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Boehringer Ingelheim and Enara Bio Enter Strategic Collaboration and Licensing Agreement to Discover Novel Shared Antigens for Cancer Immunotherapies

On January 12, 2021 Boehringer Ingelheim and Enara Bio, reported that they have entered into a strategic collaboration and licensing agreement to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform (Press release, Boehringer Ingelheim, JAN 12, 2021, View Source [SID1234573995]). This new collaboration combines Boehringer Ingelheim’s approach to tackle cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification. The aim is to provide potential new therapies for patients with difficult to treat lung and gastrointestinal cancers.

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"We are excited to partner with Enara Bio as part of our mission to bring transformative new treatments to cancer patients," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. "We are advancing a unique pipeline of cancer cell-directed agents, immuno-oncology therapies and intelligent combination approaches to help combat cancer. Enara Bio’s unique discovery platform offers a novel and highly differentiated approach that will allow us to look beyond the known proteome to identify and characterize Dark Antigens to support the development of T-Cell Receptor (TCR)-directed immunotherapies and therapeutic vaccines. We believe this is a highly innovative and promising approach to the development of the next wave of cancer immunotherapies."

Enara Bio’s proprietary Dark Antigen Platform Technology (EDAPT) will be used to discover and validate novel Dark Antigens in up to three tumor types in the lung and gastrointestinal cancer space. The discovery of shared antigens could lead to the development of vaccines that can be readily utilized to help a broader group of cancer patients.

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic dark matter, or the portion of the human genome that is normally not expressed as protein. Dark Antigen-encoding sequences are usually silenced in healthy cells but are activated and presented on tumor cells. They are associated with specific cancer types and, importantly, are shared across patients. Since typically not visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies.

"We are extremely pleased to enter this strategic licensing agreement, our first major deal leveraging our pioneering Dark Antigen discovery and validation capabilities," said Kevin Pojasek, President and CEO of Enara Bio. "Boehringer Ingelheim is an innovation-led company dedicated to producing breakthrough treatments with a significant focus on cancer. We are excited to build this relationship and are encouraged that Boehringer Ingelheim shares our view of the potential of Dark Antigens to be a source of important and unconventional targets for novel cancer immunotherapies. This agreement provides strong validation for our science and our approach to exploiting the cancer-associated antigenic repertoire derived from genomic dark matter and we look forward to a productive collaboration."

This collaboration with Enara Bio is the latest of several strategic partnerships and acquisitions for Boehringer Ingelheim to build its cancer vaccine platform and provides important validation for Enara Bio’s Dark Antigen platform. The past acquisitions of ViraTherapeutics and AMAL Therapeutics’ vaccine modalities coupled with Enara Bio’s capabilities position Boehringer Ingelheim to develop sophisticated virus and vaccine modalities for its prime/boost vaccine platform.

Under the agreement, Boehringer Ingelheim has the option to license Dark Antigens discovered and validated by Enara Bio. Boehringer Ingelheim will also be responsible for all non-clinical and clinical development, as well as commercialization of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics. Enara Bio retains rights to use any discovered antigens for use in cell therapy-based products.

Enara Bio is eligible to receive an upfront payment, together with research/preclinical milestones and licensing fees for each tumor type that is explored. Enara Bio is also eligible to receive more than EUR 876 million in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

Imago BioSciences to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 12, 2021 Imago BioSciences, Inc., a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms, reported that Hugh Young Rienhoff, Jr. M.D., CEO, will present at the 39th Annual J.P. Morgan Healthcare Conference at 4:55 p.m. EST on Thursday, January 14, 2021 (Press release, Imago BioSciences, JAN 12, 2021, View Source [SID1234573950]). An archived replay of the presentation will be available on the company’s website, www.imagobio.com, for 30 days.

With biotech funding at ‘all-time high,’ Scorpion scoops up $162 million

On January 12, 2021 Scorpion, which focuses on "precision medicine" for cancer, reported it has completed a $162 million funding round, bringing the biotech’s total venture haul to about $270 million (Press release, Scorpion Therapeutics, JAN 12, 2021, View Source [SID1234573949]). It’s a large amount for a new company that so far has kept much of its work under wraps, and a sign that the region’s early-stage biotech industry is vibrant, despite the pandemic.

"This will allow us to accelerate nearly all aspects of the business," said Gary Glick, Scorpion’s chief executive, who pointed out the oversubscribed round brought on 11 new investors.

Glick said the company would announce its first medicine candidate this year, with plans to begin clinical trials in 2022. While he declined to provide an update on how many other drugs the company has in development, Glick said the new funding could help Scorpion support multiple clinical trial programs.

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Scorpion is aiming to tackle cancer in three ways. It wants to make better medicines for known cancer mutations, which could spare healthy tissue and limit side effects, develop medicines for cancer targets previously dismissed as "undruggable," and discover new ones. Scorpion has plans to commercialize its own drugs, Glick said, instead of partnering with pharmaceutical giants.

Medivir enters into exclusive licensing agreement with IGM Biosciences for birinapant

On January 12, 2021 Medivir AB (publ) (Nasdaq Stockholm: MVIR) reported that it has entered into an exclusive licensing agreement, through which IGM Biosciences, Inc. (Nasdaq: IGMS), will receive global, exclusive development rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells (Press release, Medivir, JAN 12, 2021, View Source [SID1234573940]). The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically. Medivir will receive an upfront payment of USD 1 million upon signing the agreement, followed by an additional USD 1.5 million when birinapant is included by IGM in clinical phase I studies. The terms of the agreement furthermore entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales.

– "Agreements, such as the one announced today with IGM, continue to be a core component of Medivir’s corporate mission and business model," said Yilmaz Mahshid, Chief Executive Officer of Medivir. "Today’s announcement further exemplifies our focus and commitment to the development and commercialization of innovative treatments for cancer, and we look forward to IGM’s progress with birinapant in the clinic and beyond."

– "Based on our in vitro and in vivo models, which have shown remarkable synergy between IGM-8444 and birinapant, we are excited to explore this combination’s potential to deliver superior anti-tumor activity in patients with solid tumors," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "This agreement is part of a broader strategy to realize the full potential of our IgM drug candidates by maintaining control over the timing and development path of the more promising combinations to emerge from our preclinical and clinical work. We look forward to moving the IGM-8444-birinapant combination into clinical testing to begin validating the significance of targeting DR5 with an IgM antibody in certain combinations and to continuing to explore similar strategic options across our IgM platform."

In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a phase I dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM hopes to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid cancers later this year.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation.

The information was submitted for publication, through the agency of the contact person set out above, at 23.59 CET on January 11, 2021.

About birinapant

Birinapant is a SMAC mimetic that was acquired from TetraLogic Pharmaceuticals Corporation (TetraLogic) in 2016 and has since then been developed by Medivir. Medivir recently renegotiated the original agreement with TetraLogic so that the compensation Medivir is obliged to pay in connection with a licensing agreement is based on the distribution of actual future revenues to Medivir.

Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab as Second-Line Therapy for Squamous Non-Small Cell Lung Cancer

On January 12, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) as second-line therapy for squamous non-small cell lung cancer (sqNSCLC) (Press release, Innovent Biologics, JAN 12, 2021, View Source [SID1234573939]). The application is the third sNDA for TYVYT (sintilimab injection) in NSCLC.

This sNDA was based on a randomized, open-label, Phase 3 clinical trial (ORIENT-3)—evaluating TYVYT (sintilimab injection) as second-line therapy for patients with advanced or recurrent sqNSCLC whose cancer had progressed on first-line platinum-based chemotherapy. Based on the final analysis in the pre-specified full analysis set, TYVYT demonstrated a statistically significant improvement in overall survival (OS) compared with docetaxel, which met the pre-specified superiority criteria. The progression-free survival (PFS) and objective response rate (ORR) were also significantly improved. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference or journal.

The principal investigator of ORIENT-3, Professor Yuankai Shi, Associate Dean of Cancer Hospital, Chinese Academy of Medical Sciences, stated: "Lung cancer is the leading cause of cancer death globally, of which NSCLC accounts for 80% to 85%. In the past few decades, drug development of NSCLC has mainly focused on nonsquamous NSCLC, while drug development of squamous NSCLC has been slower due to its unique epidemiological, histopathological and molecular characteristics. In China, the options for second-line immunotherapy are even more limited. The ORIENT-3 study confirmed that the anti-PD-1 monoclonal antibody sintilimab significantly improved OS for the second-line treatment of squamous NSCLC patients, which is of great clinical value. We hope that the positive results of ORIENT-3 can potentially help more squamous NSCLC patients."

"TYVYT (sintilimab injection) is the first anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List," said Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology of Innovent. "In August 2020, the NMPA accepted a new indication application for TYVYT (sintilimab injection) in combination with chemotherapy for first-line treatment of squamous NSCLC. In ORIENT-3 study, sintilimab as second-line monotherapy demonstrated a significantly improved survival benefit for patients with advanced squamous NSCLC, and we look forward to the approval of this indication, to potentially help more patients with this type of lung cancer."

"We are excited about these results, showing TYVYT (sintilimab injection) significantly improved overall survival in this patient population. This study underscores the joint commitment from Lilly and Innovent to provide innovative treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, the investigators, the clinical trial centers and our colleagues from Innovent that are involved in the study. We look forward to working together to potentially bring this new treatment option to patients in China with squamous NSCLC."

About ORIENT-3 Trial

ORIENT-3 is a randomized, open-label, multi-center, Phase 3 clinical trial in China to evaluate the efficacy and safety of TYVYT (sintilimab injection) as second-line therapy for advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT 03150875). The primary endpoint is overall survival (OS). The secondary endpoints include progression-free survival (PFS) assessed by investigators based on RECIST v1.1, objective response rate (ORR) and safety profile.

A total of 290 patients were enrolled in ORIENT-3 and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or docetaxel every three weeks. The patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation.

About Squamous NSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85 percent of lung cancer. Approximately 70 percent of people with NSCLC have locally advanced or metastatic NSCLC at initial diagnosis, rendering many of those patients with no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 30 percent of people with NSCLC in China have tumors of the squamous subtype and there are limited second-line immunotherapies for these patients. In China, there remains a huge unmet medical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Eli Lilly and Company, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study. In January 2021, the NMPA accepted the sNDA for TYVYT as second-line therapy for sqNSCLC.

TYVYT (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.