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DiaMedica Therapeutics to Present at the 2019 Intellisight Investor Conference on August 14, 2019

On August 12, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that Rick Pauls, President and CEO, will be presenting at the 2019 Intellisight Conference, Wednesday, August 14th at 9:00 am Central Time at University of St. Thomas in Minneapolis, Minnesota (Press release, DiaMedica, AUG 12, 2019, View Source [SID1234538594]).

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About Intellisight

Intellisight is a 2-day conference sponsored by the University of St. Thomas – School of Law for institutional investors to meet with leadership teams from numerous companies, and for company leadership to meet with influential investors representing more than 200 buy-side firms.

Boehringer Ingelheim and MD Anderson form collaboration

On August 12, 2019 Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center reported a new multi-year partnership to conduct collaborative research to rapidly advance therapies for various types of cancers, including gastrointestinal and lung cancers (Press release, Boehringer Ingelheim, AUG 12, 2019, View Source [SID1234538593]). The establishment of a joint Virtual Research and Development Center will enable effective data sharing and analysis between the organizations.

The partnership is built on a flexible framework, allowing for projects to enter at different stages (research, development and/or clinical stage) over several years. It further combines the unique patient-driven drug-development capabilities of MD Anderson’s Therapeutics Discovery division (link is external) with the innovative pipeline of novel medicines from Boehringer Ingelheim.

MD Anderson’s Therapeutics Discovery division is a multidisciplinary team of clinicians and researchers focused on advancing the next generation of cancer therapies. As part of the division, the TRACTION (link is external) (Translational Research to Advance Therapeutics and Innovation in Oncology) platform conducts cutting-edge translational research to better understand how new medicines work and which patients will see most benefit.

Dr Victoria Zazulina

"We could not have chosen a better partner with all its research, translational and clinical expertise in lung and gastrointestinal cancers. Together, we hope to transform the treatment landscape for these diseases by tackling their root causes and drivers, that have so far remained elusive, exploring new and smart ways of killing cancer cells," said Dr Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim. "Our innovative oncology pipeline coupled with strong partnerships like this will contribute to unravelling the complexities of these diseases and bringing innovative solutions to people with various types of cancers."

The Virtual Research and Development Center will focus on the development of potential new treatments including:
KRAS inhibition concepts, as mutations in the KRAS gene are common in various cancers, specifically in certain types of lung and gastrointestinal cancers.
a TRAILR2 agonistic antibody, with the potential to selectively induce cancer cell death (apoptosis).
"Within MD Anderson, we are committed to a singular goal of ending cancer," said Tim Heffernan, Ph.D., executive director of TRACTION at MD Anderson. "We look forward to working with Boehringer Ingelheim to advance their innovative pipeline of cancer medicines. Our Therapeutics Discovery team is well-poised to conduct impactful translational research, and this partnership will allow us to more rapidly advance much-needed new therapies to patients."

More than 4.1 million people die from gastrointestinal and lung cancers every year worldwide1, indicating an urgent need for new treatment approaches. Gastrointestinal cancers represent a heterogeneous complex array of diseases, and include oesophageal (throat), gastric (stomach), liver, pancreatic, and colorectal cancers. In 2018, lung cancer caused more than 1.7 million deaths1. There are two main types of lung cancer: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Cellectar Reports Second Quarter 2019 Financial Results and Provides a Corporate Update

On August 12, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Cellectar Biosciences, AUG 12, 2019, View Source [SID1234538589]).

"We made considerable progress on both the clinical and regulatory fronts during the second quarter and subsequent period. CLR 131 continues to advance, delivering encouraging preliminary data with improving efficacy and a clear dose response in our ongoing Phase 1 study. In addition, the company received FDA Fast Track Designation for CLR 131 in two separate indications and believe that we continue to track toward a registrational study in at least one B-cell hematologic malignancy from our ongoing Phase 2 CLOVER-1 study," said Jim Caruso, CEO of Cellectar. "Our recently adopted fractionated dosing schedule of CLR 131 has led to the improved efficacy and tolerability observed in our latest cohorts and we are moving forward with this dosing strategy in our recently initiated pediatric Phase 1 trial for the treatment of life-threatening cancers."

Second Quarter and Recent Corporate Highlights

·Announced initial results from Cohort 6 in the company’s ongoing Phase 1 clinical study with CLR 131 in Relapsed or Refractory Multiple Myeloma (R/R MM). Data from Cohort 6 showed improved efficacy and a clear dose response compared to prior cohorts, including a 50% overall response rate, a 50% minimal response rate and 100% disease control rate. The International Myeloma Working Group defines a partial response as a 50% to 89.9% reduction in the marker of disease and minimal response as 25% to 49.9% reduction in the marker of disease. One patient achieved a minimal response with a 48% reduction in their m-protein. The other patient achieving a minimal response had a 39% reduction in m-protein remains on study and continues to be evaluated.

·Expanded the third cohort of our ongoing Phase 2 CLOVER-1 study of CLR 131 after preliminary results showed it exceeded pre-specified performance criteria. We are currently enrolling patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL) and marginal zone lymphoma (MZL) in the third cohort. The company continues to expect to report top-line data from the Phase 2 CLOVER-1 study in 2019.

·Received FDA Fast Track Designation for CLR 131 in two separate indications: in fourth line or later relapsed/refractory multiple myeloma and in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). CLR 131 is currently being evaluated in Cellectar’s ongoing CLOVER-1 Phase 2 clinical study in patients with select B-Cell lymphomas, including multiple myeloma and DLBCL.

·Closed on a financing for gross proceeds of $10 million. In a registered direct offering, Cellectar issued 1,982,000 shares of common stock. In a separate concurrent private placement transaction, Cellectar sold 2,018,000 shares of common stock. In conjunction with the offerings, the company also issued 4,000,000 warrants to purchase common stock in the private placement.

Second Quarter Summary of Financial Results

Cash and Cash Equivalents: As of June 30, 2019, cash and cash equivalents were approximately $16.8 million compared to $13.3 million as of December 31, 2018. We believe that our cash balance is adequate to fund our basic budgeted operations through the fourth quarter of 2020. Cash used in operating activities was approximately $5.5 million during the six months ended June 30, 2019 as compared to $5.7 million used during the six months ended June 30, 2018.

Research and Development Expense: R&D expense for the three months ended June 30, 2019 was $1.8 million compared to $1.7 million in the three months ended June 30, 2018. The cumulative R&D spending for the first six months of 2019 was $4.1 million as compared to $3.8 million for the first six months of 2018. The majority of the company’s R&D spend for year-to-date 2019 was dedicated to the start-up and support of our pediatric study with $1.3 million and $2.9 million spent for the three and six months ending June 30, 2019, respectively, related to clinical project costs and manufacturing expenses.

General and Administrative Expense: General and administrative (G&A) expense for the three months ended June 30, 2019 was approximately $1.4 million compared to approximately $1.2 million in the three months ended June 30, 2018. The cumulative G&A spending for the first six months of 2019 were of $2.7 million as compared to $2.6 million for the first six months of 2018.

Net Loss: Net loss for the three months ended June 30, 2019 was $(3.2) million, or a loss of $(0.46) per diluted share, compared to a net loss of $(2.9) million, or a loss of $(1.69) per diluted share, in the three months ended June 30, 2018. Net loss for the six months ended June 30, 2019 was $(6.8) million, or a loss of $(1.15) per diluted share, compared to a net loss of $(6.4) million, or a loss of $(3.75) per diluted share, in the six months ended June 30, 2018.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-Cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

$15-million DOE/NNSA award for medical isotope

On August 9, 2019 SHINE Medical Technologies LLC reported it has received a $15-million award from the Department of Energy’s National Nuclear Security Administration (DOE/NNSA) (Press release, Shine Medical Technologies, AUG 9, 2019, View Source;pk_kwd=15-million-doe-nnsa-award-for-production-of-medical-isotope [SID1234540974]). The award was made by the agency as part of its effort to establish a reliable, U.S.-produced supply of molybdenum-99 (Mo-99), the most commonly used medical isotope, without the use of highly enriched uranium. The cooperative agreement with the DOE/NNSA requires SHINE to provide $15 million of matching funds.

Medical isotopes are used in heart stress tests, cancer staging and therapeutics, and other medical applications. Chronic global shortages of Mo-99 routinely and significantly affect the diagnosis and treatment of patients in the United States and around the world.

SHINE broke ground in May on an isotope production facility in Janesville, Wisconsin. It will be the first facility of its kind in the world, using the company’s patented technology to produce Mo-99 and other isotopes used in more than 40 million procedures every year. When the facility becomes operational after the company receives approval to operate from the Nuclear Regulatory Commission (NRC), the plant will be capable of producing the majority of U.S. demand for Mo-99. The NRC’s review is expected to take up to 24 months from its acceptance of SHINE’s application.

"We are grateful for DOE/NNSA’s award as SHINE continues its progress toward production of Mo-99 and other important medical isotopes," said Greg Piefer, SHINE’s founder and CEO. "SHINE’s recently-submitted operating license application to the NRC brings us one step closer to that goal. The recent DOE/NNSA award directly supports SHINE’s continued advancement as we work to supply lifesaving medical tracers and therapeutics to an underserved, growing global market."

About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo-99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

NEC drug development investment, CYTLIMIC, secures 1.3 billion yen in financing, allowing for POC clinical trials of CYT001

On August 9, 2019 NEC Corporation (NEC; TSE: 6701) and CYTLIMIC Inc. reported that financing of 1.3 billion yen (around US$ 12 million at current rate) was completed through the achievement of the milestones, including the first IND filing of CYT001*, pursuant to the agreement with current shareholders; i.e., NEC Corporation, NEC Capital Solutions Limited, Fast Track Initiative, Inc., and SMBC Venture Capital Co., Ltd. In total, 2.3 billion yen (around US$ 21 million) has been raised since the establishment of CYTLIMIC in December 2016 (Press release, NEC, AUG 9, 2019, View Source [SID1234538959]).

In recent years, Immune-Checkpoint Inhibitors (ICI), such as anti-PD-(L)1 drug, have been expanding their applications; However, a combination of ICI with other drugs are still needed for more than 70% of patients who don’t respond to ICI alone. Among those combination drugs, cancer vaccine is considered as a promising approach to turn "Cold tumors to Hot ones" and to make ICI work. CYT001 is designed to effectively turn "Cold tumors to Hot ones" with the AI-designed optimized shared-antigen peptides, and an optimized combination adjuvant of Poly ICLC (Hiltonol) and LAG-3Ig (Eftilagimod alpha or IMP321). The recent financing allows CYTLIMIC to conduct further clinical trials for the POC establishment of CYT001.