Palm Beach, FL – November 19, 2020 – According to the American Cancer Society, the number of new acute myeloid leukemia cases is estimated to continue to grow in the U.S. due to a number of factors. The rising prevalence of acute myeloid leukemia and unmet needs of the patients have resulted in an increased focus on the development of new drugs. New drug approvals for the acute myeloid leukemia treatment, are expected to drive the growth of global acute myeloid leukemia treatment market. In fact, a report in iHealthcareAnalyist said that the global market for acute myeloid leukemia expected to reach $2.2 billion by 2025, growing at CAGR 19.6% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs. During the forecast period, the marketed drugs, pipeline drugs and others are predicted to contribute 55%, 35%, and 10% market share of the global AML market, respectively. Another report from Reports And Data had even higher projections saying that the global Acute Myeloid Leukemia Therapeutics market is forecasted to grow at a rate of 13.1% and will reach $3.56 billion in 2027. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Kintara Therapeutics, Inc. (NASDAQ: KTRA), Merck & Co., Inc. (NYSE: MRK), Kazia Therapeutics Limited (NASDAQ: KZIA), Omeros Corporation (NASDAQ: OMER).
The Reports And Data report said: “The significant factors that drive the market growth include advantages of biopharmaceuticals over unhealthy lifestyles, strong biopharmaceutical, conventional medicines, rise in geriatric population, and development of combination therapies that can treat beforehand untreated diseases. Nonetheless, the high cost of the therapeutic process and its security concerns are foreseen to hinder the growth of the market. Moreover, continuous research has managed to discover more efficient therapies for cancer, which pose attractive opportunities for the key market players. With the rising demand for targeted therapy, this segment likely to dominate the market during the forecast period. Targeted therapy is most extensively used due to fewer adverse effects and greater efficacy and completion rates than high dosage medication. Due to these factors, their sales have increased in recent years.”
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Announces New Data Demonstrating Synergistic Antitumor Activity of Annamycin Combination with Ara-C in AML – Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that new animal data has shown highly improved activity against acute myeloid leukemia (“AML”) when used in combination with the commonly used antileukemic drug Ara-C (also referred to as “cytarabine”) versus single agent. The data is being presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology (“ASH”) under the title: “High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model.”
This study was conducted in a highly aggressive AML mouse model where median survival is approximately 13 days. For animals treated with the combination of Annamycin and Ara-C, median survival ranged from 56 to 76 days, thus expanding median survival by 585%, with some animals being completely cured. The conclusion of the study is that these experiments support initiation of clinical development of the combination of Annamycin and Ara-C in AML patients.
“This is a very important discovery that will most likely change the course of development for L-Annamycin,” commented Walter Klemp, Chairman and CEO of Moleculin. “While our current AML trials are encouraging and we are seeing significant activity with Annamycin as a single agent in relapsed AML patients, this data makes a compelling case that we should move as quickly as possible to begin a clinical trial in AML for the combination of Annamycin with Ara-C, something we are calling ‘AnnAraC.’ We believe the future for Annamycin just became even more promising.”
Mr. Klemp concluded: “Annamycin has already shown human activity as a single agent in its two Phase 1 AML clinical trials, including one complete response, and showing no signs of cardiotoxicity, unlike other anthracyclines. And, it now appears, based on the observed synergy in vitro and confirmatory in vivo data, that the combination of Annamycin and Ara-C could be more effective in a clinical setting than Annamycin as a single agent. This would be consistent with current practice to use Ara-C in combination with an anthracycline like Annamycin. The current first-line therapy for AML patients is the combination of an anthracycline and Ara-C in a regimen referred to as “7+3” where Ara-C is administered daily for 7 days in parallel with 3 daily doses of an anthracycline. Simply substituting the currently used anthracycline in a similar 7+3 regimen with Annamycin would represent a familiar and well-practiced treatment modality. Beyond that, it would have the added advantages that Annamycin is active against tumor cells resistant to doxorubicin and, importantly, removes the concern for cardiotoxicity, a significant toxic side effect of currently used anthracyclines.” The study abstract, as accepted by ASH, can be viewed at: https://ash.confex.com/ash/2020/webprogram/Paper143344.html Read this full release and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Kintara Therapeutics, Inc. (NASDAQ: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, recently announced the execution of an agreement with the Global Coalition for Adaptive Research (GCAR) for VAL-083’s participation in GCAR’s Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study.
This study was conceived by an international consortium of major thought leaders in the glioblastoma (GBM) space and is designed to more efficiently identify effective therapies for GBM patients. Since the launch of the study in 2019, GBM AGILE continues to gain momentum among the GBM medical community and has recently expanded the number of participating trial sites in the U.S. from 24 to 31 centers. Kintara is currently advancing two ongoing Phase 2 clinical trials in GBM with VAL-083 in adjuvant and recurrent MGMT unmethylated GBM, and in combination with radiotherapy in newly-diagnosed MGMT unmethylated GBM. Kintara expects to provide an update on these Phase 2 studies at the Society of Neuro-Oncology SNO 2020 Virtual Conference, November 19-21, 2020.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, recently announced a collaboration with the Bill & Melinda Gates Foundation (the foundation) where the foundation is committing to provide funding to support a pivotal Phase 3 study investigating a once-monthly oral pre-exposure prophylaxis (PrEP) option in women and adolescent girls at high risk for acquiring HIV-1 infection in sub-Saharan Africa. The study, IMPOWER 22, will evaluate the efficacy and safety of islatravir — Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation for both treatment and prevention — and is anticipated to begin by early 2021. More than half of new HIV infections globally occur in sub-Saharan Africa, with women accounting for nearly 60 percent of new infections in this region.
“Our collaboration with the Bill & Melinda Gates Foundation exemplifies our shared mission to end the global HIV epidemic through meaningful innovations in HIV prevention, including additional PrEP options,” said Dr. Roy D. Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Through this collaboration, we can further explore the potential of islatravir as part of our work towards the collective global public health goal of reducing the number of new HIV infections.”
Kazia Therapeutics Limited (NASDAQ: KZIA) recently shared a summary of new paxalisib data presented at the Society for Neuro-Oncology (SNO) Annual Meeting, which was being held virtually from 19-21 November 2020.
Kazia CEO, Dr James Garner, commented, “this is very reassuring data from the glioblastoma study, confirming our earlier results with the data now much more mature. In studies such as this, volatility is the enemy of dependability. From the very first efficacy data we reported from this study, in November 2019, through the ASCO and AACR presentations in June 2020, to today’s latest analysis, the PFS and OS figures have remained extremely stable as the study has progressed. This gives us a great deal of confidence that what we are seeing is representative and reliable.”
Omeros Corporation (NASDAQ: OMER) recently announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.
This final portion of the rolling BLA submission, comprised of the BLA’s clinical sections, follows the previously submitted chemistry, manufacturing and controls (CMC) and nonclinical sections, which are under review by FDA. The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated similarly strong response across its secondary endpoints. Omeros has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application.
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