inspirnastg – Page 4

Rgenix To Present Abstract on RGX-019 at the 2019 AACR Annual Meeting

New York, NY – April 1, 2019- Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, announced today that Isabel Kurth, Ph.D., Vice President of Research at Rgenix, will present an abstract about Rgenix’s RGX-019 program at the 2019 American Association for Cancer Research Annual Meeting. The meeting is scheduled to take place Friday, March 29 through Wednesday, April 3 in Atlanta.

The details of Rgenix’s presentation are as follows:

Event: AACR Annual Meeting 2019

Date: April 3, 2019

Time: 8:00 A.M. – 12:00 P.M. EST

Description: Abstract LB-277/23, “Characterization of the anti-cancer and immunologic activity of RGX-019, a novel pre-clinical stage humanized monoclonal antibody targeting the MERTK receptor”

Location: Section 40, Georgia World Congress Center, 285 Andrew Young International Blvd NW, Atlanta, GA 30313

Dr.
Kurth will present data from pre-clinical research of RGX-019, a novel
pre-clinical stage humanized monoclonal antibody targeting the MERTK receptor.

About Rgenix

Rgenix, Inc., is a privately-held
clinical-stage biopharmaceutical company focused on the discovery and
development of novel cancer drugs that target key pathways in cancer
progression. The company is pursuing several first-in-class drug candidates to
treat cancers of high unmet need. Rgenix identifies novel cancer targets using
a microRNA based target discovery platform originally developed by Rgenix’s
scientific co-founders at The Rockefeller University and now exclusively
licensed to Rgenix. The company brings together distinguished scientific
founders, a seasoned Board, and a leadership team comprised of experienced drug
developers. The company is funded by leading biotechnology investors, including
Novo Holdings A/S, Sofinnova Partners, Lepu Holdings Limited, Oceanpine
Capital, WuXi PharmaTech Healthcare Fund I, LP, Alexandria Venture
Investments,LLC, and the Partnership Fund for New York City. For more
information, please visit www.rgenix.com.

About RGX-019

RGX-019 is an investigational drug
candidate and a humanized monoclonal antibody that targets MERTK being
developed by Rgenix for the treatment of advanced cancer. Rgenix in-licensed
RGX-019 related antibody intellectual property from Rockefeller University as
part of a world-wide exclusive licensing agreement.

MERTK is a receptor tyrosine kinase of the TAM family and
is over-expressed in several human cancers. The MERTK pathway drives cancer
progression, tumor angiogenesis, and innate immune suppression. Targeting MERTK
inhibits the growth of MERTK-expressing cancer cells and induces an M1
pro-inflammatory cytokine expression profile in tumor-associated macrophages. Rgenix has initiated IND-enabling
studies of RGX-019.

Media Contacts:

RooneyPartners

Marion Janic

212-223-4017

mjanic@rooneyco.com

Translational and Clinical Development Strategies for IO Agents Targeting the Innate Immune System

Immuno-Oncology 360° | Crown Plaza Time Square, New York City | February 6, 2019

Masoud Tavazoie, Rgenix CEO and Co-Founder speaks at Immuno-Oncology 360°

In its 5th year, the IO360 conference brings together diverse stakeholders of drug development in immuno-oncology (IO). The multi-disciplinary approach of IO has been key to its tremendous advances in the treatment of cancer, but also created unforeseen challenges. While the number and types of agents in development has exploded, and with it the number of clinical trials and combination studies, the multitude of recent failures suggest that the understanding of the field is still in its infancy. IO360 sheds light on advances and challenges of IO, both from a scientific, translational, clinical, regulatory, financial and organizational viewpoint.

Dr. Tavazoie’s talk will highlight strategies to support the translation of preclinical data into the clinic specifically for modalities targeting the innate immune system. These strategies aim to improve our understanding of disease mechanics and a better matching of therapy and patient, with the goal of achieving better patient outcomes more effectively.

Xconomy: New York Biotech – How to make it here

6:15-6:45 PM | The Rgenix Story:

From our beginnings as a small spin-out from Rockefeller University to a world-class team with multiple clinical programs and $40M in Series C funding, our executives tell the story of our Manhattan-based biotechnology company.

Xconomy: New York Biotech – How to make it here | December 18, 2018

Learn More

Rgenix CEO Masoud Tavazoie Discusses Immune System Regulation in Cancer at Plenary Session during AACR Meeting

On November 28, 2018, Masoud Tavazoie, Co-Founder and CEO of Rgenix, made a presentation at AACR’s Tumor Immunology and Immunotherapy conference in Miami, Fl.

As part of his presentation, Masoud described the LXR/ApoE pathway and its role in regulating the innate immune system in cancer. The LXR/ApoE pathway was discovered as a cancer pathway by Rgenix founding scientists utilizing an unbiased experimental approach to identify key drivers of cancer progression. This approach forms the foundation of the Rgenix target discovery platform which has yielded novel clinically relevant targets for first-in-class therapeutics currently under development at the company. This includes Rgenix’s lead drug candidate RGX-104, a novel immunotherapy agent that targets the LXR/ApoE pathway to activate anti-tumor immunity.

Dr. Tavazoie provided an overview of the role of the LXR/ApoE pathway in regulating cancer progression, highlighting its potential as a therapeutic target. Research has revealed that activation of the LXR/ApoE pathway with the small molecule LXR agonist RGX-104 can generate an anti-tumor immune response by targeting the innate immune system. In many cancers, cells of the innate immune system – such as immature myeloid cells – can inhibit the anti-tumor immune response by blocking T cell activation, which is required for successful immune attack against tumors. By depleting immature myeloid cells, RGX-104 shifts the innate immune response from immune-suppressive to immune-stimulatory. This effect is associated with activation of dendritic cells and relevant T cell populations, resulting in shrinkage of tumors in animal models and in advanced cancer patients treated with the agent.

Additionally, RGX-104 has also demonstrated the potential to enhance the efficacy of checkpoint blockade and T cell adoptive transfer therapy in mouse models. Pre-clinical and clinical data presented at the meeting establish the drug candidate RGX-104 as a novel immunotherapy agent with a unique mechanism of action and the capacity to shrink tumors via modulation of the LXR/ApoE pathway.

Learn more

Rgenix Appoints Serial Entrepreneur and Senior Executive Peter Van Vlasselaer to Board of Directors

New York, NY – Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, today announced the appointment of Peter Van Vlasselaer, Ph.D., to its Board of Directors. Dr. Van Vlasselaer is a serial entrepreneur and most recently the President and CEO of ARMO Biosciences, which he also founded, until June 2018 when the company was acquired by Eli Lilly. He holds a B.S. in Zoology and a Ph.D. in Cellular Immunology from the Catholic University of Leuven, Belgium and subsequently was a Post-Doctoral Fellow in the Immunology and Rheumatology Department at the Stanford University Medical School and at DNAX Research Institute.

“Peter is renowned as a successful entrepreneur and leading executive, having created several successful biotech companies across his career. He carries with him over two decades of experience in the biotech industry, and his knowledge and insights will be most valuable for Rgenix as we move our first-in-class clinical and pre-clinical oncology programs forward. We are extremely pleased to have him join our Board of Directors,” said Masoud Tavazoie, M.D., Ph.D., co-founder, and Chief Executive Officer of Rgenix.

In addition to founding and leading ARMO Biosciences, Dr. Van Vlasselaer also led and co-founded several other biotech companies, including: True North Therapeutics, which was acquired by Bioverativ; Arresto Biosciences, now a part of Gilead Sciences; iPierian, which Bristol-Myers Squibb ultimately acquired and Avidia, acquired by AMGEN. He was also among the start-up teams of Dendreon and Intermune. He currently serves on the Boards of TM3 Therapeutics and Blade Therapeutics.

“With its strong scientific foundation, novel target discovery approach, and exciting first-in-class programs, I strongly believe in the potential of Rgenix to fulfill its mission of bringing novel cancer therapeutics to patients with high unmet need, “said Peter Van Vlasselaer, Ph.D. “I look forward to working with the management team to further develop these therapeutic approaches.”

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA-based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, Lepu Medical, Oceanpine Capital, WuXi AppTec’s Corporate Venture Fund, Alexandria Venture Investments, and the Partnership Fund for New York City’s Innovate NY Fund and associated entities. For more information, please visit www.rgenix.com.

Media Contacts:

RooneyPartners

Marion Janic

212-223-4017

mjanic@rooneyco.com

AACR Tumor Immunology and Immunotherapy Conference

November 27 – 30, 2018 | Loews Miami Beach Hotel, Miami Beach, Florida, USA

Wednesday, Nov. 28 – Plenary Session 3:

Metabolic Regulation in Tumors: Implications for Therapy
Session Chair: Matthew G. Vander Heiden, David H. Koch Institute for Integrative Cancer Research at MIT, Cambridge, Massachusetts
3:30-6:00 p.m.

The LXR/ApoE pathway regulates the innate immune system in cancer

Masoud Tavazoie, Rgenix, Inc., New York, New York

Learn More

Rgenix Treats First Patient in Phase 1 Trial of RGX-202

NEW YORK – Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, today announced it has treated the first patient in a Phase 1 a/b study of RGX-202, an oral small molecule being developed for the treatment of gastrointestinal cancers. RGX-202 is the second clinical stage therapeutic in development at Rgenix.

RGX-202 targets the creatine transporter SLC6a8. Creatine metabolism – driven by SLC6a8 and the creatine kinase CKB – has been implicated in the progression of gastrointestinal cancers. The SLC6a8/CKB pathway is activated by gastrointestinal cancers to generate the energy required to grow and spread throughout the body. By inhibiting SLC6a8, RGX-202 suppresses the growth of colorectal, gastric, and pancreatic cancers as a single agent and in combination with chemotherapy in preclinical models. RGX-202 has also demonstrated efficacy in KRAS mutant tumor models which are generally resistant to approved targeted therapies.

The Phase 1 a/b study is a dose escalation and expansion study of RGX-202 alone and in combination with chemotherapy. RGX-202 will be evaluated in approximately 60 participants with advanced gastrointestinal tumors who have had progressive disease on available therapies, or for which there are no standard systemic therapies with relevant clinical impact. In the expansion stage, additional patients with advanced gastrointestinal malignancies will be treated at the recommended Phase 2 dose, to characterize safety, efficacy, PK, and pharmacodynamics of RGX-202 as a single agent and as part of a combination therapy. A biomarker directed approach will be utilized to select patients for the trial most likely to benefit from RGX-202 treatment.

“The launch of our Phase 1 trial for RGX-202 is a result of our commitment at Rgenix to develop treatments for patients suffering from prevalent cancers that lack effective therapies,” said Roger Waltzman, MD, and Chief Medical Officer of Rgenix. He added: “We are very excited to start this new trial and move RGX-202 as our second drug candidate into the clinic, as this illustrates the strength of Rgenix’s proprietary RNA discovery platform, the diversity of our pipeline, and ultimately our dedication to the cause of addressing unmet medical needs in oncology.”

For more information about the clinical trial please visit: https://clinicaltrials.gov/ct2/show/NCT03597581

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA-based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, Lepu Medical, Oceanpine Capital, WuXi AppTec’s Corporate Venture Fund, Alexandria Venture Investments, and the Partnership Fund for New York City’s Innovate NY Fund and associated entities. For more information, please visit www.rgenix.com.

About RGX-202

RGX-202 is a small molecule that inhibits a novel cancer metabolism pathway involved in supplying energy to cancer cells. The target of RGX-202, SLC6a8, is over-expressed in several prevalent cancer types, including gastrointestinal malignancies. RGX-202 has demonstrated anti-tumor activity in pre-clinical studies, both as a single agent as well as in combination with standard-of-care therapies.

Contacts
Media:
RooneyPartners
Marion Janic, 212-223-4017
mjanic@rooneyco.com

Rgenix Raises $40M in Series C Funding To Support Clinical Stage Oncology Programs

Lepu Holdings Limited leads the financing syndicate and is joined by existing major investors Novo Holdings A/S and Sofinnova Partners

New York, NY – October 9, 2018 — Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, announced that it has raised $40 million in a Series C financing in support of further development of the company’s clinical and pre-clinical oncology programs and for general corporate purposes.

The Series C financing was led by Lepu Medical, a publicly traded global healthcare firm, and includes Oceanpine Capital and WuXi AppTec’s Corporate Venture Fund. Existing investors also participated in the financing round, including Novo Holdings A/S, Sofinnova Partners, Alexandria Venture Investments, LLC, and the Partnership Fund for New York City’s Innovate NY Fund and associated entities.

The financing will support Phase 1b/2 clinical trials of the lead program RGX-104 in multiple cancer indications, including in checkpoint inhibitor refractory patients. It will also support early clinical development of RGX-202, a first-in-class cancer metabolism program, as well as discovery stage programs arising from the Rgenix target discovery platform.

“Lepu Medical is very pleased to make this investment in Rgenix. We truly appreciate Rgenix’s unique RNA target discovery approach in identifying various first-in-class cancer targets. We also believe RGX-104 has great potential with checkpoint inhibitors across many important cancer types,” said Dr. Zhongjie Pu, PhD, Chairman and CEO of Lepu Medical. “As Lepu Medical has PD-1, PD-L1 checkpoint inhibitors and an oncolytic virus in clinical trials, we also look forward to exploring possible collaborative opportunities with Rgenix as part of our goal to develop further in the oncology market together.”

“The addition of new investors to our already strong investor base is a testament to the power of our approach to develop first-in-class cancer therapeutics using the innovative Rgenix RNA target discovery platform to identify novel cancer targets,” said Masoud Tavazoie, MD, PhD, and Chief Executive Officer and co-founder of Rgenix. “We are delighted to have the support of these investors and to know that they share our excitement for the work we are doing to develop these new therapies for patients who suffer from cancers of high unmet need.”

RGX-104 is a first-in-class small-molecule immunotherapy that targets the Liver X Receptor (LXR) and modulates innate immunity by activating the ApoE gene. Data from a Phase 1a dose escalation of RGX-104 in advanced cancer patients demonstrated both immune-stimulatory and anti-tumor activity. Rgenix is currently enrolling patients in the Phase 1b stage of the trial in multiple cancer indications, including in combination with the checkpoint inhibitor nivolumab.

RGX-202 is a small molecule compound that suppresses gastrointestinal cancer progression by inhibiting a novel cancer metabolism pathway involved in supplying energy to cancer cells. Pre-clinical research shows the compound is active as a monotherapy and in combination with chemotherapy considered to be the standard of care. Rgenix expects to launch a Phase 1 trial of RGX-202 in 2018.

Rgenix was advised by Jefferies LLC in this Series C financing.

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo Holdings A/S, Sofinnova Partners, Lepu Holdings Limited, Oceanpine Capital, WuXi PharmaTech Healthcare Fund I, LP, Alexandria Venture Investments,LLC, and the Partnership Fund for New York City. For more information, please visit www.rgenix.com.

Contacts
Media
RooneyPartners
Marion Janic, 212-223-4017
mjanic@rooneyco.com

Rgenix Presents Data on Phase I Clinical Activity For RGX-104 at the 2018 ASCO Annual Meeting

RGX-104 shown to be well-tolerated and capable of generating immunologic and anti-tumor activity in advanced cancer patients.

Rgenix continues Phase Ia/b trial with a RGX-104 monotherapy expansion cohort and dose escalation/ expansion cohorts of RGX-104 in combination with nivolumab.

New York, NY – June 4, 2018 – Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, announced today it is presenting data on the safety, pharmacodynamics, and clinical activity from the dose escalation stage of the ongoing Phase Ia/b trial of RGX-104, an oral small molecule immunotherapy that targets the liver X receptor (LXR).

In a poster presentation of an abstract accepted for the 2018 Annual Meeting of the American Society of Clinical Oncology, “Pharmacodynamic and clinical activity of RGX-104, a first-in-class immunotherapy targeting the liver-X nuclear hormone receptor (LXR), in patients with refractory malignancies”, Rgenix showed the first-in-class compound to be capable of generating immunologic and anti-tumor activity.

RGX-104 is a small-molecule LXR agonist that modulates innate immunity by activating the ApoE gene. In murine models, the small molecule depletes myeloid derived suppressor cells (MDSCs) and stimulates dendritic cells (DCs), activating anti-tumor immunity as a single agent as well as in combination with adoptive T cell therapy or checkpoint inhibitors. The Phase 1a/b trial in progress is studying the therapy with regards to safety, efficacy, pharmacokinetics and pharmacodynamics. A total of 26 patients with a broad array of tumors have received RGX-104 at a range of dose levels and frequency as part of the dose escalation stage of the study.

RGX-104 was well tolerated across dose cohorts, with hyperlipidemia – an on target effect of LXR agonism – representing the most common adverse event. Robust ApoE target gene engagement was observed in patients, along with substantial MDSC depletion and DC stimulation in 12 of 17 evaluable patients. Activation of circulating PD-1+ T cells was observed in 11 of the 12 patients that experienced MDSC depletion.

One patient with a high-grade neuroendocrine malignancy with small cell features had a confirmed radiographic partial response with a 53% reduction in index hepatic metastases at the 160 mg BID dose. This response was associated with a greater than 12-fold increase in activated PD-1+ T cells. Additionally, seven patients had stable disease for durations of 8-16 weeks. The dose of 160 mg BID was chosen as the Recommended Phase 2 Dose, with robust pharmacodynamic effects on ApoE expression and relevant immune cell populations.

Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix, said, “Today’s presentation illustrates the promise of our lead clinical candidate RGX-104. It enables us to move forward with our plans to study the compound in expansion cohorts as a single agent as well as in combination with a PD-1 inhibitor in patients with both checkpoint-inhibitor refractory and naïve tumors.” Escalation and Expansion cohorts in the Phase 1b stage of the clinical trial are currently enrolling patients with epithelial ovarian carcinoma (EOC), melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell cancer (RCC), bladder cancer (BLC), and triple negative breast cancer (TNBC).

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, and Alexandria Venture Investments. For more information, please visit www.rgenix.com.

About RGX-104

RGX-104 is an orally-administered potent small molecule agonist of the Liver X Receptor (LXR) that is currently being evaluated in a clinical study. Activation of the LXR-ApoE pathway by RGX-104 stimulates the innate immune response in cancer via depletion of myeloid-derived suppressor cells and activation of dendritic cells, leading to stimulation of T cells and anti-tumor immunity. LXR activation also blocks the ability of tumors to recruit blood vessels. These combined effects result in suppression of tumor growth and metastasis in a broad array of animal tumor models. The LXR-ApoE pathway was originally identified as a cancer target using a novel microRNA-based discovery platform developed by Rgenix’s scientific co-founders at The Rockefeller University.

Rgenix is conducting a Phase 1a/b clinical trial of RGX-104 in patients with advanced solid malignancies—for more information about the clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT02922764.

Media Contacts:

RooneyPartners

Marion Janic

212-223-4017

mjanic@rooneyco.com

Rgenix To Present Data on RGX-104 Clinical Activity at 2018 ASCO Annual Meeting

New York, NY – May 31, 2018 — Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, announced today that it will present its abstract on RGX-104’s pharmacodynamic and clinical activity at the 2018 Annual Meeting of the American Society of Clinical Oncology. The meeting will take place in Chicago from June 1 through June 5.

The details of Rgenix’s presentation are as follows:

Event: 2018 ASCO Annual Meeting

Date: Monday, June 4, 2018

Time: 8:00 A.M. – 11:30 A.M. CDT

Description: Abstract #3095, “Pharmacodynamic and clinical activity of RGX-104, a first-in-class immunotherapy targeting the liver-X nuclear hormone receptor (LXR), in patients with refractory malignancies.”

Location: Hall A, McCormick Place, 2301 S. King Drive, Chicago, Il. 60616

About Rgenix

Rgenix, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. The company is pursuing several first-in-class drug candidates to treat cancers of high unmet need. Rgenix identifies novel cancer targets using a microRNA based target discovery platform originally developed by Rgenix’s scientific co-founders at The Rockefeller University and now exclusively licensed to Rgenix. The company brings together distinguished scientific founders, a seasoned Board, and a leadership team comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, and Alexandria Venture Investments. For more information, please visit www.rgenix.com.

About RGX-104

RGX-104 is an orally-administered potent small molecule agonist of the Liver X Receptor (LXR) that is currently being evaluated in clinical studies. Activation of the LXR-ApoE pathway by RGX-104 stimulates the innate immune response in cancer via depletion of myeloid-derived suppressor cells and activation of dendritic cells, leading to stimulation of T cells and anti-tumor immunity. LXR activation also blocks the ability of tumors to recruit blood vessels. These combined effects result in suppression of tumor growth and metastasis in a broad array of animal tumor models. The LXR-ApoE pathway was originally identified as a cancer target using a novel microRNA-based discovery platform developed by Rgenix’s scientific co-founders at The Rockefeller University.

Rgenix is conducting a Phase 1a/b clinical trial of RGX-104 with or without nivolumab in patients with advanced solid malignancies—for more information about the clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT02922764

Media Contacts:

RooneyPartners

Marion Janic

212-223-4017

mjanic@rooneyco.com