On December 29, 2017 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for AZEDRA in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors (Press release, Progenics Pharmaceuticals, DEC 29, 2017, View Source [SID1234522856]). The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA).

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"With no FDA-approved therapies for these rare tumors, AZEDRA has the potential to address the high unmet need of patients with malignant pheochromocytoma and paraganglioma," said Mark Baker, Chief Executive Officer of Progenics. "We are pleased that the FDA has accepted our NDA with Priority Review, and look forward to working with the Agency during the review process. At the same time, we will continue to lay the groundwork for our commercial plan and prepare to launch quickly following a potential approval."

The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria In Solid Tumors (RECIST). AZEDRA was also shown to be safe and generally well tolerated.

About AZEDRA

AZEDRA (iobenguane I 131) is a high-specific-activity radiotherapeutic product candidate in development as a treatment for malignant, recurrent, or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors of neural crest origin. AZEDRA is a substrate for norepinephrine reuptake transporter which is highly expressed on the cell surface of neuroendocrine tumors. AZEDRA has been granted Orphan Drug designation, Fast Track status, and Breakthrough Therapy designation in the U.S. Under a SPA agreement with the FDA, a phase 2b pivotal study has been completed in patients with malignant, recurrent, or unresectable pheochromocytoma and paraganglioma. There are currently no FDA-approved therapies for the treatment of this ultra-rare disease.

About Pheochromocytoma and Paraganglioma

Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that arise from cells of the autonomic nervous system. Pheochromocytoma forms in the adrenal medulla, whereas paragangliomas form outside the adrenal gland. Standard treatment options for these tumors include surgery, palliative therapy and symptom management. Pheochromocytoma and paraganglioma tumors frequently secrete high levels of hormones that can lead to life-threatening hypertension, heart failure, and stroke in these patients. Malignant and recurrent pheochromocytoma and paraganglioma may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.

On December 29, 2017 La Jolla Pharmaceutical presented Corporate Presentation (Presentation, La Jolla Pharmaceutical, DEC 29, 2017, View Source [SID1234522792]).

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On December 29, 2017 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (SELLAS Inc.) reported that the proposed merger of the businesses of SELLAS Life Sciences Group Ltd. (SELLAS Ltd.) and Galena Biopharma, Inc. (Galena) has closed effective December 29, 2017, following approval by Galena’s stockholders (Press release, Sellas Life Sciences, DEC 29, 2017, View Source [SID1234526857]). Upon completion of the merger, Galena was renamed "SELLAS Life Sciences Group, Inc." and now features a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematologic and solid malignancies. SELLAS Inc. is expected to commence trading on the Nasdaq Capital Market on January 2, 2018, under the ticker symbol "SLS".

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"This public listing provides us with the opportunity to further develop our novel immunotherapies for a wide range of cancers with unmet medical needs as a public company," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS Inc. "Over the past year, we have advanced the development of galinpepimut-S (GPS), our Wilms Tumor 1-targeting immunotherapy, through collaborations with Merck & Co., among others, as well as our ongoing Phase 2 trials of GPS in patients with multiple myeloma, as a monotherapy, and with ovarian cancer, in combination with Bristol-Myers Squibb’s nivolumab. We also had successful End-of-Phase 2 meetings with the FDA pertaining to our planned Phase 3 studies in acute myeloid leukemia and malignant pleural mesothelioma. We are excited by the potential of GPS, both as a monotherapy and in combination with other agents to serve as a promising therapy for patients with a broad array of cancers."

"I am delighted to be working with Angelos and the rest of the SELLAS Inc. team, who have been responsible for building the company and progressing its novel, high potential pipeline to address the unmet needs of patients battling various types of cancer. The transition to being a publicly traded company marks a significant milestone, providing the opportunity for greater financial resources and enhanced corporate structure to better advance the company’s clinical programs," noted Jane Wasman, newly-appointed Chair of SELLAS Inc.’s Board of Directors.

Following completion of the merger, the combined company will relocate its headquarters to New York City, NY, and operate under the management team of SELLAS Ltd.: Dr. Angelos M. Stergiou (Chief Executive Officer), Aleksey N. Krylov (Interim Chief Financial Officer), Dr. Nicolas J. Sarlis (Chief Medical Officer), and Dr. Gregory M. Torre (Chief Regulatory Officer). The Board of Directors now is led by Jane Wasman (Chair), along with Stephen F. Ghiglieri, Fabio Lopez, Dr. David A. Scheinberg, Dr. Angelos M. Stergiou, Robert L. Van Nostrand and John Varian.

Guggenheim Securities acted as SELLAS Ltd.’s financial advisor for the transaction, and Cooley LLP and Conyers Dill & Pearman acted as SELLAS Ltd.’s legal counsel. Canaccord Genuity Inc. acted as Galena’s financial advisor for the transaction and Paul Hastings LLP and BeesMont Law Limited acted as Galena’s legal counsel.

About the Transaction

In connection with and prior to the closing of the merger, Galena effected a 1-for-30 reverse stock split of its common stock. As a result of the reverse stock split, every 30 shares of Galena common stock issued and outstanding or held by Galena in treasury immediately prior to the effective time of the reverse stock split was automatically reclassified into one fully paid and nonassessable share of Galena common stock. Pursuant to the merger, the holders of SELLAS Ltd. shares outstanding immediately prior to the merger received 43.9972 shares of Galena common stock in exchange for each SELLAS Ltd. share in the merger. Post-merger and post-reverse split, SELLAS Inc. now has approximately 5,766,891 shares of common stock issued and outstanding, with prior SELLAS Ltd. securityholders collectively owning approximately 67.5% of the combined company, and prior Galena securityholders collectively owning approximately 32.5% of the combined company, in each case on a fully diluted basis, without taking into account certain out-of-the-money Galena warrants.

About SELLAS Inc.’s Pipeline

The combined company features a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematologic and solid tumor malignancies. SELLAS Inc. plans to initiate a Phase 3 trial of GPS for the treatment of acute myeloid leukemia (AML) in 2018, pending funding availability, and has also successfully completed a Phase 2 study of GPS in malignant pleural mesothelioma (MPM). End-of-Phase 2 meetings have been completed with the U.S. Food and Drug Administration (FDA) for GPS in both indications.

In addition, SELLAS Inc. is currently conducting two Phase 2 trials of GPS, in multiple myeloma as a monotherapy, as well as in a combination trial in ovarian cancer with nivolumab (OPDIVO; Bristol-Myers Squibb). SELLAS Inc. is currently preparing for an open label, 5-arm ‘basket’ type combination trial of GPS in combination with the anti-PD-1 therapy pembrolizumab (KEYTRUDA; Merck & Co.). SELLAS Inc. also assumes Galena’s Phase 2 investigator-sponsored nelipepimut-S clinical trials in breast cancer and a controlled release version of anagrelide for potential internal development or strategic partnership.

On December 29, 2017 CEL-SCI Corporation (NYSE American: CVM) reported financial results today for the fiscal year ended September 30, 2017 (Press release, Cel-Sci, DEC 29, 2017, View Source [SID1234522862]). The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2017.

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Clinical and Corporate Developments included:

Full enrollment was achieved in CEL-SCI’s pivotal Phase 3 head and neck cancer study. The study’s Independent Data Monitoring Committee (IDMC) completed its most recent review of the data from all 928 patients enrolled in the study and recommended continuing the study as constituted, as there was no evidence of any significant safety questions.
CEL-SCI’s LEAPS vaccine for the treatment of rheumatoid arthritis received a $1.5 million grant from the U.S. National Institutes of Health (NIH). The grant provides funding for CEL-SCI to advance its first LEAPS product candidate, CEL-4000, towards an Investigational New Drug (IND) application. Preclinical data on CEL-4000 were presented at several scientific conferences and published in a scientific journal during fiscal 2017.
In the $50 million arbitration suit brought by CEL-SCI against its former clinical research organization (CRO), the testimony phase of the arbitration has concluded, and all that remains at the trial level are closing statements and post-trial submissions.
CEL-SCI raised approximately $14.7 million gross proceeds during fiscal 2017.
"While we went through a challenging period during fiscal 2017, we are pleased to move forward with the achievement of our biggest milestone to date, completion of enrollment and treatment of all 928 patients in the world’s largest head and neck cancer study," stated CEL-SCI CEO, Geert Kersten. "The study is now fully enrolled. Per the recommendation of the study’s IDMC to continue the study, in accordance with the study protocol, the enrolled patients are being followed for survival outcome. After 298 patient deaths have occurred in the two comparator arms of the study the company will be able to determine if the study’s endpoint is achieved."

CEL-SCI reported a net loss of ($14.36) million in fiscal year 2017 versus a net loss of ($11.51) million in fiscal 2016.

The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.

On December 29, 2017 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company developing a new class of RNAi-based therapeutics reported that the Company’s President and CEO, Dr. Geert Cauwenbergh, will present at the 10th Annual Biotech Showcase (Press release, RXi Pharmaceuticals, DEC 29, 2017, View Source [SID1234522789]). Taking place during one of the industry’s largest annual healthcare investor conferences, this investor and partnering conference attracts pharmaceutical executives from around the world focused on investment and business development opportunities in the life sciences industry. The conference will be held January 8–10, 2018 at the Hilton San Francisco Union Square, California.

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Date: Monday, January 8, 2018
Time: 9:30am Pacific
Track:Yosemite – C (Ballroom Level)

Dr. Cauwenbergh will present an overview of the Company’s novel self-delivering RNAi (sd-rxRNA) technology and the multiple business development and commercial opportunities available based on this proprietary platform. The presentation will be webcast and available on the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com.

About RXi’s self-delivering RNAi (sd-rxRNA) technology platform

sd-rxRNA, RXi’s proprietary self-delivering RNAi platform, is a single chemically modified compound with delivery and therapeutic properties built directly into the compound itself. The compound is asymmetrical with a phosphorothioate backbone and contains chemical modifications that provide for efficient cellular uptake and gene silencing. These compounds are potent, stable and specific, and demonstrated to be safe and active in a clinical setting.

RXi’s novel sd-rxRNA technology differs from natural and most synthetic RNA interference (RNAi) molecules in that they are chemically modified to allow for efficient internalization of the compounds by cells and silencing of the targeted genes. Importantly, unlike other naked siRNA compounds, delivery of sd-rxRNAs are not limited to a specific cell type. For local delivery and ex vivo cell-based therapeutic applications, our compounds do not require delivery vehicles. This is a major advantage, since delivery vehicles can have related toxicity that affects cell viability. sd-rxRNA has demonstrated nearly 100 percent transfection efficiency with high cell viability in numerous cell types.