Myovant Sciences to Host Webcast and Conference Call at 8:30 a.m. Eastern Time Tuesday, November 19 to Discuss Results from Phase 3 Study Evaluating Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

On November 18, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported it will hold a webcast and conference call beginning at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on Tuesday, November 19, 2019, to discuss results from the Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer (Press release, Myovant Sciences, NOV 18, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-webcast-and-conference-call-830-am-1 [SID1234551475]).

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Webcast/Teleconference Details
To participate in the live conference call, please dial 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.

MorphoSys’s B-MIND trial of tafasitamab in DLBCL has successfully passed futility analysis

On November 18, 2019 MorphoSys AG (Prime Sector Segment, MDAX & TecDAX, NASDAQ: MOR) reported that the ongoing Phase 3 B-MIND study with the drug candidate tafasitamab has successfully passed the pre-planned, event-driven interim futility analysis (Press release, MorphoSys, NOV 18, 2019, View Source [SID1234551422]). The data was evaluated by an independent data control committee (IDMC). This recommended increasing the number of patients from the current 330 to 450. The B-MIND study compares the efficacy of the CD19 antibody tafasitamab in combination with bendamustine versus rituximab in combination with bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL).

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As part of the futility interim analysis, the IDMC examined the data for the likelihood of a positive outcome of the study at the time of graduation. The IDMC evaluated the efficacy data in the entire patient population as well as in the biomarker-positive patient subpopulation. The biomarker, which describes patients with a low number of natural killer cells at baseline, was implemented as a co-primary endpoint in the first quarter of 2019 in a supplement to B-MIND. The IDMC’s recommendation to include more patients in the trials aims to increase the statistical power of the study in both the biomarker-positive patient subpopulation and the entire study population. The data from the analysis was not shared with MorphoSys.

Continuing the B-MIND study protocol, patient recruitment will be performed according to the original inclusion and exclusion criteria. This should further enable the comparison of efficacy in the whole as well as the biomarker-positive patient group. Topline results are expected to be available in the first quarter of 2022.

"We are delighted with the IDMC’s recommendation and see it as an important step in the clinical development of tafasitamab," said Drs. Malte Peters, Chief Development Officer of MorphoSys. "DLBCL is a difficult-to-treat disease with a high unmet medical need, so new treatment options are urgently needed, and we are well on our way to approving our BLA approval application for tafasitamab in combination with lenalidomide, regardless of B-MIND positive clinical trial results L-MIND and Re-MIND by the end of 2019. "

About B-MIND
The pivotal Phase 2/3 B-MIND trial is investigating tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (R / R DLBCL) who are not eligible for high-dose chemotherapy and subsequent chemotherapy Autologous stem cell transplantation compared to the combination of the anti-CD20 antibody rituximab plus bendamustine A low number of natural killer cells in the peripheral blood at baseline was implemented as a biomarker in coordination with the FDA in the first quarter of 2019. A pre-planned, event-driven futility interim analysis in the B-MIND study took place in November 2019 and resulted in an increase in patient count to 450 (out of 330).

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed in several malignant B-cell diseases including DLBCL and CLL. It has been shown that CD19 participates in the B cell receptor (BCR) signaling pathway, which is considered to be important for B cell survival and makes CD19 a potential target in B cell disease.
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody against CD19. The Fc modification of tafasitamab should lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus improving a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered to be a critical component for B cell receptor (BCR) signaling.
In addition to B-MIND, MorphoSys is investigating tafasitamab as a therapeutic option in B-cell malignancies in a series of ongoing combination trials. The open-label Phase 2 combination trial (L-MIND trial) 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) in Question come. Based on preliminary data from L-MIND, the FDA granted the status of breakthrough therapy for tafasitamab plus lenalidomide in this patient population in October 2017.
Re-MIND, the real world data trial in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated clinical superiority of the tafasitamab / lenalidomide combination compared to lenalidomide alone. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL following the discontinuation of previous bron-tyrosine kinase inhibitor therapy (eg ibrutinib) in combination with idelalisib or venetoclax.

Codiak Presents First Preclinical Data for exoASO, Engineered Exosomes Designed to Reprogram Tumor-Associated Macrophages

On November 18, 2019 Codiak BioSciences, Inc., a company at the forefront of advancing engineered exosomes as a new class of biologic medicines, reported the first preclinical data for its engEx Platform program, exoASO. These data, which were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Special Conference on Tumor Immunology and Immunotherapy, demonstrate the potential of engineered exosomes incorporating an antisense oligonucleotide (ASO) to selectively reprogram tumor-associated macrophages and generate potent anti-tumor activity (Press release, Codiak Biosciences, NOV 18, 2019, View Source [SID1234551438]).

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"We continue to expand the therapeutic potential of engEx engineered exosomes and build our pipeline of novel biologics designed to target pathways that have been historically difficult to effectively or safely drug," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "These data show us the utility of exoASO in both selectively targeting classically undruggable transcription factors and successfully reprogramming immunosuppressive macrophages, representing a potentially groundbreaking approach."

Highly immunosuppressive macrophages (M2 phenotype) are immune cells that are potent drivers of tumor growth by creating an immunesuppressive environment in the tumor. Utilizing its proprietary engEx Platform, Codiak developed engineered exosomes exogenously loaded with an ASO as part of its exoASO program. exoASO is designed to selectively deliver ASOs to M2 macrophages, targeting and decreasing the expression of the key immunosuppressive transcription factors, STAT6 and C/EBPβ.

Key conclusions from in vitro and in vivo preclinical studies demonstrate that exoASO effectively reprogrammed M2 macrophages to a pro-inflammatory M1 phenotype, promoting targeted anti-tumor activity. In vitro, exoASO was preferentially taken up by M2 macrophages to a significantly greater extent than free ASO, resulting in greater knockdown of STAT6 and C/EBPβ mRNA. Subsequent gene expression analysis and cytokine assays showed an up to 40-fold increase in TNFα and an up to 29-fold decrease in IL-10 associated with exoASO treatment, consistent with repolarization from immunosuppressive M2 macrophages to immune stimulatory M1 macrophages. In in vivo studies using a PD1-refractory mouse tumor model, both exoASO-STAT6 and exoASO-C/EBPβ showed significant anti-tumor growth inhibition as monotherapies, resulting in 50 percent and 60 percent complete responses, respectively, compared to no complete responses with free ASO. mRNA analysis of tumor samples examining expression of M2 and M1 cytokines was consistent with reprogrammed macrophages from the M2 to M1 phenotype.

Data from the poster titled "Reprogramming of tumor-associated M2 macrophages with antisense oligonucleotides-loaded exosomes results in potent single-agent antitumor activity" (A50) is available for download on the Codiak website.

About engEx Platform

The engEx Platform is Codiak’s proprietary exosome therapeutic engine for engineering and manufacturing novel exosome product candidates designed to target multiple pathways throughout the body. Using this platform, Codiak can design exosomes with precisely engineered properties, incorporate various types of biologically active molecules and direct them to specific cell types and tissues. These exosomes engage by cellular uptake, membrane-to-membrane interaction or a combination of both, and are designed to change the biological functioning of the recipient cells in order to produce the intended therapeutic effect. Codiak is building a broad pipeline of engEx product candidates that may have a transformative impact on the treatment of many diseases.

Personalis, Inc. to Present New Data at the AACR Tumor Immunology and Immunotherapy Conference

On November 17, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will participate in the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy conference at the Boston Marriott Copley Place in Boston, MA, November 17-20, including poster presentations on November 18th and 19th (Press release, Personalis, NOV 17, 2019, View Source [SID1234551401]).

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The company will showcase ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following is a list of abstracts that will be presented at the meeting.

Scientific Poster Presentations

Poster Number


Title & Presenter


Day & Time


Location

A19

HLA allele-specific loss of heterozygosity detection
using augmented exome capture approach

Presenter: Rachel Marty Pyke, Ph.D.

November 18:
12:30 PM – 3:00 PM

Back Bay

B18

Exome scale liquid biopsy monitoring of putative
neoantigens and genomic biomarkers in patients
on anti-PD-1 therapy in squamous cell carcinoma of
the head and neck

Presenter: Charles Abbott, Ph.D.

November 19:
4:30 PM – 7:00 PM

Back Bay

Personalis will also be exhibiting during the conference (Exhibit # 10). Representatives will be available to answer questions about the company’s cancer immunogenomics services.

3SBio Selects Verseau’s PSGL-1-targeted Antibody VTX-0811 as First Partnered Macrophage Checkpoint Modulator in Immuno-Oncology Collaboration

On November 17, 2019 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc. ("Verseau") reported the selection of VTX-0811, a monoclonal antibody targeting PSGL-1, as the first licensed program under their partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, 3SBio, NOV 17, 2019, View Source [SID1234551402]).

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By targeting PSGL-1, an adhesion molecule that is highly expressed on tumor-associated macrophages across most tumor types, VTX-0811 reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Verseau’s PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive tumors and non-responsive tumors. PSGL-1 is the first unblinded target from Verseau’s pipeline of macrophage checkpoint modulators (MCMs). Verseau’s MCMs reprogram macrophages to be more inflammatory or more tolerogenic depending on the disease context.

"We are pleased to have achieved our first licensing milestone in our collaboration with 3SBio. Their decision to select VTX-0811 as the first program for development validates that PSGL-1 is an important and novel immuno-oncology target with the potential to expand the number of patients benefitting from immunotherapy," said Dr. Christine Bunt, Chief Executive Officer of Verseau. "Our innovative partnership is enabling Verseau to advance our industry-leading pipeline of macrophage checkpoint modulators with first-in-class potential across a broad range of cancer therapies."

"Early data in patient-derived primary tumors suggests that PSGL-1 antibodies could generate a greater anti-tumor inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors," said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio. "By partnering with Verseau,we are now at the forefront of one of the most promising areas of innovation within immuno-oncology and are making timely progress toward our goal of bringing novel cancer therapies to patients in China. We are eager to begin development on the first program selected under our partnership and look forward to future programs around novel macrophage targets identified by Verseau’s all human translational platform."

Under the terms of the agreement, 3SBio received an exclusive license to develop and commercialize a selected number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau retains global rights to all MCM programs outside of Greater China. Verseau is responsible for discovery and optimization of MCM antibodies for each program. 3SBio will fund and conduct antibody development, GMP manufacturing and commercialization in the Territory. Verseau and 3SBio will be eligible to receive certain milestone payments and royalties on product sales both in the Territory and globally. The selection of the first program for co-development under the partnership triggers an undisclosed milestone payment to Verseau. Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio, will be responsible for the development and commercialization of VTX-0811 in the Territory.

About PSGL-1

PSGL-1 (P-selectin glycoprotein ligand-1) is an adhesion molecule that is involved in immune cell trafficking in response to tissue injury or inflammation. Verseau discovered that modulation of PSGL-1 can lead to macrophage reprogramming. Proprietary PSGL-1 monoclonal antibodies induce tumor microenvironment activation, T-cell activation and naïve immune cell recruitment amounting to a coordinated immune attack on tumors. In patient-derived primary tumors, PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors. Given the prominent role of PSGL-1 in many tumor types, Verseau has selected PSGL-1 as the lead macrophage checkpoint modulator (MCM) program for clinical development.

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While many patients benefit from PD-1 inhibitor therapies, they are only effective in the ~25% of cancers that involve T cell infiltration. By targeting modulation of macrophages, which are present in ~75% of human cancers, Verseau aims to significantly expand the therapeutic benefit of immunotherapy. MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies.