On September 18, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company"), reported that it will unveil a new clinical initiative that expands the Company’s pipeline into the CAR-T space (Press release, Actinium Pharmaceuticals, SEP 18, 2018, View Source [SID1234529483]). CAR-T is a type of cellular therapy that genetically alters a patient’s own T cells to target and kill their cancer cells. Currently, there are 2 approved CAR-T therapies for patients with certain B-cell cancers and over 200 CAR-T candidates in preclinical and clinical development for a wide range of hematologic and solid tumor indications. Actinium’s management team along with Dr. Nirav Shah, Assistant Professor of Medicine, Division or Hematology and Oncology at Froedtert & the Medical College of Wisconsin will discuss the Companies latest pipeline initiative, its value proposition as applicable to CAR-T and the expected development pathway.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Shah said, "CAR-T is an exciting medical advancement that has demonstrated incredible promise in patients that need better treatment options and outcomes. The Froedtert & the Medical College of Wisconsin was an early adopter of CAR-T becoming one of the first FACT certified medical centers in the nation and commercial CAR-T sites, consistent with its pioneering of other techniques such as stem cell transplantation and immunotherapy. My colleagues and I, at the Froedtert & the Medical College of Wisconsin, are committed to continuing to advance the exciting field of CAR-T to further improve patient outcomes. I am excited by the potential of Actinium’s next generation technology to further advance the field of CAR-T and look forward to providing more details on this potentially disruptive clinical initiative."

In addition to Dr. Shah, Sandesh Seth, Actinium’s Chairman and CEO and Dr. Dale Ludwig, Actinium’s Chief Scientific Officer will be on the call to discuss this new pipeline initiative. Participation details for the conference call and webcast are as follows:

Date: Wednesday, September 26, 2018
Time: 4:15 PM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831

"We are excited to be forging a path into CAR-T and are thrilled to be working with Dr. Shah and his colleagues at the Froedtert & Medical College of Wisconsin who have been pioneers in this field. We look forward to the contributions they will make to our next generation technology that we believe has great potential to advance access to CAR-T and patient outcomes’" said, Sandesh Seth, Actinium’s Chairman and CEO. "I am incredibly motivated by this important pipeline expansion which has been enabled by the efforts of our new team and the potential growth opportunities it can provide for Actinium."

On September 18, 2018 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL) (Press release, OBI Pharma, SEP 18, 2018, View Source [SID1234529670]). OBI-3424 is a first in class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is the second FDA orphan drug designation for OBI-3424. In July, 2018, OBI-3424 was granted orphan drug status for the Treatment of Hepatocellular Carcinoma (HCC). A Phase 1/2 study of OBI-3424 in patients with solid tumors, including HCC and castrate-resistant prostate cancer (CRPC), has commenced enrollment at the University of Texas M.D. Anderson Cancer Center.

Amy Huang, General Manager of OBI Pharma, noted, "This additional orphan drug designation for OBI-3424 by the FDA is a significant step in the development of this drug candidate in ALL, including T-ALL, an unmet medical need disease with limited treatment options. We are excited that the FDA has recognized the need to develop novel targeted therapeutic agents such as OBI-3424 in the fight against ALL".

About Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia (ALL), also known as Acute Lymphocytic Leukemia, is a rare blood cancer affecting the maturation of B-cell and T-cell lymphoblasts from progenitor cells. The current prevalence of ALL in the US is around 86,462 cases in 2018. The disease affects primarily children, with 60% of cases occurring at age <20 years. The remission rate for pediatric ALL is approximately 90%, with overall survival around 60-70% in recent years. Current treatments for ALL have been less successful in both infant and adult patients, as well as patients with recurrent disease, leading to an unmet medical need for new treatments.

About Orphan Drug Designation (ODD)

The orphan drug designation provides OBI Pharma with potential benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S.

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including: hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and acute lymphoblastic leukemia (ALL), including T-ALL. AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

OBI Pharma holds worldwide rights for OBI-3424 with the exception of the following countries, whose rights are held by Ascenta Pharma: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey, and India.

On September 18, 2018 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, reported that the completion of a $2.7M financing effort, which includes an over-subscribed $2M round in venture-backed capital and over $670K in non-dilutive capital (Press release, PhoenixMD, SEP 18, 2018, View Source [SID1234536960]). The venture round is led by Pallasite Ventures and includes new angel investors and existing angel investors from prior funding rounds. PhoenixMD intends to use the proceeds to advance its lead asset PMD-026 through IND-enabling studies and to develop a sophisticated companion diagnostic test to determine which patients have high levels of activated RSK2, the protein that PMD-026 disrupts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This financing is a critical step forward in bringing the first disease-modifying therapeutic treatment to women suffering from TNBC. The PhoenixMD team is committed to innovating in the breast cancer field and we are excited to deploy Pallasite’s investment to such an experienced team to solve an unmet medical need," said Chris Bissonnette, Ph.D., Managing Partner of Pallasite Ventures. In connection with the financing, Dr. Bissonnette has joined PhoenixMD’s Board of Directors.

"We are thrilled to close our first venture-backed round with such high-quality investors, which is a major achievement for the company," said Sandra E. Dunn, Ph.D., CEO of PhoenixMD. "The proceeds from this financing, and the non-dilutive capital from recent research grants will advance PMD-026 through critical IND-enabling studies and will begin planning around our upcoming Phase 1 study, which we are very excited to initiate."

About Triple Negative Breast Cancer (TNBC) and RSK Kinases

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are still no targeted therapies available for TNBC.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Currently, there are no approved targeted therapies for TNBC, although several drugs are subject to research studies and clinical trials. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.