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 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 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RXDX-106, a novel oral immunomodulatory agent and TAM inhibitor, in patients with solid tumors (Press release, Ignyta, DEC 29, 2017, View Source [SID1234522787]).

Under this IND, the company intends to initiate the TITAN (Targeted Immunomodulatory TAM ANtagonist) study, a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors. TITAN is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-106.

"RXDX-106 represents a new class of immuno-oncologic precision medicines that we are excited to advance to the clinic. In preclinical studies, RXDX-106 has demonstrated the potential to elicit and potentiate an immune response to cancer, by targeting the TAM family of receptors in the tumor microenvironment, both as a single agent and in combination with checkpoint inhibitors," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018."

On December 29, 2017 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018, in San Francisco (Press release, Medtronic, DEC 29, 2017, View Source;p=RssLanding&cat=news&id=2324263 [SID1234522793]).

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Omar Ishrak, chairman and chief executive officer of Medtronic, will make a formal presentation on the company beginning at 9:00 a.m. PST (11:00 a.m. CST). Shortly following the presentation, Ishrak and Karen Parkhill, executive vice president and chief financial officer, will answer questions on the company.

A live audio webcast of the presentation and Q&A session will be available on January 8, 2018, by clicking on the Investor Events link at View Source An archive of the session will be available on the same webpage later in the day.

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

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