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.

On March 27, 2019 XenTech SAS, a company specialized in the development and sale of preclinical research services to foster the development of oncology drugs, reported a strategic collaboration with Gustave Roussy, Europe’s leading cancer center (Press release, XENTECH, MAR 27, 2019, View Source [SID1234553821]). This co-operation, the first of its kind for XenTech, will focus on the development of a collection of tumor explant models from patients who developed acquired resistance to targeted therapies following initial response. These PDX models will be used in Gustave Roussy’s oncology R&D programs, as well as being added to XenTech’s existing PDX platform for translational oncology research projects for academic and industry customers.

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Patients with tumors that harbor specific driver molecular alterations benefit from targeted therapies, but responses are generally short-lived due to the emergence of adaptive/secondary resistance. Between 2015 and 2020 the MATCH-R trial led by Gustave Roussy (NCT02517892) will have enrolled 600 patients treated with targeted therapies. Biopsies will be used to generate PDX models, obtained from 300 patients who have developed resistance following initial response. The MATCH-R PDX platform will be regularly upgraded with new models, providing a unique resource in unravelling the mechanisms involved in acquired resistance to targeted therapies and testing novel therapeutic strategies to circumvent or delay the emergence of resistance.

"We are delighted to collaborate with Gustave Roussy on this unique and ambitious program," said Jean-Gabriel Judde, CSO and president of XenTech. "These new models will expand XenTech’s bank of PDX models with focus on the advanced drug-resistant setting. The MATCH-R PDX platform will enable a better understanding of acquired resistance to last-generation targeted therapies, providing clinically relevant models to perform preclinical POC studies, translating into increased patient survival. Full clinical and molecular annotation will enable model selection for testing innovative therapies, investigating new and existing pathways, and identifying biomarkers."

"Understanding the mechanisms of acquired resistance to novel targeting agents is crucial in providing optimal care to cancer patients," said Benjamin Besse, head of the department of medical oncology at Gustave Roussy and principal investigator of the MATCH-R clinical trial. "This strategic collaboration with XenTech, a renowned expert in PDX development and in vivo pharmacological studies, is a major asset for Gustave Roussy’s precision medicine program. There is no doubt that these clinically relevant models will speed-up the development of novel therapeutic agents leading to extended clinical benefit for metastatic cancer patients."

XenTech will participate in American Association Cancer Research Annual Meeting, Friday, March 29 – Wednesday, April 3, 2019, in Atlanta, GA.

On March 27, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on dermatological and immuno-inflammatory diseases, reported that management will attend the following conference (Press release, Aclaris Therapeutics, MAR 27, 2019, View Source [SID1234534664]):

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Management will host investor meetings during the William Blair & Company 3rd Annual Late-Stage Therapeutics Conference in New York, NY Thursday, April 4, 2019.

On March 27, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported its financial results for the fourth quarter and year ended December 31, 2018 and provided a business update (Press release, Phio Pharmaceuticals, MAR 27, 2019, View Source [SID1234534681]).

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Logo – View Source

"One of the Company’s major accomplishments during the year was the successful transition to focus on developing novel immuno-oncology treatments, a strategic decision made in early 2018," said Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals. "Based on our internal R&D, and together with our corporate and academic partners, we have been demonstrating the potential of using our self-delivering RNAi platform in immuno-oncology applications. Our results to date suggest that we can improve existing and developing forms of adoptive cell therapies (ACT) based on T-cells and on NK cells. In addition, through direct intratumoral use of self-delivering RNAi compounds, we showed that we have the potential to reprogram the tumor micro-environment. With this latter approach, we hope to lower the barriers that hamper ACT success in solid tumors, a significant clinical unmet need. Based on these successes, we now have three well defined immuno-oncology R&D pipeline programs that may provide compelling alternatives to other therapeutic approaches such as antibody therapy and/or genetic engineering. Our progress laid the groundwork for us to successfully complete an equity offering in October, providing us the capital to confidently execute our R&D pipeline programs towards clinical development and further partnerships."

Year in Review and Recent Corporate Updates

On March 1, 2019, Gerrit Dispersyn, Dr. Med. Sc. became the Company’s President and Chief Executive Officer. Dr. Dispersyn succeeded Geert Cauwenbergh, Dr. Med. Sc., who retired as CEO of the Company and remains as a member of the Company’s Board of Directors.
Effective November 19, 2018, the Company changed its corporate name from RXi Pharmaceuticals Corporation to Phio Pharmaceuticals Corp. This change reflects the Company’s transition from a platform company in dermatology and ophthalmology to one that is focused on developing groundbreaking immuno-oncology therapeutics.
Research conducted using the Company’s self-delivering RNAi platform in the field of immunotherapy to treat cancer was published in a leading peer-reviewed journal, Molecular Therapy. The published paper is titled, "Self-Delivering RNAi (sd-rxRNA) Targeting PD-1 using Adoptive Cell Therapy Approach for the Treatment of Malignant Melanoma."
Presented new data on NK cells at the 16th Annual Discovery on Target Conference and the 33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
Data demonstrated potent silencing activity as well as phenotypic effect of NK cells treated with sd-rxRNA compounds targeting checkpoints such as Cbl-b and TIGIT. By treating NK cells ex-vivo with sd-rxRNA compounds the anti-tumor response of these cells can be improved.
Entered into collaborations with industry and academic leaders in immuno-oncology:
The Karolinska Institutet in Sweden is exploring the use of our sd-rxRNA compounds against targets involved in T-cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.
Iovance Biotherapeutics, Inc. is evaluating the potential synergies of our novel sd-rxRNA therapeutic compounds with their autologous cell therapy based on tumor-infiltrating lymphocytes for the use in the treatment of cancer.
Completed and reported positive results from the Company’s clinical trials in dermatology and ophthalmology:
Study RXI-109-1501, a Phase 1/2 clinical trial for retinal scarring in subjects with wet age-related macular degeneration with evidence of subretinal fibrosis, successfully met its primary objective as shown by the absence of dose-limiting and serious toxicities. The secondary objective of the study was also met with improved or stable disease in the study eyes of several subjects.
Study RXI-SCP-1502, a Phase 2 clinical trial with Samcyprone for the treatment of cutaneous warts, successfully met its primary effectiveness objectives as shown by high levels of immunotherapeutic and therapeutic response. The immunotherapeutic response rate was 97.7% across all enrolled subjects and from a therapeutic response viewpoint, more than 70% of all warts showed a positive wart response rate. The study results showed furthermore that Samcyprone was safe and well tolerated.
Successfully completed equity offerings in April and October 2018 for total net proceeds of $17.4 million, which the Company expects to provide ample funding for operations into the second half of 2020.
Select Financial Results

Cash Position

At December 31, 2018, the Company had cash of $14.9 million as compared with $3.6 million at December 31, 2017.

Revenues

Revenues for the year ended December 31, 2018 were $138,000, as compared with $15,000 for the year ended December 31, 2017. Revenues for the years ended 2018 and 2017 related to the work performed by the Company as a sub-awardee under the government grant awarded to BioAxone Biosciences, Inc. for the development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury.

Research and Development Expenses

Research and development expenses for the year ended December 31, 2018 were $4.3 million as compared with $5.4 million for the year ended December 31, 2017. The decrease was primarily due to the completion of the work in the Company’s dermatology and ophthalmology programs, including clinical trial-related and manufacturing-related expenses, and a decrease in payroll expenses due to a reduction in headcount as compared with the prior year period.

Acquired In-process Research and Development Expenses

The Company recorded acquired in-process research and development expense of $4.7 million during the year ended December 31, 2017. The expense related to the fair value of consideration given, which includes transaction costs, liabilities assumed and cancellation of notes receivable, and the deferred tax impact of the Company’s acquisition of MirImmune. The Company had no such expense during the year ended December 31, 2018.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2018 were $3.2 million as compared with $4.0 million for the year ended December 31, 2017. The decrease was primarily due to a decrease in payroll expenses due to a reduction in headcount as compared with the prior year period, as well as a decrease in professional fees for legal-related services.

Income Tax

The Company had no income tax benefit or expense for the year ended December 31, 2018. The Company recognized an income tax benefit of $1.6 million for the year ended December 31, 2017 due to the tax-related impact of the Company’s acquisition of MirImmune.

Net Loss

Net loss for the year ended December 31, 2018 was $7.4 million, or $1.04 per share, compared with $12.5 million, or $5.52 per share, for the year ended December 31, 2017. The decrease was primarily due to a decrease in acquired in-process research and development expense and the changes in operating expenses, as discussed above.