On August 27, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2018 Morgan Stanley 16th Annual Global Healthcare Conference on Friday, September 14th, at The Grand Hyatt Hotel in New York (Press release, Johnson & Johnson, AUG 27, 2018, View Source [SID1234529398]). Alex Gorsky, Chairman and Chief Executive Officer will represent the Company in a session scheduled at 9:55 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately two hours after the live webcast.

On August 27, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the European Commission approved Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) (Press release, Jazz Pharmaceuticals, AUG 27, 2018, View Source;p=RssLanding&cat=news&id=2364833 [SID1234529175]). Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.

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"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase 3 study of older adult patients with newly diagnosed therapy- related AML or AML with myelodysplasia-related changes," said Daniel Swisher, president and chief operating officer at Jazz Pharmaceuticals. "Jazz is committed to making Vyxeos available to patients in the EU and we will now pursue rolling launches of Vyxeos across the European Union on a country-by-country basis as pricing and reimbursement decisions are made."

The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.

"AML is a rare cancer in Europe and patients with therapy-related AML or AML with myelodysplasia-related changes have a particularly poor prognosis compared to people with other forms of leukaemia," said Professor Charles Craddock CBE, Academic Director, Centre for Clinical Haematology at University Hospitals Birmingham NHS Foundation Trust. "Vyxeos is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union."

The Marketing Authorisation Application (MAA) for Vyxeos included clinical data from five studies, including the pivotal Phase 3 study. Data from the Phase 3 study was published in the Journal of Clinical Oncology in July 2018. The study evaluated the efficacy and safety of Vyxeos compared to 7+3 chemotherapy in 309 patients 60 to 75 years of age with newly diagnosed t-AML or AML-MRC, a rapidly progressing and life-threatening blood cancer.

The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (2-sided p-value = 0.005; HR [95% confidence interval] = 0.69 [0.52, 0.90]). Vyxeos was also associated with a significantly higher remission rate than 7+3 with a complete response rate of 37% versus 26%; p=0.036. In addition, the overall rate of hematopoietic stem cell transplant (HSCT) was 34% in the Vyxeos arm and 25% in the 7+3 arm. The reported adverse reactions with Vyxeos were generally consistent with the known safety profile of cytarabine and daunorubicin therapy.

The incidences of non-haematologic adverse events were comparable between arms, despite a longer treatment phase and prolonged time to neutrophil and platelet count recovery with Vyxeos. Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the Vyxeos arm and 0.7% of patients in the control arm. Six percent of patients in both the Vyxeos and control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease. The most common adverse reactions (incidence ≥ 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.

About Vyxeos
Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion is an advanced liposomal formulation that delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time. Based on data in animals, Vyxeos liposomes accumulate and persist in high concentration in the bone marrow, where they are preferentially taken up intact by leukaemia cells. Vyxeos is the first product developed with the company’s proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received Orphan Drug Designation (ODD) by the European Commission in January 2012 with retention of the ODD reaffirmed in July 2018 following assessment by the Committee for Orphan Medicinal Products (COMP) and by the U.S. Food and Drug Administration (FDA) in September 2008 for the treatment of AML. Vyxeos received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in June 2018 recommending marketing authorisation for Vyxeos. Vyxeos received U.S. FDA approval and orphan drug exclusivity in August 2017.

About CombiPlex
The CombiPlex proprietary technology enables the design and rapid evaluation of various combinations of therapies to deliver enhanced anti-cancer activity. The CombiPlex technology seeks to identify the most synergistic ratio of drugs in vitro and fix this ratio in a nano-scale delivery complex that maintains the synergistic combination after administration. CombiPlex utilizes two proprietary nano-scale delivery platforms: liposomes to control the release and distribution of water-soluble drugs and drugs that are both water- and fat-soluble (amphipathic), and nanoparticles to control the release and distribution of non-water-soluble (hydrophobic) drugs.

About AML
Acute myeloid leukaemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body’s new blood cells. AML cells crowd out healthy cells and move into the bloodstream to spread cancer to other parts of the body. 1 The median age at diagnosis is 68 years old, with rising age associated with a progressively worsening prognosis.2-3 There is also a reduced tolerance for intensive chemotherapy as patients age.4 Patients with t-AML or AML-MRC have few treatment options and some of the lowest survival rates compared to people with other forms of leukaemia.5-6 A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.7

On August 27, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported its participation in three upcoming investor conferences. The three conferences are (Press release, TESARO, AUG 27, 2018, View Source [SID1234529154]):

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Citi’s 13th Annual Biotech Day at the Four Seasons Hotel in Boston on Wednesday, September 5, 2018.Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will discuss the Company’s business and development programs in an analyst-led fireside chat, and importantly, will review recent progress of the Company’s lung cancer strategy for ZEJULA and its immuno-oncology programs. The fireside chat will be webcast on September 5 from 12:15 to 1:15 PM ET, and TESARO will also host meetings with investors.

The Baird 2018 Global Healthcare Conference at the InterContinental New York Barclay in New York City on Wednesday, September 5. Tim Pearson, Executive Vice President and CFO of TESARO, and Grant Bogle, Senior Vice President and Chief Commercial Officer of TESARO, are scheduled to participate in an analyst-led fireside chat from 12:15 to 12:45 PM ET on September 5, and will also host meetings with investors.

The Wells Fargo Global Healthcare Conference at the Westin Copley Place in Boston on Thursday, September 6. Lonnie Moulder and Mary Lynne Hedley, Ph.D., are scheduled to present an overview of the Company’s business and development programs at 11:30 AM ET on September 6, and will also host meetings with investors.
Live webcasts of the presentations at the Citi, Baird, and Wells Fargo conferences will be available by visiting the Investors section of the TESARO website at www.tesarobio.com. Archived replays of these webcasts will be available on the Company’s website for 14 days following the conferences.

On August 27, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported it has commenced Stage 2 of the company’s Phase 2 trial of prexigebersen in acute myeloid
leukemia (Press release, Bio-Path Holdings, AUG 27, 2018, View Source [SID1234529151]).

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The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than would be expected with LDAC alone in this de
novo patient population.

"We are delighted to announce the expansion of our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia using a dosing schedule that administers a greater amount of prexigebersen to the patient prior to commencing LDAC dosing than in the first part of the trial. Based on compelling new data, we are also
including a cohort of patients who will be treated with a combination of prexigebersen and decitabine," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Results from the planned interim analysis of the first part of this Phase 2 study were particularly encouraging, with 47% of treated patients demonstrating a response. Consequently, we remain enthusiastic about prexigebersen’s potential and believe these protocol changes
will optimize the drug’s impact in AML cancer patients with high unmet need."

Based on recommendations from the study’s principal investigators, the Company amended the study’s protocol to change the dosing schedule in Stage 2 to that used in the Phase 1b study in relapsed and refractory AML patients as announced in April 2018. In the Phase 1b study, a greater amount of prexigebersen was administered prior to LDAC
treatment starting at day 10 versus LDAC treatment starting on day four as was the case in Stage 1 of the current Phase 2 study. Importantly, Stage 2 of the study includes a cohort of patients treated in combination with decitabine based on relatively new and positive data with this compound. Bio-Path plans to perform an interim analysis of each cohort once approximately 19 evaluable patients are reached in the cohort.

As previously announced, a planned interim analysis of Stage 1 of the study was performed on 17 evaluable patients, with four patients achieving complete responses and four patients achieving stable disease, including one patient achieving a morphologic leukemia free state and one patient who showed significantly reduced bone marrow blasts. In total, 47% of the evaluable patients showed some form of response, including stable disease, to
the combination treatment. The average patient in Stage 1 of the study was 73.5 years of age

On August 27, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), reported that it has entered into a strategic collaboration agreement with Genentech, a member of the Roche Group, to develop and commercialize novel NK cell engager-based
immunotherapeutics to treat multiple cancers (Press release, Affimed, AUG 27, 2018, View Source [SID1234529117]).

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Affimed will apply its proprietary Redirected Optimized Cell Killing (ROCK) platform, which enables the generation of both NK cell and T cell-engaging antibodies, to discover and advance innate immune cell engager-based immunotherapeutics of interest to Genentech. The collaboration includes candidate products generated from Affimed’s ROCK platform and multiple undisclosed solid and hematologic tumor targets. Affimed and Genentech will collaborate on the discovery, early research and late-stage research phases. Genentech will be responsible for clinical
development and commercialization worldwide.

"We are incredibly excited to work with Genentech, a leader in oncology with a long history of excellence in the discovery and development of medicines to treat cancer," said Dr. Adi Hoess, Affimed’s CEO. "This strategic partnership marks an important step on our path to leverage the full potential of innate immune cells in oncology."

Under the terms of the agreement, Affimed will receive $96 million in an initial upfront payment and other near-term committed funding. Affimed may be eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust
Improvements Act, and closing is expected to occur in the third quarter of 2018.

"This collaboration is based on Affimed’s innate immune cell drug discovery and development expertise and our team’s deep understanding of cancer immunology," commented James Sabry, M.D., Ph.D., Global Head of Partnering, Roche. "Our partnership with Affimed provides an opportunity to enhance our existing efforts to understand how the immune system can be activated to help people living with cancer."

About Affimed’s ROCK Platform
Affimed’s proprietary, versatile and modular ROCK (Redirected Optimized Cell Killing) platform enables the generation of first-in-class, tetravalent, multi-specific immune cell engagers. Based on its modularity, ROCK allows for antibody engineering of highly customizable NK and T cell engagers to generate clinical candidates tailored to multiple disease indications and settings, including generation of molecules against validated oncology targets to address the limitations of existing treatments of hematologic and solid tumors.