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.

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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.

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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 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy (Press release, Bristol-Myers Squibb, SEP 18, 2018, View Source [SID1234529478]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

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"Given the need for new treatment options for patients with multiple myeloma, we look forward to working closely with the EMA as they review this application," said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb. "It is our hope that this new Empliciti-based combination will soon become available for patients in the European Union with multiple myeloma, whose disease progressed on lenalidomide and a PI."

The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). Data from this study were presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

The Phase 2 ELOQUENT-3 trial randomized 117 patients with RRMM who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a PI. Patients were randomized 1:1 to receive either EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity. Patients in both the EPd and Pd arms received 4 mg of pomalidomide for days 1-21 of each cycle, and the weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75 years or >75 years, respectively. In the EPd arm, Empliciti was administered at the dose of 10 mg/kg IV weekly for the first 2 cycles and 20 mg/kg monthly starting from cycle 3. Patients randomized to EPd experienced a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) compared with patients randomized to Pd alone, with median PFS, the study’s primary endpoint, of 10.3 months (95% CI: 5.6 to not estimable) compared with 4.7 months (95% CI: 2.8 to 7.2) in Pd patients. The PFS benefit experienced among patients randomized to EPd was consistent among patients who had received two to three prior lines of therapy (HR 0.55; 95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51; CI 95%: 0.24 to 1.08).

Rates of treatment-related hematologic adverse events (AEs) were comparable between EPd and Pd groups (38% and 42%, respectively). The most commonly occurring hematologic AEs among patients receiving EPd were neutropenia (13%), anemia (10%), thrombocytopenia (8%) and lymphopenia (8%). AEs led to discontinuation in 18% of patients in the EPd arm, compared with 24% of patients in the Pd arm.

On September 18, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, reported the initiation of the APOLLO Oncology Clinical Trials Program (Press release, CBT Pharmaceuticals, SEP 18, 2018, View Source [SID1234529733]). The APOLLO series of trials will evaluate and investigate whether CBT’s proprietary assets can work in concert with other agents to improve single agent immunotherapy response rates, and, ultimately, to confer clinical benefit to patients with cancer. In Greek, the verb ‘apollymi’ means "to destroy," and in Greek mythology, Apollo is the god of healing.

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The APOLLO program has been initiated with the dosing of the first patient in the initial trial in the series: a Phase 1/2 open label, multi-center dose escalation and expansion study in which CBT’s proprietary c-Met inhibitor (bozitinib; CBT-101) will be administered concomitantly with anti PD-1 cancer immunotherapies. Utilizing biomarkers to identify patients likely to benefit from the combination, the trial will investigate whether the combination will improve single agent immunotherapy response rates as a result of the immunosuppressive tumor microenvironment due to tumor associated neutrophils (TANs).

"Initiating our APOLLO Oncology Clinical Trials Program and dosing the first patient is a major milestone for CBT as we advance our mission to improve the lives of cancer patients through combination treatment regimens," stated Sanjeev Redkar, PhD, Co-Founder and President. "The APOLLO program is designed to investigate our proprietary assets alongside each other and is focused on understanding the science and genetics to identify the appropriate patients likely to benefit from the regimen. We are grateful for the support of our investigators in running our series of trials."

The initial study is a two-arm clinical trial targeting locally advanced or metastatic disease: CBT-101 with CBT-501 (genolimzumab; anti-PD-1) in hepatocellular carcinoma (HCC), or CBT-101 and nivolumab in renal cell carcinoma (RCC). CBT-101 targets the epithelial to mesenchymal transition (EMT) pathway, and CBT-501 is CBT’s IgG4 humanized monoclonal antibody against the PD-1 membrane receptor on immune cells. Nivolumab (OPDIVO; Bristol-Myers Squibb Company) is approved for advanced kidney cancer.

Dr. Alex Powell, MBBS, FRACP, Affinity Oncology, Hollywood Private Hospital in Perth, Western Australia, added, "One of the newer paradigms for treating cancer patients is combining immunotherapy agents as this synergistic approach may provide improved outcomes. In this first trial in the series, we believe that giving a c-Met inhibitor concomitantly with an anti PD-1 therapy may produce a positive added response in patients with HCC and RCC where monotherapy treatment has proven effective. Affinity Oncology, and the entire Australia and New Zealand team, is thrilled to partner with CBT on this combination approach."

The primary objective of the Phase 1 portion of the trial will be to identify any dose limiting toxicities, evaluate overall safety, and assess the tolerability of CBT-101 and CBT-501 for HCC and CBT-101 and nivolumab for RCC. The Phase 2 primary objective is to assess preliminary efficacy by objective response rate (ORR) and duration of response (DOR) per irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors). Secondary objectives include: determination of the recommended Phase 2 dose, determination of the pharmacokinetic (PK) parameters of CBT-101 and CBT-501 when administered in combination, assessment of clinical benefit rate, progression free survival, and overall survival at 6, 12, 18 and 24 months. Whole blood, serum, plasma and peripheral blood mononuclear cells will be collected to assess TANs. For additional information regarding the trial, please visit clinicaltrials.gov identifier: NCT03655613.

About Hepatocellular Carcinoma and Renal Cell Carcinoma

Hepatocellular Carcinoma (HCC)

Liver cancer is the sixth most common cancer in the world, and hepatocellular carcinoma (HCC) is the most common type of liver cancer. HCC occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. While it is estimated that there will be approximately 42,000 new cases and 30,000 deaths from liver and intrahepatic bile duct cancer in the United States in 2018, about 83% of liver cancer cases occur in less developed countries. The highest incidence of liver cancer is in Asia and Africa.

Renal Cell Carcinoma (RCC)

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer that begins in the lining of the renal tubules in the kidney. The renal tubules filter the blood and produce urine. Kidney cancer is the 12th most common cancer in the world with 338,000 new cases diagnosed in 2012. About 59% of kidney cancer cases occurred in more developed countries with the highest incidence in Northern America and Europe. It is estimated that there will be approximately 65,000 new cases and 15,000 deaths from kidney and renal pelvis cancer in the United States in 2018.

On September 18, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, and NovellusDx, Ltd., a leader in functional genomics, reported the signing of a definitive agreement under which NovellusDx will merge with a newly formed Israeli subsidiary of Cancer Genetics and shareholders of NovellusDx will receive stock equal to approximately 49% of the equity of Cancer Genetics on a fully diluted basis (with certain adjustments) (Press release, Cancer Genetics, SEP 18, 2018, View Source [SID1234531536]). Cancer Genetics will be the surviving entity and expects to remain listed on the Nasdaq Stock Market.

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This transaction will combine Cancer Genetics’ scale, expansive test portfolio and broad data set related to tumor biology, cultivated over more than a decade, with NovellusDx’s proprietary technology and machine learning capabilities to form a leading, oncology-focused precision medicine company. The aim of the combined company is to accelerate and enhance therapeutic development, effectively matching patients to targeted therapies to improve treatment success rates for biopharma companies.

John A. Roberts, Chief Executive Officer of Cancer Genetics commented, "This is truly an exciting day for CGI and its shareholders. We believe that the combination of Cancer Genetics and NovellusDx will result in an organization that is uniquely positioned within the oncology ecosystem. The combined company has an opportunity to become an essential partner for biopharma companies to support their efforts to develop better, more targeted therapeutics and improve patient outcomes in cancer treatment. Over the last several months, we have made significant progress in positioning Cancer Genetics as a value-added partner with biopharma companies. We are confident that this transaction significantly strengthens our value proposition for both existing and potential biopharma partners. We look forward to planning, with the NovellusDx team, the integration of our respective strategic plans to bring innovative product and service offerings as we advance toward closing."

Mr. Roberts will become CEO of the combined company. Dr. Charles Woler, MD, PhD, currently Chairman of the Board of NovellusDx, will serve as Chairman of the Board of the combined company. Dr. Woler has spent the last 30 years in the healthcare industry, in large multinational pharmaceutical companies, SMEs and also in smaller, earlier stage biotech companies. His positions have included CEO of Roche France, CEO of SmithKline Beecham’s European pharmaceutical business (London), CEO of Cadus Pharmaceuticals (US), CEO of Neuro3d & Endotis Pharma (France), and recently Biomnis (France). He holds non-executive chairman and directorship positions in companies in Europe, the United States and Israel.

The Boards of Directors of both companies have approved the proposed merger, which is expected to close in the first quarter of 2019, subject to the approval of Cancer Genetics’ and NovellusDx’s shareholders, tax regulatory approvals, financing, and other customary closing conditions. Existing NovellusDx shareholders, including OrbiMed Israel Partners II, L.P., Pontifax (Israel) IV LP, Helsinn Investment Fund SA, SICAR, and Windham Venture Partners have indicated that they will invest $10 million in additional equity as part of a concurrent PIPE financing, which is expected to close immediately following and in connection with the closing of the merger. NovellusDx will also be providing up to a $2.3 million bridge loan to Cancer Genetics in conjunction with the signing of the definitive merger agreements.

Haim Gil-Ad, Co-founder and Chief Executive Officer of NovellusDx added, "We are pleased to enter into this merger agreement with Cancer Genetics and excited by what the future holds for the combined company and our shareholders. This merger will result in a company offering advanced science and cutting-edge technology to empower oncologists and the biopharma industry to make optimal treatment decisions and develop new therapies to benefit patients in need. We believe that the combined company will have a level of capability and expertise unmatched in the oncology arena and will be well-positioned to compete, particularly in the fast-growing immuno-oncology segment."

Raymond James is serving as exclusive financial advisor to Cancer Genetics and rendered a fairness opinion in connection with the merger. Chardan is serving as exclusive financial advisor to NovellusDx.