On August 6, 2019 MorphoSys Discloses Biomarker to Stratify Patient Population in B-MIND Study of Tafasitamab plus Bendamustine in r/r DLBCL (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538248]).

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!

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported specifications of the biomarker that was implemented in the currently ongoing phase 3 B-MIND study. B-MIND compares the efficacy of tafasitamab (MOR208) plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). The biomarker, which is the basis for a co-primary endpoint, is described as a low baseline peripheral blood natural killer (NK) cell count and was implemented in agreement with the FDA as an amendment of B-MIND in the first quarter of this year.

Patients with a low number of NK cells (defined as 100 or fewer NK cells per microliter blood) at study entry represent approximately 50% of the overall study population and are believed to exhibit a less favorable response to anti-CD20-based therapies. Pre-clinical data generated at MorphoSys suggests that tafasitamab’s potential to more efficiently recruit effector cells, predominantly NK cells, may therefore be of particular benefit for this patient population.

The co-primary endpoint allows for efficacy testing in the overall patient population as originally planned, and also in those patients with a low NK cell count at baseline. An event-driven interim analysis is expected to occur in Q4 2019 following a longer than expected duration of response in the overall patient population.

"Patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation have a poor prognosis, which is even worse for patients who are characterized by a low baseline NK cell count. The enhanced NK cell recruitment that tafasitamab is believed to exert through its ENFORCERTM format may activate even minimal NK cell numbers, which could potentially translate into enhanced activity against tumor cells," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "The amendment of the B-MIND study allows us to test this hypothesis and potentially to provide a benefit for a distinct patient population that does not have targeted treatment alternatives."

About B-MIND
The phase 3 B-MIND study is designed to investigate the CD19 antibody tafasitamab in combination with bendamustine versus a combination of the CD20 antibody rituximab plus bendamustine in patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation. The biomarker had been implemented in agreement with the FDA in the first quarter of 2019. The pre-planned, event-driven interim analysis of B-MIND is expected to take place in the fourth quarter of 2019. In case the overall study population passes the futility analysis, an event-driven primary analysis of the study is expected in late Q1 2020. In case the overall study population fails, but the biomarker subpopulation passes the futility analysis, the study will continue, but an increase from 330 to 450 patients is required, in which case an event-driven primary analysis of the study is expected in Q1 of 2021. Only if both groups do fail the interim analysis for futility the overall study can be considered futile.

On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its intention to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) based on its phase 2 L-MIND study of tafasitamab (MOR208) and lenalidomide in relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538247]). A letter of intent was submitted to EMA in early July and MorphoSys plans to complete the MAA submission by mid-2020.

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!

L-MIND is a single-arm, open-label phase 2 study investigating the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. In July 2019, the company presented positive primary analysis data from L- MIND at the ICML conference in Lugano. These data will form the basis for the planned filing package of the MAA that, if granted, allows for earliest approval in Europe in 2021.

"We are excited about the progress we are making with our plan for a possible regulatory approval for tafasitamab in Europe," said Dr. Malte Peters, Chief Development Officer at MorphoSys. "The preceding constructive interaction with the European regulatory authorities has given us the confidence to pursue an MAA submission for approval in Europe based on L-MIND. This complements our current focus on seeking approval of tafasitamab in the U.S. on the basis of L-MIND, for which we will complete a BLA submission to the FDA by year-end."

On August 6, 2019 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that it signed a clinical trial agreement with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, GEIS) to support a Phase 1b/randomized Phase 2 study of doxorubicin, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS), versus doxorubicin plus LB-100 (Press release, Lixte Biotechnology, AUG 6, 2019, View Source [SID1234538246]).

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. John S. Kovach, CEO of Lixte, said, "We are pleased to support this investigator-initiated trial proposed by GEIS, a leader for many years in seeking improved therapies for ASTS. GEIS has a network of referral centers in Spain and across Europe that has an impressive track record of efficiently conducting innovative studies in ASTS. We believe GEIS and their EU collaborators are an excellent team to evaluate the potential benefit of adding Lixte’s non-cytotoxic inhibitor of DNA damage repair to standard treatment for this challenging disease. The goal is to enter the first patient in the last quarter of this year and to complete enrollment of approximately 170 patients over two years."

Dr. Kovach continued, "Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100, an inhibitor of protein phosphatase2A (PP2A), consistently enhances the antitumor activity of doxorubicin without apparent increases in toxicity and, in a Phase 1 clinical trial, LB-100 alone was associated with stabilization of an advanced chondrosarcoma and fibrosarcoma for 6 and 9 months, respectively, without toxicity. LB-100 potentiates the effectiveness of agents like doxorubicin by inhibiting multiple steps required to repair chemotherapy induced DNA damage. We are excited to learn if the combination of LB-100 and doxorubicin will finally advance the effectiveness of ASTS therapy."

Dr. Javier Martin-Broto, Coordinating Investigator of the trial and medical oncologist at Virgen del Rocío University Hospital (Seville) commented, "Although there has been an increase in overall survival in advanced sarcoma in recent years, this gain has not been accompanied by advances in first line therapy. Anthracyclines, and specifically doxorubicin, is still the standard initial treatment. The growing list of negative phase III trials indicates to us that sarcoma therapy is in crisis. It is true that sarcoma encompasses more than 60 different subtypes and, for some of them, substantial advances have emerged. But it is also true that the most frequent sarcoma subtypes desperately need a turning point. One promising topic of research is the combination of doxorubicin with drugs that are able to impair the mechanisms of DNA repair. LB-100 has demonstrated synergistic action in in vivo preclinical mesenchymal tumors. GEIS will lead a European initiative to conduct a phase I/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas".

On August 6, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported that Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics, will provide an overview and update on the company’s business at the 2019 Wedbush PacGrow Healthcare Conference in New York City (Press release, United Therapeutics, AUG 6, 2019, View Source [SID1234538235]).

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!

The presentation will take place on Tuesday, August 13, 2019, at 10:20 AM Eastern Time, and can be accessed via a live webcast on the United Therapeutics website at View Source under the "Investors" tab in the "Events and Presentations" section. An archived, recorded version of the presentation will be available approximately twenty-four hours after the presentation ends and can be accessed at the same location for 90 days. [uthr-g]

On August 6, 2019 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will be presenting at Canaccord Genuity’s 39th Annual Growth Conference on Wednesday, August 7, 2019, at 10:30 am ET. The conference will be held at the InterContinental Hotel in Boston, MA (Press release, Palatin Technologies, AUG 6, 2019, View Source [SID1234538234]).

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!

Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies, will provide an update on Palatin’s corporate and development programs, including:

Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
On June 21, 2019, the U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc’s New Drug Application (NDA) for Vyleesi, a melanocortin receptor agonist developed by Palatin, indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity.
The FDA’s approval of the NDA triggered a $60 million milestone payment to Palatin (received July 2019) under its North American license agreement with AMAG.
AMAG is expected to launch Vyleesi nationally in September 2019.
Discussions with multiple parties on potential commercial partnerships for territories outside North America, China and South Korea are advancing.
Melanocortin Anti-Inflammatory / Autoimmune Programs under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis)
A Phase 2 proof-of-concept clinical study for PL-8177 with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study for PL-8177 with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 clinical study for PL-9643 in dry eye disease is currently anticipated to commence in the first quarter of calendar year 2020. A recently completed Type B pre-IND (Investigational New Drug) meeting with the FDA established the development pathway for activities, including CMC, non-clinical studies and clinical studies, required for an NDA (New Drug Application) submission.
Cash and cash equivalents at June 30, 2019, on a pro forma basis, which includes the $60 million milestone payment by exclusive North American licensee, AMAG Pharmaceuticals, Inc., is approximately $102 million dollars.