REM-001 Therapy

REM-001 Therapy consists of three parts, a laser light source, a light delivery device and the drug REM-001 (collectively, REM-001 Therapy). REM-001 is a second generation photosensitizer drug that has undergone late stage clinical development, and which we believe possesses multiple advantages over earlier generation PDT compounds. Our lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer (CMBC), a disease that may affect individuals with advanced breast cancer and for which effective treatment options are limited. For this and similar cutaneous applications, the light delivery device is a simple and easy to use fiber optic wand that the physician employs to directly illuminate the tumor with light.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Xencor to Present at Upcoming Investor Conferences

On February 7, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that company management will participate in fireside chats at two upcoming conferences (Press release, Xencor, FEB 7, 2018, View Source [SID1234524358]):

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Leerink Partners 7th Annual Global Healthcare Conference
Date: Wednesday, February 14, 2018
Time: 1:00 p.m. ET
Location: New York, NY
RBC Capital Markets 2018 Global Healthcare Conference
Date: Wednesday, February 21, 2018
Time: 10:30 a.m. ET
Location: New York, NY

Live webcasts of both events will be available under "Events & Presentations" in the Investors section of the Company’s website located at View Source A replay of the presentations will be posted on the Xencor website approximately one hour after the live events and will be available for 90 days following the presentations.

Myriad’s myRisk® Hereditary Cancer Test Finds More Than 12 Percent of Men with Prostate Cancer Carry an Inherited Genetic Mutation

On February 7, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from a large 1,162 patient study of the Myriad myRisk Hereditary Cancer test will be featured during the poster presentation at the 2018 Genitourinary Cancer Symposium in San Francisco, Calif (Press release, Myriad Genetics, FEB 7, 2018, View Source [SID1234523799]). The key finding is that more than 12 percent of men with prostate cancer had an inherited (i.e. hereditary) mutation in a cancer-causing gene.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"As one of the largest studies of hereditary cancer risk assessment ever conducted in prostate cancer, our myRisk Hereditary Cancer test demonstrated that roughly the same percentage of men with prostate cancer carry hereditary cancer-causing mutations as do women with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "These compelling findings provide a strong reason for expanding the use of genetic testing in men diagnosed with prostate cancer consistent with existing professional medical guidelines."

The key data are summarized below and the abstract is available at: abstracts.asco.org. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #GU18.

Title: Inherited Germline Mutations in Men with Prostate Cancer.
Presenter: Robert Reid, M.D., Virginia Cancer Specialists.
Date: Sunday, February 9, 2018, 12:15 — 1:45 p.m. and 6:00 p.m. — 7:00 p.m.
Location: Poster Board E4; Poster Abstract 357.

The study will be presented by Robert Reid, M.D. from the Virginia Cancer Specialists who served as the lead investigator of this study. The study objective was to evaluate genetic testing using the 28-gene myRisk Hereditary Cancer test in 1,162 men with a personal history of prostate cancer. Of these, 64 percent had a history of prostate cancer, while 36 percent had a history of prostate cancer and at least one additional cancer. The results showed that 12.1 percent of men with prostate cancer were positive for one or more hereditary cancer mutations in the genes tested. Additionally, the positive rate was significantly higher among men with prostate cancer plus one other cancer (14.7 percent). The inherited mutations were found in genes with a well-known prostate cancer risk (i.e., BRCA2) as well as genes historically associated with other cancer types including breast and colon. These findings suggest that hereditary cancer testing in men with prostate cancer may aid in medical management decision making to reduce overall cancer risk.

"We believe hereditary cancer testing can help inform treatment decisions for these men, including whether to pursue active surveillance, increased screening for secondary cancers and potentially for treatment selection with PARP inhibitors or other medicines in the future," said Dr. Lancaster. "Additionally, once men know they carry an inherited mutation, they can encourage their family members to get tested to learn if they’re at increased risk for cancer and potentially help them prevent future cancers."

The National Comprehensive Cancer Network, American Urological Association (AUA) and an academic consensus panel all support hereditary cancer risk assessment for patients with prostate cancer deemed to be high risk due to metastatic disease or high grade cancer with a family history of BRCA associated cancers including breast, ovarian, pancreatic or prostate cancer.

Importantly, the AUA position states that: "Patients with localized prostate cancer who are at highest risk for developing metastatic castration-resistant prostate cancer, may have a higher incidence of germline DNA repair mutations than expected from published reports. The presence of germline DNA repair gene mutations has important implications for the prostate cancer patient in terms of general cancer screening and possible future prostate cancer treatment decisions. Additionally the presence of germline DNA repair mutations is of utmost relevance to the patient’s first-degree family members due to increased cancer risk and screening implications."

About Prostate Cancer
One in nine American men will have prostate cancer during his lifetime. Prostate cancer is the second leading cause of cancer death among American men and is the most commonly diagnosed. The American Cancer Society estimates in its Cancer Facts & Figures 2018 report that 164,690 men will be told they have prostate cancer in 2018. Currently, there are nearly 2.9 million American men living with the disease and every 18 minutes another American man dies from prostate cancer. That’s a little more than 80 deaths per day and 29,430 this year.

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. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification and exceptional customer service.

Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and qualify for myRisk Hereditary Cancer test.

Moleculin Announces Activity with Pancreatic Cancer Drug

On February 7, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it has been able to show promising tumor suppression activity with its inhibitor of glycolysis, WP1122 (Press release, Moleculin, FEB 7, 2018, View Source [SID1234523798]).

"We have previously announced that our glycolysis inhibitors have shown a remarkable affinity for concentrating in the pancreas," commented Walter Klemp, Chairman and CEO of Moleculin. "And, we know that pancreatic cancer is highly glycolytic. Now, we have solid data showing the ability of WP1122 to inhibit pancreatic tumor growth in mice."

Mr. Klemp continued, "This is the indicator we were looking for to support our going after pancreatic cancer as a primary target for the WP1122 portfolio. We couldn’t be more excited given the intense unmet need in pancreatic cancer."

Cellectar Receives USPTO Notice of Allowance for Patent Covering Use of CLR 131 in Multiple Myeloma

On February 7, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the United States Patent and Trademark Office has issued a notice of allowance for U.S. Patent Application No. 15/095,641, entitled "Alkylphosphocholine Analogs for Multiple Myeloma Imaging and Therapy," which covers a method of use for CLR 131, the company’s lead radiotherapeutic Phospholipid Drug Conjugate (PDC) in multiple myeloma (MM) (Press release, Cellectar Biosciences, FEB 7, 2018, View Source [SID1234523792]).

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CLR 131 is Cellectar’s investigational compound under development for a range of orphan designated cancers. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver the cytotoxic radioisotope iodine-131 directly to tumor cells. CLR 131 is currently being evaluated in a Phase 1 clinical trial in patients with relapse or refractory MM, as well as in a Phase 2 clinical trial for relapsed or refractory MM and select relapsed or refractory lymphomas. The U.S. Food and Drug Administration has granted orphan drug designation for CLR 131 in the treatment of MM.

"This patent allowance enhances our intellectual property estate and underscores the novelty of CLR 131 for the treatment of multiple myeloma, a life-threatening disease with high unmet medical need," said James Caruso, chief executive officer of Cellectar Biosciences. "Importantly, upon issuance, this patent will extend our coverage into the mid-2030s."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.