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Pionyr and Abcam extend partnership to evaluate TREM2-expressing cells in cancer patients

On June 22, 2021 Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s anti-tumor immunity and Abcam (AIM: ABC) (NASDAQ: ABCM), a global innovator in life science reagents and tools, reported the extension of their collaboration with a new commercial licensing agreement to support the progression of PY314, the first to the clinic of Pionyr’s compounds (Press release, Pionyr Immunotherapeutics, JUN 22, 2021, View Source [SID1234584252]).

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Currently in Phase 1 clinical study[1], PY314 is an anti-TREM2 (Triggering Receptor Expressed on Myeloid cells 2) monoclonal antibody for the treatment of advanced solid tumors. PY314 is designed to tune the tumor microenvironment by selectively depleting immune suppressive TREM2-expressing tumor-associated macrophages to promote anti-tumor immunity.

Pionyr’s Phase 1 clinical study will recruit patients with predefined tumor types where macrophages expressing TREM2 in the tumor microenvironment are most likely implicated as a driver of resistant metastatic disease. Under the terms of the agreement, Pionyr will evaluate Abcam’s anti-TREM2 antibody to detect the presence of TREM2-expressing macrophages in tumor biopsy samples from patients enrolled in the first-in-human study. Pionyr will explore the potential for developing a companion diagnostic test leveraging Abcam’s high quality reagents and end-to end-expertise to facilitate and de-risk the diagnostics development journey.

Kevin Baker, SVP and Chief Development Officer at Pionyr, said: "We are excited to collaborate with Abcam to support the clinical development of our PY314 program for the treatment of solid tumors. Abcam’s in-depth knowledge and track record of successfully supporting diagnostic assay development is invaluable to anticipate late-stage development requirements, and to facilitate access to the right expertise at the right time."

John Baker, SVP Business Development at Abcam, said: "Pionyr’s Phase 1 PY314 is a promising therapy that has the potential to unlock durable benefits for cancer patients. Precise monitoring of the presence of TREM2 in tumor biopsy samples throughout the clinical development process, enabled by Pionyr’s use of Abcam’s EPR20243 clone, will provide vital support to the success of the trial. We are thrilled to be working with Pionyr and supporting their efforts to enhance the immune system’s anti-tumor response."

[1] Study of PY314 in Subjects With Advanced Solid Tumors – NCT04691375

Sintilimab in Combination with Chemotherapy Meets Overall Survival Primary Endpoint in the Global Phase 3 ORIENT-15 Study for the First-Line Treatment of Esophageal Squamous Cell Carcinoma

On June 22, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the Phase 3 ORIENT-15 study met the predefined overall survival primary endpoint. ORIENT-15 is a global randomized, double-blind, multi-center clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, JUN 22, 2021, View Source [SID1234584250]).

Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified. These results will be presented at an upcoming medical meeting.

The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute stated, "More than half of new and fatal cases of esophageal cancer in the world occur in China every year. In China, esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer, and squamous cell carcinoma (ESCC) is the predominant histologic type. Treatment options for people with ESCC are limited. Chemotherapy is currently the main treatment for ESCC and, in recent years, immunotherapy has brought new hope in the treatment of this type of cancer, with some PD-1 inhibitors receiving approval as a second-line treatment for patients with ESCC in China. We are encouraged by these interim results of the ORIENT-15 study which demonstrated that sintilimab in combination with chemotherapy prolonged overall survival in the first-line treatment of patients with ESCC, regardless of PD-L1 status."

Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "The treatment options for locally advanced or metastatic ESCC are limited and represent a significant unmet clinical need. ORIENT-15 is the largest clinical study of sintilimab conducted by Innovent to date. Despite the COVID-19 pandemic, the joint effort of the study’s investigators and broader team have enabled us to reach this milestone. We would like to express our sincere gratitude to all the patients who participated in the ORIENT-15 study. We hope these results can help to provide a new treatment option for patients with ESCC."

About the ORIENT-15 Study

ORIENT-15 is a global randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. Patients were enrolled regardless of PD-L1 status. The primary endpoints included overall survival in all randomized patients and overall survival in PD-L1 positive (defined as CPS ≥10) patients.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease globally. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. More than half of new and fatal cases of esophageal cancer in the world occur in China. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, which has a five-year survival rate of only 30 percent.

The two main types of esophageal cancer are squamous cell carcinoma (SCC) and adenocarcinoma. In China, SCC is the predominant histologic type – accounting for more than 90 percent of all esophageal cancer. Currently, first-line standard systemic therapy in China is chemotherapy based on platinum drugs for unresectable, locally advanced recurrent or metastatic ESCC. There have been a few PD-1 inhibitors recently approved for the second-line treatment of patients with ESCC.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for three indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
Innovent also has two clinical studies that have met primary endpoint for sintilimab:

in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
The second-line treatment for esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

TRexBio Closes the Final Tranche of $59 Million Series A Financing to Advance Innovation in Tissue Immunobiology for the treatment of Cancer and Inflammatory Diseases

On June 22, 2021 TRexBio, a discovery stage company decoding human tissue immune biology to create revolutionary therapeutics, reported the successful close of the final tranche of a $59 million Series A financing (Press release, TRexBio, JUN 22, 2021, View Source [SID1234584249]). Proceeds from the financing will be used to expand the company’s unique discovery platform that maps human tissue regulatory T cell (Treg) behavior to dysregulation in disease, and to advance its six preclinical therapeutic programs. Investors include Eli Lilly and Company (Lilly), SV Health, Johnson & Johnson Innovation, Pfizer Ventures, and Alexandria Venture Investments.

"The continued support from our investors further validates our approach to creating breakthrough therapeutics," said Carol Gallagher, Pharm.D., Executive Chair of TRexBio, and former President and CEO of Calistoga Pharmaceuticals. "We look forward to working with our investors and our academic and industry collaborators as we continue to create and advance a robust pipeline that addresses serious illnesses including cancer and auto-immune diseases."

TRexBio also announced the appointment of Johnston Erwin as Chief Executive Officer, and Ovid Trifan, M.D., Ph.D., as Chief Medical Officer, as part of the company’s plan to accelerate growth. Johnston, a seasoned industry veteran with experience in business development, venture investment, collaboration management, and clinical and regulatory development, joins TRexBio after a 36 year career with Lilly. He most recently served as VP of Corporate Business Development leading Lilly’s internal venture portfolio.

"TRex is at the forefront of one of the most exciting new areas in immunobiology and tissue homeostasis," said Johnston. "The company has a significant foundation in place, with a compelling vision, dedicated team and robust science. I am excited to lead the company into its next stage of development and ultimately transform the lives of patients by bringing a new generation of immune-based therapies to the world."

Dr. Trifan brings more than 20 years of medical research experience to TRexBio. Most recently he was the Chief Medical Officer and VP of Development at Apexigen, a clinical stage biotech company focused on immuno-oncology. Prior to Apexigen he held senior roles in clinical research at leading pharmaceutical companies including Bristol Myers Squibb and Johnson & Johnson, where he contributed to the development of multiple successful oncology drugs. Dr. Trifan will lead the advancement of TRexBio’s oncology programs into the clinic by the end of next year.

Mr. Erwin and Dr. Trifan are joined on the management team by Chief Scientific Officer Melanie Kleinschek, DVM, Ph.D., who has led the development of TRexBio’s unique ‘deep biology’ discovery platform. The platform uses high-resolution profiling of human tissue, modern computational biology tools, a proprietary system to generate tissue-like Tregs and disease-relevant phenotypic assays to generate novel insights into human tissue biology.

TRexBio’s accomplishments to date include:

Foundational collaborations with Lilly and the University of California San Francisco.
Advancement of six preclinical therapeutic programs across immuno-oncology and inflammation, two of which are on track to name development candidates in the next 12 months.
Identification of more than 20 novel tissue-focused targets from its proprietary ‘deep biology’ platform
The company works with an internationally recognized team of founding scientific advisors, including

Michael D. Rosenblum, M.D., Ph.D., Professor of Dermatology, Vice Chair of Research UCSF, and Co-Founder of Delinia Therapeutics;
Houman Ashrafian, BM Bch, DPhil, Managing Partner at SV Health Investors and former VP, Head of Clinical Science at UCB;
Adil Daud, M.D., Professor, Department of Medicine, Hematology/Oncology Director Melanoma Clinical Research, UCSF;
Diane Mathis, Ph.D., Professor in the Department of Immunology at Harvard Medical School, and holder of the Morton Grove-Rasmussen Chair in Immunohematology; and
Allison Simmons, M.D., Ph.D., Professor of Gastroenterology and Director of the MRC Human Immunology Unit at the University of Oxford.

Personalis Announces NeXT Level Biomarkers Symposium

On June 22, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported its inaugural event, NeXT Level Biomarkers Symposium, which will showcase novel research into emerging biomarkers using the Personalis NeXT Platform (Press release, Personalis, JUN 22, 2021, View Source [SID1234584247]).

This event will detail the latest research from Personalis as well as a case study done in collaboration with the Parker Institute for Cancer Immunotherapy. Presentations from Personalis will focus on recently published research into HLA loss of heterozygosity, neoantigen prediction, as well as Personalis’ novel composite biomarker, the Neoantigen Presentation Score (NEOPS). In addition, Dr. Theresa LaVallee will be presenting findings from the PRINCE trial based on data developed and analyzed in collaboration with Personalis.

The agenda for NeXT Level Biomarkers Symposium will cover:

Biomarker Discovery with ImmunoID NeXT Platform
Exploring HLA LOH with the DASH (Deletion of Allele-Specific HLAs) Algorithm
Neoantigen Binding Prediction and Biomarker Discovery with SHERPA
Composite Biomarkers and our Neoantigen Presentation Score (NEOPS)
Parker Institute Case Study: The PRINCE Trial
NeXT Liquid Biopsy Overview and Review of AACR (Free AACR Whitepaper) Data
NeXT Dx and Companion Diagnostics (CDx) with Personalis
"We are excited to share our latest technology and product advances with our partners," said Richard Chen, MD, Personalis CSO. "Given the complex biology underlying cancer progression and response to treatment, our mission at Personalis is to provide broader, more comprehensive molecular profiling and testing for each patient’s cancer, thereby giving biopharma, physicians, and patients the information they need for precision oncology now and with an eye to the future. These new technologies help further that mission."

Cyteir Therapeutics Announces Closing of Initial Public Offering

On June 2, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported the closing of its initial public offering of 7,400,000 shares of its common stock at an initial public offering price of $18.00 per share (Press release, Cyteir Therapeutics, JUN 22, 2021, View Source [SID1234584246]). All of the shares are being offered by Cyteir. In addition, Cyteir has granted the underwriters a 30-day option to purchase up to an additional 1,110,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Cyteir’s common stock is listed on The Nasdaq Global Select Market under the ticker symbol "CYT."

The gross proceeds to Cyteir from the offering were $133.2 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

J.P. Morgan, Morgan Stanley and BofA Securities acted as joint book-running managers for the offering and Wedbush PacGrow acted as co-manager.

A registration statement relating to the shares sold in this offering was declared effective by the Securities and Exchange Commission on June 17, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by telephone: 1-866-718-1649; or BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.