Acorda Therapeutics to Present at the Leerink Partners 7th Annual Global Healthcare Conference

On February 8, 2018 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that Ron Cohen, M.D., Acorda’s President and CEO, will present at the Leerink Global Healthcare Conference on Thursday, February 15 at 1:30pm EST (Press release, Acorda Therapeutics, FEB 8, 2018, View Source [SID1234523810]).

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A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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ERYTECH to Present at the 2018 BIO CEO & Investor Conference

On February 8, 2018 ERYTECH Pharma (Euronext Paris: ERYP, Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Gil Beyen, Chief Executive Officer, will present at the 2018 BIO CEO & Investor Conference, being held February 12-13, 2018 at the New York Marriott Marquis in New York City (Press release, ERYtech Pharma, FEB 8, 2018, View Source;p=RssLanding&cat=news&id=2331180 [SID1234523801]).

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Mr. Beyen will deliver ERYTECH’s presentation detailing the Company’s ERYCAPS platform and targeted treatment applications.

Details for the presentation are below:

Event: 2018 BIO CEO & Investor Conference

Date: Tuesday, February 13, 2018

Time: 2:00 pm ET

Presentation Room: Odets Room

Mr. Beyen, CEO, will be available for one-on-one meetings on February 13th, 2018. To arrange a meeting with management, please contact Naomi Eichenbaum at [email protected] or visit the BIO CEO One-on-One Partnering webpage to schedule a meeting directly.

10-Q – Quarterly report [Sections 13 or 15(d)]

Myriad Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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TC BioPharm and the NIPRO Corporation Announce Strategic Programme Co-Developing a Novel Gamma-Delta CAR-T Product to Treat Cancer

On February 7, 2018 The NIPRO Corporation (TSE: 8086) and TC BioPharm Ltd (TCB), reported that they have formed a strategic collaboration to co-develop a novel immunotherapy product using TCB’s safe CAR-T platform, based on unique properties of modified gamma delta (γδ) T cells to selectively target cancer whilst leaving healthy cells untouched (Press release, TC Biopharm, FEB 7, 2018, http://www.tcbiopharm.com/index.php/component/content/article/96 [SID1234524275]). TCB intends to use this novel platform to develop new CAR-based immunotherapies, with the aim of treating a broad range of cancers and major viral disease.

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"TCB’s world-class GMP-compliant manufacturing facility and experienced in-house clinical team will allow us to leverage patient treatment at established cancer therapy centers throughout Europe", said TCB’s Chief Operating Officer, Angela Scott, "since commencing operations in 2014, we have treated numerous cancer patients successfully with unmodified gamma-delta T cells and built sufficient infrastructure to progress our innovative proprietary next-generation CAR-T towards phase I studies during 2018."

The NIPRO Corporation will provide non-dilutive funds in the form of up-front fees, milestone payments and research-support to progress elements of TCB’s CAR-T program to clinical studies. NIPRO cash will provide the Osaka-based company with an exclusive right to sell, and distribute CAR-T product worldwide.

TCB and NIPRO will co-develop an autologous gamma-delta CAR-T therapy directed against CD19, which is expressed in several B cell tumors such as multiple myeloma and lymphoma. Preclinical studies developing the product will be supported by a Scottish Enterprise ‘seek-and-solve’ grant which will provide £2.7m of additional non-dilutive funding. Commenting on both the grant and collaboration, Jim Watson, director of Innovation & Enterprise Services at Scottish Enterprise, said, "This particular grant is designed to encourage investment in R&D and inspire Scottish companies to partner with international players to expand market reach, it’s fantastic to see a pre-revenue company like TCB collaborating with NIPRO. TCB’s strong international mindset will help the company reap benefits of this collaboration – both in terms of financial support and the market knowledge that NIPRO brings to the table. The Seek and Solve project will allow TCB to accelerate route to market, meaning potentially quicker returns for the Scottish economy, helping establish TCB as a global leader in cancer-specific cell therapies."

TCB’s proprietary ImmuniCAR platform uses the innate ability of gamma-delta T cells to target cancer, this has allowed the Company develop a wide-range of innovative safe therapies designed to treat a variety of tumours without toxic side-effects seen in many current CAR-T products. NIPRO’s Managing Director, Toshiaki Masuda, said, "The collaboration with TC Biopharm – who has stand-alone technology in developing CAR-T products; and NIPRO – an experienced company in manufacturing cell culture products, will establish the safe and innovative cancer therapeutics for practical use in the global market."

Head of the Department of Oncology at the University of Oxford, Professor Mark Middleton noted that, "the combination of gamma delta and CAR T cell therapy gives us the opportunity to test this promising new treatment in patients for the first time.’ He added that, ‘those of us who treat solid tumors have followed use of CAR T cells in hematological malignancy with great interest, this exciting collaboration between TCB and NIPRO has potential to overcome safety challenges when developing such treatments in patients with solid tumors".

The collaboration with NIPRO is TCB’s first major pharma deal centred in Asia, and represents a strong endorsement of the therapeutic approach. Remarking on this significant milestone for the Company, Chief Executive Dr Michael Leek iterated that, "This commercial collaboration represents the cutting-edge of cell-based immunotherapy, providing clinicians and cancer patients access to next-generation, safe, innovative oncology products, we are privileged to be working alongside the NIPRO Corporation as they continue to build a formidable presence in the regenerative medicine sector ".

Chief Business Officer Dr Artin Moussavi added, "TCB has been very active over the last 12 months raising over $35m cash, sealing long-term commercial relationships with a potential combined pre-market income over $1bn. The NIPRO collaboration is our latest such deal, representing a joint-effort to build a significant immune-oncology business in Japan and Asia".

CELGENE CORPORATION ANNOUNCES POSITIVE RESULTS FROM THE PIVOTAL PHASE III ‘OPTIMISMM’ STUDY OF POMALYST/IMNOVID® FOR THE TREATMENT OF RELAPSED OR REFRACTORY MULTIPLE MYELOMA

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 7, 2018, View Source [SID1234523791]).

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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.