On February 11, 2019 Recombinetics reported that named Mark Platt the organization’s Chief Executive Officer (Press release, Recombinetics, FEB 11, 2019, View Source [SID1234533249]).

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"Recombinetics is at the forefront of innovative research and development to address issues of global significance, like feeding the hungry, improving population health and the humane treatment of animals," Platt says. "I’m joining at this transformational time to ensure the organization and its strategic investors thrive, with all aligned to positively impact people, places and animals at home and abroad."

"Our organization will benefit greatly from Mark’s leadership experience," says Peter Hajas, chairman of the Board, Recombinetics. "Mark brings an excitement for the possibilities of our innovative work and is the right person to guide our corporate culture and nurture relationships with key stakeholders to achieve goals of improving human lives, feeding the world’s growing population, and reducing animal suffering."

Platt’s experience includes his time as President and CEO of Multistack, LLC, in Sparta, Wis., where he provided strategic long-term direction of the company and was directly involved in emerging technology, research and development. From 2002 to 2012, Mark led the company through its highest period of growth, with total revenue increasing by more than 1,000 percent.

Most recently Executive Sales Leader at the Trane, Inc. Midwest sales office, Platt played a role in doubling the organization’s market share in less than two years. He was also Senior Vice President of Business Services for Gundersen Health System from November 2013 to April 2017. In this role, Platt oversaw business development and marketing, government relations, supply chain, facility operations and community wellness initiatives. He has also served on the Gundersen Board of Trustees.

Platt received his bachelor’s degree in electrical engineering from Vanderbilt University, Nashville, Tenn. He was also a commissioned officer in the U.S. Air Force with 17 years of service and held the rank of captain in the U.S. Air Force Reserve.

Tammy Lee, who served as President and CEO of Recombinetics since August 2017, is taking a leave of absence from the company. Recombinetics thanks Lee for her leadership, which included securing $34 million for the company’s Series A financing round.

On February 11, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, reported that it has acquired the Somerset, NJ manufacturing facility for AZEDRA (iobenguane I 131) for cash consideration of $8.0 million (Press release, Progenics Pharmaceuticals, FEB 11, 2019, View Source [SID1234533235]). AZEDRA is the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, ultra-rare cancers.

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This Somerset site serves as the launch facility for AZEDRA and will also provide manufacturing support for the Company’s development stage radiopharmaceuticals, including 1095. The production of AZEDRA uses a proprietary Ultratrace process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic "cold" MIBG molecules, giving AZEDRA a uniquely high specific activity.

Progenics has also secured the long-term supply of iodine necessary for the production of both AZEDRA and 1095.

"This strategic transaction extends our leadership position in radiopharmaceuticals, establishing the infrastructure and manufacturing capabilities to label multiple types of isotopes, including iodine-131," stated Mark Baker, CEO of Progenics. "With this transaction, we are building the capabilities to ensure the supply of AZEDRA."

On February 11, 2019 AbbVie (NYSE: ABBV), Teneobio, Inc. and its affiliate TeneoOne, Inc. reported that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma (Press release, AbbVie, FEB 11, 2019, View Source [SID1234533234]).

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B-cell maturation antigen (BCMA) has emerged as an attractive target for multiple myeloma therapeutics. TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3, utilizing Teneobio’s unique anti-CD3 platform. Through this dual targeting mechanism, TNB-383B is designed to direct the body’s own immune system to target and kill BCMA expressing tumor cells. Teneobio is expected to begin the clinical program for TNB-383B in the first half of 2019.

Roland Buelow, CEO of Teneobio, Inc. and TeneoOne, Inc. added, "We are excited to partner with AbbVie on our first clinical candidate, TNB-383B, which targets BCMA using our unique T-cell redirecting platform. Combined with AbbVie’s commitment to scientific advancement and bringing oncology products to the world-wide commercial market, we will be able to quickly progress the development of TNB-383B for patients in need."

"Developing novel targeted treatments for patients with cancer continues to be our key priority," said Mohit Trikha, Ph.D., vice president and head, oncology early development, AbbVie. "Multiple myeloma is one of the most common hematological cancers and an area of significant medical need. Teneobio’s novel approach to T-cell redirection with TNB-383B has the potential to be a treatment option that may offer new hope for myeloma patients."

Under the terms of the agreement, TeneoOne will receive an upfront payment of $90 million and will continue developing TNB-383B through Phase 1. AbbVie will hold the exclusive right to acquire TeneoOne and lead subsequent global development and commercialization of TNB-383B. If AbbVie exercises its right to acquire TeneoOne, the former stockholders of TeneoOne will also be eligible for regulatory and commercial sales milestones.

On February 11, 2019 Active Biotech (NASDAQ STOCKHOLM: ACTI) reported that their partner NeoTX enters a clinical collaboration with AstraZeneca Group Plc (NYSE: AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating ANYARA in combination with AstraZeneca’s IMFINZI (Press release, Active Biotech, FEB 11, 2019, View Source [SID1234533232]). IMFINZI (durvalumab) is a human monoclonal antibody that blocks the immune checkpoint protein programmed death-ligand (PD-L1). Under terms of the agreement, NeoTX and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in solid tumors. NeoTX will sponsor the study, while AstraZeneca will supply durvalumab. Up to 195 patients are planned to be enrolled in this multicenter, open-label study, which is planned to start during 2019.

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"We are very pleased with NeoTX’s progress in the ANYARA project. The collaboration with AstraZeneca validates the project and is an important step towards start of the clinical study" says Helén Tuvesson, CEO, Active Biotech AB.

See also www.neotx.com for NeoTX’s communication related to this information.

ABOUT ANYARA

ANYARA (Naptumumab, Naptumomab estafenatox,) is a tumor targeting immunotherapy that enhances the ability of the immune system to recognize and kill the tumor. ANYARA induces the activation and expansion of specific T cells outside of the tumor microenvironment and redirect the T cells to attack the tumor cells. Preclinical data demonstrate that ANYARA has synergistic effect with checkpoint inhibitors in various tumor models.

Active Biotech has an agreement with NeoTX Therapeutics Ltd since October 2016 for the global development and commercialization of ANYARA for the treatment of cancer.

About NeoTX
NeoTX Ltd. is a clinical-stage biopharmaceutical company dedicated to developing promising therapeutic candidates in the field of immuno-oncology. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies.

Lund February 11 2019

Helèn Tuvesson
President & CEO

For further information, please contact:
Helén Tuvesson, CEO
Tel +46 46 19 21 56

Hans Kolam, CFO
Tel +46 46 19 20 44

On February 11, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the first patient has been dosed in a Phase 1 trial of ADU-S100 (MIW815), a novel stimulator of interferon genes (STING) pathway activator, in combination with YERVOY (ipilimumab), an approved anti-CTLA-4 antibody for the treatment of relapsed and refractory melanoma (Press release, Aduro Biotech, FEB 11, 2019, View Source;p=RssLanding&cat=news&id=2386898 [SID1234533231]). The multicenter trial (see www.clinicaltrials.gov, identifier: NCT02675439), which is part of an ongoing research and development collaboration with Novartis, will enroll advanced melanoma patients who have relapsed after or are refractory to treatment with anti-PD-1 antibodies, nivolumab or pembrolizumab.

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"We are pleased to initiate this study evaluating ADU-S100 with ipilimumab in a homogeneous patient population. Despite recent advancements in treating earlier stages of melanoma, the relapsed and refractory patient segment remains underserved due to a lack of therapeutic options. Based on their potential synergistic activity, ADU-S100 in combination with an anti-CTLA-4 antibody could generate a systemic adaptive immune response in patients with late-stage melanoma," commented Stephen Isaacs, chairman, president and chief executive officer of Aduro Biotech. "As demonstrated leaders in the STING pathway, we are committed to build upon the growing body of data we’ve generated thus far, including encouraging clinical signals demonstrated by ADU-S100 as a single agent and in combination with spartalizumab, an investigational anti-PD-1 antibody."

The protocol for investigation of ADU-S100 as a single agent was amended to include evaluation of ADU-S100 in combination with ipilimumab. During the ongoing dose escalation phase of the trial, ipilimumab will be administered at its approved dose and schedule, while the dose of ADU-S100 will be escalated. The dose expansion phase of the trial will evaluate the optimized dose of ADU-S100 in combination with ipilimumab in two expansion cohorts that will enroll patients with cutaneously and viscerally accessible melanoma.

As previously presented at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, target engagement of ADU-S100 and activation of the STING pathway was demonstrated in the ongoing Phase 1 dose escalation of ADU-S100 alone through increases in key systemic cytokines, IL-6, MCP-1 and IFN- β after administration. Partial responses were observed in 4.9 percent of patients (n=2/41), including one patient with parotid gland cancer who received prior anti-PD-1 therapy. Stable disease (SD) was achieved in 26.8 percent of patients (n=11/41), including five patients who had received prior checkpoint inhibitor therapy. In the ongoing study of ADU-S100 in combination with spartalizumab, clinical responses were observed in several tumor types, including two patients who had previously demonstrated responses to checkpoint inhibitor therapy alone.

In preclinical models, activation of the STING pathway has been shown to rapidly invoke an innate immune response, which subsequently leads to a systemic and sustained adaptive immune response through tumor-specific-CD8+ T cells. Ipilimumab may further augment such immunity, by blocking the activity of the checkpoint protein, CTLA-4, resulting in enhanced activity of T cells that attack melanoma cells in the body, supported by the demonstration of combined activity of ADU-S100 and anti-CTLA-4 in preclinical models.

About STING Pathway Activator Technology
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

Aduro’s lead molecule, ADU-S100, is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 monoclonal antibody. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.