On May 16, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that a trial in progress (TiP) poster will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from May 31 to June 4, 2019 (Press release, Replimune, MAY 16, 2019, View Source [SID1234536427]). The abstract is available on the ASCO (Free ASCO Whitepaper) website (View Source). The poster will describe the design and current status of the Company’s ongoing Phase 1/2 clinical trial in approximately 150 patients of RP1 alone and in combination with nivolumab anti-PD1 therapy in four solid tumor types, and will be made available on the Company’s website at the time of presentation.

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Details of Replimune’s poster presentation:

Abstract Title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors (Abstract TPS2671)

Session Title: Developmental Immunotherapy and Tumor Immunobiology

Session Date and Time: Saturday June 1st, 8:00am-11:00am CDT

Location: McCormick Place, Exhibit Hall A, Poster Board #301b

About RP1
RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

On May 16, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that a total of four abstracts have been accepted for presentation at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper) meeting (June 13-16, Amsterdam, Netherlands) (Press release, Oncopeptides, MAY 16, 2019, View Source [SID1234536426]).

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Updated data from the Phase 2 HORIZON study evaluating melflufen for the treatment of relapsed/refractory multiple myeloma (RRMM) patients with no or limited remaining treatment options will be presented as an oral presentation by Professor Paul G. Richardson. Three poster presentations, one of which is from the ongoing Phase 1/2 ANCHOR study, will also be presented.

The data in the abstracts regarding the ANCHOR and HORIZON studies is from February 6th 2019 and consequently similar to the data already presented at ASH (Free ASH Whitepaper) 2018. Additional data supporting melflufen’s activity have been generated during the spring of 2019 and will be presented in full at EHA (Free EHA Whitepaper).

CEO
"With the abstracts accepted at EHA (Free EHA Whitepaper), we have now already more than doubled the amount of abstracts accepted for presentations in 2019 compared to the full year of 2018. This underlines the increase in clinical experience that we are generating with melflufen for the treatment of patients with RRMM, and that melflufen continues to show strong activity alone or in combination with other myeloma drugs in this patient population. As always, the abstract book contains quite old data from the ongoing studies and we are excited about the opportunity to present the full data-sets at EHA (Free EHA Whitepaper)", said Jakob Lindberg CEO of Oncopeptides.

Upcoming presentations at EHA (Free EHA Whitepaper)
The HORIZON data will be presented as an oral presentation by Professor Paul G. Richardson, in the session "Novel strategies in multiple myeloma" on June 16 at 08.45 (CET) in the auditorium. Paul G. Richardson, MD, is Professor of Medicine at Harvard Medical School and Clinical Program Leader, Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute in Boston, Massachusetts, USA.

The posters will made public presented on Friday, June 14 at 09.30 and presented between 17.30 – 19.00 (CET).

Oncopeptides will also host a symposium at EHA (Free EHA Whitepaper) on June 13th between 18.45 – 20.45 (CET) at the Amsterdam RAI Hall 3B, under the title "Challenging the Treatment Paradigm in Multiple Myeloma".

The four abstracts can be found on the company webpage under:
www.oncopeptides.com / Investors & Media / Presentations / EHA (Free EHA Whitepaper) Abstracts 2019

HORIZON (OP-106): Updated efficacy and safety of melflufen in relapsed / refractory multiple myeloma (RRMM) patients refractory to daratumumab (DARA) and/or pomalidomide (POM)
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Novel strategies in multiple myeloma
Abstract Code – S 1605

ANCHOR (OP-104): A phase 1/2 study update of melflufen and dexamethasone plus bortezomib or daratumumab in in relapsed / refractory multiple myeloma patients refractory to an IMiD or a proteasome inhibitor
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Myeloma and other monoclonal gammopathies – Clinical
Abstract Code – 608

O-12-M1: An evaluation of time to next treatment in melflufen and dexamethasone treated patients with relapsed / refractory multiple myeloma
Topic: Myeloma and other monoclonal gammopathies – Clinical
Session Title: Myeloma and other monoclonal gammopathies – Clinical
Abstract Code – PF 628

Tolerability of treatments for relapsed / refractory multiple myeloma: A systematic review
Topic: Quality of life, palliative & supportive care, ethics and health economics
Session Title: Quality of life, palliative & supportive care, ethics and health economics
Abstract Code – PF 726

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

This information was submitted for publication at 15.00 CET, May 16, 2019.

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On May 16, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract highlighting additional immune-based biomarker data used to help predict patient response to pelareorep in combination with checkpoint inhibitor therapy (Press release, Oncolytics Biotech, MAY 16, 2019, View Source [SID1234536425]). The abstract was published online as part of the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the Meeting Proceedings, an online supplement of ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology.

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The abstract, titled, "Prediction of response to pelareorep plus pembrolizumab in pancreatic ductal adenocarcinoma (PDAC)," describes further immune analysis of the peripheral blood of patients from REO 024, a completed phase 1b study of pelareorep and Keytruda (pembrolizumab) in combination with chemotherapy in patients with advanced (second-line) pancreatic cancer. A phase 2 trial of pelareorep plus pembrolizumab in advanced PDAC is currently ongoing.

"The gene expression and cytokine data analysis, as well as TCR-sequencing, provides further insight into the immune environment prior to and during treatment with pelareorep and pembrolizumab," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These additional findings further highlight pelareorep’s ability to create an inflamed phenotype, resulting in a primed immune system that we believe supports combination treatment with immune checkpoint inhibitors. It also builds on our discovery that T cell clonality can serve as a predictive and prognostic biomarker for clinical benefit when used to identify patients who may respond well to this therapeutic combination. This new biomarker data supports the potential selection of patients in future clinical studies, giving these studies a higher likelihood of success."

Key data and conclusions:

•Clonal T cell diversity was expanded during therapy, broadening the potential repertoire of T cells that can target tumor cells.
•~30% of expanded clones at day eight of pelareorep therapy were durable after one cycle of treatment suggesting a refinement of T cell clones that target the best tumor cell antigens.
•Gene expression analysis in peripheral blood mononuclear cells (PBMCs) helps to validate the changes in T cell diversity, where responding patients had higher levels of pro-inflammatory cytokines expressed by activated T cells, compared to non-responders. Importantly, there was a statistically significant upregulation of genes that aid in the recruitment and activation of T cells including IL17F, CCL7, and ICOS (raw p < 0.05).
•Gene expression analysis in PBMCs may serve as a separate and independent biomarker, and helps to corroborate our previously published blood-based T cell clonality biomarker for pelareorep therapy.

The abstract was authored by Dr. Christos Fountzilas, Assistant Professor, Dept. of Medicine – GI Medical Oncology, Roswell Park Comprehensive Cancer Center and his colleagues, in collaboration with Oncolytics Biotech, Northwestern University, UT Health San Antonio, and Adaptive Biotechnologies. The publication of the abstract can be found on the Posters & Publications page of Oncolytics’ website, View Source

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 16, 2019 NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported first quarter 2019 financial results for the period ending March 31, 2019 (Press release, NGM Biopharmaceuticals, MAY 16, 2019, View Source [SID1234536424]).

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"We’ve had a productive 2019 thus far, making progress on multiple fronts, including the initiation of a Phase 2b clinical trial evaluating NGM282 in patients with non-alcoholic steatohepatitis (NASH) and F2-F3 liver fibrosis," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "Bolstered by the successful completion of our IPO in April and a strong cash position, we continue to advance our broad clinical and preclinical pipeline of next generation medicines. We look forward to sharing further developments regarding these programs later this year."

First Quarter 2019 and Recent Highlights

Completed Initial Public Offering (IPO) and concurrent private placement with Merck. The company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "NGM" on April 4, 2019. The IPO, priced at a public offering price of $16.00 per share, raised $111.9 million in aggregate net proceeds, including shares sold to the underwriters pursuant to the partial exercise of their overallotment option and after deducting the underwriting discounts and commissions. The company received $65.9 million in additional proceeds from a concurrent private placement of shares of common stock to Merck Sharp & Dohme Corp. (Merck) at the IPO public offering price of $16.00 per share.

Dosed first patient in Phase 2b ALPINE 2/3 clinical study in NASH patients with F2-F3 fibrosis for NGM282. The Phase 2b ALPINE 2/3 study is expected to enroll approximately 150 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis, and will assess the efficacy, safety and tolerability of NGM282 compared to placebo. The primary efficacy objective is to evaluate the treatment effect after 24 weeks of three dose levels of NGM282 (0.3 mg, 1 mg and 3 mg) on liver histology, which is defined as an improvement in liver fibrosis (³ 1 stage change) with no worsening of NASH or a resolution of NASH (defined as a NAFLD activity score for inflammation of 0 or 1 and ballooning score of 0) with no worsening of fibrosis. NGM anticipates announcing preliminary results from this Phase 2b clinical study in 2020.

Extended strategic collaboration with Merck. In March, Merck exercised its option to extend its broad, strategic collaboration with NGM for an additional two-year period from March 2020 to March 2022. During the two-year extension period, Merck will continue to fund NGM’s research and development efforts at the same levels as the original collaboration terms and, in lieu of a $20 million extension fee payable to NGM, Merck will make additional payments totaling $20 million in support of NGM’s research and development activities during 2021 and the first quarter of 2022. The companies also announced that Merck will terminate its license to NGM’s growth differentiation factor 15 (GDF15) receptor agonist program, effective May 31, 2019, at which time the program rights will return to NGM.

Appointed Hsiao D. Lieu, M.D., as Senior Vice President, Chief Medical Officer. In March, NGM announced the appointment of Hsiao D. Lieu, M.D. as Senior Vice President, Chief Medical Officer. Dr. Lieu most recently served as Vice President of Early Clinical Development at Genentech, where he was responsible for early phase drug development for all non-oncology indications, including ophthalmology, metabolic, neurology and inflammation. Concurrent with Dr. Lieu’s appointment, Alex DePaoli, M.D., who had served as NGM’s founding Chief Medical Officer, transitioned to the role of Senior Vice President, Chief Translational Officer. In this new role, Dr. DePaoli is focused on guiding NGM’s robust discovery portfolio into clinical development.

First Quarter Financial Results

Related party revenue for the first quarter of 2019 was $25.6 million compared to $18.6 million for the same period in 2018.

Research and development expenses for the first quarter of 2019 were $29.5 million, as compared to $19.5 million for the same period in 2018. The increase in research and development expense was primarily related to an increase in external research and development expenses associated with the advancement of NGM’s growing pipeline and increased NGM282 program expenses due to the ongoing Phase 2 clinical trials.

General and administrative expenses for the first quarter 2019 were $5.4 million, as compared to $3.9 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations.

For the first quarter of 2019, NGM reported a net loss of $8.3 million, compared to a net loss of $3.9 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities were $193.4 million as of March 31, 2019, which does not include the net proceeds from NGM’s initial public offering and the private placement of shares with Merck, which closed in April, compared to $206.6 million as of December 31, 2018.

On May 16, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported results from the primary analysis (cut-off date November 30, 2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND (Press release, MorphoSys, MAY 16, 2019, View Source [SID1234536423]).

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The primary endpoint, defined as best ORR compared to published data on the respective monotherapies, has been met. The ORR was 60% (48 out of 80 patients), and the CR rate was 43% (34 out of 80 patients). The mPFS was 12.1 months with a median follow-up of 17.3 months. The mDoR was 21.7 months. These results provide overall confirmation of the strong L-MIND data previously published at ASH (Free ASH Whitepaper) in December 2018.

The data reported today included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update are based on response rates assessed by an independent review committee for all 80 patients.

"We are delighted to see that the overall results fom the primary analysis of our L-MIND trial have confirmed the strong data we had presented at ASH (Free ASH Whitepaper) in 2018", commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "We strongly believe we have a remarkable drug candidate and these data further support our plan to develop tafasitamab in combination with lenalidomide as a potential chemo-free treatment option for patients with r/r DLBCL. We remain highly committed to completing the submission of a BLA to the FDA by end of this year."

"The results fom the primary analysis are very encouraging. We are particularly pleased to see such a high complete response rate and a prolonged response duration, which is unsual in this population of relapsed or refractory DLBCL. If approved, given its safety profile, tafasitamab has the potential to become a new treatment option to improve quality of life and outcome for patients with this disease", says Professor Gilles Salles, Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of L-MIND.

L-MIND is designed to investigate the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Tafasitamab is an investigational humanized Fc-enhanced monoclonal antibody directed against CD19 and is currently in clinical development in blood cancer indications.

MorphoSys’s management will be available for a Q&A session on the headline data on Monday, May 20, 2019 at 2:00pm CEST (1:00pm BST/8:00am EDT).

MorphoSys plans to present detailed results at the ICML conference in Lugano in June this year.

Dial-in number for the Q&A session on Monday, May 20, 2019 at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 59149632#

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 has been reported to enhance B cell receptor (BCR) signaling, which is assumed important for B cell survival, making CD19 a potential target in B cell malignancies.
Tafasitamab (MOR208) is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab 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. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. The pivotal phase 2/3 B-MIND study is designed to investigate tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in comparison to the combination of the anti-CD20 antibody rituximab plus bendamustine. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.