On January 5, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX), a clinical-stage biopharmaceutical company, reported that it is reshaping its strategy and operations to prioritize its emerging clinical and preclinical immuno-oncology portfolio (Press release, Dynavax Technologies, JAN 5, 2017, View Source [SID1234517380]). The company has implemented significant organizational restructuring and cost reductions to align around its immuno-oncology business, while allowing it to advance HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)], its investigational hepatitis B vaccine candidate, through the U.S. Food and Drug Administration (FDA) review process and an approval decision. Dynavax continues to believe that HEPLISAV-B is an approvable product and plans to submit its response to the FDA’s outstanding questions shortly.

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To achieve these savings, Dynavax has suspended manufacturing for HEPLISAV-B and reduced its global workforce by 38 percent. The company will incur restructuring costs, currently estimated to be $3.0 million, primarily in the first quarter of 2017. The company estimates that its cash, cash equivalents and marketable securities were approximately $81.4 million as of December 31, 2016. Going forward, it expects HEPLISAV-B costs prior to any FDA decision to be less than $1 million per month, and all other operating costs to be less than $60 million per year to support continued development of its oncology program. This restructuring is currently estimated to result in approximately a 40 percent reduction in cash burn. The company will continue to evaluate the possibility of a partnership to support HEPLISAV-B as it increasingly concentrates its own strategic focus on oncology.

"We value all of our colleagues, so reducing our workforce is a sad and difficult decision. But it is one we believe is necessary to align our organization to reflect that of a clinical R&D-stage company with a promising immuno-oncology pipeline, which has become a strategically important area of our business and one we believe can potentially benefit thousands of people with cancer," said Eddie Gray, chief executive officer of Dynavax. "These measures will increase our financial strength and position us well to create significant long-term clinical and financial value. They also will allow us to advance HEPLISAV-B toward approval while we continue to evaluate the possibility of a partnership to support its approval and launch. We are grateful to all affected employees for their dedication to bringing us this far."

Prioritizing Diversified Immuno-Oncology Pipeline
Dynavax has made notable progress in the rapidly advancing area of immuno-oncology, and is focusing on two promising compounds that have shown potential to enhance the immune response against cancer.

The company’s lead clinical candidate, SD-101, an investigational cancer immunotherapeutic, is currently being studied in several Phase 1/2 studies evaluating its potential to be broadly effective against multiple solid tumors and hematologic malignancies. SD-101, an intratumoral TLR9 agonist, has shown encouraging early clinical data in metastatic melanoma.

At the Society for Melanoma Research conference in November 2016, Dynavax announced the first findings from an ongoing Phase 1/2 study of SD-101 in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment. Early results evaluating 13 patients with metastatic melanoma for efficacy and 19 patients for safety were reported. In patients naïve to anti-PD-1 treatment, objective responses were observed in four of five patients (80 percent), including one complete response and three partial responses. In a small number of patients with progressive disease stable disease was observed while receiving Keytruda and SD-101 in combination. The combination of the two drugs was well-tolerated with no dose-limiting toxicities. These encouraging clinical data will be enhanced by a dose-expansion phase to further explore the efficacy of this combination.

Dynavax is also developing a second TLR9 agonist, DV281, which has completed preclinical testing in models for lung cancer. Lung cancer remains an area of high unmet need, with fewer than 20 percent of patients responding to the most recently-approved immunotherapies. DV281 will be administered as an inhaled therapeutic. Dynavax intends to begin Phase 1 studies of DV281 in the second quarter of 2017.

The company expects to present additional data from its immuno-oncology portfolio at medical conferences throughout 2017, including at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper).

Continuing to Advance HEPLISAV-B while Maintaining Manufacturing Capacity at Reduced Cost
Dynavax plans to respond this month to the November 2016 Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for HEPLISAV-B, and will advance the vaccine through an expected six-month FDA review period. The company remains confident that the existing clinical data package meets the requirements for approval. During the regulatory review period, Dynavax will retain, but furlough, the majority of the workforce supporting its manufacturing facility in Germany. This approach will enable the company to leverage the existing stockpiled inventory of HEPLISAV-B, while providing it with the ability to re-activate and scale for commercial launch activities.

Conference Call Details
The Dynavax management team will host a conference call and webcast today, Thursday, January 5, 2017, at 4:30 p.m. Eastern Time, to provide more information about the restructuring. The live call can be accessed by phone by dialing (877) 479-1857 (domestic) or +1 (503) 343-6309 (international) and specifying conference call code 47911578. A link to the live webcast may be accessed by visiting the "Investors" section of the Dynavax website or directly at www.dynavax.com. A replay of the conference call may be accessed for one week following the call by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406, and using the passcode 47911578.

About SD-101
SD-101 is Dynavax’s proprietary CpG-C class oligodeoxynucleotide. SD-101 is a potent activator of dendritic cells, activating them to mature and produce Type 1 interferons through specific binding to TLR9, a key recognition receptor in the innate immune system. SD-101 is delivered directly to the tumor, where it can stimulate highly effective immune responses to tumor antigens. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

About DV281
DV281, a newly developed TLR9 agonist, is a CpG-C class oligodeoxynucleotide developed specifically for inhaled delivery to lung tumors that are not easily accessible for intratumoral injection. Inhaled DV281 induces dendritic cell activation and tumor microenvironment changes comparable to intratumoral injection of SD-101. Studies in animal models of lung tumors show that DV281 dramatically reduces lung tumor burden and leads to immune-mediated control of tumor metastases outside the lung. Dynavax intends to initiate a Phase 1 study in the second quarter of 2017.

About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary TLR 9 agonist to enhance the immune response. HEPLISAV-B is administered in two doses over one month. In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The investigational vaccine’s safety profile is based on clinical trials that generated safety data from more than 14,000 participants. The most frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine.

Dynavax has worldwide commercial rights to HEPLISAV-B.

On January 5, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform, and Servier, an independent international pharmaceutical company, reported a broad collaboration in immuno-oncology (IO) (Press release, Pieris Pharmaceuticals, JAN 5, 2017, View Source [SID1234517279]). Despite the impressive clinical efficacy of checkpoint inhibitors to date, a majority of patients fail to respond to approved therapies. The collaboration seeks to address this significant unmet clinical need by advancing a series of novel molecules, including multiple dual immune checkpoint blockade approaches.

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Under the collaboration, Pieris and Servier will initially pursue five bispecific therapeutic programs, led by Pieris’ PRS-332 program, a potentially best-in-class PD-1-targeting bispecific checkpoint inhibitor. Pieris and Servier will jointly develop PRS-332 and split commercial rights geographically, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. The four additional committed programs have been defined, which may combine antibodies from the Servier portfolio with one or more Anticalin proteins based on Pieris’ proprietary platform to generate innovative immuno-oncology bispecific drug candidates. The collaboration may be expanded by up to three additional therapeutic programs. Pieris has the option, at a predefined time point, to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332, while Servier will be responsible for development and commercialization of the 4 other programs worldwide.

The financial terms of the collaboration include an upfront payment to Pieris of EUR30 million (approximately $31.3 million USD). Pieris may also receive FTE funding for specific projects, an option fee upon potential expansion of the collaboration as well as development-dependent and commercial milestone payments for PRS-332 and each additional program. The total development, regulatory and sales-based milestone payments to Pieris could reach EUR324 million (approximately $338 million USD) for PRS-332, and up to EUR193 million (approximately $201 million USD) for each of the other programs.Pieris and Servier will share preclinical and clinical development costs for each co-developed program. In addition, Pieris will be entitled to receive tiered royalties up to low double digits on the sales of commercialized products in the Servier territories.

Pieris’ multispecific technology allows simultaneous checkpoint inhibition on the same cell, which could have a clear advantage over monoclonal antibody cocktails against different checkpoint targets. PRS-332 is a novel PD-1-based bispecific, comprising an anti-PD-1 antibody genetically linked to an Anticalin protein targeting an undisclosed checkpoint target. Pieris has developed PRS-332, which is currently in preclinical development, with the intent to simultaneously block two immune checkpoints co-expressed on exhausted T cells to further improve on existing PD-1 therapies.

"Servier is a highly complementary partner for Pieris, with a very clear commitment to oncology and outstanding development capabilities," stated Dr. Louis Matis, Senior Vice President and Chief Development Officer of Pieris. "The synergies of building unique bispecifics from Servier’s antibodies and Pieris’ Anticalin proteins are multifold, as the versatility of our platform allows for extensive combinatorial target opportunities with the numerous IO ‘building blocks’ our team has discovered to date."

"This alliance will significantly enhance Servier’s portfolio in immuno-oncology, which already comprises 5 products in late preclinical or early development. Servier’s recognized expertise in drug development will efficiently complement Pieris’ innovative technology, allowing both companies to bring innovative solutions to cancer patients," stated Jean-Pierre Abastado, PhD, Director of Oncology R&D at Servier.

"Servier has built a diversified and innovative portfolio in oncology that includes small molecules, engineered antibodies, and cell therapies for the treatment of both hematological malignancies and solid tumors. Today’s alliance with Pieris adds another dimension to our strategy of becoming a key player in oncology, providing several next-generation bispecific IO drugs to our pipeline," added Emmanuel Canet, M.D., Ph.D., President of Servier R&D.

"Our alliance with Servier is clearly a transformative one for Pieris and is the type of partnership we deliberately set out to achieve to create significant long-term value. This collaboration provides not only an opportunity to advance multiple programs with retained rights in the number one oncology market, but also provides significant funding and flexibility for Pieris to balance financial and operational resources as we enter the next stage of corporate development," stated Stephen Yoder, President and Chief Executive Officer of Pieris. "The Servier alliance will act as a significant building block of our pipeline expansion in immuno-oncology and demonstrates the value of our proprietary Anticalin drug class."

On January 4, 2017 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective anti-cancer medicines, reported highlights from 2016 and outlined expected milestones for 2017 (Press release, Tarveda Therapeutics, JAN 4, 2017, View Source [SID1234517285]).

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"2016 was a year of transformative progress for Tarveda’s Pentarin platform and acceleration in the development of our novel treatments to improve the effectiveness of cancer therapies for patients with solid tumors. The company raised substantial capital and strengthened its premier venture capital syndicate, completed the in-licensing of PEN-866, which will be in a Phase I clinical trial in 2017, and embarked on our first-in-human trial for our lead drug candidate PEN-221," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "We have constructed an attractive pipeline of novel, anti-cancer medicines, built a solid foundation on which to create true value for patients and our Company’s stakeholders, and look forward to achieving additional, validating milestones in 2017."

Key 2016 Accomplishments

Secured $38 million in Series C financing co-led by Novo A/S and New Enterprise Associates (NEA) with Flagship Pioneering, NanoDimension and Eminent Venture Capital also participating

Concentrated the Company’s development and discovery resources on Tarveda’s Pentarin Platform through the spin-off of BTP-114 to Placon Therapeutics. BTP-114 is a next-generation, platinum-based chemotherapy that is now in a Phase I clinical trial in collaboration with a domestic pharmaceutical partner

Expanded clinical program and R&D expertise with the appointment of Leila Alland, M.D. to Chief Medical Officer. Dr. Alland brings more than 15 years of pharmaceutical drug development experience including her most recent leadership roles in oncology clinical development at AstraZeneca and Bristol-Myers Squibb

In-licensed the broad Heat Shock Protein 90 (HSP90) targeting conjugate platform, including lead drug PEN-866, from Madrigal Pharmaceuticals

Miniaturized HSP90 targeting drug conjugates are designed to have high affinity for the well-characterized intracellular target, HSP90, and increase the killing of cancer cells while reducing collateral damage to normal cells

PEN-866 accumulates and is retained in xenograft tumors, releasing over time the potent tumor-killing payload SN-38, the active component of the approved anticancer medicine, irinotecan

PEN-866 has shown efficacy and durability of response in multiple preclinical tumor models including small cell lung, pancreatic, and ovarian cancers, sarcoma and patient derived tumor models

Presented preclinical data for PEN-221 demonstrating complete and sustained tumor regressions in hard-to-treat, somatostatin receptor 2 (SSTR2) positive cancer models

Miniaturized size and unique design of Pentarins such as PEN-221 allow for rapid penetration deep into solid tumors to drive efficacy
PEN-221 binds with high affinity to the cell surface target, SSTR2, internalizes into the tumor cell and releases its DM1 payload, which is retained in the tumor cell long after PEN-221 is cleared from circulation

Initiated a first-in-human Phase 1/2a trial of PEN-221 at multiple, premier clinical sites in the United States

The Phase 1/2a study of PEN-221 selects patients most likely to respond to PEN-221 by using FDA approved imaging diagnostics to identify those with tumors expressing SSTR2

Expected Key 2017 Milestones
Complete PEN-221 Phase 1 dose escalation and identify the recommended Phase 2 dose of PEN-221 in patients with SSTR2 expressing neuroendocrine tumors and small cell lung cancer in 2017

Initiate the first-in-human trial of PEN-866 in 2017, a Phase 1/2a dose escalation/expansion study evaluating safety and efficacy of PEN-866 in advanced, topoisomerase-1 sensitive cancer patients

Report preclinical data in 2017 on new Pentarins that bind to intracellular and cell-surface targets and drive anti-tumor activity
Announce the Tarveda Scientific Advisory Board in the first quarter of 2017

About Pentarins
Tarveda is developing Pentarins, potent and selective miniaturized drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cell killing agent through a chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for effective penetration and distribution into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

On January 4, 2017 Abbott (NYSE: ABT) reported it has completed the acquisition of St. Jude Medical, Inc., establishing the company as a leader in the medical device arena (Press release, Abbott, JAN 4, 2017, View Source [SID1234517289]). The transaction provides Abbott with expanded opportunities for future growth and is an important part of the company’s ongoing effort to develop a strong, diverse portfolio of devices, diagnostics, nutritionals and branded generic pharmaceuticals.

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"Abbott has a strong track record of successfully integrating dozens of businesses on a global scale and accelerating growth," said Miles D. White, chairman and chief executive officer, Abbott. "The addition of St. Jude Medical strengthens our global medical device leadership while offering innovative products to address more areas of care, in more physicians’ offices and hospitals around the world."

Pursuant to the terms of the Merger Agreement, upon completion of the acquisition, St. Jude Medical became a wholly-owned subsidiary of Abbott. As a result of the completion of the acquisition, Jan. 4, 2017, was the last day of trading of St. Jude Medical shares on the New York Stock Exchange.

Strategic Fit
St. Jude Medical’s strong positions in fast-growing areas such as atrial fibrillation, heart failure, structural heart and chronic pain complement Abbott’s leading positions in coronary interventions and mitral valve disease. Together, the company will compete in nearly every area of the $30 billion cardiovascular market and hold the No. 1 or 2 positions across large and high-growth cardiovascular device markets. This leading combined portfolio will have the depth, breadth, scale and innovation to help patients restore their health, improve outcomes and deliver greater value to customers and payors. Furthermore, the acquisition balances and strengthens the Abbott portfolio, which includes leading positions across all of its four core businesses.

Breakthrough Invention
Abbott will have a powerful pipeline across cardiovascular and neuromodulation patient care ready to deliver next-generation medical technologies and offer improved efficiencies for health care systems around the world. In fact, Abbott will continue to bring numerous new products to key markets during the coming years, including:

EnSite Precision (which received U.S. FDA approval last month) next-generation cardiac mapping system to visualize and navigate catheters in the heart during ablation procedures

ConfirmRx Implantable Cardiac Monitor to help physicians remotely diagnose and treat the most difficult to detect cardiac arrhythmias

HeartMate 3, which offers physicians more options for patients with advanced stage heart failure
Portico Transcatheter Aortic Heart Valves for patients with severe aortic stenosis – the narrowing of the aortic valve that obstructs blood flow from the heart

Proclaim DRG system and other stimulation waveform technologies to provide more options for patients with chronic pain
Absorb, the world’s first bioresorbable coronary stent and MitraClip, the world’s first transcatheter mitral-valve repair device in additional countries

"We continue to deliberately shape our business for long-term success by securing leadership positions in attractive markets and focusing on customer needs," said Mr. White. "This philosophy has served as the foundation for significant and sustainable value creation for our shareholders. The addition of St. Jude Medical creates one of the broadest medical device portfolios in the world and provides a steady stream of new technologies and therapies for many years to come."

On January 4, 2017 Rubius Therapeutics, Inc., a Flagship Pioneering company, has reported the hiring of two key company leaders, David Epstein and Torben Straight Nissen, to accelerate development of new medicines from the company’s potentially revolutionary new product platform: Red-Cell Therapeutics (RCTs). Specifically, Epstein is joining as Chairman of the Board and Straight Nissen as President of the company. Flagship Pioneering developed Rubius in its innovation foundry, Flagship VentureLabs, throughout 2014 and launched the company in 2015 with an initial capital commitment of $25 million.

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Through the use of patented, advanced engineering techniques and know-how the company has successfully produced red blood cells that express therapeutic proteins that enable their use for the treatment of serious diseases. Rubius is now demonstrating that these newly equipped high performing, "off the shelf" Red-Cell Therapeutics have pre-clinical activity across a spectrum of medical applications. For example, in cancer a red blood cell can be transformed to express multiple synergistic proteins which can both inhibit cancer cell growth as well as activate the patient’s immune system. Alternatively, red blood cells have been engineered to replace missing enzymes for patients living with a variety of rare diseases, or even to remove unwanted metabolic products from the blood stream. Rubius has generated more than 200 prototypes to date. RCTs have demonstrated potential advantages compared to other cellular approaches to treating disease, such as greater durability, easier manufacturing scale-up and safety advantages due to the unique features of red blood cells.

"David and Torben bring a unique combination of scientific and business leadership experience which will accelerate Rubius’ development. As founders and primary investors, we are delighted to have the duo take the helm of this transformative company from the leadership provided by the Flagship VentureLabs team," stated Dr. Noubar Afeyan, Chairman of the Board of Rubius and CEO of Flagship Pioneering.

David Epstein, former CEO of Novartis Pharmaceuticals, has joined to serve as a Chairman of the Board. He will also will be serving in the newly created role of Executive Partner for Flagship Pioneering. At Novartis, Epstein was responsible for leading the development and commercialization of over 30 new medicines including breakthroughs such as Glivec, Gilenya, Cosentyx and Entresto.

As President of Rubius, Torben Straight Nissen, Ph.D, brings 20 years of deep scientific knowledge and business experience to expand the company’s platform and clinical programs. Torben joins Rubius from Pfizer, where he held multiple scientific and business leadership roles to advance the company’s therapeutic innovation, research and development.

"Flagship is breaking boundaries and exploring new frontiers that, I believe, could genuinely result in breakthroughs that directly improve survival and quality of life. I am tremendously excited to be part of the Rubius board and Flagship team," said David Epstein.

"Genetically-modified red blood cells hold incredible potential to provide superior treatment for many diseases, from rare to common conditions. Rubius is working on an exciting platform that could bring forward multiple therapies and modalities that improve and save lives," said Dr. Straight Nissen. "I am looking forward to growing the company and helping Rubius harness its platform to the fullest."

Commenting on the hires, Rubius Founding CEO and Flagship Partner Avak Kahvejian said, "The past two years of development at Rubius have shown the vast scope and applicability of Red-Cell Therapeutics. I look forward to continuing with this exciting venture in a new capacity as Chief Innovation Officer as Torben and David lead the transformation of Rubius into a development stage company in the near future."

About Rubius Therapeutics
Rubius Therapeutics is developing Red-Cell Therapeutics TM (RCTs) as a new treatment modality to address a wide array of indications including cancer, autoimmune disease, rare disease and metabolic disease. RCTs are enucleated cell-based therapies that can be engineered to have diverse activities. The company has established a platform for the rapid design, generation, testing and development of RCT products. The company was founded and launched by Flagship VentureLabs, the innovation foundry of Flagship Pioneering.