On March 27, 2019 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, reported it will present data on its innovative microbiome-based approach for the development of therapeutic peptide cancer vaccines for the first time in a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA (March 29 to April 3) (Press release, Enterome, MAR 27, 2019, View Source [SID1234534662]).

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Enterome’s innovative approach is based on the concept of "molecular mimicry" whereby microbiome-derived bacterial antigens show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs). Based on this similarity, bacterial antigens ("onco-mimics") mimic key tumor antigens that are highly expressed by tumors to trigger tumor-specific cytotoxic T cell immune responses.

Enterome has developed a proprietary discovery platform to identify such bacterial onco-mimics from the human gut microbiome. The data to be presented at AACR (Free AACR Whitepaper) 2019 demonstrate that onco-mimics identified by Enterome elicited strong immune responses against self-peptides that were, by themselves, not immunogenic. While mice vaccinated with TAAs did not generate an immune response, vaccination with onco-mimics were observed to result in a strong immune response against both bacterial peptides and selected TAAs. Furthermore, adoptive transfer of T cells from mice immunized with onco-mimics into tumor-engrafted nude mice led to tumor control in the presence of checkpoint inhibitors.

Dr. Christophe Bonny, CSO of Enterome, commented: "We are very excited by these data that we believe represent an early validation of our innovative approach to cancer immunotherapy. It is now well recognized that the gut microbiome plays an important role in driving the development of T cells and the presence of commensal-specific memory T-cells. We believe our approach, based on bacterial molecular mimicry, has the potential to open up opportunities to develop new targeted therapies against tumor cells that are not detected as non-self by the immune system."

Enterome’s first product candidate developed using its molecular mimicry approach, EO2401, comprises three onco-mimics that are highly homologous to solid tumor antigens. Enterome expects to initiate a Phase 1b/2a clinical trial of EO2401 in 2019 as a potential new immunotherapy for glioblastoma multiforme (GBM), for which no curative treatments exist.

The presentation details are:

Poster title: Microbiome derived peptides stimulate strong immune response against tumor associated antigens and trigger in vivo tumor regression after vaccination
Session Title: Cancer Vaccines and Intratumoral Immunomodulation
Abstract ID#: 1475 (poster board 30)
Poster presentation: April 1, 8 am – 12 pm EST, Georgia World Congress Center, Exhibit Hall B, Poster Section 22

On March 27, 2019 Trillium Therapeutics Inc. (Nasdaq/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported it will be presenting preclinical data from its previously undisclosed STING agonist program at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Trillium Therapeutics, MAR 27, 2019, View Source [SID1234534705]). The meeting will be held March 29 – April 3 in Atlanta, GA. Details of the poster presentation are listed below.

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Title: "Preclinical characterization of a novel non-cyclic dinucleotide small molecule STING agonist with potent antitumor activity in mice"

Presenter: Zezhou Wang, Ph.D., Trillium Therapeutics Inc.

Date and Time: April 2, 2019 from 1:00 p.m. – 5:00 p.m. ET

Location: Georgia World Conference Center, Poster Section 12

Abstract Number: 3854

On March 27, 2019 New immunotherapy drug targets for cancer will be progressed through a multimillion-pound drug discovery alliance reported (Wednesday) between Cancer Research UK, LifeArc and Ono Pharmaceutical Co., Ltd (Press release, LifeArc, MAR 27, 2019, View Source [SID1234534663]).

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The multi-year partnership brings together Cancer Research UK’s network of world-leading scientists and drug discovery expertise, LifeArc’s renowned therapeutic antibody engineering and development expertise, and Ono’s considerable track record in developing cancer immunotherapies.

The collaboration will identify targets for the development of both antibody and small molecule therapeutics. Boosted by a multimillion-pound investment from Ono and a further investment from LifeArc, drug discovery experts will be pursuing targets within Cancer Research UK’s extensive portfolio of immuno-oncology research.

This new collaboration expands upon an existing alliance between Cancer Research UK and LifeArc announced in 2017. Ono’s investment and expertise will help identify new therapeutic targets, accelerate target validation within the alliance, and support validated targets through the drug discovery phase.

Under the terms of the deal, LifeArc will progress antibody projects via its antibody screening and development expertise. Small molecule projects will be taken forward by Cancer Research UK’s Therapeutic Discovery Labs.

Morphological changes in breast cancer cellsOno will have option rights to licence the outputs of the alliance and take on clinical development and commercialisation of successful projects with worldwide exclusive rights. Cancer Research UK and LifeArc will receive an upfront access fee for entering the alliance, as well as additional upfront, milestone, and royalty payments for licensed projects.

Dr Hamish Ryder, director of Cancer Research UK’s Therapeutic Discovery Labs, said: "We’re thrilled to welcome Ono to join and expand our successful collaboration with LifeArc and create one of our most ambitious alliances to date. This unique alliance is a melting pot of world-leading cancer research and each organisation’s extensive expertise in oncology drug discovery.

"As we enter into a new age of immuno-therapeutic approaches to cancer care, we hope that this partnership will accelerate the development of new treatments, bringing them to patients with cancer much faster."

LifeArc CEO, Melanie Lee, noted; "At LifeArc, we are committed to translating medical innovation to benefit patients with new therapies, diagnostics or by building on the understanding of disease. This collaboration with Cancer Research UK and Ono is an example of how shared goals and collaboration can create real value."

"We greatly appreciate Cancer Research UK’s network of scientists, drug discovery expertise together with LifeArc’s antibody development capabilities," said Dr. Toichi Takino, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono.

"We are very pleased to join in the successful collaboration between Cancer Research UK and LifeArc and we believe that we together will successfully identify novel drug candidates for new cancer treatment in the immuno-oncology field, which will be further developed and commercialized by us throughout the world and fulfil unmet medical needs."

On March 27, 2019 Elicio Therapeutics, a next generation immuno-oncology company, engineering therapies for cancer killing immune responses, reported the appointment of Robert Connelly as CEO (Press release, Elicio Therapeutics, MAR 27, 2019, View Source [SID1234534680]). Elicio is developing precision vaccines, immuno stimulators and cellular therapies based on the ground-breaking work of Darrell Irvine, Ph.D., Professor of Biological Engineering and Materials Sciences and Howard Hughes Investigator at the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology.

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Elicio was formed to transform the lives of patients by re-engineering the body’s immune response to cancer. By combining expertise in materials science and immunology, Elicio is engineering potent cancer vaccines and immunotherapies for an array of aggressive solid and hematologic cancers. Elicio’s Amphiphile platform enables, for the first time, precise targeting and delivery of immunogens directly to the lymphatic system, substantially enhancing the body’s own system of immune defenses, with the aim to achieve durable cures.

Elicio has demonstrated promising preclinical data in multiple in vivo models of cancer. The company’s lead vaccines targeting pancreatic, colorectal and head and neck cancers will enter initial patient studies in the first half of 2020. These programs are followed by a broad preclinical pipeline of vaccines, adjuvants, cellular therapy vaccines and immuno stimulatory therapeutics.

Elicio Executive Chairman Julian Adams, Ph.D., commented, "The Amphiphile platform developed by Elicio alongside Darrell Irvine and his MIT team has the potential to truly unlock the immune response leading to durable cures for an array of cancers. We are delighted to bring in Robert Connelly, a proven entrepreneur and leader, to build this company as we enter our initial patient trials."

"I am honored to lead this amazing Elicio team and work closely with Julian and Darrell," said Robert Connelly, CEO of Elicio. "The great early promise of cancer vaccines has fallen well short and exciting new immunotherapies often fail or are limited due to their inability to target and concentrate in lymph nodes, where the immune response is orchestrated. There is no other platform that can potentially produce highly effective cancer vaccines and adjuvants while also combining with cellular therapies such as CAR-T, TILs, and NK cells to substantially enhance their effectiveness and address their deficiencies."

Connelly is a prolific entrepreneur and company builder with more than 30 years of experience in the life science industry, nearly 20 of those spent as a CEO building startup and early stage novel therapeutic platform companies. He was the founding CEO and first employee of Domantis, which sold to GlaxoSmithKline in 2007 for $454 million, and served as CEO of Pulmatrix (NASDAQ: PULM) and Axcella Health, as well as a Director on numerous biotechnology company Boards. Over the course of his career, Mr. Connelly has raised over $300 million in private equity financing, led numerous partnering transactions including product and platform licensing, government and foundation funding, and M&A transactions, and launched innovative platforms and products across disease areas. Mr. Connelly also serves as a director for Anchiano Therapeutics (NASDAQ: ANCH) and was previously a Venture Partner with Flagship Pioneering. Connelly began his career at Abbott Laboratories.

On March 27, 2019 Equillium, Inc. (Nasdaq: EQ), a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the fourth quarter and full-year ended December 31, 2018, and recent business highlights (Press release, Equillium, MAR 27, 2019, View Source [SID1234534706]).

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Business Highlights:

Completed a successful initial public offering in October 2018 resulting in gross proceeds of $71.6 million

Received FDA Fast Track designation and Orphan Drug designations for EQ001 for both the prevention and treatment of acute graft-versus-host disease (aGVHD)

Initiated the Phase 1b portion of the EQUATE trial for the frontline treatment of aGVHD

Announced plans to develop EQ001 for the treatment of lupus nephritis with a Phase 1b proof-of-concept clinical trial expected to commence in the second half of 2019

"The progress that we made during 2018, highlighted by our successful initial public offering in October, sets the stage for continued advancement of our pipeline this year with three clinical trials of our lead therapeutic candidate, EQ001, beginning with our EQUATE trial in aGVHD that commenced earlier this month," said Daniel Bradbury, chairman and chief executive officer of Equillium. "The recent announcement that we are exploring the clinical utility of EQ001 in lupus nephritis, in addition to aGVHD and uncontrolled moderate to severe asthma, leverages our research into the role of CD6-ALCAM pathway in immuno-inflammatory diseases, and represents a natural expansion of our pipeline targeting this potentially promising pathway. As we progress through 2019, we have line-of-sight to multiple potentially value-creating data catalysts beginning early next year, and believe we are well positioned to introduce a new class of therapeutic that can transform the lives of patients suffering from these serious and underserved medical conditions."

Upcoming Milestones:

Planned initiation of Phase 1b EQUIP proof-of-concept trial evaluating EQ001 for the treatment of uncontrolled moderate to severe asthma by the end of the second quarter of 2019

Planned initiation of Phase 1b proof-of-concept trial evaluating EQ001 for the treatment of lupus nephritis during the second half of 2019

Data from the Phase 1b portion of the EQUATE aGVHD trial expected during the first quarter of 2020, approximately 12 months following initiation

Fourth Quarter 2018 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended December 31, 2018 were $2.5 million, compared with $0.5 million for the same period in 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support Equillium’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended December 31, 2018 were $1.7 million, compared with $0.2 million for the same period in 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.

Net loss. Total net loss for the three months ended December 31, 2018 was $5.0 million, compared with a net loss of $1.1 million for the same period in 2017.

Full-Year 2018 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2018 were $4.9 million, compared with approximately $1.3 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support Equillium’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2018 were $3.7 million, compared with $0.4 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs incurred during the fourth quarter of 2018 associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.

Net loss. Total net loss for the year ended December 31, 2018 was $13.3 million, compared with a net loss of $2.3 million for the period March 16, 2017 (inception) through December 31, 2017.

Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling approximately $65.9 million at December 31, 2018, compared to $7.1 million at December 31, 2017. The increase was due to Equillium’s initial public offering in October 2018, partially offset by cash used in operations during 2018.