Palm Beach, FL – December 17, 2020 – Soft tissue sarcoma (STS) is a rare type of cancer that develops in tissues such as nerves, muscles, fats, blood vessels and deep skin tissues. Generally occurring in the muscles, tissues, and blood vessels that protect, support and surround the organs. Moreover, it is not categorized as tumor, but can be life-threatening if the cancer spreads to other parts of the body. Currently, there are very few products approved for the treatment of soft tissue sarcoma, while the cases continue to increase. Industry reports say that the total number of soft tissue sarcoma patients in the seven major global markets is estimated to reach 46,864 by 2030 from 37,393 in 2019 at a CAGR of 2.0%. Increase in the incidence and prevalence of different types of cancers, rising cases of soft tissue sarcoma, increasing R&D activities on drugs and other therapies, patent expiry of branded drugs, are some of the factors fueling the growth of the soft tissue sarcoma market over the forecast period. A report from Report Ocean, discussed in Medgadget predicted that the global soft tissue sarcoma market is estimated to reach USD 6,465.7 million by 2030 from USD 2,943.3 million in 2019 at a CAGR of 7.4%. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Cardiff Oncology, Inc. (NASDAQ: CRDF), Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL), MannKind Corporation (NASDAQ: MNKD), AstraZeneca PLC (NASDAQ: AZN).
An earlier report from Grand View Research focused on the increase of the companion drugs market size, predicting that the global sarcoma drugs market size is expected to be valued at USD $1.2 billion by 2023, progressing at a CAGR of 8.5% during the forecast period. The report said: “The growth of the market is largely driven by factors such as new product launches, increasing adoption of novel therapeutics, and growing target population. Sarcomas account for less than 1.0% of all adult cancers. Though sarcomas represent a heterogeneous group of over 50 different histological subtypes, the two major subtypes are soft tissue sarcomas (STS) and bone sarcoma. The introduction of targeted therapy has revolutionized the treatment paradigm for sarcoma. Targeted therapies and pipeline breakthroughs will continue to play a pivotal role in the growth of the market throughout the forecast period.”
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases – Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the company’s Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect. This allows Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with soft tissue sarcoma that has metastasized to the lungs after first-line therapy for their disease.
It is estimated that there are approximately 36,000 new cases of soft tissue sarcoma (STS) in the 7 major markets (US, EU5 and Japan) each year, and an estimated annual market size of over $177 million for the treatment of STS lung metastases. Our clinical advisors estimate that approximately half of all STS patients will eventually develop lung metastases from their primary tumor. Although first-line treatments such as surgical resection, chemotherapy and radiation may provide initial therapeutic benefit for an estimated 35% of those patients, there are no approved or emerging second-line therapies for the remaining 65% who relapse or are refractory. Although the lungs tend to be a major site of relapse, we are aware of only 2 active clinical trials specifically targeting STS lung metastases, indicating that Annamycin faces limited competition in this area of development.
Moleculin recently announced that Annamycin demonstrates consistently high antitumor activity in vivo in all tested animal models of different types of lung-localized cancers, including sarcoma. These promising findings correlate with surprisingly high uptake of Annamycin to the lungs in animal models. This uptake is up to 34-fold higher than that of doxorubicin, the primary first-line chemotherapy for STS. The limited pulmonary uptake of doxorubicin in animal models may help explain its lack of activity against STS lung metastases in humans. Additionally, clinical data show no cardiotoxicity associated with the use of Annamycin, as well as the ability to avoid multidrug resistance mechanisms, both of which are often treatment-limiting effects of anthracyclines (which includes doxorubicin) in this setting. Taken together, these factors suggest that Annamycin could represent an important treatment to help address a significant unmet need in patients with STS lung metastases.
“Since the discovery in animal models of Annamycin’s effectiveness in lung metastases, we have been moving quickly to begin a clinical trial in the US to study Annamycin for this indication,” commented Walter Klemp, Chairman and CEO of Moleculin. “Recognizing the importance of building on the results with human clinical data, we preemptively included this upcoming trial as part of our budget plan, so our anticipated cash runway into the third quarter of 2021 remains unchanged. We are also collaborating with our partners and physicians in Poland who have shown a high level of interest in testing Annamycin in STS lung metastases and are currently pursuing a possible investigator-led clinical trial in Europe. It is our goal to have to have our US clinical trial begin by mid-2021, with the possibility of also initiating a European investigator-funded clinical trial in 2021.”
Mr. Klemp concluded: “Along with the results in STS lung metastases, our animal models have shown significant activity in other lung metastases, including colorectal and triple negative breast cancer, as well as meaningful concentration levels of Annamycin in the liver, spleen and pancreas. Additionally, when tested in a highly aggressive AML mouse model, Annamycin significantly reduced tumor burden in the spleen, lungs and liver, leading to a significant increase in survival. Based on this promising preclinical data, we believe the ultimate market opportunity for Annamycin could be much larger than just STS lung metastases. For all these reasons, we are excited to be moving from the animal models to clinical study.” Read this full release and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, recently announced the presentation of updated data from its Phase 1b/2 study in relapsed/refractory acute myeloid leukemia (AML). The data were presented as a virtual oral poster presentation at the 62nd American Society of Hematology (ASH) Annual Meeting.
The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML. Nine of 45 (20%) patients achieved a complete remission with or without hematologic count recovery (CR/CRi – 5 in Phase 1b and 4 in Phase 2); 55% of responders had a mutation in a splicing factor. Two patients proceeded to transplant following CR and four patients remain on treatment with duration of response of 9, 10, 17 and 20 months, respectively. Together with data demonstrating the safety and tolerability of the combination therapy, these findings highlight onvansertib’s potential to address critical unmet needs in hematologic malignancies.
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) recently announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be presented in two poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition which was held virtually December 5-8, 2020. The poster presentations will be made available on the event’s website.
Rigel will present an analysis of long-term safety data on fostamatinib in more than 3,500 patients at various dosing regimens with immune thrombocytopenia (ITP) or rheumatoid arthritis (RA). No new safety signals nor cumulative toxicity were observed with up to 62 months (5.2 years) of continuous treatment in ITP patients and up to 81 months (6.8 years) of continuous treatment in RA patients.
An overview of Rigel’s ongoing Phase 3 clinical trial of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) will also be presented. This is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary wAIHA who have failed at least one prior treatment. This study is based on Rigel’s Phase 2, open-label, multi-center study for the treatment of wAIHA. Results of that study demonstrated that 44% (11/25) of patients had markedly improved hemoglobin (Hgb) levels and adverse events were consistent with those in the fostamatinib safety database.
MannKind Corporation (NASDAQ: MNKD) recently announced that it has acquired QrumPharma, Inc., a privately held pharmaceutical company developing inhalation treatments for severe chronic and recurrent pulmonary infections, including Nontuberculous Mycobacterial (NTM) lung disease. “We have focused on building a stronger pipeline to treat unmet needs for orphan lung diseases, an area where we can leverage our experience and technology to create differentiated therapeutic products,” said Michael Castagna, Chief Executive Officer of MannKind. “This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021. In addition, our combined capabilities have the potential to create a dry powder formulation that will enable patients suffering from NTM to have a much more positive treatment experience. We are also very excited to add the QrumPharma development team to our roster of talent, with their deep expertise of inhaled drug delivery.”
“My team and I are thrilled to be joining forces with the MannKind development team,” said Dr. Thomas Hofmann. “I look forward to leveraging MannKind’s best-in-class technology to bring new therapies to patients with orphan lung diseases.”
NTM lung disease is a serious chronic condition associated with a reduction of lung function and quality of life. It is estimated that 75,000-105,000 people in the U.S. were diagnosed in 2018 and the NTM population is growing 8% per year, with women, senior citizens and people with underlying lung conditions at greater risk. QrumPharma’s lead program (QRM-003) is focused on an inhaled, nebulized formulation of clofazimine, which would provide several clinical advantages over the current solid oral dosage form. The U.S. Food and Drug Administration has designated QRM-003 as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary nontuberculous Mycobacterial infections.
AstraZeneca PLC (NASDAQ: AZN) A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with CALQUENCE® (acalabrutinib) monotherapy for chronic lymphocytic leukemia (CLL), the most common type of adult leukemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation. This data was presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 7 December 2020.
The analysis included patients with previously untreated and relapsed or refractory CLL treated with CALQUENCE alone from the ELEVATE TN and ASCEND Phase III trials, as well as the 15-H-0016 Phase II trial and ACE-CL-001 Phase I/II trial. In the analysis, 129 patients (17%) reported a cardiac AE of any grade at a median follow up of 25.9 months, and seven patients (0.9%) discontinued treatment due to cardiac AEs.
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