On December 6, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported results from a ground-breaking validation study to better define the risk of breast cancer in women of European ancestry who test negative for a hereditary cancer mutation with the myRisk Hereditary Cancer test (Press release, Myriad Genetics, DEC 6, 2017, View Source [SID1234522406]). The results are being featured in a Spotlight presentation today at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

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"Myriad Genetics is the first to bring to market a comprehensive approach to lifetime breast cancer risk assessment that includes 28 genes, family history evaluation, and well-validated SNPs through riskScore," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "This comprehensive approach delivers the most precise tool in the industry to help physicians assess a patient’s breast cancer risk and empower choices that may prevent a patient’s breast cancer from ever happening."

A summary of this study appears below and more information about the company’s presentation can be found at: View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.

myRisk Hereditary Cancer with riskScore Spotlight Presentation
Title: Development and Validation of a Combined Residual Risk Score to Predict Breast Cancer Risk in Unaffected Women Negative for Mutations on a Multi-Gene Hereditary Cancer Panel.
Presenter: Elisha Hughes, Ph.D.
Date: Wednesday, Dec. 6, 2017, 5:00—7:00 p.m.
Location: Poster Discussion, PD1-08

This study was designed to validate the new riskScore test’s ability to predict the 5-year and lifetime risk of breast cancer compared to the Tyrer-Cuzick model alone. riskScore is a novel test that combines data from the Tyrer-Cuzick model with 86 genetic markers, called single nucleotide polymorphisms (SNPs), to comprise a combined risk score that accounts for clinical, familial and genetic variables.

The validation study included 1,617 women: 990 women with breast cancer and 627 controls. The results show that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=5.2×10-39 and p=4.1×10-35, respectively). Moreover, riskScore was statistically significantly superior to Tyrer-Cuzick alone for both 5-year and lifetime risk of breast cancer (1.0×10-12 and 8.3×10-13, respectively), underscoring the important contribution of the SNPs to the test.

"The combination of the SNP panel with Tyrer-Cuzick provides even greater precision than previously demonstrated from family history models," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "As a result, we believe our myRisk Hereditary Cancer test, now enhanced with riskScore, provides the most comprehensive breast cancer risk assessment available today."

In a separate analysis, the riskScore test was applied to a real-world cohort of 6,479 women who tested negative for mutations in 11 genes associated with hereditary breast cancer to determine their remaining lifetime risk of developing breast cancer. The results show that riskScore remaining lifetime risk estimates ranged from 0.88 percent to 66.4 percent (Graph 1). Additionally, 38.2 percent of patients tested with riskScore had a lifetime risk >20 percent and 7.4 percent had a lifetime risk >3 times the general population (35 percent).

"These data confirm the important contribution of SNPs to breast cancer risk assessment in unaffected women who test negative for mutations in hereditary breast cancer genes with a precise measure of breast cancer risk," said Lanchbury. "The addition of the SNP data appears to be especially helpful in identifying those patients at higher risk for developing breast cancer."

Graph 1: View Source

"Patients who are above 20 percent lifetime risk are candidates for additional screening based on U.S. Preventive Services Task Force recommendations and those above 35 percent may be candidates for more aggressive medical interventions," said Lancaster. "Importantly, these data show that riskScore identifies a larger number of high-risk patients than either BRCA1 or BRCA2 testing and represents the next major epoch in hereditary cancer risk assessment and patient care."

About riskScore
riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from greater than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

On December 5, 2017 Moleculin Biotech, Inc. presented Investor Presentation (Presentation, Moleculin, DEC 5, 2017, View Source [SID1234522381]).

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On December 5, 2017 At the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 59th Annual Meeting and Exposition in Atlanta, Georgia, researcher Gustavo Milone, MD, and his team reported that will present a study that investigates the post-marketing trends of Novex, a biosimilar rituximab that has been approved in Argentina for the same indications as the reference product (MabThera, Rituxan) (Press release, mAbxience, DEC 5, 2017, View Source [SID1234594760]).1 Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

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In order to determine deviations from expected frequencies of adverse events (AEs), a prospective treatment registry for the biosimilar was implemented from the start of its commercialization on November 26, 2014. Data in the study are reported until June 30, 2017. Physicians, 180 in total, tracked age, gender, indication, dose, dose frequency, and date of treatment initiation and finalization for each patient receiving the biosimilar.

The study comprised the records of 525 patients who had at least 1 follow-up. The majority of patients were female (52%), the mean age was 63.3 years (range, 10-90), and most patients received the biosimilar rituximab for hematological disease (91.2% of cases). The treatment duration ranged from 154 to 309 days, with the number of treatment cycles varying from 1 to 12. Individual Case Safety Reports (ICSRs) were collected from 24 patients with 29 AEs.

The most frequently reported AEs were:

Acute infusion-related reaction (14)
Arrhythmia (3)
Pneumonia (2)
Stroke (2)
The researchers noted that 41 treatments with rituximab were initiated before the launch of the product; assuming treatment began with MabThera, these 41 treatments imply switching to the biosimilar from the reference.

Researchers investigating data from the post-marketing surveillance found a similar incidence of AEs after the use of rituximab biosimilar when compared to the published data of the reference product. Thus, in terms of tolerability, the biosimilar has a similar safety profile compared with its reference.

On December 5, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) reported that it will host an Investor & Analyst conference call and webcast on its investigational proprietary program MOR208 on December 12, 2017 at 5:00 pm CET (4:00 pm GMT, 11:00 am EST) after the 2017 ASH (Free ASH Whitepaper) Annual Meeting (Press release, MorphoSys, DEC 5, 2017, View Source [SID1234522383]).

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In the call the MorphoSys Management will present and discuss updated clinical data from the ongoing phase 2 L-MIND trial with the Company’s investigational program MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL), which had been presented in a poster at the 2017 ASH (Free ASH Whitepaper) Annual Meeting in Atlanta on December 11th.

Dial-in numbers (listen only):

Germany: +49 89 2444 32975
United Kingdom: +44 20 3003 2666
USA: +1 202 204 1514

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a prompt start and a secure line.

The presentation slides and webcast link will be available at the Company’s website at www.morphosys.com/conference-calls

A slide-synchronized audio replay of the conference will also be available at the corporate website following the live event.

On December 5, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant, and for the targeting and killing of cancer cells, reported Actimab-MDS, a new clinical initiative focused on myelodysplastic syndrome or MDS (Press release, Actinium Pharmaceuticals, DEC 5, 2017, View Source [SID1234522385]). Actimab-MDS is the latest clinical initiative from the Company’s CD33-Alpha Program, which combines the CD33 targeting ability of the antibody lintuzumab with the cell killing power of the alpha-particle emitting radioisotope Actinium-225. Actimab-MDS builds on the Company’s clinical development experience in over 100 patients and several clinical trials with Actimab-A for patients with acute myeloid leukemia (AML) and Actimab-M for patients with multiple myeloma (MM).

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Actinium, together with Dr. Roboz, will conduct a webcast at 8 AM ET on December 5, 2017 to introduce Actimab-MDS and the planned Phase 2 trial. Participants can register and view the webcast through the following link:

View Source

or via Actinium’s Investor Relations Calendar View Source

Participants may also participate by phone. The dial-in information is below:

Dial-in: U.S. (646) 402-9440

Dial-in: U.S./Canada (855) 698-6739

MDS occurs when the bone marrow produces stem cells that fail to mature to red blood cells, white blood cells or platelets. The only potentially curative treatment option for patients with MDS is a bone marrow transplant (BMT) also known as a hematopoietic stem cell transplant. Approximately 19% of MDS patients have a p53 genetic mutation. Data show that p53 mutation positive patients have shorter survival and poorer outcomes following a BMT as evidenced by shorter time to relapse and shorter Overall Survival (OS). The planned Phase 2 trial is intended to study Actimab-MDS as a conditioning regimen for patients with MDS and p53 mutations who will undergo a bone marrow transplant. Dr. Gail Roboz, Director of the Leukemia Program and Professor of Medicine at Weill Cornell New-York Presbyterian Hospital, will serve as principal investigator for the trial and lead a consortium of leading medical centers in the treatment of MDS that are expected to participate in the trial. The MDS Clinical Research Consortium members are the Cleveland Clinic, Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center, Moffitt Cancer Center and Weill Cornell.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Actinium is delighted to be working with Dr. Roboz and the other members of the consortium. As our clinical experience using our CD33 antibody labelled with Actinium-225 has expanded, it has become evident that it has minimal extramedullary toxicities. We believe that this property would be beneficial in numerous indications as the broad expression of CD33 in various hematologic indications affords many opportunities for continued expansion of our CD33 program. Given the poor prognosis of MDS patients, particularly those with p53 mutations, we are committed to executing this trial for Actimab-MDS effectively in collaboration with Dr. Roboz and the consortium while forging an efficient regulatory pathway forward that will enable us to make this therapy available to patients as soon as possible."

Patients in the planned Phase 2 trial will receive 4.0 µCi/Kg administered via a single infusion 12 days prior to receiving their bone marrow transplant. Actinium has studied its CD33 antibody and Actinium-225 at this dose level in a previously completed Phase 1 clinical trial in acute myeloid leukemia. At this dose level the construct showed good tolerability with no extramedullary toxicities or side effects outside of the bone marrow. The myelosuppression effect of the construct at this dose level was strong and impacted all the treated subjects.

MDS or myelodysplastic syndrome is an Orphan Drug indication with an estimated prevalence of 60,000 patients in the US and 40,000 patients in the EU. Approximately nineteen percent of these patients test positive for a mutation of the p53 gene and these patients are considered high-risk in terms of their survival. Although bone marrow transplants can be curative or significantly extend survival for many MDS patients, those who are p53+ do not benefit as greatly and presence of the mutation is associated with significantly lower survival. It has been shown that approximately seventy-five percent of the MDS population expresses CD33 at expression levels greater than the twenty-five percent targeted in the Actimab-MDS trial. The addressable market for Actimab-MDS is expected to be in the neighborhood of fourteen thousand patients in the U.S. and EU combined with over eight thousand five hundred in the U.S.

Sandesh Seth, Actinium’s Chairman and CEO said, "Actimab-MDS aligns perfectly with Actinium’s strengths as we have significant expertise and know in the area of bone marrow transplant as a result of our experience with our pivotal Phase 3 program, Iomab-B. Looking forward, we believe there exists for Actinium a compelling revenue opportunity in the 2020-2021 timeframe by launching not one but possibly two therapies that can provide safer myeloablation with the potential for increasing curative outcomes from bone marrow transplant. Due to the involvement of Dr. Roboz and the MDS Clinical Research Consortium, we expect that the Actimab-MDS trial will benefit from their significant expertise; high patient volumes treated and defrayed costs. Due to these factors and with sufficient drug supply on hand, we expect trial costs in the low single-digit millions over the life of the trial most of which would be incurred in 2019, and after the anticipated milestones from our other trials. Bone marrow transplant remains a highly concentrated market with the top fifty centers performing a majority of the transplants and via our clinical development programs, we have already established a supply chain and presence in over twenty such centers that account for over 33% of the market. Having two novel therapies, serving two patient populations with high, unmet needs, would allow us to achieve scale and efficiency that we believe will unlock significant value. Actimab-MDS indeed has the potential to transform the outlook for the Company in a very positive manner and we look forward to discussing this program."

About Actimab-MDS

Actimab-MDS is Actinium’s third CD33 program with expected initiation of a Phase 2 clinical trial in 2018 for patients with Myelodysplastic Syndromes that have a p53 genetic mutation. MDS occurs when the bone marrow produces stem cells that fail to mature to red blood cells, white blood cells or platelets. The only potentially curative treatment option for patients with MDS is a bone marrow transplant (BMT), also known as a hematopoietic stem cell transplant. Approximately 19% of MDS patients have a p53 genetic mutation and it has been shown that p53 mutation positive patients have poorer survival and poorer outcomes following a BMT indicated by shorter time periods to relapse and shorter Overall Survival (OS).