On October 24, 2016 Bristol-Myers Squibb’s (NYSE:BMY) reported that Coast 2 Coast 4 Cancer has raised more than $1,050,000 to support Stand Up To Cancer’s collaborative cancer research programs (Press release, Bristol-Myers Squibb, OCT 24, 2016, View Source [SID1234515983]). In this third year of the relay, six teams of BMS employees — with 80 employees in total — set out on September 7 to bike 2,800 miles in 21 days from the Oregon Coast to the New Jersey shore to support Stand Up To Cancer, whose collaborative "Dream Teams" of scientific researchers are working together to accelerate cancer research and to provide innovative treatments to patients faster. Bristol-Myers Squibb matched all money raised by the cyclists, dollar-for-dollar, up to $500,000.

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"Our teams of cyclists demonstrated what drives all of us at Bristol-Myers Squibb every day: to challenge ourselves individually and together to fight cancer. They woke before dawn in towns far from home to bike along roads stretching across the continent with one thing in mind: to raise money and awareness to accelerate cancer research," said Chris Boerner, PhD, president and head of U.S. commercial operations, Bristol-Myers Squibb, who rode several legs of this year’s relay himself. "I’m deeply proud of these riders, many of whom have never seriously biked before. Coast 2 Coast 4 Cancer is an enormously meaningful event for us all because we are devoted to fighting for patients."

One of this year’s riders, Whitney Melton, reflected, "There were moments on the road that were very hard to push through, to be honest. We all got tired and we all had to rely on our teammates to get us over that next hill in 90 degree weather. But every time, we prevailed and it was because of the inspiring examples of people facing cancer. We rode for them."

"The Coast 2 Coast 4 Cancer Ride is so moving because of the deeply personal commitment these 80 individuals make, one of whom is a cancer patient," said Katie Couric, Yahoo Global News anchor and Stand Up To Cancer co-founder. "Stand Up To Cancer is about taking collaboration to new levels. Working as teams, they rode in honor of friends and family who’ve contended with this terrible disease. The monies pledged in connection with the ride — and generously matched by Bristol-Myers Squibb — will fund innovative research, enabling more cancer patients to become long-term survivors. On behalf of all of us at Stand Up, I want to thank these Bristol-Myers Squibb employees and everyone at the company for this extraordinary grassroots support of our efforts."

On October 24, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box,reported that Manuel Hidalgo, MD, PhD has agreed to serve as the Principal Investigator (PI) for PharmaCyte’s clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, OCT 24, 2016, View Source [SID1234515987]). Dr. Hidalgo is an internationally respected oncologist and a recognized authority in the treatment of pancreatic cancer. Currently, he serves as Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and Chief of the Division of Hematology-Oncology at the prestigious Beth Israel Deaconess Medical Center in Boston and is a member of PharmaCyte’s Medical and Scientific Advisory Board.

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Commenting on his selection, Dr. Hidalgo said, "I am pleased to have been selected to be the PI of this important clinical trial, having been a part of its overall design. I have been involved in numerous successful clinical trials and will be drawing on that experience in this one. I believe that the Cell-in-Box plus low dose ifosfamide combination chemotherapy may well prove to be of great value for the development of new therapies for pancreas and other solid tumor cancers. This novel technology has exceedingly broad application. I am looking forward to working with other clinical oncologists in the U.S. and in Europe to insure that PharmaCyte’s therapy meets the critical unmet medical need the study is designed to address."

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, also commented, "As we close in on an engagement date with the FDA, we are extremely pleased and fortunate that Dr. Hidalgo has agreed to assume the important position of PI for our clinical trial in patients with LAPC. The available treatments of this disease are only marginally effective. Dr. Hidalgo is well known around the world as an expert in successfully developing therapies for pancreatic cancer, the third deadliest of all forms of cancer. Dr. Hidalgo’s acceptance of the role of PI for our clinical trial lends credence to our belief that PharmaCyte’s therapy will be successful in treating patients with LAPC."

In his role as PI, or "general supervisor" for how the trial is conducted, Dr. Hidalgo will be responsible for ensuring that all of the clinical trial study sites conduct their studies in accordance with the clinical trial protocol and that all associated procedures and regulations are followed by those study sites. As PI, Dr. Hidalgo will also play a major role in developing the final clinical trial report that will be presented to the FDA, which summarizes and analyzes the trial results from all of the study sites.

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane plus gemcitabine. The study will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.

On October 24, 2016 ApeX Therapeutics, a clinical stage biotechnology company focused on developing novel compounds to treat cancer, reported that it has changed its corporate name to Apexian Pharmaceuticals, Inc (Press release, Apexian Pharmaceuticals, OCT 24, 2016, View Source [SID1234517417]). As part of this name change, the company has also launched a new corporate website at www.ApexianPharma.com and a new Twitter handle @ApexianPharma.

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"Now is the time to acknowledge that our key priorities are increasingly focused on advancing our innovative oncology molecules through the clinic" stated Steve Carchedi, President and CEO of Apexian Pharmaceuticals, "We are committed to developing innovative new medicines to extend and enhance the lives of cancer patients. The name change to Apexian Pharmaceuticals is indicative of the great progress we’ve made in advancing our APE1/Ref-1 targeted drug candidates. Specifically, our recent IND acceptance by the FDA for APX3330 highlights our focus on bringing safe and effective medicines into the clinic."

ApeX Therapeutics recently announced acceptance by the U.S. Food and Drug Administration of an Investigational New Drug Application to evaluate the tolerability and anti-tumor effects of APX3330, a small molecule in development to treat late stage cancer.

On October 24, 2016 Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported that it will be presenting data from its Phase 1 clinical trial of CLR 131 in relapsed or refractory multiple myeloma at a poster session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition in San Diego (Press release, Cellectar Biosciences, OCT 24, 2016, View Source [SID1234515977]).

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Poster: #4485, "Phase 1, Open-Label, Dose Escalation Study of I-131-CLR1404 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)"
Presenter: Sikander Ailawadhi, MD, vice chair, clinical practice, Division of Hematology/Oncology, Department of Medicine at the Mayo Clinic, Florida,
Session/Date/Time: #653 — "Myeloma: Therapy, Excluding Transplantation,"
December 5, 2016, 6:00pm — 8:00pm PT
Location: San Diego Convention Center in Hall GH

"The ASH (Free ASH Whitepaper) conference is an important and prestigious event that provides a unique opportunity to share some of the encouraging data from our ongoing Phase 1 study of CLR 131 for the treatment of relapsing or refractory multiple myeloma," said Jim Caruso, president and CEO of Cellectar Biosciences. "Relapse/refractory multiple myeloma is a difficult to manage hematologic cancer that continues to require new therapeutic approaches and CLR 131 potentially offers patients a novel treatment alternative."

Abstracts are expected to be available at www.hematology.org on November 3, 2016 at 9:00 AM ET. In addition, the abstracts will be published online in the December 3, 2016 supplemental volume of Blood.

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.

As previously disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on November 15, 2013, CTI BioPharma Corp. (the "Company") entered into a Development, Commercialization and License Agreement (as amended, the "License Agreement") with Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA (collectively, "Baxter") on November 14, 2013 (Filing, 8-K, CTI BioPharma, OCT 24, 2016, View Source [SID1234516747]). Baxalta Incorporated and its affiliates (collectively, "Baxalta") were assigned Baxter’s rights and obligations under the License Agreement. Pursuant to the License Agreement, among other things, the Company granted to Baxalta, as successor to Baxter, a license with respect to pacritinib, Baxalta and the Company agreed to collaborate as to the development and commercialization of pacritinib, and the Company obtained the contingent right to receive certain milestone and royalty payments. As previously disclosed in a Current Report on Form 8-K filed with the SEC on June 9, 2015, the License Agreement was amended on June 5, 2015. Baxalta was subsequently acquired by Shire plc ("Shire"). As of June 3, 2016, Shire beneficially owned approximately 5.5% of the Company’s common stock.
As previously disclosed in a Current Report on Form 8-K filed with the SEC on September 19, 2016, on September 19, 2016, the Company entered into a letter agreement (the "First Letter Agreement") amending the License Agreement. The First Letter Agreement provided that if the Company and Baxalta were unable to negotiate and execute within 30 days (the "Letter Agreement Deadline") a definitive agreement reflecting the terms contained within the non-binding term sheet agreed to between the parties on September 19, 2016 (the "Term Sheet") regarding the termination of the License Agreement and the return of the asset, then for purposes of computing any applicable termination periods and deadlines under Section 15.2 of the License Agreement, September 13, 2016 would have been deemed the effective date of the notice of termination of the License Agreement received by the Company from Baxalta on September 13, 2016. On October 19, 2016, the Company and Baxalta entered into a letter agreement (the "Second Letter Agreement") extending the Letter Agreement Deadline to 5:00pm Eastern Time on October 21, 2016.
Prior to the Letter Agreement Deadline, on October 21, 2016, the Company and Baxalta entered into an Asset Return and Termination Agreement (the "Termination Agreement"). Pursuant to the Termination Agreement, the Company has reacquired worldwide rights for the development and commercialization of pacritinib, and the License Agreement has been terminated in its entirety, provided that certain customary provisions in the License Agreement, including those pertaining to confidentiality and indemnification, survive termination. In addition, Baxalta will pay to the Company a one-time cash payment in the amount of approximately $10.3 million as reimbursement for certain expenses incurred or to be incurred.
The Company in exchange has agreed to provide a one-time payment to Baxalta, upon the first regulatory approval or any pricing and reimbursement approvals of a product containing pacritinib, in the amount of approximately $10.3 million which represents certain amounts paid by Baxalta for the benefit of the pacritinib program manufacturing efforts. The Company has also agreed not to transfer, license, sublicense or otherwise grant rights with respect to intellectual property of pacritinib unless the transferee/licensee/sublicensee agrees to be bound by the terms of the Termination Agreement. The Company has not acquired a trademark owned by Shire.
The foregoing descriptions of the Second Letter Agreement and Termination Agreement do not purport to be complete and are subject to, and qualified in their entirety by, the full text of the Second Letter Agreement and Termination Agreement, copies of which are attached hereto as Exhibit 10.1 and 10.2 and incorporated herein by reference.

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