On September 18, 2018 Provectus (OTCQB: PVCT) reported that the United States Patent and Trademark Office (USPTO) has allowed the Company’s patent application for the use of adoptive cell transfer (ACT) of PV-10-induced T cells for the treatment of solid tumor cancers (Press release, Provectus Biopharmaceuticals, SEP 18, 2018, View Source [SID1234529473]). Co-inventors include current and former members of a longstanding, PV-10-focused, translational research team at Moffitt Cancer Center (Moffitt) in Tampa, Florida, which has undertaken work in melanoma, breast cancer, and pancreatic cancer starting in 20111.

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PV-10 is Provectus’ lead investigational drug for the treatment of adult and pediatric solid tumor cancers, and is the first small molecule oncolytic immunotherapy. It is administered via intralesional injection directly into superficial or visceral tumors to elicit immunogenic cell death of these injected tumors. PV-10 is the subject of several ongoing clinical trials of adults in melanoma2,3 and cancers of the liver3,4. PV-10 has also been shown to induce cell death in pediatric solid tumor cell lines derived from relapsed neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma6.

Under the treatment concept of the allowed patent application, which is entitled "Method of Ex Vivo Enhancement of Immune Cell Activity for Cancer Immunotherapy with a Small Molecule Ablative Compound," PV-10 is injected into solid tumors and the resulting immune products – T cells trained via PV-10 oncolytic immunotherapy to be functional against treated tumors – are harvested, banked, and amplified. Amplified T cells may be administered via ACT, if needed. The allowed patent application also covers the ACT treatment of either the original patient or other immunologically-suitable patients.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Hundreds of patients have received intralesional PV-10 for a variety of solid tumor types. One of several logical paths for expanding our clinical development program is to explore harnessing functional immunologic activation produced by PV-10 oncolytic immunotherapy via the use of adoptive cell transfer. Protecting Provectus’ intellectual property in this regard was an important and necessary task."

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On September 17, 2018 Inspyr Therapeutics reported that it has entered into an agreement with Ridgeway Therapeutics Inc. in which Ridgeway will license and assume control of certain assets relating to Inspyr’s oncology development programs, including intellectual property rights relating to adenosine antagonists owned by Inspyr (Press release, Inspyr Therapeutics, SEP 17, 2018, View Source [SID1234568253]).

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Adenosine receptors have a variety of functions in the body that are expressed through four subtypes (A1, A2A, A2B, and A3). The adenosine A2 receptor subtypes (A2R) are of particular interest as potential targets for the treatment of cancer. Extremely high levels of adenosine are found locally in the tumor microenvironment. These have a direct immunosuppressive effect on T-cells and other cell types that would otherwise attack and kill cancer cells. Inhibition of the A2R has the potential to reverse these immunosuppressive effects.

Inspyr and Ridgeway will collaborate on certain aspects of development which will include a minimum level of purchased services by Ridgeway within 18 months of this transaction. In addition, Inspyr is eligible for approximately $12 million in success-based milestones from the Transaction. Inspyr is also entitled to receive royalties on all commercial sales. In the event Ridgeway sub-licenses these assets, Inspyr is entitled to share in the proceeds of any future transaction.

On September 17, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported closing of a $3 million private placement (Press release, Navidea Biopharmaceuticals, SEP 17, 2018, View Source [SID1234530336]). The Company entered into a definitive securities purchase agreement with an existing investor, John K. Scott, Jr., pursuant to which the Company received aggregate gross proceeds of $3 million in exchange for the issuance of 18,320,610 shares of the Company’s common stock, par value $0.001 per share. The securities to be issued to Mr. Scott will represent approximately 10% of the Company’s outstanding common stock after such issuance. The securities are subject to a 180-day lock-up and there are no registration rights.

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The Company will use the proceeds from the private placement for general working capital purposes, including, but not limited to, research and development, and other operating expenses.

"Our family has been a long-term shareholder since 2003 and we now have confidence in the science, management and the direction of the company. This is why we have made this investment at this time. Our intent is to the give the company additional flexibility and stability," stated John K. Scott, Jr.

"We are very happy that an existing long-term shareholder continues to show faith in the potential of Navidea as well as the future direction of the Company led by a new, streamlined management team," commented Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The ability to quickly raise $3 million without having to pay any fees, give any warrants and at a price near market was an opportunity that the Company could not pass up. It also gives the Company significant runway to allow for the planned launch of the confirmatory rheumatoid arthritis study in the upcoming quarter."

This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 17, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131 for the treatment of osteosarcoma, a rare pediatric cancer (Press release, Cellectar Biosciences, SEP 17, 2018, View Source [SID1234530175]). CLR 131 is Cellectar’s lead Phospholipid Drug Conjugate (PDC) product candidate.

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"CLR 131 has demonstrated promise as an anticancer agent in preclinical and clinical settings, and we are working now to establish its impact on various rare and deadly pediatric cancers," said John Friend, M.D., chief medical officer of Cellectar. "Cellectar is pleased to have the opportunity to work closely with the FDA on our planned Phase 1 trial for these indications and we remain committed to advancing the pediatric programs as rapidly as possible."

Since May 2018 the company has received RPDD for CLR 131 in four pediatric cancers: neuroblastoma, rhabdomyosarcoma, Ewing’s Sarcoma and, most recently, osteosarcoma. Should any of these indications reach approval, the RPDD may enable Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive Priority Review for a future NDA or BLA submission, which would reduce the FDA review time from 12 months to six months. Currently, these vouchers can also be transferred or sold to another entity. Over the last 16 months, five priority review vouchers were sold for between $110 million and $150 million each.

The FDA grants Rare Pediatric Disease Designation for diseases that primarily affect children from birth to 18 years old, and affect fewer than 200,000 persons in the U.S. This program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

About Osteosarcoma

Osteosarcoma derives from bone forming mesenchymal, or connective tissue, cells and is the most commonly diagnosed primary bone malignancy among children and adolescents. The incidence is about 4.4 cases per 1 million per year in children younger than 24 years [Mirabello 2009]. While there is a 70% cure rate among patients with localized disease, 5-year overall survival rates are approximately 20% for among patients who develop metastatic disease [Saraf 2018]. Additionally, among patients who experience disease progression or recurrence survival for is less than 30% [Chou 2005].

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2. All study doses have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On September 17, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported that it is expediting analyses of myelopreservation data from its randomized Phase 2 trial of trilaciclib in combination with chemotherapy and Tecentriq (atezolizumab) in first-line small cell lung cancer (SCLC) (Press release, G1 Therapeutics, SEP 17, 2018, View Source [SID1234529790]). Myelopreservation results from the trial will be reported in the fourth quarter of 2018.

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"We elected to make myelopreservation the primary outcome of the randomized trilaciclib/chemotherapy/Tecentriq trial based on the strength of the first-line small cell lung cancer myelopreservation results from our randomized Phase 2 trilaciclib/chemotherapy trial, which we reported in March," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, Research and Development. "This protocol amendment, which we have discussed with U.S. and European regulatory authorities, enables us to accelerate analyses of mature myelopreservation data collected from the trilaciclib/chemotherapy/Tecentriq trial. The trial will remain blinded to investigators and participants, with no impact on our timeline to report overall survival data."

This randomized, double-blind Phase 2 trial enrolled 107 patients to receive trilaciclib or placebo in combination with chemotherapy (carboplatin + etoposide) and Tecentriq as first-line treatment for SCLC. The trial is evaluating the myelopreservation potential of trilaciclib. Myelopreservation is the ability to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Anti-tumor efficacy measures including overall response rate, progression-free survival and overall survival are also being evaluated. Under the revised protocol, myelopreservation results are now the primary outcome and overall survival is being assessed as a secondary outcome. The trial completed enrollment in February 2018.

"Data from the trilaciclib/chemotherapy/Tecentriq trial have the potential to confirm the myelopreservation results observed in our randomized Phase 2 trial of trilaciclib in combination with chemotherapy. Both trials evaluated trilaciclib in first-line small cell lung cancer using the same chemotherapy backbone," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "By the end of the year we will have myelopreservation data from all four randomized Phase 2 trials of trilaciclib, including three in small cell lung cancer and one in triple negative breast cancer. In these trials, trilaciclib was used in first-, second- and third-line settings in combination with a variety of chemotherapy regimens. We plan to discuss the totality of the data, which includes approximately three hundred participants who received trilaciclib, with U.S. and European regulatory authorities in the first half of 2019."

Webcast and Conference Call

The G1 management team will host a webcast and conference call at 8:30 a.m. ET today to discuss the trilaciclib clinical development program. The live call may be accessed by dialing 866-763-6020

About Trilaciclib

Trilaciclib is a first-in-class myelopreservation therapy designed to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Trilaciclib is a short-acting intravenous CDK4/6 inhibitor administered prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials. In March 2018, G1 announced positive Phase 2 data showing myelopreservation benefits in newly diagnosed, treatment-naive small cell lung cancer (SCLC) patients (NCT02499770). Additional results from this trial will be reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress being held October 19-23. The company plans to report data from three other randomized Phase 2 trials in 2018: a trial in combination with chemotherapy and Tecentriq in first-line SCLC, (NCT03041311), a trial in combination with chemotherapy in previously treated SCLC (NCT02514447), and a trial in combination with chemotherapy in triple-negative breast cancer (NCT02978716).