StemCell Therapy

PALM BEACH, Fla., Oct. 21, 2020 /PRNewswire/ --Cancer immunotherapy has emerged as a new avenue for revenue generation for pharmaceutical companies. Adverse effects, such as recurrence of cancer and organ failure, associated with conventional chemotherapies and rising demand for technologically advanced healthcare solutions are boosting the demand for immunotherapies. Moreover, introduction of newer drug classes, such as target receptors for multiple myeloma and checkpoint inhibitors, is poised to make way for advanced therapeutics in the market.Monoclonal antibodies are the most widely used immunotherapeutic drugs globally. Development of monoclonal antibodies as effective immunotherapeutic options areresulting in discovery of new therapeutic options for cancer treatment. A recent industry reportfrom MarketsAndMarkets projected that the global immunotherapy drugs market is projected to reach USD 274.6 billion by 2025 from USD 163.0 billion in 2020, at a CAGR of 11.0 % during the forecast period. The growth of this market is majorly attributed to the rising prevalence of target diseases, increasing demand for monoclonal antibodies and biosimilars, increasing adoption of immunotherapy drugs over conventional treatments, and a favorable approval scenario. However, timeline issues, side-effects, and manufacturing complexities and a high attrition rate in the product development cycle are expected to challenge market growth. Active biotech and pharma companies in the markets this week include Actinium Pharmaceuticals, Inc. (NYSE: ATNM), AstraZeneca PLC (NASDAQ: AZN), Bristol Myers Squibb (NYSE: BMY), Northwest Biotherapeutics(OTCQB: NWBO), Merck (NYSE: MRK).

The report said that: "Based on type, the immunotherapy drugs market is segmented into monoclonal antibodies, checkpoint inhibitors, interferons & interleukins, and other immunotherapies. The monoclonal antibodies segment accounted for the largest share of the global immunotherapy drugs market in 2019. This large share can be attributed to their high specificity and fewer side-effects, increasing focus on personalized medicines, initiatives by industry players, and the rising target disease incidence and patient pool On the basis of therapeutic area, this market is segmented into cancer, autoimmune & inflammatory diseases, infectious diseases, and other therapeutic areas. Cancer accounted for the largest share of the global immunotherapy drugs market, by therapeutic area, in 2019. The large share of this segment can be attributed to the growing prevalence of cancer, rising research activity in this area, and reimbursement coverage for immunotherapies for oncology."

Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) BREAKING NEWS: Actinium Pharmaceuticals, Inc. Awarded Grant by National Institutes of Health to Study Novel Iomab-ACT Targeted Conditioning with a CD19 CAR T-Cell Therapy - Actinium Pharmaceuticals, Inc. ("Actinium" or the "Company") today announced that the National Institutes of Health has awarded Actinium a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center ("MSK") to study Iomab-ACT, Actinium's CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK. The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) or diffuse large B-cell lymphoma (DLBCL). MSK will lead this first of its kind study to utilize targeted radiopharmaceutical ARC-based lymphodepletion to replace chemotherapy-based conditioning prior to CAR T-cell therapy. The study will assess the feasibility of using Iomab-ACT targeted lymphodepletion prior to MSK's 19-28z CAR-T and assess safety and efficacy outcomes relative to results with MSK's CAR-T 19-28z in patients who had received chemotherapy-based lymphodepletion prior to CAR-T administration.

Results published in the New England Journal of Medicine with MSK's 19-28z CD19 CAR-T in 53 patients with R/R B-ALL reported complete remissions in 83% (44/53) of patients. Median event-free survival (EFS) was 6.1 months and median overall survival (OS) was 12.9 months at a median follow up period of 29 months (range 1 65 months) for all patients. Patients with low disease burden, defined as less than 5% blasts in the bone marrow, had markedly enhanced outcomes with increased median EFS of 10.6 months and median OS of 20.1 months. There was a 26% (14/53) rate of Grade 3 of greater cytokine release syndrome (CRS), with 1 patient death as a result, and 42% of patients experienced Grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS). In addition to improved duration of response and survival, patients with low disease burden prior to receiving CAR T-cell therapy had lower rates of CRS and neurotoxicity.

"We are excited to be collaborating with MSK on this trial as they are aleader in the field of cellular therapies. We selected MSK's 19-28z CAR T-cell therapy for this NIH grant funded collaboration because ithas produced high response rates in patients with relapsed or refractory B-ALL who have previously undergone several lines of standard therapy. However, toxicities such as cytokine release syndrome and neurologic toxicity, as well as durability of response, remain a challenge as is the case with many other CAR T-cell therapies" commented Dr. Mark Berger, Actinium's Chief Medical Officer. "Iomab-ACT enables the delivery of targeted radiation that selectively and specifically targets immune cells, including those implicated in the CAR-T-associated toxicities of cytokine release syndrome and neurotoxicity. We are hopeful that this study will demonstrate improvements in safety and outcomes with MSK's CAR 19-28z as a result of Iomab-ACT targeted lymphodepletion and that this will allow clinicians to make important improvements in patients' ability to receive CAR T-cell therapies."

CAR-T is a type of cellular therapy in which a patient's own (autologous) T-cells are genetically engineered outside of the body to target the patient's cancer cells and which are then reinfused back into the patient to seek out and kill cancer cells. Currently there are 2 approved CD19 targeted CAR-T therapies, which both require chemotherapy-based conditioning to deplete the patient's lymphocytes, known as lymphodepletion, and many other CAR-T constructs in development that also use chemotherapy conditioning for lymphodepletion.

Iomab-ACT targets cells that express CD45, an antigen found on immune cells such as lymphocytes and macrophages as well as leukemia and lymphoma cancer cells and delivers the radioisotope warhead iodine-131 to achieve cell depletion. Iomab-ACT is intended to deplete CD45+ immune cells such as macrophages that are implicated in CAR-T related toxicities and may also have an anti-tumor effect on chemo-refractory cancers. Iomab-ACT is a low dose extension of Actinium's lead program, Iomab-B, which is being studied in a pivotal Phase 3 trial for targeted conditioning prior to a bone marrow transplant. Preclinical data supporting Iomab-ACT's application in targeted lymphodepletion prior to ACT such as CAR-T was recently published in the journal Oncotarget (https://www.oncotarget.com/archive/v11/i39/). In addition, clinical data with trace doses of Iomab-B has shown transient, reversible lymphodepletion in patients and drug clearance pharmacokinetics that fit within the vein to vein time of CAR-T manufacturing and administration.

Sandesh Seth, Actinium's Chairman and CEO, said, "This clinical trial collaboration with MSK is a strong step forward for Actinium and our targeted conditioning program. The 19-28z CAR-T has already produced promising data and we look forward to working with MSK to explore Iomab-ACT's potential to reduce toxicities and improve patient outcomes. As we advance towards the SIERRA interim analysis in the fourth quarter, we are focused on the continued expansion of our ARC-based targeted conditioning program for bone marrow transplant and cell and gene therapies with the goal of providing targeted conditioning regimens that are less toxic and more effective than current chemotherapy-based conditioning. With these therapies being administered in a select number of concentrated centers, we see a large and growing market opportunity where our ARC-based targeted conditioning can improve outcomes and increase access to these important curative treatment options." Read this full release and more news for ATNM at: https://www.financialnewsmedia.com/news-atnm/

Other recent developments in the biotech industry include:

AstraZeneca PLC (NASDAQ: AZN) AstraZeneca's TAGRISSO(osimertinib) recently announced it has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.

Bristol Myers Squibb (NYSE:BMY) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval ofOpdivo(nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. The European Commission (EC), which is authorized to approve medicines for the European Union (EU), will now review the CHMP recommendation.

"This positive CHMP opinion underscores the potential ofOpdivoin the EU treatment landscape for esophageal squamous cell carcinoma, with the ATTRACTION-3 trial showing clinically meaningful survival coupled with a favorable safety profile," said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. "We look forward to the EC's final decision, which could mark the first time an immunotherapy is approved for any upper gastrointestinal cancer in the EU. We remain committed to continuing to explore the potential benefits ofOpdivoin earlier settings of esophageal cancer."

Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 followed by PNEUMOVAX23 one year later. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results also showed that at 30 days post vaccination with either V114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13. In PNEU-DAY (V114-017), a Phase 3 study in immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination. Results from both studies are based on opsonophagocytic activity (OPA) responses a measure of vaccine-induced functional antibodies. V114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.

Northwest Biotherapeutics(OTCQB: NWBO), a biotechnology company developing DCVaxpersonalized immune therapies for solid tumor cancers, recently announced that the database for the Phase III trial of DCVax-L for Gliobastoma has been locked. With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

DISCLAIMER: FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM has been compensated forty five hundred dollars for news coverage of the current press releases issued by Actinium Pharmaceuticals, Inc. by a non-affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

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