On September 17, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported that it has dosed the first patient in its Phase 2 clinical trial – of GM102 single agent and in combination with Trifluridine/Tipiracil (Lonsurf) – in patients with advanced or metastatic colorectal cancer (CRC) (Press release, GamaMabs Pharma, SEP 17, 2018, View Source [SID1234529581]).

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GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody targeting tumor antigen AMHRII. AMHRII is re-expressed in approximately 70% of colorectal cancer patients. GM102 exerts its anti-tumor activity through macrophage and NK cell engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and ADCC (Antibody Dependent Cell Cytotoxicity).

This phase 2 study resulted from collaborative research with various European academic research centers and hospitals, which unveiled a wide AMHRII expression in human CRC tumors and a substantial expression of the target on tumor cells at the membrane level. These results were published at the AACR (Free AACR Whitepaper) Annual meeting in April 2018.

"The C201 study will investigate the anti-tumor activity of GM102 in this new indication and its potential synergism with Lonsurf for patients who have progressed on prior therapies. Most CRC tumors express moderate to large macrophage infiltration. GM102 therefore has a potential to enhance macrophage phagocytosis on tumor cells in addition to acting synergistically with Lonsurf," said Isabelle Tabah-Fisch, M.D., GamaMabs’ chief medical officer. "This is a key step in the development of our molecule, which has already shown excellent tolerability in patients with gynecological cancers and first signs of activity in the first patients in the phase 1a/1b C101 study, recently presented at the ASCO (Free ASCO Whitepaper) 2018 conference."

"We are still in serious need of active drugs for our CRC patients," said Professor B. Melichar, investigator at Olomouc University Hospital, Olomouc, Czech Republic. "AMHRII is yet another unexplored target in CRC. GM102 is the latest generation immunological agent to be tested in colorectal cancers, especially those which do not respond to checkpoint inhibitors. We look forward to evaluating this new agent and I am happy to have the first patient already enrolled in the study."

The European multicenter two-parallel non-randomized cohort C201 Phase 2 study will assess objective response rates, immunological changes in the tumor microenvironment, progression-free and overall survival rates for patients with advanced/metastatic colorectal cancers treated with GM102 single agent and in combination with Lonsurf. The study will enroll patients who have progressed after at least two lines of prior systemic therapies for metastatic or locally advanced disease and have received all prior available therapies (cohort 1) or are candidates to receive Lonsurf (cohort 2).

Lonsurf (trifluridine-tipiracil hydrochloride) is a chemotherapy drug, used to treat metastatic colorectal cancer. Servier commercializes Lonsurf in Europe and other countries outside of the United States, Canada, Mexico and Asia. Taiho Pharmaceutical has the right to develop and commercialize Lonsurf in the United States, Canada, Mexico, and Asia.

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 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will be presenting at the 2018 Cantor Global Healthcare Conference being held in New York on Tuesday, October 2, 2018 at 8:00 am ET (Press release, Coherus Biosciences, SEP 17, 2018, View Source;p=RssLanding&cat=news&id=2367664 [SID1234529471]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source

On September 17, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its third-quarter 2018 financial results on Friday, November 2 2018, before the market opens (Press release, AbbVie, SEP 17, 2018, View Source [SID1234529546]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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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.