On October 3, 2018 Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a new class of T cell engaging therapeutics, reported that it has appointed Natalie R. Sacks, M.D., as Chief Medical Officer (Press release, Harpoon Therapeutics, OCT 3, 2018, View Source [SID1234529726]).

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"We are thrilled to welcome Dr. Sacks as our new Chief Medical Offer. Natalie brings a strong record of accomplishment in the development and commercialization of oncology therapeutics, which will be instrumental as we advance our pipeline in the clinic," said Jerry McMahon, Ph.D., President and Chief Executive Officer, Harpoon.

"As an oncologist, I look forward to joining a company that is pioneering new ways to treat cancer and impact the lives of patients in need," says Dr. Sacks. "I am excited about the potential of Harpoon’s clinical programs and its novel TriTAC platform to redirect a patient’s own T cells to attack tumor cells."

Dr. Sacks most recently served as Chief Medical Officer of Aduro Biotech, a company focused on the advancement of novel immuno-oncology technologies. Previously, she was Vice President of Clinical Development at Onyx Pharmaceuticals (acquired by Amgen) where she played a key role in the development and approval of Kyprolis, an FDA-approved therapy for the treatment of multiple myeloma, and in business development strategy. Prior to that, she served as Vice President of Clinical Research for Exelixis where she directed the development of a portfolio of small molecules, with responsibilities ranging from IND filings to late-stage development, including development of Cometriq. Earlier in her career, Dr. Sacks served as Vice President of Clinical Development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR)-T cells. She received her M.D. from the University of Pennsylvania School of Medicine, her M.S. in Biostatistics from the Harvard University T.H. Chan School of Public Health and her B.A. in Mathematics from Bryn Mawr College. Dr. Sacks was an Assistant Clinical Professor at the University of California, San Francisco, and served as volunteer Attending Physician in Hematology-Oncology at San Francisco General Hospital for more than a decade. She serves as a board member for Zymeworks Inc. and Caribou Biosciences.

On October 3, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial results for the third quarter of 2018 on Tuesday, November 6, 2018 (Press release, Eli Lilly, OCT 3, 2018, View Source [SID1234529747]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On October 3, 2018 ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, reported that they have entered into an agreement to develop and commercialize a next generation sequencing (NGS)-based companion diagnostic (CDx) assay (Press release, ArcherDX, OCT 3, 2018, View Source,-darmstadt,-germany-selects-archerdx-for-strategic-global-companion-diagnostic-assay-development-collaboration [SID1234529767]).

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Under the terms of the agreement, ArcherDX will develop and seek regulatory approval for a CDx assay that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX will develop the CDx using the Archer diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP) technology with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software. The CDx assay will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.

"We are pleased to launch this strategic companion diagnostic initiative," stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. "The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies."

On October 2, 2018 BioInvent International AB (OMXS: BINV) reported that the company will present two posters together with its transgender for a new checkpoint blocking antibody optimized for slow elimination and its targeted oncolytic virus vector at Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s (SITC) (Free SITC Whitepaper) annual meeting that will be held November 7-11 in Washington DC (USA) (Press release, BioInvent, OCT 2, 2018, View Source [SID1234529707]). The anti-CTLA-4 antibody encoding oncolytic virus product candidate is developed for tumor localized cancer immunotherapy.

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Generation and characterization of a CTLA-4 antibody with improved Fc γ R -dependent Treg deletion of tumor microenvironment-targeted oncolytic virotherapy of cancer

Author: Monika Semmrich, Jean-Baptiste Marchand, Petra Holmkvist, Linda Mårtensson, Ulla-Carin Tornberg, Laetitia Fend, Mathilda Kovacek, Ulla-Carin Tornberg, Ingrid Teige, Andre McAllister, Eric Quéméneur, Björn Frendéus.
Poster number: P602
Antibody-armed oncolytic vaccinia virus to block immunosuppressive pathways in the tumor microenvironment

Author: Jean-Baptiste Marchand, Monika Semmrich, Laetitia Fend, Ulla-Carin Tornberg, Nathalie Silvestre, Björn Frendéus, Eric Quéméneur
Poster number: P615
The posters will be shown on Friday and Saturday, November 9-10 in the poster (hall E).

Björn Frendéus, BioInvents Chief Scientific Officer, said: "We are pleased to announce a potentially safe and more effective strategy for combining anti-CTLA 4 and anti-PD-1 / PDL1 checkpoint inhibition in oncolytic viral therapy. By building on the extensive clinical validation of checkpoint blockers, onkoviral tumor localized administration of our monoclonal antibody optimized for slow elimination potential has improved the therapeutic window for CLTA-4 targeted checkpoint intervention, enabling a better tolerated and more effective combination therapy with approved antibodies directed against the PD-1 / PD-L1 axis. "

On October 2, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported its updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Cellectar Biosciences, OCT 2, 2018, View Source [SID1234530173]).

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The results to date show that OS is currently at 19.4 months. Cellectar continues to monitor these patients and intends to update OS results as data become available. All 15 patients from the Phase 1b, single-dose cohorts were heavily pretreated, receiving an average of 5 previous lines of multidrug therapy including anti CD38, immunomodulating drugs and proteasome inhibitors. All patients were relapsed or refractory to at least one proteasome inhibitor and IMiD. Most patients presented with advanced stage 2 or 3 disease and 67% had previously received at least 1 stem cell transplant.

"We are extremely pleased to announce that CLR 131 has achieved OS of 19.4 months in our Phase 1b trial in R/R MM. We view this outcome as impressive considering all patients were heavily pretreated and presented with high tumor burden," said James Caruso, president and chief executive officer of Cellectar Biosciences. "Most drugs currently approved for third-line or later R/R MM average approximately 12 months of survival, including several recent approvals. We believe extending OS to beyond 19 months with a more patient-friendly dosing regimen provides both a unique product profile and potential for beneficial patient outcomes."

The objective of this multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 administered as a single-dose, 30-minute infusion in patients with R/R MM. Patients received doses of 12.5 mCi/m2 up to 31.25 mCi/m2. All doses were deemed safe and well tolerated by an independent data monitoring committee.

Data from a fifth cohort, released in August, evaluated a split or fractionated dose of 31.25 mCi/m2 for tolerability and safety. The dosing schedule provided higher average drug exposure but lower peak serum levels than non-fractionated dosing potentially reducing adverse events and improving efficacy. The independent Data Monitoring Committee (DMC) determined the fractionated dose used in Cohort 5 to be safe and well tolerated and recommended advancement to a higher dose cohort.

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2. All study doses have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.