On May 14, 2020 Novartis reported that data from more than 110 abstracts, including Novartis-sponsored and investigator-initiated trials, will be presented during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and the European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress (Press release, Novartis, MAY 14, 2020, View Source [SID1234558037]). The ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings will be held May 29-31, and June 11-14, respectively.

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 living in a world of uncertainty, but cancer won’t wait. Now, more than ever, we need to continue to be bold together. Our data at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight our unique approach to harnessing the power of multiple treatment platforms to deliver transformative medicines to people living with cancer and blood disorders," said Susanne Schaffert, PhD, President, Novartis Oncology. "We look forward to ‘seeing’ everyone virtually at the congresses and helping participants access key data and information through our dedicated congress portals."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper):

Kisqali overall survival subgroup analysis from MONALEESA-3 and -7 trials, and results on Piqray plus fulvestrant in ABC patients with a PIK3CA mutation from the BYLieve study:
Overall survival in patients with ABC with visceral metastases (mets), including those with liver mets, treated with ribociclib plus endocrine therapy in the MONALEESA-3 and -7 trials [Abstract # 1054; poster 139]
Alpelisib + fulvestrant in patients with PIK3CA-mutated HR+/HER2- ABC previously treated with cyclin-dependent kinase 4/6 inhibitor + aromatase inhibitor: BYLieve Study Results [Abstract #1006; oral presentation]

Five-year Tafinlar+Mekinist data in the adjuvant treatment of BRAFV600-mutated melanoma, and updated data in combination with immune checkpoint inhibitor spartalizumab (PDR001):
Long-term benefit of adjuvant dabrafenib+trametinib in patients with resected stage III BRAF V600–mutant melanoma: 5-year analysis of COMBI-AD [Abstract #10001; oral presentation]
The anti-PD-1 antibody spartalizumab in combination with dabrafenib and trametinib in advanced BRAF V600-mutant melanoma: efficacy and safety findings from Parts 1 and 2 of the Phase III COMBI-i trial [Abstract #10028; poster 377]

Tabrecta data updates from multiple analyses from the GEOMETRY study among patients with METex14-mutated and MET-amplified advanced non-small cell lung cancer (NSCLC):
Capmatinib in patients with METex14-mutated advanced NSCLC who received prior immunotherapy: results from the Phase 2 GEOMETRY Mono-1 study [Abstract #9509; oral presentation]
Capmatinib in patients with METex14-mutated or high MET-amplified advanced NSCLC: results from Cohort 6 of the phase 2 GEOMETRY mono-1 study [Abstract #9520; poster 286]

Safety data from a US expanded access program with radioligand therapy Lutathera (lutetium Lu 177 dotatate)*** in patients with advanced neuroendocrine tumors (NETs):
Safety of 177Lu‑DOTATATE in patients with advanced NETs: data from a US expanded access program [Abstract #4604; poster 212]

Learnings from the inclusion of patient insights in the research and development process, through the Novartis Global Oncology Patient Insight Panels (GOPIPs):
Patient engagement in clinical trial design and implementation: A pragmatic approach to valued insights [Abstract #e14084; online publication]
In addition, TheraP, sponsored by the Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, comparing investigational radioligand therapy 177Lu-PSMA-617 to cabazitaxel in patients with metastatic castration resistant prostate cancer (mCRPC) progressing after docetaxel, will be presented:

TheraP: A randomised phase II trial of LuPSMA theranostic versus cabazitaxel in mCRPC progressing after docetaxel: Initial results (ANZUP protocol 1603) [Abstract #5500; oral presentation]
Key highlights of data accepted by EHA (Free EHA Whitepaper):

Efficacy and safety data on the investigational anti-TIM-3 monoclonal antibody MBG453, which targets both immune and myeloid cells in patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML):
Anti-TIM-3 antibody MBG453 in combination with hypomethylating agents in patients with high-risk MDS and AML: a Phase 1 study [Abstract #S185; oral presentation; Sunday, June 14, 8:00 AM CEST]

A longer term Phase I safety and efficacy analysis of asciminib, an investigational treatment specifically targeting the BCR-ABL myristoyl pocket (STAMP), in heavily pre-treated patients with chronic myeloid leukemia (CML):
Asciminib in heavily pretreated patients with Philadelphia chromosome-positive (Ph+) CML in chronic phase sensitive to TKI therapy [Abstract #S170; oral presentation; Friday, June 12, 8:30 AM CEST]

Efficacy results in patients with acute graft-versus-host disease (GvHD) treated with Jakavi (ruxolitinib)****:
Ruxolitinib versus best available therapy in patients with steroid-refractory acute GvHD: overall response rate by baseline characteristics in the randomized Phase 3 REACH2 trial [Abstract #S255; oral presentation; Friday, June 12, 8:00 AM CEST]
More information, including the list of Novartis-sponsored abstracts, and access to the presentations for registered participants will be available on View Source, starting on May 28, and on View Source, by June 11.

On May 14, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported its financial results for the three and six month periods ended March 31, 2020 (Press release, NeuBase Therapeutics, MAY 14, 2020, View Source [SID1234558036]).

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 have generated a solid foundation of data that we expect will enable us to produce mutation-specific genetic medicines for a multitude of diseases. The positive non-human primate pharmacokinetic (biodistribution) and patient-derived cell line pharmacodynamic (activity) data released on March 31st illustrate our ability to create a new class of mutation silencing therapies. In addition, our proprietary targeting technology enables our PATrOL compounds to achieve therapeutically relevant drug concentrations throughout the body, including in the brain," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase.

"Our therapeutic development programs continue to drive forward, despite the difficult macroenvironment, as evidenced by the recent positive platform validation data and well-received public offering. As we look ahead, our initial focus is to continue advancing our Huntington’s disease ("HD") and myotonic dystrophy type 1 ("DM1") programs through lead optimization and IND-enabling studies. We expect to announce the lead candidate for the NT0100 Program for HD by the end of calendar year 2020, followed by the initiation of IND-enabling studies during the first half of calendar year 2021. Finally, our unique biodistribution profile allows us the opportunity to develop therapies against targets and organ systems that we believe other antisense companies cannot currently reach in the body, including into the brain after systemic delivery, which is one of the grand challenges in drug delivery of macromolecules. We believe this unique ability validates our large opportunity in the antisense space," continued Dr. Stephan.

Second Fiscal Quarter of 2020 and Recent Operating Highlights

·Announced positive, preclinical pharmacokinetic ("PK") and pharmacodynamic ("PD") data validating the first-in-class genetic therapy PATrOL platform:
oPK studies of the PATrOL-enabled compound in non-human primates (NHPs) demonstrated, among other things, rapid uptake of the compound out of the body’s circulation after systemic intravenous administration, penetration by the compound into every organ and tissue system studied, and retention of therapeutically relevant doses for greater than one week after single-dose injection;
oPD studies in patient-derived cell lines demonstrated, among other things, activity in engaging target disease-causing transcripts and knocking-down resultant malfunctioning mutant protein levels preferentially over normal protein knock-down; and dose-limiting toxicities were not observed relative to a control either at or above the doses demonstrating activity in human cells in vitro; and
oPATrOL enabled compounds were generally well-tolerated in vivo after systemic administration, both after single dose administration in NHPs and multi dose administration in mice for over a month.

Financial Results for the Fiscal Quarter Ended March 31, 2020:

·At March 31, 2020, the Company had cash and cash equivalents of approximately $5.8 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. Subsequent to the end of the fiscal second quarter of 2020, the Company completed a public equity offering that generated net proceeds of approximately $33.3 million. The Company believes that its current cash balance will provide sufficient capital to fund operations into the second calendar quarter of 2022;
·For the three month period ended March 31, 2020, the Company reported a net loss of approximately $4.4 million, or a net loss of $0.26 per share, compared with a net loss of approximately $2.0 million, or a net loss of $0.33 per share, for the same period last year; and
·For the three month period ended March 31, 2020, total operating expenses were approximately $4.4 million, consisting of approximately $2.8 million in general and administrative expenses and $1.6 million of research and development expenses. This compares with total operating expenses of $1.9 million for the same period last year, which was comprised of approximately $1.9 million in general and administrative expenses and $0.03 million in research and development expenses.

Financial Results for the Six Month Period Ended March 31, 2020:

·For the six month period ended March 31, 2020, the Company reported a net loss of approximately $8.9 million, or a net loss of $0.52 per share, compared with a net loss of approximately $3.5 million, or a net loss of $0.59 per share, for the same period last year; and
·For the six month period ended March 31, 2020, total operating expenses were approximately $8.1 million, consisting of approximately $5.3 million in general and administrative expenses and $2.8 million of research and development expenses. This compares with total operating expenses of $3.4 million for the same period last year, which was comprised of approximately $2.3 million in general and administrative expenses and $1.1 million in research and development and research and development- license acquired expenses.

On May 14, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that multiple abstracts from the Company’s tafasitamab program have been accepted for oral and poster presentations at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Meeting, May 29 – May 31, 2020 and at the virtual 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25 Virtual), June 11-14, 2020 (Press release, MorphoSys, MAY 14, 2020, View Source [SID1234558035]). Tafasitamab is MorphoSys’ investigational anti-CD19 antibody, currently under priority review by the FDA in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).

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 excited to provide a number of important updates on tafasitamab in this new virtual setting," commented Dr. Malte Peters, Chief Research and Development Officer of MorphoSys. "The data we and our partners will present highlight our progress towards making novel therapies available to eligible patients in need as soon as possible."

MorphoSys will meet registered ASCO (Free ASCO Whitepaper)20 Virtual and EHA (Free EHA Whitepaper)25 Virtual attendees at its virtual booths accessible through the conference websites.

Key abstracts accepted for presentation at ASCO (Free ASCO Whitepaper)20 Virtual and EHA (Free EHA Whitepaper)25 Virtual include:

ASCO20 Virtual

E-Poster Presentation

RE-MIND STUDY: A PROPENSITY SCORE-BASED 1:1 MATCHED COMPARISON OF TAFASITAMAB + LENALIDOMIDE (L-MIND) VERSUS LENALIDOMIDE MONOTHERAPY (REAL-WORLD DATA) IN TRANSPLANT-INELIGIBLE PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

Abstract/Poster No.: 8020/353
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Presentation Time: Friday, May 29, 2020, 8:00 AM EDT

EHA25 Virtual

Oral Presentation

RE-MIND STUDY: COMPARISON OF TAFASITAMAB + LENALIDOMIDE (L-MIND) VS LENALIDOMIDE MONOTHERAPY (REAL-WORLD DATA) IN TRANSPLANT-INELIGIBLE PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Abstract No.: S238
Session: 19. Aggressive Non-Hodgkin lymphoma – Clinical
Presentation Time: Friday, June 12, 8:30 CEST

E-Poster Presentations:

LONG-TERM OUTCOMES FROM THE PHASE II L-MIND STUDY OF TAFASITAMAB (MOR208) PLUS LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Abstract No.: EP1201
Session: 19. Aggressive Non-Hodgkin lymphoma – Clinical
Presentation Time: Friday, June 12, 8:30 CEST

EXPRESSION OF CD19 ANTIGEN ON CHRONIC LYMPHOCYTIC LEUKEMIA CELLS AFTER TAFASITAMAB (ANTI-CD19) TREATMENT: PHASE I TRIAL DATA

Abstract No.: EP671
Session: 05. Chronic lymphocytic leukemia and related disorders – Biology & Translational Research
Presentation Time: Friday, June 12, 8:30 CEST

COMBINATION OF TAFASITAMAB (MOR208) AND LENALIDOMIDE ENHANCES TUMOR CELL DEATH OF B-CELL LYMPHOMA IN VITRO
Abstract No.: EP1343
Session: 20. Lymphoma Biology & Translational Research
Presentation Time: Friday, June 12, 8:30 CEST

Please refer to the ASCO (Free ASCO Whitepaper)20 Virtual (View Source) and EHA (Free EHA Whitepaper)25 Virtual (View Source) online programs for full session details and data presentation listings.

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On May 14, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in a Phase 1 dose escalation study evaluating XMT-1592, its Dolasynthen ADC targeting NaPi2b (Press release, Mersana Therapeutics, MAY 14, 2020, View Source [SID1234558034]). XMT-1592 is the Company’s first clinical candidate created using its new customizable and homogenous Dolasynthen ADC platform.

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!

"XMT-1592 has shown a differentiated preclinical profile, particularly in NSCLC where we saw a four-fold increase in efficacy over XMT-1536, consistent with increased exposure to the DolaLock payload in the tumor, and we look forward to working to validate the clinical differentiation of this candidate," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "XMT-1592 also has the potential to further extend our leadership position in NaPi2b-expressing malignancies, and we are very pleased to have reached this important 2020 goal of advancing this promising ADC candidate into the clinic."

This Phase 1, open-label, dose-escalation study is designed to determine the maximum tolerated dose (MTD) of XMT-1592 in patients with non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. Upon completion of the dose-escalation portion of the study, the Company will determine the path forward to further assess the safety and activity of XMT-1592 in the expansion portion of the study.

About XMT-1592

XMT-1592 is an ADC targeting NaPi2b-expressing tumors. XMT-1592 was created with the Dolasynthen platform, retaining the Company’s proprietary NaPi2b antibody and auristatin DolaLock payload with controlled bystander effect plus the added benefits of site-specific conjugation, precise drug-to-antibody ratio, and even greater hydrophilicity for further enhanced drug-like properties and tumor exposure. In preclinical studies, Dolasynthen has shown four times greater efficacy in a patient-derived lung tumor model in comparison to Dolaflexin, a platform that has already shown success when targeted to NaPi2b.

On May 14, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that updated Phase 1b data on ME-401, its investigational oral phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor drug-candidate in clinical development for the treatment of follicular lymphoma and other B-cell malignancies, will be presented in a poster session at the Virtual Edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress to be held June 11 to June 14, 2020 (Press release, MEI Pharma, MAY 14, 2020, View Source [SID1234558033]).

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!

Presentation at EHA (Free EHA Whitepaper)25 Virtual Congress

Title: The PI3kδ Inhibitor ME-401 is Well-Tolerated on Intermittent Schedule and Produces a High-Rate of Durable Responses in Relapsed Refractory (R/R) Indolent B-Cell Malignancies
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Authors: John Pagel, et. al.
Abstract ID: EP1174
Session Type: Poster

The abstract is available on the EHA (Free EHA Whitepaper) Annual Congress website. Presentations and posters will be available on the EHA (Free EHA Whitepaper) website for on-demand viewing beginning on June 12, 2020 at 8:30 a.m. ET.