COHERUS BIOSCIENCES ANNOUNCES FDA ACCEPTANCE OF 351(K) BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR CHS-1701 (PEGFILGRASTIM BIOSIMILAR CANDIDATE)

On October 6, 2016 Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, reported that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, OCT 6, 2016, View Source;p=irol-newsArticle&ID=2210016 [SID:SID1234515636]).

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The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.

Cerulean Announces Data Presentations at the 2016 European Society for Medical Oncology Annual Meeting

On October 6, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported it will present clinical data from its CRLX101 and CRLX301 programs at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Copenhagen, Denmark on October 7-11 (Press release, Cerulean Pharma, OCT 6, 2016, View Source [SID:SID1234515635]). Details of the ESMO (Free ESMO Whitepaper) poster presentations are as follows:

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Title: A phase 1b/2 study of the nanoparticle-drug conjugate CRLX101 in combination with weekly paclitaxel in patients with platinum-resistant ovarian cancer
Date and time: Saturday, October 8 – 13:00 to 14:00 pm Central European Time
Abstract number: 1483
Location: Hall E
Poster board number: 864P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This Phase 1b/2 trial evaluates the potential synergy of CRLX101, a topoisomerase 1 inhibitor, in combination with paclitaxel, a standard of care taxane, in patients with platinum-resistant ovarian cancer (PROC). In this trial, CRLX101 is dosed every other week at 12 or 15 mg/m2 in conjunction with weekly paclitaxel at 80 mg/m2. Data from the nine patients in the Phase 1b portion of the trial suggest CRLX101 administered every other week in combination with weekly paclitaxel demonstrate antitumor activity. Additionally, the combination has been generally well tolerated with no dose-limiting toxicities reported. Early data from the first nine patients in the Phase 2 portion of the trial also show activity and tolerability.

Title: Evaluation of weekly dosing of CRLX101 alone and in combination with bevacizumab in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1781
Location: Hall E
Poster board number: 393P
Summary: CRLX101, an investigational NDC containing the payload camptothecin, has been shown to be active in different tumor types as a topoisomerase 1 inhibitor. This study evaluated the dosing and tolerability of a weekly dosing schedule of CRLX101 alone and in combination with bevacizumab. In arm 1, CRLX101 was administered intravenously as a monotherapy at 12 or 15 mg/m2 weekly; in arm 2, this same dosing regimen was administered in combination with every other week dosing of bevacizumab at 10 mg/kg. In arm 1, the maximum tolerated dose for CRLX101 weekly monotherapy is 15 mg/m2. In arm 2, the maximum tolerated dose for CRLX101 in combination with bevacizumab is either 12 mg/m2 weekly or 15 mg/m2 for 3 of 4 weeks. Partial responses were observed in three patients. There was increased cystitis, but no new safety concerns were observed.

Title: Pharmacokinetics of CRLX101 administered weekly in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1767
Location: Hall E
Poster board number: 394P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This study evaluated the pharmacokinetics of CRLX101 in patients with advanced solid tumors. CRLX101 was administered intravenously at 12 or 15 mg/m2 on a weekly dosing schedule. The data suggest CRLX101 exhibits high drug retention in the plasma, slow clearance and controlled slow release of camptothecin from the NDC without drug accumulation, supporting weekly dosing of CRLX101 at 15 mg/m2, which represents a 100% increase in dose intensity when compared to a dosing schedule of every other week.

Title: A dose-escalation study of weekly intravenous CRLX301 in patients with advanced solid tumor malignancies
Poster presentation: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1793
Location: Hall E
Poster board number: 413Tip
Summary: CRLX301 is an investigational NDC containing the payload docetaxel currently being investigated in a Phase 1/2a trial of patients with advanced solid tumors. The first portion of the trial determined the maximum tolerated dose for IV CRLX301 administered every three weeks to be 75 mg/m2. The second portion of the trial is evaluating the maximum tolerated dose for weekly administration of CRLX301. Based on data from the first portion of this trial, the weekly starting dose was 25 mg/m2. This dose escalating trial also evaluates safety, PK and antitumor activity.

Electronic copies of the posters will be available upon request following ESMO (Free ESMO Whitepaper) by emailing [email protected].

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication. CRLX101 has shown activity in multiple tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 400 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer, Fast Track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

About CRLX301

CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in Phase 1/2a clinical development.

CRT and University of Manchester receive success payment from GlaxoSmithKline for cancer epigenetics research collaboration

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

CRT and University of Manchester receive success payment from GlaxoSmithKline for cancer epigenetics research collaboration

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

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Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."

Cellectar Biosciences Announces Enrollment of First Patient into Third Cohort of Its Phase I Clinical Study of CLR 131 in Multiple Myeloma

On October 6, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported the enrollment of the first patient into Cohort 3 of the company’s Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma (Filing, 8-K, Cellectar Biosciences, OCT 6, 2016, View Source [SID:SID1234515634]).

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Cohort 3 of the Phase 1 study of CLR 131 will consist of at least three patients with relapsed or refractory multiple myeloma that have been treated previously with at least one proteasome inhibitor and one immunomodulatory agent. Patients in this cohort will receive 25mCi/m2 of CLR 131 as a single dose infusion, which represents a 33 percent increase in the dose from the previous cohort.

"We are highly encouraged with CLR 131’s safety profile, overall clinical activity and PFS observed from a single dose infusion, particularly in such a heavily pretreated patient population. The PFS demonstrated in Cohort 2 already compares favorably to other treatments that require multiple doses, either daily or weekly," said Jim Caruso, president and CEO of Cellectar Biosciences. "We plan to accelerate Cohort 3 enrollment as well as initiate a Phase II study in the first half of 2017 to further define the clinical benefits of this novel compound in selected hematologic malignancies with limited treatment options."

In this multi-center, open label Phase I dose escalation study, CLR 131 is administered as a single dose, 30-minute infusion. The primary study objective is to characterize the safety and tolerability of CLR 131 in patients with relapsed or refractory multiple myeloma. Secondary study objectives include establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity, including progression-free survival (PFS) and efficacy endpoints.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first half of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides patients with a novel approach to treating hematological diseases and may provide patients with an improvement in progression-free survival and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.