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 [SID1234529079]).

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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."

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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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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 DURECT Corporation (Nasdaq: DRRX) announced today that James E. Brown, President and CEO, will be presenting at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., on Thursday, September 6 at 9:10 a.m. Eastern Time (Press release, DURECT, AUG 27, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2364967 [SID1234529080]). The conference is being held at the St. Regis Hotel in New York City. Institutional investors and analysts that are attending the conference may request a one-on-one meeting through the conference coordinators.

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A live audio webcast of the presentation will be available by accessing View Source

A live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section

On August 27, 2018 CStone Pharmaceuticals (CStone) reported that its IND application for CS1002, an investigational cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, has been approved by the China National Drug Administration (CNDA) (Press release, CStone Pharmaceauticals, AUG 27, 2018, View Source [SID1234529081]).

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"We are very pleased to obtain our third China IND approval of our investigational drugs in 2018. CStone already initiated CS1002’s Phase I clinical trial in Australia and dosed the first patient in May." said Dr. Frank Jiang, Chairman and Chief Executive Officer of CStone. " With today’s IND approval of CS1002, CStone is currently the only biopharmaceutical company in China that has all three immuno-oncology ‘backbone’ products (anti-PD-L1, anti-PD-1, and anti-CTLA-4 mAbs) in the clinical stage."

"CS1002 has demonstrated a high level of selectivity, specificity and high affinity to CTLA-4 in preclinical studies," said Dr. Jingrong Li, Senior Vice President of Product Development and Manufacture at CStone. "Combination therapies of anti-CTLA-4 mAb with anti-PD-1 mAb have demonstrated promising efficacy in multiple tumor types by global clinical trials. CStone will explore combination potentials between CS1002 and other drug candidates in our pipeline to provide better therapies for cancer patients in China and beyond."

As of today, CStone has built a portfolio of 14 oncology products, 8 of which are at clinical development stage, including 3 in registration studies. CS1001, China’s first fully human, full-length anti-PD-L1 mAb developed by CStone, has entered pivotal Phase II clinical studies, and will potentially become one of the first locally-developed anti-PD-L1 cancer drugs launched in China. In June 2018, CStone announced the exclusive collaboration and license agreements with Blueprint Medicine and Agios Pharmaceuticals. With these two deals, CStone in-licensed 4 post proof of concept assets, including ivosidenib, which is recently approved by U.S. FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, and avapritinib, which has entered global Phase III clinical studies.

About the CTLA-4 pathway

Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligands, B7.1 and B7.2, a pathway also used by tumor cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumor immune responses. CTLA-4 provides a new immuno-therapeutic approach to a number of diseases, including tumors.

Presently, Bristol-Myers Squibb’s Yervoy (ipilimumab) is the only anti-CTLA-4 antibody to gain a market approval worldwide, although Yervoy has not yet been approved in China. Pre-clinical tests have shown that CS1002 has a relatively strong affinity to CTLA-4 and is expected to match Yervoy in terms of efficacy.