On April 18, 2016 Heron Therapeutics, Inc. (NASDAQ: HRTX), reported that the U.S. Food and Drug Administration (FDA) has provided the Company with an update on its review of the New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release (Press release, Heron Therapeutics, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2158021 [SID:1234510998]). The FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.

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SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.

On April 18, 2016 Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology therapeutics, reported the final data from a study aiming to confirm the mechanism of action of Livatag, a doxorubicin loaded nanoparticle formulation based on Onxeo’s Transdrug technology in overcoming cellular resistance in hepatocellular carcinoma (HCC) (Press release, Onxeo, APR 18, 2016, View Source [SID:1234511024]). Livatag is currently being evaluated in a Phase III trial (ReLive) in patients with advanced HCC, or primary liver cancer.

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Results, presented today in a poster (Abstract #2143 / Poster #13) by Dr. Graham Dixon, PhD, Onxeo’s Chief Scientific Officer, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrated that the bio-distribution of doxorubicin Transdrug (Livatag) nanoparticles showed a preferential affinity for the liver and an increased exposure in plasma compared to free doxorubicin, together supporting the use of Livatag in the treatment of patients suffering from advanced HCC.

While evaluating the mechanism of action the study showed that the nanoparticle formulation of doxorubicin Transdrug (Livatag) entered into HCC cell lines via passive diffusion and avoided recognition by certain multi-drug resistance (MDR) proteins, (P glycoprotein 1, or Pgp) leading to major accumulation of the drug in the cells and a dramatic increase in cytotoxicity in HCC cell lines compared to free doxorubicin.

Further investigations will be performed to test if doxorubicin Transdrug (Livatag) also overcomes resistance induced by other MDR-related proteins expressed by HCC cells as well as the involvement of the Livatag nanoparticle "ion pair" in overcoming the efflux-mediated resistance.

Graham Dixon, PhD, Chief Scientific Officer of Onxeo, commented, "These are important findings as they confirm that the underlying mechanism of action of Livatag’s nanoformulation effectively accumulates doxorubicin specifically in the liver and evades tumor cell resistance mediated by multiple drug resistance MDR efflux pumps, enabling an efficacious and safe approach to cancer treatment. These results further support our ongoing Phase 3 ReLive study of Livatag for the treatment of patients with advanced HCC, for which we anticipate preliminary data readout mid-2017."

On April 18, 2016 Nektar Therapeutics (NASDAQ: NKTR) reported new preclinical data for the company’s investigational immuno-stimulatory cytokine therapy, NKTR-214, which demonstrate both its activity as a single-agent and its synergistic activity with checkpoint blockade (Press release, Nektar Therapeutics, APR 18, 2016, View Source [SID:1234510977]). In a TCR repertoire analysis conducted to assess both anti-tumor T cell clonality and T cell tumor infiltration (TIL clonality and infiltration), the combination of NKTR-214 and a checkpoint inhibitor resulted in dramatically higher increases for both parameters as compared to dual checkpoint inhibition. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, LA on April 17, 2016.

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TIL clonality establishes the frequency of T cells with a specific TCR Vβ and TCR Jβ chain usage at the tumor site, which suggests increased CD8-positive effector T cell function against the specific tumor.1 The concomitant presence of both TIL clonality and infiltration has been significantly correlated with clinical response and better survival outcomes in patients.1 In a CT26 colon carcinoma model, sequencing for TCRs in the tumor was conducted using Adaptive Biotechnologies’ ImmunoSEQ platform. Measurements of TIL clonality and infiltration were assessed seven days after treatment. NKTR-214 as a single-agent led to superior increases in TIL clonality and infiltration as compared to either anti-CTLA-4 or anti-PD-1 therapy alone. The combination of NKTR-214 with either mode of checkpoint inhibition led to superior increases in both TIL clonality and infiltration relative to the combination of CTLA-4 and PD-1 inhibitors. The highest increases occurred when NKTR-214 was added to an anti-PD-1 therapy.

"We are particularly excited by these new preclinical data for the combination of NKTR-214 with a checkpoint inhibitor which show an induced oligoclonal T cell response along with high TIL infiltration, "said Dr. Jonathan Zalevsky, Vice President of Biology at Nektar Therapeutics. "These data demonstrate that the addition of NKTR-214 to either an anti-CTLA-4 or anti-PD-1 agent could improve T cell clonality differences over checkpoint blockade therapies."

NKTR-214 is an investigational CD122-biased agonist currently in Phase 1/2 clinical development. NKTR-214 is designed to stimulate the patient’s own immune system to kill tumor cells by preferentially activating production of specific immune cells which promote tumor killing, including CD8-positive T cells and Natural Killer (NK) cells, within the tumor micro-environment. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these types of T cells.2

In studies conducted in multiple established tumor models presented at AACR (Free AACR Whitepaper), NKTR-214 demonstrated activity as both a single-agent and when co-dosed with either an anti-PD-1 agent or an anti-CTLA-4 agent. In a tumor re-challenge study conducted in an EMT6 colon carcinoma model, sequential dosing of anti-CTLA-4 followed by NKTR-214 resulted in durable immunity, with complete responders resisting a tumor re-challenge. Following a second re-challenge, 100% of the animals remained tumor-free without additional treatment.

"Our latest preclinical findings continue to show that treatment with NKTR-214 either as a single-agent or in combination with checkpoint blockade is superior to single or dual checkpoint inhibition in multiple models," added Steve Doberstein, PhD, Senior Vice President and Chief Scientific Officer of Nektar Therapeutics. "These new data emphasize the cellular mechanisms underlying the remarkable efficacy of NKTR-214 in our preclinical models of cancer."

The data presentation at AACR (Free AACR Whitepaper) entitled, "Durable antitumor activity of the CD122-biased immuno-stimulatory cytokine NKTR-214 combined with immune checkpoint blockade," can be accessed at View Source

In preclinical studies, NKTR-214 demonstrated a highly favorable mean ratio of 450:1 within the tumor micro-environment of CD8-positive effector T cells relative to regulatory T cells.3 Furthermore, the pro-drug design of NKTR-214 enables an antibody-like dosing regimen for an immuno-stimulatory cytokine.4

About the NKTR-214 Phase 1/2 Clinical Study

A Phase 1/2 clinical study is underway to evaluate NKTR-214 in patients with advanced solid tumors, including melanoma, renal cell carcinoma and non-small cell lung cancer. The first stage of this study, which is expected to be complete in the second half of 2016, is evaluating escalating doses of single-agent NKTR-214 treatment in approximately 20 patients with solid tumors. The primary objective of the first stage of the study is to evaluate the safety and efficacy of NKTR-214 and to identify a recommended Phase 2 dose. In addition, the study will also assess the immunologic effect of NKTR-214 on tumor-infiltrating lymphocytes (TILs) and other immune cells in both blood and tumor tissue, and it will also include TCR repertoire profiling. Dose expansion cohorts are planned to evaluate NKTR-214 in specific tumor types, including melanoma, renal cell carcinoma and non-small cell lung cancer.

The NKTR-214 clinical study is being conducted initially at two primary investigator sites: MD Anderson Cancer Center under Drs. Patrick Hwu and Adi Diab; and Yale Cancer Center, under Drs. Mario Sznol and Michael Hurwitz. Patients and physicians interested in the ongoing NKTR-214 Study can visit the "Clinical Trials" section of www.mdanderson.org using identifier 2015-0573 or visit View Source

On April 18, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that its fully human antibody approach to cancer therapeutics and imaging will be featured in three separate poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting currently underway in New Orleans (Press release, MabVax, APR 18, 2016, View Source [SID:1234511000]).

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"We are an innovator in using fully human antibodies to identify and combat cancer antigens that have historically proven difficult to target," said David Hansen, CEO of MabVax. "It is highly gratifying that our novel approach to harnessing the human immune system is being recognized in multiple presentations at the prestigious AACR (Free AACR Whitepaper) Annual Meeting. We are currently in a Phase I trial with our lead candidate MVT-5873 as an immunotherapy for patients with metastatic pancreatic cancer. Preparations are also underway to begin a second Phase I trial in May, which will evaluate MVT-2163 as a next-generation PET imaging agent for the diagnosis and management of pancreatic cancer. We look forward to announcing preliminary data from both trials during the third quarter of this year."

An overview of the poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting are as follows:

"Phase I trial of HuMab-5B1 (MVT-5873), a novel monoclonal antibody targeting sLea, in patients with advanced pancreatic cancer and other CA19-9 positive malignancies" (O’Reilly, et al.) is being presented today by Paul Maffuid, Ph.D., MabVax’s Executive Vice President of Research and Development. The poster provides an overview of the development and rationale for evaluating MabVax’s HuMab-5B1 antibody in patients with the CA19-9 tumor biomarker that is expressed in approximately 90% of pancreatic cancers. As background for HuMab-5B1’s clinical development, the poster covers antibody discovery, tissue binding selection, cytotoxicity profile, antitumor efficacy and pharmacokinetics. The poster features MabVax’s Phase I development platform for evaluating HuMab-5B1, which includes the ongoing trial as a therapeutic antibody in patients with pancreatic cancer, as an immune-PET imaging agent with the trial slated to begin in May 2016, and as a radioimmunotherapy targeting pancreatic and other CA19-9 positive tumors, with that trial expected to commence in early 2017.

"Improving the efficacy of pretargeted radioimmunotherapy in preclinical murine models by utilizing bioorthogonal click chemistry" (Houghton, et al) is being presented by Jacob Houghton, Ph.D., Memorial Sloan-Kettering Cancer Center, on Tuesday, April 19. Pretargeted radioimmunotherapy employs the process of attaching a radioactive label to monoclonal antibodies after the antibodies have accumulated at the target site within the body. This allows for harnessing the power of monoclonal antibodies to deliver therapeutic radiation to cancer cells while limiting high radiation doses to healthy organs. Recently an innovative approach based on the use of a radioligand and modified monoclonal antibodies has yielded PET images with high contrast while delivering only a small fraction of the radiation dose produced by directly labeled monoclonal antibodies. This novel approach also overcomes intrinsic problems with past pretargeted radioimmunotherapy such as immunogenicity and noncovalent binding. Research in the poster evaluated leveraging this novel technology for the development of a safe and effective therapy. Single-dose therapy using this approach in studies in mice bearing human xenografts cancer showed marked reduction in size or complete elimination of the tumors, while reducing the effective absorbed dose of radiation. Studies to expedite clinical translation are currently underway.

"Novel fully human anti-GD2 monoclonal antibodies with potent therapeutic activity against neuroblastoma, sarcoma and melanoma" (Ragupahti, et al.) is being presented by Wolfgang Scholz, Ph.D., MabVax’s Vice President of Antibody Discovery, on Wednesday, April 20. Gangliosides such as GD2, GD3 and GM2, are promising targets for antibody-mediated cancer therapy since they are expressed at high levels on the surface of several cancers, including neuroblastomas, sarcomas and melanomas. Monoclonal antibodies with anti-GD2 abilities have shown promising clinical outcomes in neuroblastoma and a chimeric anti-GD2 antibody was recently approved by FDA. However, murine-derived antibodies discovered so far show adverse effects that limit their clinical utility. The research presented in this poster evaluated the ability of two select fully human antibodies derived from immunized patients to overcome the limitations of murine-derived antibodies. The development candidates used in this research were derived from vaccinated, patient-produced antigen-specific antibodies with single and dual specificity for GD2 and GM2. These antibodies were shown to be very active in functional assays. Based on favorable in vitro and in vivo studies conducted in this research, the two selected fully human monoclonal antibodies merit further development efforts to evaluate potential utility for treatment of GD2-positive cancers.

On April 18, 2016 Genzyme, the specialty care global business unit of Sanofi, reported that positive new brain volume data from an ongoing clinical study of Lemtrada (alemtuzumab) will be presented at the 68th American Academy of Neurology (AAN) Annual Meeting (Press release, Genzyme, APR 18, 2016, View Source [SID:1234511027]). In addition, new data from an exploratory study will be presented which demonstrate the impact of Lemtrada on retinal nerve fibers.

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Lemtrada Investigational Brain Volume Data: Relapsing-remitting multiple sclerosis (RRMS) patients treated with interferon beta-1a in CARE-MS I and II for two years who switched to Lemtrada in the extension study experienced a reduced rate of brain volume loss over the next three years.

Median yearly brain volume loss in interferon beta-1a treated patients in year two in CARE-MS I (-0.50%) and CARE-MS II (-0.33%) was reduced in years one, two and three after switching to Lemtrada (CARE-MS I: -0.07%, -0.13%, -0.09%; CARE-MS II: 0.02%, -0.05%, -0.14%).

Lemtrada Investigational Retinal Data: A measurable improvement in retinal nerve fiber layer (RNFL) thickness was seen in 26 Lemtrada-treated RRMS patients. Over two years, the change in average RNFL thickness for all eyes was +1.5 micrometers (95% CI 0.2, 2.9; p=0.032). The observed thickening of retinal fibers may reflect protection of retinal axons in these patients.

"The Lemtrada data being presented at AAN from the ongoing extension study demonstrating slowed brain volume loss over three years are consistent with sustained effects seen in prior clinical, imaging and atrophy analyses," said Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. "In addition, given the critical importance of neuroprotection in the treatment of MS, the retinal nerve fiber data are also exciting and support further investigation."

In clinical trials, serious side effects associated with Lemtrada included infusion-associated reactions, autoimmune disorders (such as thyroid disease, autoimmune cytopenias, and nephropathies), infections and pneumonitis. Risk management programs incorporating education and monitoring help support early detection and management of key identified and potential risks. The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. (See Important Safety Information below.)

About Lemtrada (alemtuzumab)
Lemtrada is approved in more than 50 countries, with additional marketing applications under review by regulatory authorities globally. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients worldwide and 5,400 patient-years of follow-up.

In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.

The precise mechanism by which alemtuzumab exerts its therapeutic effects in MS is unknown. Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Lemtrada depletes circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes.

Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialization in multiple sclerosis. Bayer Healthcare receives contingent payments based on global sales revenue.

Lemtrada (alemtuzumab) U.S. Indication
LEMTRADA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).

IMPORTANT SAFETY INFORMATION

LEMTRADA can cause serious side effects including:

Serious autoimmune problems: Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include:

• Immune thrombocytopenia, which is when reduced platelet counts in your blood cause severe bleeding that, if not treated, may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; heavier menstrual periods than normal; bleeding from your gums or nose that is new or takes longer than usual to stop; small, scattered spots on your skin that are red, pink, or purple

• Kidney problems called anti-glomerular basement membrane disease, which can, if untreated, lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: blood in the urine (red or tea-colored urine); swelling of legs or feet; coughing up blood

It is important for you to have blood and urine tests before you receive, while you are receiving and every month, for 4 years or longer, after you receive your last LEMTRADA infusion.

Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.

• You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.

Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:

• swelling in your mouth or throat

• trouble breathing

• weakness

• fast, slow, or irregular heartbeat

• chest pain

• rash

To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them after they happen.

Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:

• new lump

• swelling in your neck

• pain in front of neck

• hoarseness or other voice changes that do not go away

• trouble swallowing or breathing

• cough that is not caused by a cold

Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.

Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:

• excessive sweating

• unexplained weight loss

• eye swelling

• nervousness

• fast heartbeat

• unexplained weight gain

• feeling cold

• worsening tiredness

• constipation

Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as:

• weakness

• chest pain

• yellowing of the skin or whites of the eyes (jaundice)

• dark urine

• fast heartbeat

Serious infections: LEMTRADA may cause you to have a serious infection while you receive and after receiving a course of treatment. Serious infections may include:

• Herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take any medicines as prescribed by your healthcare provider to reduce your chances of getting these infections.

• Tuberculosis. Your healthcare provider should check you for tuberculosis before you receive LEMTRADA.

• Hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.

These are not all the possible infections that could happen while on LEMTRADA. Call your healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:

• shortness of breath

• cough

• wheezing

• chest pain or tightness

• coughing up blood

Before receiving LEMTRADA, tell your healthcare provider if you:

• are taking a medicine called Campath (alemtuzumab)

• have bleeding, thyroid, or kidney problems

• have HIV

• have a recent history of infection

• have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine

• are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby. You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment

• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should receive LEMTRADA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.

The most common side effects of LEMTRADA include:

• rash

• headache

• thyroid problems

• fever

• swelling of your nose and throat

• nausea

• urinary tract infection

• feeling tired

• trouble sleeping

• upper respiratory infection

• herpes viral infection

• hives

• itching

• fungal infection

• joint pain

• pain in your arms or legs

• back pain

• diarrhea

• sinus infection

• mouth pain or sore throat

• tingling sensation

• dizziness

• stomach pain

• sudden redness in face, neck, or chest

• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.

You are encouraged to report side effects of prescription drugs to the FDA. Visit View Source or call 1-800-FDA-1088

Please click here for full U.S. Prescribing Information, including boxed WARNING and Medication Guide, for additional Important Safety Information