On February 6, 2018 Varian (NYSE: VAR) reported the Halcyon cancer treatment platform has received Atomic Energy Regulatory Board (AERB) Certificate for Import and Supply in India (Press release, Varian Medical Systems, FEB 6, 2018, View Source [SID1234523896]). This registration allows Varian to now market this new system in India. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT), and is well suited to treat a majority of cancer patients, offering advanced treatments for prostate, breast, head & neck, and many other forms of cancer.

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"With AERB No Objection Certificate, clinicians in India now have access to Halcyon, which is engineered to revolutionize the clinical workflow and could help advance cost-effective cancer care across the country," said Ashok Kakkar, senior managing director, Varian India. "We look forward to continuing our close collaboration with clinical partners across India and helping realize a world without fear of cancer."

Halcyon is an advanced system that was designed to improve patient comfort, simplify operations, and shorten the time from installation to first-treatment without sacrificing quality. Its quiet operating environment, which is up to 2x quieter than other systems, has been designed with the patients in mind. Additionally, Halcyon has a low couch height for easy patient access, and soft indirect ambient lighting in the gantry opening.

Featuring a 100cm gantry opening, which is larger than those on standard CT machines, Halcyon is capable of rotations 4x faster than c-arm gantries for rapid imaging and treatment. The system is also capable of fast and sharp volumetric imaging in as little as 15 seconds. With Halcyon treatments, a complex image guided IMRT plan is clinically accelerated compared to those delivered on traditional devices.

Operationally, Halcyon features a streamlined workflow that only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies. To assist in the reduction of time and construction costs from installation to first patient treatment, Halcyon comes pre-commissioned, requires less shielding than traditional systems, can fit in a vault as small as 5.9 meters (19.68 feet) x 5.539 meters (18.17 feet) x 2.743 meters (8.99 feet) high and can be installed in two weeks or less.

For more information on Halcyon visit www.varian.com/halcyon.

On February 6,2018 Redx (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that it has commenced its Phase 1/2a study for the Porcupine inhibitor RXC004 with the first patient having now been dosed at The Christie in Manchester (Press release, Redx Pharma, FEB 6, 2018, View Source [SID1234524741]).

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RXC004 is a novel, oral, potent small molecule Porcupine inhibitor, which targets the Wnt pathway, an embryonic signalling pathway that is implicated in the maintenance of cancer stem cells in multiple cancer types. This pathway is associated with tumorigenesis, metastasis, recurrence and resistance in cancer. RXC004 has now progressed into the dose-finding Phase 1 element of the study in patients with cancer. Once completed, the selected dose will then be used as a monotherapy in a larger number of patients with difficult to treat cancers (Phase 2a). In addition, the Company will look to explore the potential of RXC004 in combination with a PD-1 checkpoint inhibitor following the completion of the safety and tolerability phase of this first in man clinical trial.

As mentioned at the time of the publication of the Company’s strategic update on 6 November 2017, Redx expects initial data from the 1a segment of this trial in H2 2018.

Iain Ross, Chairman of Redx Pharma plc, commented, "We are very excited by the potential of RXC004 to make a major difference in cancer treatment, and intend to progress RXC004 initially as a monotherapy and thereafter in combination with a (PD-1) checkpoint inhibitor through clinical development. We believe that RXC004 has great potential to treat some very challenging cancers that currently have very poor prognosis and we look forward to updating the market on our progress."

On February 6, 2018 MannKind Corporation (NASDAQ:MNKD) reported that David M. Kendall, MD, will join the company as Chief Medical Officer and assume full responsibility for leading MannKind’s scientific research, clinical development, regulatory, and medical affairs activity, effective February 12 (Press release, Mannkind, FEB 6, 2018, View Source [SID1234524353]). Dr. Kendall will report directly to Michael Castagna, Pharm.D., Chief Executive Officer, and will join the company’s executive leadership team. He will be based out of MannKind’s Westlake Village, California headquarters.

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"David is a world renowned diabetes expert and represents an important addition to our executive leadership team," said Castagna, Chief Executive Officer of MannKind. "His extensive experience in diabetes research, development, and clinical care in both U.S. and international markets, will be instrumental in helping us achieve the growth potential that we believe Afrezza clearly possesses."

Dr. Kendall’s career includes over 30 years of experience in diabetes and metabolism research, clinical management, research, and policy advocacy. Most recently, he served as Research Physician and Vice President of Global Medical Affairs for Lilly Diabetes, and during that time was responsible for all medical affairs activities and guided research and development strategy across multiple geographies. In this role, he worked to re-establish Lilly Diabetes as a world class medical organization — and added to his extensive experience with both injected and mealtime insulins, as well as devices and continuous glucose monitors. Prior to joining Eli Lilly, Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. Earlier in his career, Dr. Kendall served as Medical Director at the International Diabetes Center, and the Park Nicollet Clinic, as well as at Amylin Pharmaceuticals. He received his M.D. and completed his Post Graduate Medical Training at the University of Minnesota, and earned a B.A. in Biology from St. Olaf College.

"The research and clinical response to Afrezza as a mealtime insulin supports ongoing efforts to establish this product as the standard of care for those living with type 1 or type 2 diabetes," said Dr. Kendall. "Afrezza is the only inhaled fast-acting mealtime insulin on the market, and offers the right patients a flexible, safe, and effective treatment option. I’m thrilled to join MannKind, and look forward to being part of a company that has the potential to transform the lives of so many people that are living with diabetes."

On February 6, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a phase 1 study evaluating the safety and tolerability of U3-1402, an investigational and potential first-in-class HER3-targeting antibody drug conjugate (ADC), in patients with metastatic or unresectable epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (C) whose disease has progressed while taking an EGFR tyrosine kinase inhibitor (TKI) (Press release, Daiichi Sankyo, FEB 6, 2018, View Source [SID1234523766]).

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Treatment with EGFR TKIs such as erlotinib, gefitinib, or afatinib is used as first-line therapy for metastatic EGFR-mutated NSCLC.1,2,3,4 However, patients eventually develop resistance to these treatments, typically experiencing disease progression within a year.1,2,3,4 More than half of these patients develop resistance with a secondary EGFR mutation called T790M, which may be treated with EGFR TKI osimertinib.1,2,3,4 Patients who experience disease progression following EGFR TKI treatment and who have tumors that lack the T790M mutation may be treated with chemotherapy, immunotherapy, or with investigational treatments.3,4

Expression of HER3, a member of the HER family of receptor tyrosine kinases, is believed to play a role in tumor growth and proliferation in many different types of cancer including NSCLC.5 Studies have shown that HER3 overexpression in lung cancer can also be associated with acquired resistance to other EGFR family targeted interventions such as TKIs and anti-EGFR antibody therapies.5 Patients with NSCLC with high levels of HER3 may face a significantly worse prognosis and decreased survival.5,6,7 Currently, there are no approved HER3-targeted therapies.

"While the treatment of metastatic EGFR-mutated NSCLC has significantly improved over the past decade, new treatments are needed that work to overcome resistance associated with current EGFR TKIs," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "In this study, we are exploring whether the smart delivery of chemotherapy with U3-1402 to cancer cells that express HER3 – a known feature of resistance in pre-treated EGFR-mutated NSCLC – could become a new treatment strategy for these patients."

About the Study

The global, phase 1, open label, two-part study will enroll patients with metastatic or unresectable EGFR-mutated NSCLC whose disease has progressed while taking an EGFR TKI. This includes patients who experienced disease progression during treatment with erlotinib, gefitinib, or afatinib and whose tumors have tested negative for the T790M mutation and patients who experienced disease progression during treatment with osimertinib regardless of T790M status. The primary objectives of the study are to assess the safety and tolerability of U3-1402 and determine the recommended dose for the dose expansion part of the study. The secondary objectives are to characterize the pharmacokinetics of U3-1402 and to evaluate preliminary efficacy by measuring antitumor activity of U3-1402. The study is expected to enroll more than 60 patients at approximately 17 sites globally. For more information about the study, visit ClinicalTrials.gov.

About U3-1402

Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, U3-1402 is an investigational and potential first-in-class ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, U3-1402 is a smart chemotherapy comprised of a human anti-HER3 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

U3-1402 is currently being evaluated in two phase 1 clinical studies including a phase 1/2 study for HER3-expressing metastatic or unresectable breast cancer and a phase 1 study for metastatic or unresectable EGFR-mutated NSCLC. U3-1402 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

On February 6, 2018 Celgene Corporation (NASDAQ:CELG) reported that the Phase III, randomized, open-label, international clinical study, OPTIMISMM, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the pomalidomide arm versus the comparator arm (Press release, Celgene, FEB 6, 2018, View Source [SID1234523754]).

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OPTIMISMM evaluated the efficacy and safety of POMALYST/IMNOVID (pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. It is the only phase III trial to investigate a triplet combination in patients who have all received prior lenalidomide (REVLIMID), a population for which there is a growing unmet medical need.

"The OPTIMISMM results confirm the expanding role of pomalidomide in previously treated multiple myeloma patients," said Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana Farber Cancer Institute, RJ Corman Professor of Medicine, Harvard Medical School and principal investigator of the study. "We see the PVd combination as an important step in improving care, and especially for patients previously treated with lenalidomide in this setting."

In the study, the safety profile was consistent with previously reported data. Detailed data from OPTIMISMM will be presented at future medical meetings.

The combination of POMALYST/IMNOVID, bortezomib and low-dose dexamethasone is not currently approved for use.

About POMALYST/IMNOVID

Indication

POMALYST (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a restricted distribution program called POMALYST REMS.

Venous and Arterial Thromboembolism

Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.

CONTRAINDICATIONS

Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS
Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
Blood Donation: Patients must not donate blood during treatment with POMALYST and for 1 month following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
POMALYST REMS Program: See Boxed WARNINGS
Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
Hypersensitivity Reactions: Angioedema and severe dermatologic reactions have been reported. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy.
Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
ADVERSE REACTIONS

Nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). The most common adverse reactions (≥15%) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15%) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).

DRUG INTERACTIONS

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%.

USE IN SPECIFIC POPULATIONS

Pregnancy: See Boxed WARNINGS. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436.
Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed infant, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from POMALYST, advise a nursing woman to discontinue breastfeeding during treatment with POMALYST.
Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients > 65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
Renal Impairment: Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days.
Hepatic Impairment: Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment.
Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction.

Please see full Prescribing Information, including Boxed WARNINGS.