Development of Advanced Novel AML Drugs Target Increasing Cases of Acute Myeloid Leukemia

PALM BEACH,  Fla., Dec. 3, 2020 /PRNewswire/ -- Acute myeloid leukemia (AML) is a rare and heterogeneous blood cancer with a poor overall prognosis. It affects predominantly older adults with a median age at diagnosis of 66 years but also includes about 15% of children from birth to 19 years of age diagnosed with leukemia have acute myeloid leukemia. The standard therapy for acute myeloid leukemia has not changed meaningfully for the past four decades which means that the level of R&D and clinicals in the sector signal continued revenue growth for years to come. Reports say that, even with the slowdown in world economic growth, the Acute Myeloid Leukemia Drugs industry has also suffered a small impact, but still maintained a relatively optimistic growth, the past four years. Analysts believe that in the next few years, Acute Myeloid Leukemia Drugs market size will continue to further expand and that market size of the Acute Myeloid Leukemia Drugs market revenues will reach all-time highs.    Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), iBio, Inc. (NYSE: IBIO), Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), AstraZeneca PLC (NASDAQ: AZN).

A recent report from MarketsAndMarkets said that the leukemia therapeutics market is projected to reach USD 17.1 billion by 2024 from USD 12.3 billion in 2019, at a CAGR of 6.8% during the forecast period Market growth is largely driven by the rising prevalence of all types of leukemia including acute myeloid leukemia (AML) and increasing approvals of novel & innovative drugs and immunotherapies. The report said that the targeted drugs & immunotherapy segment dominated the leukemia therapeutics market. It said: "Owing to the surging demand for targeted drugs, this segment likely to dominate the market during the forecast period. Targeted drugs are most widely used owing to their fewer side effects and higher efficacy and success rate as compared to chemotherapy Owing to these factors, their sales have increased in recent years.

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin To Present Antitumor Activity of Annamycin in Combination with Ara-C in AML at American Society for Hematology Annual Conference - Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, after receiving confirmation this week that the US Food and Drug Administration (FDA) has approved its request for a "Rare Pediatric Disease" designation for its drug candidate WP1066, today announced that it will present animal data demonstrating highly improved activity against acute myeloid leukemia ("AML") in combination with the commonly used antileukemic drug Ara-C (also referred to as "cytarabine") versus single agent 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."

"We are extremely encouraged by the strong pre-clinical efficacy demonstrated by the combination of Annamycin and Ara-C against AML," commented Walter Klemp, Chairman and CEO of Moleculin. "While we firmly believe in the promise and efficacy Annamycin has demonstrated as a single agent against AML in our two current Phase 1 clinical trials, we believe this discovery warrants further consideration to the potential expansion of its clinical development into clinical trials for the combination of Annamycin with Ara-C ("AnnAraC") against AML."

Mr. Klemp concluded, "The combination of Annamycin with Ara-C is particularly intriguing considering the current first-line therapy for AML patients is "7+3", where Ara-C is administered daily for 7 days in parallel with 3 daily doses of an anthracycline. Substituting a currently used anthracycline such as doxorubicin with Annamycin would be a familiar and well-practiced treatment modality. Furthermore, the combination of Annamycin with Ara-C may offer potential advantages given Annamycin's demonstrated lack of cardiotoxicity and activity against tumor cells resistant to doxorubicin. We look forward to further discussing the promise of this combination at the 62nd Annual Meeting & Exposition of the American Society for Hematology."

As previously announced, the study was conducted in a highly aggressive AML mouse model where median survival, left untreated, is approximately 13 days.  Median survival in animals treated with the combination of Annamycin and Ara-C ranged from 56 to 76 days, expanding median survival by 585%. Notably, several animals in the study were completely cured. The Company believes these experiments support initiation for the clinical development of the combination of Annamycin and Ara-C in AML patients.   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:

iBio, Inc. (NYSE American: IBIO) a biotech innovator and biologics contract development and manufacturing organization ("CDMO"), recently announced that it has entered into its first Statement of Work ("SoW") under a Master Services Agreement with Belgium-based ATB Therapeutics ("atbtherapeutics") to produce its bioengineered antibody-toxin fusion proteins using iBio's FastPharming® System.  The fusion proteins, called atbodies™, are being designed for the treatment of cancers. iBio will develop a manufacturing process and assays for select atbodies per the SoW.

"We are pleased to be chosen as the process development and manufacturing partner for atbtherapeutics, whose platform technology offers a unique approach for hard-to-treat hematological malignancies and solid tumors," said Tom Isett, Chairman & CEO of iBio. "We are looking forward to helping atbtherapeutics rapidly build a scalable manufacturing process so that its atbody drug candidates may quickly reach the clinic and begin to realize their potential in oncology."

Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) recently announced its third quarter 2020 financial results for the period ended September 30, 2020.  "We are pleased that both Ipsen Pharmaceuticals and Elevation Oncology continue to enroll patients in separate clinical stage programs which could result in milestone payments to Merrimack," said Gary Crocker, Chairman of Merrimack's Board of Directors. "We remain focused on conserving cash and reduction of our operating expenses to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen and Elevation."

Merrimack reported net loss of $1.0 million for the third quarter ended September 30, 2020, or $0.08 per basic share, compared to a net loss of $0.7 million, or $0.05 per basic share, for the same period in 2019.

Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage biopharmaceutical company, recently announced that the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of edasalonexent compared to placebo. The secondary endpoint timed function tests (time to stand, 10-meter walk/run and 4-stair climb) also did not show statistically significant improvements. Edasalonexent was observed to be generally safe and well-tolerated in this trial. Catabasis is stopping activities related to the development of edasalonexent including the ongoing GalaxyDMD open-label extension trial. The Company plans to work with external advisors to explore and evaluate strategic options going forward.

"We are deeply saddened and disappointed by the results of our Phase 3 PolarisDMD trial," said Jill C. Milne, Ph.D., Chief Executive Officer of Catabasis. "I want to sincerely thank all of the boys, their families and caregivers, investigators and the trial sites that participated in and enabled this program. The entire Catabasis team has worked tirelessly to find a treatment for this progressive disease. We hope that our data and work to date can be used to benefit ongoing and future.

AstraZeneca PLC (NASDAQ: AZN) AstraZeneca's IMFINZI® (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved IMFINZI dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

The approval by the Food and Drug Administration (FDA) was based on data from several IMFINZI clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing in unresectable Stage III NSCLC, and the CASPIAN Phase III trial which used four-week, fixed-dosing during maintenance treatment in ES-SCLC. The decision follows the Priority Review granted by the FDA in August 2020.

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