Alligator Bioscience to Host Conference Call to Provide Full Year Report 2017 Business Update

On February 12, 2019 Alligator Bioscience reported that it will publish its report for the year ended 31 December 2017 (Press release, Alligator Bioscience, FEB 12, 2018, https://alligatorbioscience.se/en/alligator-bioscience-to-host-conference-call-to-provide-full-year-report-2017-business-update/ [SID1234538680]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the Full Year Report, on the same day at 1:15 PM CET. The event will be hosted by CEO Per Norlén and the presentation will be held in English.

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!

When: 1:15 pm CET Friday 16 February 2018

To participate in the telephone conference, please use the dial in details shown below:

SE: +46856642664

UK: +442030089802

US: +18558315945

The presentation can also be reached at:
View Source

The conference call will be made available on the company´s website after the call: View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected].

The information was submitted for publication, through the agency of the contact person set out above, at 1:30 p.m. CET on 12 February 2018.

AVID BIOSERVICES AND ONCOLOGIE ENTER INTO ASSET ASSIGNMENT AND PURCHASE AGREEMENT FOR AVID’S PS-TARGETING PROGRAM INCLUDING BAVITUXIMAB

On February 12, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) ("Avid") and Oncologie, Inc. reported that the companies have entered into an Asset Assignment and Purchase Agreement for Avid’s phosphatidylserine (PS)-targeting program including bavituximab (Press release, Peregrine Pharmaceuticals, FEB 12, 2018, View Source [SID1234523979]). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets PS, a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. In addition to bavituximab, the deal includes Avid’s other PS-targeting antibodies, including betabodies, as well as certain other assets and licenses useful and/or necessary for the potential commercialization of bavituximab.

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!

Under terms of the agreement, Avid will receive an aggregate of $8 million in upfront payments from Oncologie paid over a period of six months from the execution date of the agreement and will be eligible to receive up to $95 million in development, regulatory and commercialization milestones. Oncologie will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs, with Avid receiving royalties on net sales that are upward tiering into the mid-teens. As part of the deal, Oncologie will also enter into an agreement with Avid for future contract development and manufacturing activities in support of bavituximab. Roth Capital Partners acted as financial advisor to Avid in this transaction, rendering a Fairness Opinion to its board of directors.

"Partnering our PS-targeting program including bavituximab with a biopharmaceutical company focused on therapeutics in oncology has long been a key corporate objective and we have engaged in discussions with a broad range of potential collaborators throughout the course of the development program. Oncologie is a company with a deep understanding of cancer biomarkers that might be particularly relevant to bavituximab and we believe they have the resources and expertise to maximize the potential of the program," said Roger J. Lias, Ph.D., president and chief executive officer of Avid. "Importantly, this deal marks the completion of our transition to a dedicated CDMO, while providing additional capital, both upfront and potentially downstream, to support our CDMO business."

"We are pleased to add bavituximab as our new lead development program through this agreement with Avid," said Laura E. Benjamin, Ph.D., chief executive officer of Oncologie. "We believe that PS targeting possesses significant promise in the treatment of cancer and look forward to highlighting the therapeutic potential of the approach through innovative clinical trials. To this end, we intend to continue ongoing collaborations with the current investigators who are overseeing investigator-initiated trials, as well as NCCN-sponsored studies, designed to evaluate the immune modulating potential of bavituximab."

Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, bavituximab has also demonstrated a favorable safety and tolerability profile across several clinical trials conducted to date, which may offer the compound a key advantage as the evolving cancer treatment landscape continues to shift to a combination therapy approach. The ability to be added to a range of other cancer therapies without causing added safety concerns may position bavituximab favorably as a component of combination treatments.

Corporate Presentation

On February 12, 2018 Lipocine reported to have presented its Corporate presentation (Press release, Lipocine, DEC 12, 2018, View Source [SID1234523947]).

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!

Athersys to Host Year-End 2017 Financial Results Call

On February 12, 2018 Athersys, Inc. (Nasdaq:ATHX) reported that it will release its year-end 2017 financial results at approximately 4:00 PM Eastern Time on Tuesday, March 13, 2018, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results (Press release, Athersys, FEB 12, 2018, View Source [SID1234523906]). Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host the call as follows:

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!

Date March 13, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: US and Canada (800) 273-1254
Telephone access: International (973) 638-3440
Access code 8898346
Live webcast www.athersys.com under Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on March 27, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 8898346.

Actinium Announces Submission of IND For Actimab-A in Combination with CLAG-M for Patients with Relapsed or Refractory AML

On February 12, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that an Investigational New Drug (IND) application has been submitted with the U.S. Food and Drug Administration (FDA) for Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia (AML) patients (Press release, Actinium Pharmaceuticals, FEB 12, 2018, View Source [SID1234523904]). The planned Phase 1 trial studying Actimab-A in combination with CLAG-M will be an investigator initiated trial conducted at the Medical College of Wisconsin in a Phase 1, dose escalation study led by principal investigator Dr. Ehab Atallah in collaboration with Dr. Sameem Abedin. CLAG-M, a salvage chemotherapy regimen consisting of cladribine, cytarabine, and filgrastim, with mitoxantrone, is designed to induce remission in AML patients who are refractory to or have relapsed after standard induction 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!

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "CLAG-M has become a widely used regimen for patients that is the standard of care at many institutions across the U.S. based on its ability to produce remissions in patients in relapse. By utilizing Actimab-A with CLAG-M, we expect to leverage Actimab-A’s potency and minimal extramedullary toxicities to derive synergies when used in combination with other active AML drugs. This important Phase 1 study will assess safety of the combination and determine an appropriate dose level for future studies. In future studies, we believe that this exciting combination could increase remission rates in relapsed patients. We also expect to use the Actimab-A CLAG-M combination regimen to increase the rate of successful stem cell transplant in relapsed patients, via improved myeloablation with the combination regimen. We look forward to work with Dr. Atallah and his colleagues at the Medical College of Wisconsin."

Actinium will host a conference call on Tuesday, February 13, 2018 at 4:30 PM ET that will be led by Dr. Mark Berger, Actinium’s Chief Medical Officer, and Dr. Atallah.

Webcast Registration:
View Source
U.S. Participant Dial-in: (646) 402-9440
U.S./Canada Toll Free Dial-in: (855) 698-6739
Conference ID: 2540

Sandesh Seth, Actinium’s Chairman and CEO said, "The advantageous properties of our CD33 targeting ARC or Antibody Radio-Conjugate have enabled us to expand our CD33 Program from a single indication to the only multi-disease program in the industry. In addition to the Actimab-A trial in newly diagnosed older AML, we have the only CD33 targeting agent in multiple myeloma via the Actimab-M trial. We are also exploring its use in targeted myeloablation in high-risk MDS with Dr. Roboz and the MDS Clinical Research Consortium via the planned Actimab-MDS trial. We are excited to now be studying the combination with CLAG-M for a large relapsed, refractory AML patient population with high unmet needs. Our intent is to further improve our positioning as the best in class CD33 program with applications as a therapeutic, myeloablative agent, and also the synergistic value of adding internalized radiation as a therapeutic modality to chemotherapy and other treatment approaches. In doing so, we intend to maximize the value of the program to a great number of potential partners and collaborators."

About Actimab-A

Actimab-A is Actinium’s lead drug candidate from its CD33 program and is an Antibody Radio-Conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope. Actimab-A is currently being studied in Phase 2 clinical trial in patients that are newly diagnosed with AML who are over the age of 60 that are ineligible for intense chemotherapy, also known as unfit patients. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration and the European Medicines Agency. The Company expects to complete patient enrollment of the Phase 2 trial in the first half of 2018 and report top line data results in the second half of 2018. The Company is also developing Actimab-M and Actimab-MDS, which are also CD33 actinium-225 ARCs. Actimab-M is being studied in a Phase 1 investigator-initiated trial for patients with refractory multiple myeloma. The Phase 1 Actimab-M trial is expected to complete enrollment and report top line data in the second half of 2018. Actimab-MDS is expected to begin a Phase 2 clinical trial in the second half of 2018 following a pre-IND meeting with the FDA in the first half of 2018. Actimab-MDS is intended to bridge patients with high-risk myelodysplastic syndrome (MDS) that have a p53 genetic mutation to a bone marrow transplant via targeted myeloablation. Actimab-A is a second-generation therapy from the Company’s CD33 Program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients in four clinical trials.