On January 9, 2020 Grey Wolf Therapeutics, a drug discovery biotechnology company focused on developing first-in-class therapies for immuno-oncology (IO), reported it has completed a £2.5 million ($3.3 million) Series A2 financing round with existing leading international healthcare investors Andera Partners and Canaan (Press release, Grey Wolf Therapeutics, JAN 9, 2020, View Source [SID1234552910]).

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The new funding – all from existing investors – will allow the company to accelerate development of therapies targeting endoplasmic reticulum aminopeptidase 2 (ERAP2), following many positive signals of its potential. Funds will also be used to continue to drive the lead endoplasmic reticulum aminopeptidase 1 (ERAP1) modulator program. For context, both of Grey Wolf’s novel ERAP approaches are aimed at directly altering tumor cells, illuminating them for attack and destruction by the immune system. The goal is to exploit this increased tumor visibility in monotherapy and to extend the therapeutic benefit of already approved immunotherapies to many more cancers. The company is developing small molecule modulators of ERAP1 and ERAP2, two key proteins in the antigen presentation pathway, to change the antigen repertoire of tumors and thereby increase the number and range of cancer-related antigens, including neoantigens, presented on tumor cells available to engage an immune response.

"We are delighted to have the continued support of Andera and Canaan." said Peter Joyce, Chief Executive Officer and Co-Founder. "The financing reflects growing potential in both our ERAP1 and ERAP2 approaches. We continue to see momentum, both in our own work and in the broader scientific community. These funds will allow us to further capitalize on this opportunity and expand our leadership position in the discovery and development of both ERAP1 and ERAP2 modulators."

Grey Wolf is expanding efforts around ERAP2 for two reasons. First, clinical data continues to demonstrate that tumors which are more visible to the immune system show improved responses to checkpoint inhibitors. One such example is the recent November 2019 paper published in Nature Medicine by the Chan group at MSKCC. The results are consistent across patients which either have a higher tumor mutational burden, heterozygosity of the Class I HLA locus or greater structural / sequence divergence at the Class I HLA locus. Second, the company has developed unique insight into the targeting of the ERAP enzymes through the lead program ERAP1 and validated the role for ERAP inhibition in modulating the cancer-related antigen repertoire. These in-house data provide compelling evidence that the therapies could have a real impact in the treatment of oncology.

"We have continued to generate data showing that modulation of both ERAP pathways drives change to the cancer-related antigen repertoire," said Tom McCarthy, Executive Chairman and Co-Founder of Grey Wolf Therapeutics. "Data clearly demonstrates that modulation of ERAP2 drives an altogether different change to the antigen repertoire, when compared with ERAP1 modulation, due to ERAP2’s clearly differentiated peptide substrate specificities. With this investment and the prior knowledge base within Grey Wolf we will be able to accelerate the ERAP2 program quickly through optimization, building on our leading position in ERAP disease-related biology."

The additional funds represent further confidence from investors. "Grey Wolf have already provided compelling insight into the potential of ERAP1 modulation," said Raphaël Wisniewski, Partner at Andera Partners. "This timely investment further underlines our excitement in these approaches. Grey Wolf are fast becoming true experts in modulation of ERAP biology for treatment of cancer." Brent Ahrens, General Partner at Canaan, added: "Canaan continues to be excited by the potential of targeting the ERAP pathway and are impressed with the progress the team has made in such a short space of time since closing Series A. The additional A2 investment enables the Company to push forward ERAP2 whilst maintaining the momentum on the lead ERAP1 program."

On January 9, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that ROTH Capital Partners (ROTH) will conduct a Key Opinion Leader call today at 10:30 am ET for their institutional clients (Press release, Oncolytics Biotech, JAN 9, 2020, View Source [SID1234552909]). The call, "Proteasome Inhibitors Augment Pelareorep in Multiple Myeloma" will feature Dr. Flavia Pichiorri Ph.D. and Dr. Craig Hofmeister M.D., both of whom are working on ongoing multiple myeloma studies with Oncolytics’ oncolytic virus, pelareorep.

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The equity research team at ROTH will host and moderate the call for their clients, with a focus on recent data presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, and how it could impact the design of future multiple myeloma trials with oncolytic viruses versus the standard of care.

Management plans to provide a recap of the call next week, including key messages and insights provided by Dr. Pichiorri and Dr. Hofmeister.

Dr. Flavia Pichiorri Ph.D., Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA and Department of Hematologic Malignancies Translational Science, Beckman Research Institute, City of Hope, Duarte, CA.

Dr. Craig Hofmeister M.D., Winship Cancer Institute /Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.

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 January 9, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics, will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 8:00 AM PT (11:00 AM ET) in San Francisco (Press release, Jounce Therapeutics, JAN 9, 2020, View Source [SID1234552908]). Following the presentation, management will participate in a question and answer session at 8:30 AM PT (11:30 AM ET).

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A live webcast of the presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On January 9, 2020 Genprex Presented the Investor Presentation (Presentation, Genprex, JAN 9, 2020, View Source [SID1234552907]).

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On January 9, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported that key objectives and anticipated milestones for 2020 and provided an overview of recent progress (Press release, Synlogic, JAN 9, 2020, View Source [SID1234552906]).

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"In 2020 we look forward to advancing our platform and our growing development stage pipeline of Synthetic BioticTM medicines – advancing our phenylketonuria program and additional oral metabolic programs that build on the critical capabilities we have established in development and manufacturing, as well as advancing our first clinical program in oncology," said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive officer. "We believe that Synthetic Biotic medicines have potential across multiple diseases and conditions. Our expanded collaboration with Ginkgo Bioworks, strong balance-sheet and solid momentum out of our discovery and development efforts position us well to execute on our near-term clinical plans."

2020 Goals and Milestones
Clinical Programs

SYNB1618: SYNB1618 is an orally delivered, Synthetic Biotic medicine designed to consume phenylalanine (Phe) in the gastrointestinal (GI) tract for the treatment of phenylketonuria (PKU) in patients regardless of age or disease type.
In the first half of 2020, Synlogic expects to initiate a Phase 2 clinical trial to evaluate the Phe-lowering potential of its solid formulation of SYNB1618 in patients with PKU. In addition, the study is expected to provide valuable information to validate predictive mathematical and preclinical modeling.
Strain development and optimization work is being carried out under Synlogic’s 2019 research and development agreement with Ginkgo Bioworks.
SYNB1891: Synlogic’s first clinical immuno-oncology (IO) program, SYNB1891, is an intratumorally delivered Synthetic Biotic medicine designed to produce a STING agonist and act as a dual innate immune activator for the treatment of refractory solid tumors and lymphoma.
SYNB1891 is being evaluated as a monotherapy in a Phase 1 open-label, multicenter, dose escalation clinical trial (NCT04167137) in patients with refractory solid tumors and lymphoma. Three U.S. sites have been activated to enroll and the first subject has been dosed. Synlogic expects to have data from the monotherapy arm of this study in 2020.
After establishing a maximum tolerated dose (MTD) for SYNB1891, Synlogic will initiate a second arm of the trial in which subjects will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, atezolizumab (Tecentriq), to establish a recommended dose for the combination regimen.
Pre-clinical data and early pipeline programs:
Synlogic has advanced two new preclinical programs onto its development pipeline, for the treatment of secondary hyperoxaluria and MSUD, respectively. Strain development and optimization work is being carried out under Synlogic’s 2019 research and development agreement with Ginkgo Bioworks.
Synlogic expects to publish and present data at major scientific and medical meetings throughout the year demonstrating the breadth and potential of its Synthetic Biotic platform.
Corporate

Synlogic ended the third quarter of 2019 with $138.7 million in cash, cash equivalents and short- and long-term investments and expects that this will fund Company operations through 2021 under its current plan.
The Company will continue to explore additional strategic opportunities to maximize the potential of its Synthetic Biotic platform.
2019 Accomplishments and Highlights
Clinical Pipeline

SYNB1618
Presentation of positive data from Phase 1/2a study of SYNB1618 in patients with phenylketonuria (PKU) using the liquid formulation as well as modeling work to estimate target dosing of SYNB1618. SYNB1618 was well tolerated in healthy volunteers and patients with PKU and the data demonstrated equivalent SYNB1618-dependent Phe-consumption from the GI tract in both populations.
Development of a solid oral formulation of SYNB1618 that is stable at room temperature. Synlogic executed a bridging study in healthy volunteers of a new solid oral formulation to identify an MTD that could be used to evaluate lowering of blood Phe levels in PKU patients based on Synlogic’s modeling data. Data from this study will be presented at an appropriate medical meeting in 2020. Synlogic expects to advance SYNB1618 into a Phase 2 study in patients in the first half of 2020.
SYNB1891:
Initiation of a Phase 1 open-label, multicenter, dose escalation trial of its STING-agonist producing bacterial strain, SYNB1891, for the treatment of refractory solid tumors and lymphoma.
Corporate

Establishment of a collaboration with Ginkgo Bioworks that provides expanded synthetic biology capabilities and strengthened Synlogic’s balance sheet. In June 2019, Synlogic and Ginkgo entered into a long-term strategic platform collaboration. Under the agreement Ginkgo invested $80.0 million in Synlogic at a premium to market. Synlogic is using Ginkgo’s cell programming platform for building and testing microbial strains to accelerate progression of early preclinical leads to drug candidates optimized for further clinical development. Under the terms of the agreement, Synlogic paid $30.0 million to Ginkgo for synthetic biology services and has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to intellectual property covering such products.
Strengthened Synlogic’s executive leadership with the following appointments:
Richard Riese, M.D. Ph.D., joined Synlogic in September 2019 as chief medical officer assuming responsibilities for all clinical and regulatory functions from current president and CEO, Aoife Brennan. Prior to joining Synlogic, he served as Vice President, Clinical Development at Alnylam Pharmaceuticals where he led clinical development projects in several areas across Alnylam’s rare disease portfolio.
Gregg Beloff was appointed as Synlogic’s interim chief financial officer, in October 2019. Mr. Beloff has more than 20 years of experience in the life sciences industry and brings significant expertise in operational management, strategic planning, corporate and business development, fundraising and mergers and acquisitions.
Patricia Hurter, Ph.D., chief executive officer of Lyndra Therapeutics, was appointed to the Synlogic board of directors in January 2019. Dr. Hurter previously served as Senior Vice President at Vertex. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck.
Established a clinical collaboration with Roche that enables evaluation of SYNB1891, in combination with atezolizumab in the second arm of Synlogic’s ongoing Phase 1 study in patients with advanced solid tumors and lymphoma.
Established GMP manufacturing capabilities and manufactured solid and liquid formulations of clinical trial material for its oral and intra-tumoral programs, respectively.
Advanced collaboration with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease resulting in payment to Synlogic of a $2.5 million milestone in March 2019.
Published first in human clinical data of a Synthetic Biotic medicine (SYNB1020) as well as preclinical data from the program in Science Translational Medicine.