On January 1, 2018 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported the closing of a Series A financing co-led by new investor ArrowMark Partners and existing investor Barer & Son Capital, along with significant participation from Piedmont Capital Partners (Press release, NexImmune, JAN 1, 2018, View Source [SID1234554966]). In conjunction with the financing, Tony Yao, MD, PhD, a Partner at ArrowMark Partners, will join NexImmune’s Board of Directors.

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"NexImmune has developed a very practical, precise system that may transform the way we use technology to direct the immune system," commented Dr. Sol Barer of Barer & Son Capital. "We are excited about the potential of this ‘next generation’ approach to help patients with a variety of cancers."

NexImmune is advancing immunotherapy products based on its proprietary Artificial Immune Modulation (AIMTM) nanotechnology platform, originally developed at Johns Hopkins University. The AIM Technology enables simultaneous enrichment, activation and expansion of endogenous T cells (non-genetically manipulated) directed at multiple tumor-relevant antigen targets across a broad range of solid and hematologic malignancies.

Core to the AIM Technology are nanoparticle-based artificial Antigen Presenting Cells (aAPC) that bypass the antigen processing and presentation role of natural dendritic cells. aAPC engage directly with targeted T cell receptors on naïve and memory T cells, an approach that is designed to combine a robust effector response with the generation of long-term immunologic memory.

NexImmune’s lead product candidate, AIM ACT, is a cellular therapy designed to generate T cells targeting multiple tumor antigens associated with several hematologic malignancies. The initial Phase I/II clinical trial will include patients with acute myeloid leukemia and/or myelodysplastic syndromes who have relapsed after an allogeneic Hematopoietic Stem Cell Transplant.

"We believe that antigen-specific T cells expanded from the endogenous repertoire have the potential to eradicate tumor cells through naturally occurring recognition and killing mechanisms, which should translate into significant benefit for cancer patients. NexImmune is developing a novel technology that could make this approach a reality. I’m looking forward to working with their team as we advance this promising therapy into Phase I/II clinical studies in 2018," commented ArrowMark’s Dr. Yao.

Since its acquisition in January 2017 by the Barer & Son-led syndicate, NexImmune has made significant progress in its transition from a research-based, pre-clinical company to one with an extensive technology platform ready for clinical scale manufacturing and clinical trial application. Proceeds from this Series A financing are expected to fund NexImmune through the completion of currently planned Phase I/II clinical trials.

"As the field of immunotherapy continues to evolve, adoptively transferred T cell therapies that target single antigens on the surface of cancer cells are emerging as potentially curative options for many patients with hematological malignancies," stated Scott Carmer, NexImmune’s President and Chief Operating Officer.

"Unfortunately, many patients who experience an initial response to these treatments now relapse due to loss of target antigen expression. NexImmune’s AIM technology generates T cells capable of targeting multiple tumor-relevant antigens, and we believe this approach will enhance overall treatment effectiveness and reduce the likelihood of disease relapse due to target loss."

Trout Capital LLC served as the placement agent for NexImmune’s Series A financing.

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.

Rich Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Rich Pharmaceuticals, 2017, DEC 29, 2017, View Source [SID1234522790]).

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