On October 30, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, reported data demonstrating that the company’s phospholipid ether delivery vehicle conjugated to a non-reactive iodine (I-127), or CLR 127, decreased tumor volumes and markedly delayed tumor regrowth in preclinical in vitro and in vivo animal studies of both pediatric and adult cancers. Investigators observed that CLR 127 was taken up and retained in the tumor cells at 6-10 fold higher level than normal tissue and sensitized the tumor cells to external radiation (Filing, 8-K, Cellectar Biosciences, OCT 30, 2017, View Source [SID1234521312]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

University of Wisconsin investigator, Dr. Mario Otto presented these data during a poster presentation held at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute and European Organisation for Research and Treatment of Cancer. The poster, titled “The Phospholipid Ether Analog CLR 127 Delays Radiation-Induced dsDNA Damage Repair in Pediatric and Adult Solid Tumors,” was presented on Saturday, October 28th at 12:30 PM ET at the Pennsylvania Convention Center in Philadelphia.

Dr. Otto and his fellow investigators treated adult and pediatric cancer cells and in vivo xenograft-bearing mice with CLR 127 followed by external radiation. The group reported that the effect of the radiation was meaningfully increased versus external radiation alone and persisted at higher levels for up to 24 hours post-administration of the external radiation. Additionally, treatment with CLR 127 appears to inhibit DNA repair function that typically occurs in the tumor cells following radiation treatment.

“The data presented by Dr. Otto and his team provide external confirmation of Cellectar’s PDC tumor targeting capabilities and retention in the tumor cells that may improve clinical outcomes,” said Jim Caruso, president and CEO of Cellectar Biosciences. “This study reports important additional data regarding the potential benefits of combining our PDC platform with external beam radiation for the treatment of both adults and pediatric cancers.”

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate the discovery and development of improved targeted novel therapeutic compounds. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

On October 30, 2017 Endocyte, Inc., (NASDAQ:ECYT) reported that the company will host a conference call on Monday, Nov. 6th, at 4:30 p.m. EST to discuss its third quarter financial results and provide an operational update (Press release, Endocyte, OCT 30, 2017, View Source [SID1234521315]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company’s website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).

The webcast will be recorded and available on the Company’s website for 90 days following the call.

On October 30, 2017 Boehringer Ingelheim and Sarah Cannon Research Institute reported an expansion of their strategic partnership to bring innovative treatments to cancer patients by developing novel immuno-oncology therapies (Press release, Boehringer Ingelheim, OCT 30, 2017, View Source [SID1234521329]). The new effort combines Boehringer Ingelheim’s oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment to evaluate BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

SMAC mimetics are a new class of targeted, small molecules that trigger tumor cell death and immune system activation that may enhance the activity of immunotherapies in the treatment of cancer. Through this collaboration, Boehringer Ingelheim’s BI 891065 will be studied in a Phase I clinical trial [NCT03166631] (link is external) alone and in combination with BI 754091 (anti-PD-1) in patients with advanced metastatic solid tumors. The first patient has been enrolled in the Phase I study, which aims to include approximately 100 patients. Previously, the partners had announced a joint clinical development program to study Boehringer Ingelheim’s BI 754091 (anti-PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs. More immune-oncology combination studies are planned moving forward.

Mehdi Shahidi, M.D.
“Ground-breaking advances in immuno-oncology are expected to transform cancer treatment paradigms. We are significantly expanding our efforts in this area including a broad research program focusing on the development of rational combinations of novel immuno-oncology approaches,” said Mehdi Shahidi, M.D., Global Medical Head Oncology, Boehringer Ingelheim. “As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development,” added Shahidi.

Preclinical data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the Keystone Symposia Conference on Molecular and Cellular Biology earlier this year, suggest that BI 891065 is a promising combination partner for checkpoint inhibitors and, when used together, may provide a new approach to cancer therapy.

“We look forward to continuing our research to find more effective therapies for patients across tumor types through novel immune therapies and combinations of therapies,” said Howard A. “Skip” Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments in the community for our patients.”

Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization (CRO), Sarah Cannon is providing comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. Expansion of the collaboration with Sarah Cannon, will enable rapid patient enrollment and expand access to Boehringer Ingelheim’s investigational oncology treatments through Sarah Cannon’s extensive network across the U.S. and UK.

About Sarah Cannon Research Institute
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.

Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com (link is external).

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for non-small-cell lung cancer (NSCLC) that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

On October 30, 2017 Aviragen Therapeutics, Inc. (NASDAQ:AVIR), a company focused on the discovery and development of direct-acting antivirals to treat infections that have limited therapeutic options, and Vaxart, Inc., a privately-held, clinical-stage company focused on developing oral recombinant vaccines based on its proprietary delivery platform that allows for administration by tablet rather than by injection, reported that the companies have entered into a definitive merger agreement (Press release, Aviragen Therapeutics, OCT 30, 2017, View Source [SID1234639795]). The merger will result in a combined company, Vaxart, Inc., focused on developing orally-delivered therapeutics and prophylactics to address a variety of viral infections.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"We are thrilled with the prospect of combining forces with Aviragen, which will create a deep pipeline of antiviral products and allow Vaxart to accelerate development of the promising vaccine candidates that are based on our proprietary oral delivery platform," said Wouter Latour, M.D., Chief Executive Officer of Vaxart. "This transaction gives us the opportunity to build on the positive Phase 2 challenge study results we announced recently for our influenza oral tablet vaccine, as well as the excellent results we obtained in the safety and immunogenicity studies with our norovirus vaccine. Additionally, it will provide us access to Aviragen’s antiviral assets, including their BTA074 Phase 2 program for the treatment of condyloma caused by HPV, which is on track to complete enrollment this quarter and to report top-line safety and efficacy data in the second quarter of 2018."

"We believe our oral vaccine programs are significantly de-risked based on the positive clinical outcome of the BARDA-funded H1N1 influenza Phase 2 challenge study which serves as proof of concept for our technology platform as a whole," continued Latour, "and we look forward to taking our norovirus vaccine into a Phase 2 challenge study next. Norovirus is the leading cause of acute viral gastroenteritis in the United States, causing frequent outbreaks across the population, and we believe our oral tablet vaccine would be the optimal approach to address this unmet medical need."

The Vaxart technology platform has been engineered for the delivery of a wide range of oral vaccines, initially targeting norovirus, human papilloma virus (HPV), respiratory syncytial virus, and influenza, using a convenient and room temperature-stable tablet, which eliminates the need for injection. In clinical studies to date, Vaxart vaccines consistently generated broad systemic and local immune responses that could provide important advantages in preventing infection, as well as robust T cell responses that we believe are essential to obtain a therapeutic benefit in chronic viral infection and cancer.

"After a comprehensive review of strategic alternatives, we are delighted to announce this transaction with Vaxart, which will complement Aviragen’s focus on infectious diseases and position us to create both near and long-term value for our stockholders," said Joseph M. Patti, Ph.D., President and Chief Executive Officer of Aviragen Therapeutics. "Vaxart is well-funded to advance its norovirus and HPV antiviral vaccine programs, and together with BTA074, the combined companies are poised to provide meaningful value-creating data readouts."

Today, Vaxart will be announcing positive results from the company’s Phase 1b open-label, dose-ranging study assessing the safety and immunogenicity of VXA-G1.1-NN, Vaxart’s norovirus oral tablet vaccine, in 60 healthy adult volunteers. VXA-G1.1-NN met both the primary and secondary endpoints for safety and immunogenicity in the clinical trial. Based on the favorable clinical data, a Phase 2 norovirus challenge study is expected to begin in the second half of 2018. To date, Vaxart has dosed more than 300 adult volunteers with its vaccines for norovirus, respiratory syncytial virus and influenza.

About the Transaction

The exchange ratio in the merger agreement was determined by assigning $60 million in value to Aviragen for its financial and clinical assets and $90 million in value for Vaxart’s assets. On a pro forma basis, after giving effect to the number of shares of Aviragen common stock issued in the merger, Vaxart’s securityholders will own approximately 60% of the combined company and Aviragen securityholders will own approximately 40% of the combined company, subject to certain potential adjustments as described in the merger agreement. The transaction has been approved by the board of directors of both companies. The merger is expected to close in the first quarter of 2018, subject to the approval of the stockholders of each company as well as other customary conditions. Wouter Latour, M.D., will serve as Chief Executive Officer of the combined company.

Upon the closing of the transaction, the name of the combined company will become Vaxart, Inc. and shares of the combined are expected to continue trading on NASDAQ under the proposed ticker symbol "VXRT."

Stifel, Nicolaus & Company, Incorporated is acting as financial advisor to Aviragen, and Dechert LLP is serving as legal counsel to Aviragen. Cooley LLP is serving as legal counsel to Vaxart.

Aviragen will reduce its workforce by six to a total of 10 full-time employees, who will remain on board to complete the BTA074 Phase 2 clinical trial and assist with the transition of duties to the Vaxart management team.

Aviragen and Vaxart management will host a conference call this morning, Monday, October 30, 2017 at 8:30 a.m. EDT to discuss the planned merger. To participate in the conference call, please dial (877) 312-5422 (United States) or (253) 237-1122 (international) and refer to conference ID number 6295889. A replay of the conference call can be accessed under the Investors section of Aviragen’s website at www.aviragentherapeutics.com and on the Vaxart website at www.vaxart.com.

On October 30, 2017 Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that on November 7, 2017, the Company will release its financial results for the quarter ended September 30, 2017 (Press release, Affimed, OCT 30, 2017, View Source [SID1234521338]). The Company’s management team will host a conference call to discuss the Company’s financial results and recent corporate developments on Tuesday, November 7, 2017 at 8:30 a.m. ET. The call can be accessed by dialing one of the numbers listed below five minutes prior to the start of the call and providing the confirmation code 3213767.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Local – Amsterdam, the Netherlands: +31 (0)20 716 8295

Local – Copenhagen, Denmark: +45 32 71 16 60

Local – Frankfurt, Germany: +49 (0)69 2222 10625

Local – Zurich, Switzerland: +41 (0)44 580 7214

Local – London, U.K.: +44 (0)20 3427 1907

Local – New York City, U.S.A.: +1 646 254 3366

Local – Paris, France: +33 (0)1 76 77 22 23

An audio webcast of the conference call can be accessed in the “Events” section on the “Investors & Media” page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.