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Moleculin Announces Positive Independent Report of No Cardiotoxicity in Annamycin Phase 1 To Date

On February 20, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has received an independent assessment of the absence of cardiotoxicity in patients treated with Annamycin in both its US and European open label and single arm Phase 1 clinical trials (Press release, Moleculin, FEB 20, 2020, View Source [SID1234554627]). Data from the first 5 patients in the US and the first 9 patients in Europe were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of this data, the independent expert concluded that he "does not see evidence of cardio-toxicity."

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. For a small population of patients, ECHO strains were not provided due to the limitations of delivery of such data by the clinical sites. "ECHO strain imaging" is a method in echocardiography (medical ultrasound) for measuring regional or global deformation of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.

"We are pleased to receive this independent assessment which further validates the absence of cardiotoxicity in patients to date of Annamycin," stated Wally Klemp, Chairman and CEO of Moleculin. "Currently approved anthracyclines are notoriously cardiotoxic, so demonstrating that Annamycin is not cardiotoxic, even in patients who have received more than the lifetime maximum cumulative anthracycline exposure established by the FDA, supports our claim that Annamycin is truly in a class by itself, and indeed a ‘Next Generation’ anthracycline." He continued, "We are excited to continue to demonstrate Annamycin’s excellent safety profile. We believe continuing to demonstrate the lack of cardiotoxicity, along with initial efficacy data shown while increasing the dosage to a therapeutic level, will make Annamycin an extremely promising new drug candidate."

Single Copy Loss of a Gene Cluster May Contribute to Initiation and Progression of Multiple Myeloma in Preclinical Study

On February 20, 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) reported that the loss of one copy of the miR15a/miR16-1 gene cluster promoted initiation and progression of multiple myeloma in mice, according to results published online in Blood Cancer Discovery, the latest journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, AACR (Free AACR Whitepaper), FEB 20, 2020, View Source [SID1234554626]).

Multiple myeloma is a cancer of antibody-producing cells called plasma cells. It is preceded by a premalignant condition known as monoclonal gammopathy of undetermined significance (MGUS), in which abnormal plasma cells are present but do not expand. A hallmark of both MGUS and multiple myeloma is the detection of an M spike, which indicates the accumulation of an abnormal secreted antibody in the patient’s blood.

"The risk of progression from MGUS to malignant multiple myeloma is approximately 1 percent each year, but the factors that contribute to progression are not well understood," said Marta Chesi, PhD, associate professor of medicine at the Mayo Clinic. "The purpose of our study was to model genetic risk factors that may contribute to initiation and progression of multiple myeloma. This understanding could eventually allow us to identify the mechanisms that increase the risk of progressing to multiple myeloma."

One copy of chromosome 13 is deleted in approximately half of patients with MGUS and multiple myeloma; however, the significance of this deletion on prognosis and disease progression remains controversial. Chesi and colleagues hypothesized that individual genes on chromosome 13 may promote disease initiation and/or progression.

The authors examined the impact of two genetic loci found on human chromosome 13 – RB1 and MIR15A/MIR16-1 – on disease initiation and progression. Both RB1 and MIR15A/MIR16-1 are considered tumor suppressor genes due to their roles in regulating cellular proliferation. The RB1 protein is known to be inactivated in many cancers, including multiple myeloma. A previous study demonstrated that deletion of MIR15A/MIR16-1 enhances proliferation of human B cells, and deletion of the gene in mice promotes development of another blood cancer, chronic lymphocytic leukemia.

In this study, the authors deleted a single copy of either Rb1 or miR15a/miR16-1 in wild-type mice and in a transgenic mouse model of multiple myeloma they previously developed. The authors found that deletion of one copy of Rb1 did not affect disease initiation or progression. In contrast, deleting one copy of miR15a/miR16-1 in wild-type mice significantly accelerated the development of an M-spike. Furthermore, the deletion of one copy of miR15a/miR16-1 in mice with multiple myeloma significantly enhanced the aggressiveness of the disease and led to increased expression of genes that promote cellular proliferation.

The authors also analyzed a genetic dataset of multiple myeloma patients and found that deletion of one copy of MIR15A/MIR16-1 in patient tumors was associated with increased expression of the same cellular proliferation genes that were upregulated in mice.

"Losing one copy of the MIR15A/MIR16-1 gene appears to promote tumor cell proliferation in both mice and patients," said Chesi. "For many years, we thought that deletion of chromosome 13 was just a byproduct of other genetic changes in the tumor and that it did not directly affect disease progression. Our study now demonstrates that deletion of chromosome 13, and specifically deletion of MIR15A/MIR16-1, appears to alter the biology of the tumor.

"However, the fact that the entire chromosome 13, and not just MIR15A/MIR16-1, is lost in many cases of MGUS or multiple myeloma suggests that other genes on this chromosome are also likely to be important for pathogenesis," added Chesi. In particular, Chesi is interested in studying DIS3, another gene located on chromosome 13 that is frequently mutated in multiple myeloma. The authors were not able to assess its contribution in this study due to the lack of relevant mouse models.

Another limitation of the study is that it was not possible to delete Rb1 or miR15a/miR16-1 only in myeloma cells due to technical restrictions of their mouse model. As a result, these genes were deleted in all cells, including immune cells, which could have led to indirect effects on disease progression, explained Chesi. However, Chesi added that results from additional control experiments indicate that the observed results are unlikely to be indirect, as transplanted tumors behaved similarly in both wild-type and miR15a/miR16-1-deleted mice. This study was sponsored by grants from the National Institutes of Health. Chesi declares no conflict of interest.

TRACON To Report Fourth Quarter And Full Year 2019 Financial Results And Company Highlights On February 27, 2020

On February 20, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its fourth quarter and full year 2019 financial and operating results after the close of U.S. financial markets on Thursday, February 27, 2020 (Press release, Tracon Pharmaceuticals, FEB 20, 2020, View Source [SID1234554615]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly and full year financial results.

Conference call and webcast:
Date: February 27, 2020
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3228345
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section
A replay of the webcast will be available for 60 days on the website.

Atara Biotherapeutics to Participate at Two Upcoming Investor Conferences

On February 20, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Pascal Touchon, the Company’s President and Chief Executive Officer, will participate at two upcoming investor conferences in March (Press release, Atara Biotherapeutics, FEB 20, 2020, View Source [SID1234554614]):

Cowen 40th Annual Health Care Conference
Fireside Chat: Monday, March 2, 2020 at 4:10 pm EST
Boston Marriott Copley Place in Boston, MA

Barclays Global Healthcare Conference
Company Presentation: Wednesday, March 11, 2020 at 11:45 am EDT
Loews Miami Beach Hotel in Miami Beach, FL

Live audio webcasts will be available by visiting the Investors & Media – News & Events section of atarabio.com. Archived replays of the webcasts will be available on the Company’s website for 14 days following the live webcasts.

OPKO Health to Report Fourth Quarter 2019 Financial Results on February 26, 2020

On February 20, 2020 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended December 31, 2019, as well as provide guidance on expected revenues and operating expenses for the first quarter and full year 2020, after the close of the U.S. financial markets on Wednesday, February 26, 2020 (Press release, Opko Health, FEB 20, 2020, View Source [SID1234554613]).

OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, February 26, 2020.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, February 26, 2020. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 877-783-8475
INTERNATIONAL DIAL-IN: 614-999-1827
PASSCODE: 9678678
WEBCAST: OPKO 4Q19 Results Conference Call

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 9678678. The replay can be accessed for a period of time on OPKO’s website at OPKO 4Q19 Results Conference Call.