On February 27, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that new data on its pipeline programs and technology platform will be presented in four posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, to be held March 29 – Apr 3, 2019 at the Georgia World Congress Center in Atlanta, Georgia (Press release, Molecular Templates, FEB 27, 2019, View Source [SID1234533763]).

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Preclinical data on TAK-169, the company’s CD38-targeted ETB (partnered with Takeda Pharmaceutical Company Limited), will be presented for the first time at the AACR (Free AACR Whitepaper) meeting. This molecule is the most potent ETB that Molecular Templates has developed against any target to date. Importantly, in preclinical models, TAK-169 is active in the presence of daratumumab and active against daratumumab resistant cells.

"We are excited to be presenting new data on multiple pipeline programs as well as potential new applications of our ETB technology platform," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We believe that TAK-169 could be an important new therapy for multiple myeloma patients and these new preclinical data support our rationale for the partnership we announced with Takeda in September 2018. We look forward to the start of clinical development for TAK-169 this year. We believe that data on our CD20 and PD-L1 ETBs support our clinical development plans for those programs. Furthermore, the data on bispecific ETBs highlight the breadth of potential application of our technology, which we expect to drive continued pipeline expansion and partnership opportunities."

Date: Monday, April 1
Time: 1:00pm – 5:00pm Eastern Time
Session: Immunology: Therapeutic Antibodies 3
Abstract #: 2384
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25, Poster Board Number 8
Poster Title: TAK-169, an Exceptionally Potent CD38 Targeted Engineered Toxin Body, as a Novel Direct Cell Kill Approach for the Treatment of Multiple Myeloma
Authors: Erin K. Willert1, Garrett L. Robinson1, Jack P. Higgins1, Jensing Liu1, Janice Lee2, Sakeena Syed2, Yuhong Zhang2, Dan Tavares2, Anya Lublinsky2, Nibedita Chattopadhyay2, Haiqing Wang2, Laura Packer2, Pu Shi2, Carole Harbison2, Sanjay Patel2, John Newcomb2
1Molecular Templates Inc., Austin, TX; 2Takeda, Cambridge, MA
Molecular Templates will present on its CD38-targeted ETB, TAK-169. Although CD38 is a poorly internalizing receptor, TAK-169 is able to efficiently internalize and directly kill CD38-expressing cells. This novel mechanism of action may be relevant in patients who have progressed after or are unlikely to respond to CD38-targeted antibody therapy. TAK-169 has demonstrated potent cytotoxicity across a range of myeloma cell lines with a range of CD38 expression in vitro as well as in patient-derived samples including those with previous exposure to daratumumab. Furthermore, TAK-169 retains activity in the presence of excess approved, CD38 targeted therapeutic daratumumab. In xenograft models, complete regressions were observed using both a once-weekly and bi-weekly schedule of TAK-169. Tolerability studies in non-human primates demonstrate that repeat administration is tolerated at doses that are expected to be efficacious. TAK-169 is expected to enter the clinic in 2019.

Date: Monday, April 1
Time: 1:00pm – 5:00pm Eastern Time
Session: Experimental and Molecular Therapeutics: Apoptosis, Necrosis, and Cancer Cell Survival
Abstract #: 2060
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 9, Poster Board Number 12
Poster Title: Combination of CD20 targeted Engineered Toxin Body, MT-3724, with chemotherapy or IMiDs for the treatment of Non Hodgkin’s Lymphoma
Authors: Jack P. Higgins, Aimee Iberg, Caleigh Howard & Erin K. Willert
MT-3724 is a CD20-targeted ETB that has demonstrated single agent anti-tumor activity in heavily pre-treated relapsed/refractory (R/R) Non-Hodgkin’s lymphoma (NHL) patients in a Phase I clinical study. The combination of MT-3724 with chemotherapeutic agents (doxorubicin, gemcitabine, bendamustine, and vincristine) or an immunomodulatory (IMiD) agent (lenalidomide) all demonstrated additive or synergistic cytotoxicity of NHL cell lines. Additional clinical studies to evaluate MT-3724 as single agent and in combination with gemcitabine and oxaliplatin (GEMOX) or lenalidomide are underway and expected to generate data in 2019.

Date: Tuesday, April 2
Time: 1:00pm – 5:00pm Eastern Time
Session: Experimental and Molecular Therapeutics: Pharmacokinetics and Pharmacodynamics / Preclinical Toxicology
Abstract #: 3900
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 13, Poster Board Number 20
Poster Title: The Safety and efficacy Profile of a PD-L1 Directed, Engineered Toxin Body, as a Novel Targeted Direct-Cell Kill Approach for the Treatment of PD-L1 Expressing Cancers
Authors: Hilario J. Ramos, Asis K. Sarkar, Sara Le Mar, Brigitte Brieschke, Joseph D. Dekker, Veronica R. Partridge, Pablo A. Maceda, Michaela M. Sousares, Garrett L. Robinson, Aimee Iberg, Shaoyou Chu, Jensing Liu, Jack P. Higgins, Erin K. Willert.
Molecular Templates has developed PD-L1-targeting ETBs as an approach to directly target tumor cells and overcome resistance mechanisms against PD-1 and PD-L1 antibodies. The cytotoxicity delivered by PD-L1-specific ETBs is engineered to be independent of a requirement for tumor infiltrating lymphocytes, high tumor mutational burden, or modulatory effects of the tumor microenvironment. Further, the activity is not dependent on blockade of the PD-1/PD-L1 checkpoint axis. Thus, PD-L1-targeting ETBs represent a distinct class of therapeutics with direct cell-kill mechanism of action and ability for activity in patients who have progressed on current standard of care or checkpoint therapy. In this presentation, we highlight the efficacy and safety profile of MT-6020, a human and cynomolgus cross-reactive, PD-L1 targeted, ETB. MT-6020 binds to cell lines expressing non-human primate PD-L1 and elicits cytotoxic responses comparable to those observed on human tumor target cells. Molecular Templates’ PD-L1 ETB, MT-6035, is built upon the MT-6020 scaffold and can also deliver a viral peptide for cell surface presentation and targeting by a specific antiviral CTL population for a second and complementary mechanism for tumor cell destruction, referred to as antigen seeding. MT-6020 and MT-6035 represent a novel approach to targeting and destroying tumors expressing PD-L1 that is unlikely to be inhibited by resistance mechanisms to current checkpoint inhibitors, is well tolerated in relevant toxicity models, and has the capacity for activity in indications where standard of care has failed. Molecular Templates expects to initiate clinical development of the PD-L1-targeted-ETB (with antigen seeding) in 2H19.

Date: Tuesday, April 2
Time: 8:00am – 12:00pm Eastern Time
Session: Experimental and Molecular Therapeutics: Diagnostics, Biomarkers, and the Tumor Microenvironment
Abstract #: 2984
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 11, Poster Board Number 6
Poster Title: Design and Characterization of Bispecific Engineered Toxin Bodies for Targeted Cancer Therapy
Authors: Aimee Iberg, Garrett L. Cornelison, Caleigh Howard, Paul Amador, Steven Rivera, Michael Jamaleddine, Garrett L. Robinson, Erin K. Willert
To further expand the therapeutic benefit of its ETB platform, Molecular Templates is characterizing ETBs that are targeted through multiple binding domains. Bispecific ETBs that target two epitopes on the same receptor, or two distinct cell surface molecules both expressed on cancer cells, may allow for enhanced activity profiles. These possibilities include: (i) activity in the presence of a competitive binding protein (ii) sustained activity when one target molecule is shed or downregulated, (iii) synergistic binding events to increase overall potency, and (iv) increased specificity towards cancer over normal tissue. Bispecific ETBs have been generated to engage a variety of target combinations, relevant to both solid and hematologic cancer treatment. MTEM is exploring therapeutically relevant target combinations to facilitate the development of a bispecific clinical lead. By pairing the biology and potency of ETB-mediated killing with the expanded targeting possibilities afforded by bispecific molecules, Molecular Templates aims to develop a new class of therapeutics to benefit cancer patients.

On February 27, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that data from its Phase II HORIZON study and Phase I/II ANCHOR study evaluating the company’s novel candidate melflufen, a peptide-conjugated alkylator belonging to the novel class of peptidase enhanced compounds, have been selected as poster presentations at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on 29 March – 3 April 2019 in Atlanta, Georgia, USA (Press release, Oncopeptides, FEB 27, 2019, View Source [SID1234533791]).

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– Data demonstrate tolerability and high level of activity associated with melflufen in relapsed/refractory multiple myeloma (RRMM) patients –

– Early signs of high efficacy are encouraging; studies are ongoing –

"Our rigorous clinical development program is initially focused on our first-in-class candidate melflufen, which is currently being studied in global Phase II studies and the Phase III OCEAN study," said Jakob Lindberg, CEO of Oncopeptides. "We are extremely pleased that these data have been selected for poster presentation at AACR (Free AACR Whitepaper), following their initial presentation at the ASH (Free ASH Whitepaper) 2018 Annual Meeting, and believe that this further validates the promise that melflufen holds for the treatment of patients with advanced multiple myeloma whose treatment options are limited."

Melflufen’s novel mechanism of action works by eliciting increased cytotoxicity in target multiple myeloma (MM) cells and substantially reduced off-target cell toxicity. Melflufen is in a pivotal Phase III study, OCEAN, for its initial indication in RRMM under a Special Protocol Assessment from the US Food and Drug Administration (FDA). Based on ongoing preclinical studies, Oncopeptides is also exploring the potential for the use of melflufen, or other peptide-conjugated drugs, to treat various cancers beyond MM.

The full AACR (Free AACR Whitepaper) 2019 Annual Meeting abstract book can be viewed at www.aacr.org.

The posters we present are found under the title:
HORIZON: Melflufen in patients (pts) with relapsed/refractory multiple myeloma (RRMM) refractory to daratumumab (dara) and/or pomalidomide (pom) (OP-106)

ANCHOR: Melflufen and dexamethasone (dex) plus bortezomib (BTZ) or daratumumab (dara) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) (OP-104)

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

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

This information was submitted for publication at 22.30 CET, 27 February 2019

On February 27, 2019 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its interim report and financial results for the half-year ended 31 December 2018 (Press release, Starpharma, FEB 27, 2019, View Source [SID1234533744]).

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Financial Summary

Reported loss of $7.3M (Dec 2017: $6.2M); and
Cash position at 31 December 2018 of $44.4M (June 2018: $51.3M), which excludes the expected $4.0M FY18 R&D tax incentive to be received.
VivaGel

VivaGel BV was licensed to ITF Pharma, Inc., for the US for milestones of up to US$101M in addition to escalating, double-digit royalties;
Starpharma and its partners, Mundipharma and Aspen, undertook extensive preparations for the upcoming launches of VivaGel BV in multiple regions scheduled for the first half of 2019. Extensive marketing activities such as packaging design, sales staff training, promotional material development, and launch meetings occurred in parallel with supply chain activities. Manufactured product has been delivered to Aspen subsequent to half-year end, and manufacturing of product for Europe is well-advanced;
US FDA completed its review of the VivaGel BV NDA and advised it requires confirmatory clinical data prior to approval. In preparation for a meeting with the FDA to discuss the data required, Starpharma has been working closely with expert FDA consultants and is currently awaiting confirmation of the meeting date;
VivaGel condom received final regulatory approval in Japan and Starpharma’s partner, Okamoto, commenced launch activities; and
Positive independent market research was conducted in the US for SPL7013 ophthalmic drops for viral conjunctivitis and a patent was granted for the product.
DEP Drug Delivery

Recruitment activities progressed well for two DEP clinical trials – for DEP docetaxel (phase 2) and DEP cabazitaxel (phase 1 / 2), with new sites opened to support recruitment. Efficacy signals have been observed in a number of patients and both products continue to exhibit a notable lack of bone marrow toxicity and other common side effects including hair-loss, anaphylaxis and oedema;
Final preclinical work for the DEP irinotecan phase 1 / 2 trial was completed, study product was manufactured, and other trial preparations, including CRO/site selection, are well advanced ahead of the planned trial commencement later in FY19;
AstraZeneca’s first patent application on DEP Bcl2/xL inhibitor conjugates was published and included compelling efficacy data on DEP Bcl2/xL inhibitor conjugates, both alone and in combination with market-leading anti-cancer treatments, in various human leukemia models;
DEP irinotecan showed impressive efficacy and safety benefits over standard irinotecan in combination with 5-FU in a human pancreatic cancer model;
DEP docetaxel & DEP cabazitaxel outperformed both gemcitabine & Abraxane in a human pancreatic cancer model; and
A range of DEP radiopharmaceutical and other DEP candidates have been made and are currently undergoing testing in a variety of models.
Starpharma concluded the half-year in a strong financial position with a cash balance of $44.4 million, which does not include the $4.0M FY18 R&D tax incentive expected to be received after 31 December 2018. The net loss after tax for the half-year of $7.3 million (Dec 2017: $6.2 million) reflects investment across the VivaGel and DEP portfolio, including DEP docetaxel, DEP cabazitaxel, and DEP irinotecan. Expenditure includes an increased investment in commercialisation, regulatory and operating costs associated with the US VivaGel BV licence and the preparation for product launch in a number of territories.

Starpharma’s CEO, Dr Jackie Fairley, commented: "We achieved several important milestones in the VivaGel portfolio during the half-year, including signing a US licence for VivaGel BV with ITF Pharma, Inc. We were clearly surprised and disappointed by the FDA’s request for confirmatory data and we are working with expert FDA consultants to expedite this process. In non-US territories, launch activities are in the final stages as we approach the launch of VivaGel BV in Australia and Europe (1HCY19). We also continue to work closely with our partner, Mundipharma, on further registrations to support launches in several other regions."

Commenting on the DEP drug delivery portfolio, Dr Fairley said: "We’re pleased to see efficacy signals once again in both our DEP clinical trials as well as a notable lack of bone marrow toxicity and other common side effects. An abundance of positive data from the DEP platform, both preclinical and clinical, continues to build amid partnered program discussions with a number of multinational and US pharmaceutical companies. Our first partnered program with AstraZeneca for AZD0466 is expected to commence clinical trials this year and preparations at AstraZeneca for this activity continue with priority. This partnered program is just one example of the value that can be generated from our unique DEP platform."

Dr Fairley concluded: "We expect to announce a number of key milestones throughout 2019, in addition to the launch of VivaGel BV in Australia and Europe, and regulatory progress across a range of markets, including the US; launch of the VivaGel condom in Japan; regulatory approval of the VivaGel condom in other regions; and progress across internal and partnered DEP programs including commencement of the DEP irinotecan and AZD0466 clinical trials."

On February 27, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract demonstrating a biomarker for predicting clinical response in patients treated with pelareorep (Press release, Oncolytics Biotech, FEB 27, 2019, View Source [SID1234533792]). This analysis was conducted in patient samples from REO 024; a study of pelareorep and Keytruda in combination with chemotherapy in patients with second-line pancreatic cancer. Detailed results will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 30 through April 3 in Atlanta, Georgia.

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”With a simple blood draw, this biomarker data allows physicians to understand which patients are likely to respond to treatment, allowing for the design of clinical studies that are cheaper, faster and more likely to succeed,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. ”Our biomarker data that we will present at AACR (Free AACR Whitepaper) is immediately applicable to future clinical studies. Investigators should now be able to predict which patients will respond to pelareorep in combination with a checkpoint inhibitor. This biomarker will be evaluated in our clinical studies with checkpoint inhibitors, including both of our multiple myeloma studies, the AWARE-1 breast cancer study, and importantly, in the same setting this data was produced, our phase two second-line pancreatic study in combination with Keytruda.”

"Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies’ immunoSEQ Assay to measure the diversity or clonality of the T cell population,” said Dr. Rita Laeufle, CMO of Oncolytics Biotech. ”Results from this analysis demonstrate that higher clonality after one three-week cycle of treatment can identify patients likely to respond to combination treatment of pelareorep and a checkpoint inhibitor.”

The results suggest that those patients with a statistically significant change in their T cell population demonstrate a clinical benefit from pelareorep treatment. High T cell clonality correlates with progression free survival at baseline (HR=0.05, p=0.01). Moreover, high clonality correlates with overall survival at both baseline (HR=0.124, p=0.01) and after one cycle of treatment (HR=0.08, p=0.01). This research highlights the potential utility of measuring T cell clonality as a predictive and prognostic biomarker of pelareorep therapy.

The abstract, authored by Dr. Grey Wilkinson, a translational scientist at Oncolytics Biotech, and his colleagues, in collaboration with Northwestern University, UT Health San Antonio and Adaptive Biotechnologies, can be found online at View Source!/6812/presentation/4866. Full details from the poster presentation will be announced after it is presented.

Poster Board Number: 1
Presentation Number: 2272
Title: Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma
Date: Monday, April 1
Lecture Time: 1:00 p.m. ET – 5:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 20
Speakers: Grey Wilkinson
Session Category: Clinical Research
Session: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 3

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 February 26, 2019 ImaginAb, Inc., a clinical stage immuno-oncology imaging company, reported the appointment of Ian Wilson as Chief Executive Officer while Martyn Coombs steps down for family reasons, effective immediately (Press release, ImaginAb, FEB 27, 2019, View Source [SID1234534236]). In addition, Tim Irish has joined ImaginAb’s Board of Directors as an independent non-executive Director and Jeffrey Evelhoch, Ph.D. has joined the Company’s Scientific Advisory Board.

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Ian Wilson, CEO of ImaginAb said, "I am honored to take this leadership role at ImaginAb, and continue to build on the many successes we have achieved, most notably in the last two years. Our ImaginAb team extends a warm welcome to Tim and Jeff as they embark on their new Board roles. We look forward to leveraging their extensive experience within global pharmaceutical companies as we continue to expand our strategic relationships and our clinical programs."

With over 25 years of experience in the commercial development of in vivo medical diagnostics and imaging medical devices, Ian originally joined ImaginAb in early 2018 as Chief Operations Officer, driving clinical execution and R&D. Prior to that, he was CEO and Chief Technology Officer of Edinburgh Molecular Imaging Ltd., leading the development of novel optical imaging agents. Ian has also held positions at Xstrahl Ltd., as CTO and COO, and numerous roles at GE Healthcare including Portfolio and Strategy Manager and Head of Biology.

"I am delighted to be joining the ImaginAb Board of Directors, as the team forges its exciting path towards developing much-needed tools that can measure CD8 T Cells in patients. This vital technology will aid the whole immuno-oncology area in patient selection and management and drive us toward improved outcomes," said Mr. Tim Irish.

Tim Irish has worked in the life sciences industry for thirty years with a career spanning global health technology companies across Europe and North America, including GSK, GE and Philips. Between 2007 and 2015 Tim served on ten Boards, five as Chair, where he successfully executed two trade sales and raised significant equity financing, including an IPO. Since 2015 his governance portfolio covers Life Sciences and Healthcare, both public and private, including board roles as Senior Independent Director and Non-Executive Director at NICE, four European NED roles, and Professor of Practice at King’s College London’s School of Management and Business.

"ImaginAb’s application of precision imaging has the potential to increase our understanding of cancer immunology and may fundamentally change how cancer is treated," said Jeff Evelhoch, Ph.D. "I am excited to work with the other esteemed members of the ImaginAb Scientific Advisory Board to help advance this novel technology."

Jeff Evelhoch, Ph.D., is responsible for development and qualification of novel biomarkers, use of biomarkers to inform pipeline decisions and the development and deployment of companion diagnostics at Merck. Jeff joined Merck Research Laboratories in 2008 as Vice President and Head of Imaging and was named Vice President and Head of Translational Biomarkers in 2015. He joined Merck after four years at Amgen as Executive Director and Head of Imaging Sciences, which followed 2 years at Pfizer Global Research & Development and Pharmacia as Director of Structural Imaging.