On June 11, 2020 Accellix, the Cell Therapy QC company, reported a Series D financing round of $9.5 million led by bioMérieux, a world leader in the field of in vitro diagnostics for over 55 years (Press release, Accellix, JUN 11, 2020, View Source [SID1234561016]). All existing major investors participated in this raise and have also agreed to convert their pre-existing convertible note in the amount of $8.5 million, bringing the company’s total funding in this round to $18 million. This latest round of funding will be used to further expand the market reach of the Accellix system for Cell Therapy QC, enabling its customers greater access to the expertise, scale, resources, and technology needed to effectively assess the quality of life saving immunotherapies.

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"Companies developing cellular therapies in the area of immuno-oncology and other therapeutic areas understand the need to replace costly and complicated flow cytometry based procedures with an easy to use sample-to-answer system. Being recognized by bioMérieux for our achievements to-date and having access to their vast array of resources and expertise, will help us serve our existing customers while attracting new ones," said Nir Nimrodi, Accellix Chairman and CEO.

"The Accellix platform eliminates extensive training and complex operational procedures by automating inherent manual complex flow cytometry processes. It provides accurate and immediate flow cytometry results at the point of need, removing the requirement of sending samples out to a central lab. We have been searching for such a platform that will complement our Industry-leading Microbial Quality Control offering and it is our intention to work with Accellix on enabling them to advance their market reach and service and support capabilities," stated Michael Reynier, bioMérieux Vice President, Healthcare Industries Business Area. "Testing a precious cell therapy product for sterility and for quality, swiftly, accurately and reproducibly, will improve patients’ access to the lifesaving cellular therapies that are currently being developed."

On June 11, 2020 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that it has signed an exclusive, worldwide licensing agreement with Scopus BioPharma Inc., a biopharmaceutical company focused on novel therapeutics for serious diseases with significant unmet medical needs (Press release, City of Hope, JUN 11, 2020, View Source [SID1234561015]). Scopus will further develop and plans to commercialize a City of Hope first-in-class, targeted immuno-oncology gene therapy.

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A first in-human phase 1 clinical trial for B cell lymphoma patients that uses the licensed gene therapy drug, CpG-STAT3siRNA, a STAT3 inhibitor, is expected to commence at City of Hope in the second half of this year.

Growing evidence links B cell non-Hodgkin lymphomas to persistent activation of STAT3, a gene that drives tumor cell growth and anti-tumor immune suppression. The STAT3 inhibitor is a highly selective and targeted therapy that silences the activity of the STAT3 gene by way of RNA interference. It also stimulates the TLR9 receptors to activate the body’s immune defense to recognize and kill cancer cells.

In preclinical testing at City of Hope, the STAT3 inhibitor has successfully reduced growth and metastasis of various preclinical tumor models, including melanoma, and colon and bladder cancers, as well as leukemia and lymphoma.

City of Hope’s Hua Yu, Ph.D., Billy and Audrey L. Wilder Professor in Tumor Immunotherapy, associate chair/professor in the Department of Immuno-Oncology, and co-leader of the Cancer Immunotherapeutics Program, and Marcin Kortylewski, Ph.D., associate professor in the Department of Immuno-Oncology, who are both leading experts in the role of STAT3 in tumor angiogenesis and tumor immune evasion and in oligonucleotide-based cancer immunotherapies, developed the STAT3 inhibitor. The strategy was developed based on seminal discoveries by Yu’s team defining the key role of STAT3 in cancer cell survival and immune tolerance, combined with pioneering work by Kortylewski’s team on STAT3 targeting using TLR9-targeted delivery of siRNA oligonucleotide therapeutics into immune cells.

"City of Hope is proud to work with Scopus to bring this long-anticipated STAT3 drug to our clinical trial patients," Yu said. "STAT3 is critical for the survival and metastasis of cancer cells, and for suppressing anti-tumor immune responses. If City of Hope and Scopus can develop the first therapy against STAT3, many cancer patients will benefit from this lifesaving drug."

"Our laboratories were the first to demonstrate that successful cancer immunotherapy needs to be two-step since TLR9 immunostimulation is only effective when STAT3 in the tumor microenvironment is no longer active," Kortylewski added. "It is exciting to see this technology approaching clinical application with a strong ally in biopharma."

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"Scopus is extremely excited about licensing such a promising gene therapy drug with a robust intellectual property portfolio, compelling preclinical efficacy and safety profile, and a plan to enter phase 1 this year," said Joshua R. Lamstein, Scopus co-chairman. "We are privileged to have the opportunity to work with City of Hope, a globally recognized research institution and cancer center. We are looking forward to working with Drs. Yu and Kortylewski, who are among the preeminent researchers in immuno-oncology."

On June 11, 2020 Egle Therapeutics SAS, an emerging biotechnology company focused on developing first-in-class immunotherapies targeting immune suppressor regulatory T-cells for oncology and autoimmune diseases, reported a corporate strategic research alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal of validating novel tumor-infiltrating regulatory T-cell (Treg) targets against which Takeda will develop potential therapies (Press release, Egle Therapeutics, JUN 11, 2020, View Source [SID1234561014]).

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As a newly established bioscience company spun out of Institut Curie in the field of Treg immune modulation, Egle Therapeutics has assembled a proprietary translational based target discovery engine leveraging patient samples to map out – at the single cell level – unique transcriptomic signatures and targets specific for tumor-infiltrating Treg sub-populations. Capitalizing on these newly identified tumor-infiltrating Treg targets, the company is building a proprietary Treg modulating drug pipeline which also includes computationally designed resurfaced IL-2 proprietary variants, featuring unique mechanism of action to engage or dis-engage Tregs.

Under the terms of the agreement, Egle Therapeutics will lead target validation efforts on a subset targets Egle has identified and Takeda will be responsible for the development, manufacturing, and commercialization of resulting therapies. Egle Therapeutics will receive an upfront payment and research funding, and will be eligible to receive additional development and sales milestone payments based on the exclusivity of targets selected by Takeda.

Luc Boblet, co-founder and CEO of Egle Tx, commented "We are thrilled to engage with Takeda to fully exploit the great therapeutic potential of inhibiting the most immunosuppressive arm of immunity to restore antitumor immune response. We believe that joining forces would be the most efficient path to successfully develop novel generation of anti-Treg immunotherapies for the benefit of patients."

"Working with Egle to leverage the unique translational derived patient data bringing tumor-specific Treg targets is an exciting prospect to further advance our immuno-oncology drug discovery efforts," said Loïc Vincent, Head, Oncology Drug Discovery Unit at Takeda. "Targeting tumor-infiltrating regulatory T-cells to overcome the immune suppression in tumor microenvironments will complement our current immuno-oncology approaches and help advance an exciting portfolio."

In addition to the funding of the multi-target research collaboration, Takeda will invest €4.6 million in convertible debt through its venture arm, Takeda Ventures, Inc. ("TVI"), to support Egle’s corporate growth and internal programs on IL-2-based Treg modulation. Egle’s flagship program pioneers the dis-engagement of tumor-infiltrating Treg through unique proprietary series of IL-2 variants that act as IL-2 antagonists.

"While the whole competition converges solely on a similar approach to enhance effector T cells by disrupting binding of IL-2 to Tregs, our IL-2 variants conserve intact IL-2 binding to CD25, conferring a unique mechanism of action for starving Treg from endogenous IL-2, while leaving active the CD8+ effector T cell arm of the immune response," Luc Boblet added. "Takeda’s equity commitment will help Egle’s launch strikingly hit the road building on our excellent scientific foundation."

On June 11, 2020 Cullinan Oncology LLC and PDI Therapeutics, a portfolio company of Avalon Ventures, reported a collaboration to bring CLN-619, a first-in-class monoclonal antibody reinvigorating the MICA/NKG2D axis into human clinical testing (Press release, Cullinan Oncology, JUN 11, 2020, View Source [SID1234561013]). As a result of the transaction, Cullinan MICA, Inc., a Cullinan Oncology portfolio company, will assume operational control of the asset.

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"We have been very impressed with the work of Neil Gibson and his team at PDI Therapeutics," stated Owen Hughes, CEO of Cullinan Oncology. "The agonistic anti-MICA antibody CLN-619 represents a novel approach to broadly engage NK cells and certain T cell populations for tumor cell lysis and may have very broad therapeutic potential across multiple cancer indications as seen for certain check point inhibitors. We look forward to initiating clinical development in the coming months."

"We are pleased to partner with the Cullinan team and are excited to advance this highly innovative immuno-oncology mechanism into Phase 1 development," stated Dr. Neil Gibson, President and CEO of PDI Therapeutics Inc. "An agent capable of boosting both the innate and adaptive arms of the immune system could represent a new breakthrough in our fight against cancer."

PDI Therapeutics was incubated by COI Pharmaceuticals, which provides Avalon Ventures’ portfolio companies operational support and intellectual knowhow through a fully equipped R&D infrastructure. It is within this environment that PDI Therapeutics was able to take CLN-619 from bench to bedside in a little over 3 years. The program is supported by a robust in vitro and in vivo data package, with strong single agent activity and a clean safety profile in non-human primates. There is also a strong rationale for combination of CLN-619 with checkpoint inhibitors.

"We were attracted to CLN-619 given its potential broad utility across a large number of cancers and untapped biology," stated Patrick Baeuerle, Chief Scientific Officer, Biologics and co-founder of Cullinan Oncology. "Natural killer cells and killer T cells share NKG2D receptors that recognize cancer cells by their stress-inducible MICA ligand. To escape this deadly connection with killer cells, cancer cells have a way to shave off MICA from their surface. Cullinan MICA’s antibody effectively prevents the shedding of MICA from cancer cells and restores recognition by the patient’s killer cells. In addition, we expect the MICA antibody to exert potent antibody-dependent cellular cytotoxicity, or ADCC, against MICA-expressing cancer cells, which we believe will further potentiate the anti-tumor effect of CLN-619."

Cullinan MICA is financed by a recently completed $26M Series A, with participation from Cullinan Oncology LLC, Avalon Ventures, Bregua Corporation and the Myeloma Investment Fund, a venture philanthropy fund for the Multiple Myeloma Research Foundation (MMRF). "As we contemplate future development paths, we are excited to explore the utility of CLN-619 across a number of cancers, including both solid tumors, as well as hematologic malignancies like myeloma," added Dr. Jon Wigginton, Chief Medical Officer of Cullinan Oncology. "We look forward to building on the efforts of our colleagues at PDI to advance this novel, first-in-class immunotherapeutic agent into the clinic, and to leverage the many strengths of the MMRF to make an immediate and meaningful impacts on patients’ lives."

On June 11, 2020 Pfizer Inc. (NYSE: PFE) reported the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim).1 NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (Press release, Pfizer, JUN 11, 2020, View Source [SID1234561012]).2

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"The FDA approval of NYVEPRIA is a positive step that could both enable cost savings and increase access to an important treatment option," said Andy Schmeltz, Global President, Pfizer Oncology. "We are proud to add this new, long-acting supportive care option to our robust portfolio, now with six FDA-approved oncology biosimilars including three specifically approved for supportive care for patients with cancer. We look forward to making NYVEPRIA available to U.S. patients and physicians later this year."

The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

"Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens," said Ali McBride, PharmD, MS, BCPS, BCOP, Immediate Past President of the Association of Community Cancer Centers (ACCC). "The FDA approval of NYVEPRIA provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy."

Biosimilars play an important role in the treatment of cancer or as supportive care, with the ability to both help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. With more than a decade of global in-market experience, a portfolio of nine approved biosimilar products in the U.S. and the broadest biosimilar portfolio for oncology supportive care, Pfizer is proud to be a global leader in biosimilars and at the forefront of this vital healthcare segment. Pfizer has also filed its pegfilgrastim biosimilar candidate for regulatory approval with the European Medicines Agency (EMA) and the application is currently under review.

Pfizer is committed to ensuring that patients who are prescribed NYVEPRIA have access to this therapy. Upon launch, patients in the U.S. will have access to Pfizer Oncology Together, which offers personalized support and financial assistance resources to help patients access their prescribed Pfizer Oncology medications. Pfizer Oncology Together can help patients understand their benefits and connect them with financial assistance resources, regardless of their insurance coverage.

About NYVEPRIA (pegfilgrastim-apgf)

NYVEPRIA, a biosimilar to Neulasta, is approved by the FDA to help reduce the chance of infection due to a low white blood cell count in people with non-myeloid cancer who receive anti-cancer medicines, like chemotherapy, that can cause fever and low white blood cell count.2 This condition, known as febrile neutropenia, is a common side effect of many types of chemotherapy and lowers the body’s ability to defend itself against infections.3

NYVEPRIA INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Contraindication

NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
Reactions have included anaphylaxis
Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving NYVEPRIA
Acute Respiratory Distress Syndrome (ARDS)

Can occur in patients receiving pegfilgrastim products
Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving NYVEPRIA
Discontinue NYVEPRIA in patients with ARDS
Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
The majority of reported events occurred upon initial exposure
Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti‐allergic treatment
Permanently discontinue NYVEPRIA in patients with serious allergic reactions
Do not administer NYVEPRIA to patients with history of serious allergic reactions to pegfilgrastim products or filgrastim products
Use in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products
Discontinue NYVEPRIA if sickle cell crisis occurs
Glomerulonephritis

Glomerulonephritis has occurred in patients receiving pegfilgrastim products
The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy
Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products
If suspected, evaluate for cause, and if causality is likely consider dose-reduction or interruption of NYVEPRIA
Leukocytosis

White blood cell counts of 100 x 109/L or higher have been observed in patients receiving pegfilgrastim products
Monitoring of complete blood count (CBC) during NYVEPRIA therapy is recommended
Capillary Leak Syndrome (CLS)

CLS has been reported after granulocyte-colony stimulating factor (G‐CSF) administration, including pegfilgrastim products
Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
Episodes vary in frequency and severity and may be life‐threatening if treatment is delayed
Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells

G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines
The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded
Aortitis

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
Manifestations may include generalized signs and symptoms, such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c‑reactive protein and white blood cell count)
Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NYVEPRIA if aortitis is suspected
Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most Common Adverse Reactions

Bone pain