of-life during treatment.
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About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.

On January 5, 2017 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) ("OncoGenex"), a publicly held oncology biopharmaceutical company, and Achieve Life Science, Inc. ("Achieve"), a privately held specialty pharmaceutical company, reported that they have entered into a definitive merger agreement under which OncoGenex will acquire Achieve in an all-stock transaction (Press release, OncoGenex Pharmaceuticals, JAN 5, 2017, View Source [SID1234517294]).

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Upon completion of the proposed merger, Achieve’s equity holders are expected to own 75% of the combined company’s outstanding shares and current stockholders of OncoGenex are expected to own the remaining 25% of the combined company’s outstanding shares. Following completion of the merger, OncoGenex Pharmaceuticals, Inc. will be renamed Achieve Life Sciences, Inc.

In addition, prior to the completion of the proposed merger, OncoGenex is expected to distribute to its stockholders contingent value rights (CVRs) for 80% of any net proceeds of certain payments arising from a future sale, transfer, license or similar transaction involving OncoGenex’s apatorsen oncology product candidate.

The combined company’s executive management team will be led by Rick Stewart, Chairman of Achieve; Anthony Clarke, Chief Scientific Officer of Achieve; John Bencich, Chief Financial Officer of OncoGenex; and Cindy Jacobs, Chief Medical Officer of OncoGenex. The combined company plans to utilize select clinical and corporate resources from OncoGenex’s existing operations to accelerate the clinical development program of cytisine for smoking cessation. The board of directors of the combined company is expected to consist of seven members, four of which will be designated by Achieve and three of which will be designated by OncoGenex.

The proposed merger will create a clinical-stage company focused on clinical and commercial development of cytisine, a selective nicotine receptor partial agonist currently in late-stage development for smoking cessation. Two recent Phase 3 trials in over 2,000 patients using cytisine as a smoking cessation aid have been completed, with positive results published in the New England Journal of Medicine. In total, over 10,000 individuals have now participated in clinical trials evaluating cytisine. The product is currently marketed by a third party in Central and Eastern Europe and is believed to have treated in excess of 20 million patients.

In addition to cytisine, the combined company’s pipeline will also include apatorsen (OGX-427), a once-weekly intravenous drug designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance. Positive Phase 2 results were recently reported following final analysis of the Borealis-2 trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (HR=.80; 95% CI: 0.65-0.98; p=0.078). Efforts will continue to establish a strategic partnership to further the development of apatorsen.

"After extensive and thorough review of strategic alternatives, we are very pleased to announce this proposed merger with Achieve as it adds both immediate and long-term product opportunities in indications with significant patient need and commercial opportunity," said Scott Cormack, President and CEO of OncoGenex. "With cytisine in late-stage development for smoking cessation and having a defined regulatory path with FDA, we believe the proposed merger provides our stockholders with an opportunity to realize value from their investment in OncoGenex."

Rick Stewart, Chairman of Achieve, added, "Achieve is expecting to meet a number of significant clinical and regulatory milestones within the next 12-18 months culminating in a final, large-scale Phase 3 clinical trial. The merger of OncoGenex and Achieve provides additional clinical and corporate resources to meet those milestones."

The transaction has been approved unanimously by the boards of directors of both companies. The proposed merger is expected to close by mid-2017, subject to customary closing conditions.

MTS Health Partners is acting as exclusive financial advisor to OncoGenex and Fenwick & West LLP is acting as legal counsel. Paul Hastings LLP is acting as legal counsel to Achieve.

Important Additional Information about the Proposed Merger

This communication is being made in respect of the proposed merger involving OncoGenex Pharmaceuticals, Inc. and Achieve Life Science, Inc. OncoGenex will file with the Securities and Exchange Commission, or SEC, a current report on Form 8-K, which will include the merger agreement and related documents. In addition, OncoGenex intends to file a registration statement on Form S-4 with the SEC, which will contain a joint proxy statement/prospectus and other relevant materials, and plans to file with the SEC other documents regarding the proposed transaction. The final joint proxy statement/prospectus will be sent to the stockholders of OncoGenex and Achieve. The joint proxy statement/prospectus will contain information about OncoGenex, Achieve, the proposed merger, and related matters. STOCKHOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS) AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE MERGER AND RELATED MATTERS. In addition to receiving the joint proxy statement/prospectus and proxy card by mail, stockholders will also be able to obtain the joint proxy statement/prospectus, as well as other filings containing information about OncoGenex, without charge, from the SEC’s website (View Source) or, without charge, by directing a written request to: OncoGenex Pharmaceuticals, Inc., 19820 North Creek Parkway, Suite 201, Bothell, WA 98011, Attention: Investor Relations or to Achieve Life Science, Inc., 30 Sunnyside Avenue, Mill Valley, CA 94941, Attention: Rick Stewart.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in Solicitation
OncoGenex and its executive officers and directors may be deemed to be participants in the solicitation of proxies from OncoGenex’s stockholders with respect to the matters relating to the proposed merger. Achieve and its officers and directors may also be deemed a participant in such solicitation. Information regarding OncoGenex’s executive officers and directors is available in OncoGenex’s proxy statement on Schedule 14A, filed with the SEC on April 21, 2016. Information regarding any interest that OncoGenex, Achieve or any of the executive officers or directors of OncoGenex or Achieve may have in the transaction with Achieve will be set forth in the joint proxy statement/prospectus that OncoGenex intends to file with the SEC in connection with its stockholder vote on matters relating to the proposed merger. Stockholders will be able to obtain this information by reading the joint proxy statement/prospectus when it becomes available.

About Achieve and Cytisine
Achieve is developing cytisine as a smoking cessation aid. Cytisine is a plant-based alkyloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including approximately 2,000 patients in Phase 3 clinical trials conducted in Europe and New Zealand. Achieve’s focus is to address the global smoking health epidemic, which is currently the leading cause of preventable death and responsible for nearly six million people losing their lives annually worldwide. Discussions have been held with FDA and a European regulatory agency to determine the clinical and regulatory pathway towards making cytisine widely available.

On January 5, 2017 Trethera Corporation and Nanotherapeutics, Inc. reported the signing of an exclusive worldwide agreement whereby Nanotherapeutics has granted Trethera an exclusive license for the global development, manufacturing and marketing of Triapine (3-AP) and all formulations, for the treatment of hematological malignancies (Press release, Nanotherapeutics, JAN 5, 2017, View Source [SID1234517286]). Triapine is a clinical-stage, small molecule inhibitor of ribonucleotide reductase (RNR), a key enzyme in the de novo pathway of nucleotide biosynthesis.

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Trethera has advanced preclinical development of proprietary, small molecule inhibitors of deoxycytidine kinase (dCK), the rate-limiting enzyme in the salvage pathway of nucleotide biosynthesis. Results of its preclinical studies indicate robust and durable anti-leukemic activity of its dCK inhibitors when combined with inhibitors of RNR, and these combinations have demonstrated superior activity over single agent treatments. Trethera aims to commence a Phase I clinical trial for its orally administered, lead dCK inhibitor, TRE-515, in H2 2017.

"This license agreement marks an important step in addressing the needs of patients and physicians combating acute leukemia as well as other blood cancers," said Johanna Holldack, MD, Chief Executive Officer and President of Trethera Corporation. "Our recent non-clinical studies indicate how powerful the combination of Triapine and TRE-515 could be. Securing this partnership accelerates our development pathway and ensures that the potential of this pioneering combination therapy will be fully realized."

Prasad Raje, Ph.D., President and Chief Executive Officer of Nanotherapeutics, commented, "We are delighted to be able to license Triapine to Trethera for the treatment of hematological malignancies. Trethera’s scientific team is pursuing critically important research which may unlock this compound’s ability to yield new blood cancer therapies in the future and we look forward to watching their progress."

On January 5, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML) reported an agreement with the U.S. Food and Drug Administration (FDA) on the registration pathway for SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, JAN 5, 2017, View Source [SID1234517283]). To support the filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, Stemline is currently enrolling an additional small cohort, planned for 8-12 first-line BPDCN patients, into its ongoing Phase 2 trial. To date, approximately half of these new patients are enrolled into the study, with full enrollment expected this quarter. Stemline intends to file a BLA in 2H17, which is anticipated to undergo an expedited review given SL-401’s Breakthrough Therapy Designation. If successful, Stemline projects a commercial launch of SL-401 in 2018.

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Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are extremely pleased with the outcome of our meeting with the FDA and the Agency’s continued guidance regarding SL-401, which was granted Breakthrough Therapy Designation this past August. The Agency has now provided us with a clear and potentially rapid pathway to obtain full approval of SL-401 in first-line BPDCN, as well as the possibility for review in the relapsed/refractory setting. We are actively enrolling patients who are to be included in the final cohort of the trial and are targeting completion of enrollment this quarter." Dr. Bergstein continued, "In parallel, our operations and regulatory teams are working hard to ensure a timely and comprehensive BLA filing, including addressing additional data requests from the Agency, while our commercial team is setting the stage, if approved, for a successful launch of SL-401. Additionally, we continue to advance SL-401 into other indications in an effort to provide benefit to patients who are battling aggressive cancers."

Conference Call and Webcast
Stemline Therapeutics will host a conference call and audio webcast Friday, January 6, 2017 at 8:00 AM ET. Interested participants and investors may access the conference call by dialing 888-778-9052 (U.S./Canada) or 913-312-0850 (International) and referencing conference ID: 9093286. An audio webcast can also be accessed via the Investor Relations tab of the Stemline Therapeutics website at View Source

About Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
For more information on BPDCN, please visit Stemline’s patient and physician resource site: www.bpdcninfo.com.