On October 15, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, MacroGenics, OCT 15, 2020, View Source [SID1234568521]). This represents the third publication of flotetuzumab data in 2020. Flotetuzumab (also known as MGD006), is an investigational, clinical-stage bispecific DART molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T-cell-mediated killing of leukemic blasts. This most recent publication reports on the role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia (AML).

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It has previously been shown1 that an inflammatory (IFN-γ-related) gene expression signature in patients with AML correlated with a lack of response to induction chemotherapy. The same gene signature was shown to be associated with an increased probability of this subset of patients to respond to flotetuzumab. As further described in the article titled "TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in AML," AML with TP53 abnormalities was also associated with immune infiltration in the tumor microenvironment (TME); moreover, patients with TP53 abnormalities derived benefit from flotetuzumab immunotherapy.

"Previous translational studies demonstrated that patients who failed to respond to induction therapy (primary induction failure, or PIF, AML) or those who relapsed within six months of achieving an initial remission (early relapsed, or ER, AML) had an immune-infiltrated TME that not only associated with resistance to standard-of-care chemotherapy regimens, but also with response to flotetuzumab," said Sergio Rutella, M.D., Ph.D., FRCPath, John van Geest Cancer Research Centre, College of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom. "Included in this PIF/ER AML population are patients harboring TP53 abnormalities, a particularly difficult to treat subset of AML associated with poor prognosis. Interestingly, these patients who responded poorly when treated with standard-of-care chemotherapy regimens appeared to benefit from flotetuzumab therapy."

"The results published today in Blood Advances, combined with data from previous articles published in Blood and Science Translational Medicine, further support our decision to conduct a pivotal study of flotetuzumab in AML patients who have previously experienced either a primary induction failure or an early relapse when treated with standard-of-care chemotherapy regimens. These individuals represent approximately 40-50% of all AML patients," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our single arm clinical trial is ongoing as an expansion of the Phase 1/2 study, for which we plan to enroll up to 200 patients. We plan to present interim results at a medical conference later this year."

1 "Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia," Blood, 2020; and "Immune Landscapes Predict Chemotherapy Resistance and Immunotherapy Response in Acute Myeloid Leukemia," Science Translational Medicine, 2020.

About Acute Myeloid Leukemia

AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure, or PIF) or experience disease recurrence after a short remission duration (<6 months; early relapsed, or ER). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations. The discovery by the Rutella lab of an immunological gene signature in the AML tumor microenvironment forms the basis for a potential predictive biomarker for further clinical validation.

About Flotetuzumab

Flotetuzumab (also known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. Data from the Phase 1/2 clinical study of flotetuzumab in patients with primary induction failure / early relapse (PIF/ER) AML were presented in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML. (Press release, MacroGenics, OCT 15, 2020, View Source [SID1234568521])

On October 15, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that biomarkers associated with clinical response in patients with r/r DLBCL treated with DPX-Survivac combination therapy will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting (Press release, IMV, OCT 15, 2020, View Source [SID1234568520]).

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Poster Title:

Baseline PD-L1 expression and tumor immune infiltration is associated with clinical response in patients with r/r DLBCL treated with DPX-Survivac, low-dose cyclophosphamide and pembrolizumab

Poster Presentation Details:

Presenter: Neil Berinstein, MD, FRCPC, ABIM
Hematologist at the Sunnybrook Health Science Centre, Toronto.
Abstract Number: 356

Important dates:

November 9 – 8.00am EST: Full abstract will be released on the SITC (Free SITC Whitepaper) meeting platform,

November 11 – 9.00am EST: Poster will be posted on Company’s website and poster presentation will be available on the SITC (Free SITC Whitepaper) conference platform,

November 12 – 8.00am EST: Company will discuss data during a live webcast,

November 12 from 4.50-5.20pm EST and November 14 from 1.00-1.30pm EST, a Q&A session will be held on the SITC (Free SITC Whitepaper) meeting platform.

The final poster presentation will include additional data collected between the abstract submission on April 1, 2020 and the presentation itself. The poster will be available under the Scientific Publications & Posters section on IMV’s website on the day of presentation.

Webcast registration will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website. The video recording will be available for replay shortly thereafter.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that generates targeted and sustained immune response in vivo. Treatments with DPX-Survivac have demonstrated the potential for sustained and targeted cancer cell killing capabilities with limited adverse events.

DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

DPX-Survivac is currently being evaluated in three Phase 2 studies: advanced ovarian cancer, relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and a basket trial of five solid tumors. All of which are expected to report topline results in 2020.

About the SPiReL Study

"SPiReL" is a Phase 2 non-randomized, open label, efficacy and safety study of a novel immunotherapy combination with DPX-Survivac and pembrolizumab. Intermittent low dose cyclophosphamide is given as an immune-modulator. Subjects with r/r incurable DLBCL and survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria to the combination treatment. Secondary outcomes include the documentation of: changes in tumor volume, toxicity profile, duration of response (Cheson criteria).

On October 15, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, and The University of Texas MD Anderson Cancer Center reported a strategic five-year collaboration agreement for the preclinical and clinical investigation of AlloCAR T candidates across Allogene’s broad portfolio of hematologic and solid tumors (Press release, Allogene, OCT 15, 2020, View Source [SID1234568519]).

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"MD Anderson’s expertise in innovative clinical trials and well established translational research infrastructure will provide unique insights that will help expedite the development of AlloCAR T therapies," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Allogene. "Coupled with Allogene’s cell therapy expertise, we believe this institution-industry alliance could play an important role in bringing this next revolution in oncology treatment to patients."

Under the agreement, MD Anderson and Allogene will collaborate on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. Allogene will provide funding, developmental candidates, and other support. Responsibility for regulatory filings will be agreed upon by the joint steering committee.

"We share Allogene’s commitment to advancing novel therapies that will translate into effective treatments for cancer patients," said Christopher Flowers, M.D., ad interim division head of Cancer Medicine and chair of Lymphoma and Myeloma at MD Anderson. "This collaboration will enable us to work together closely to advance allogeneic cell therapies to better address significant unmet medical needs for patients across the spectrum of oncologic diseases."

On October 15, 2020 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, reported the appointment of Premal Patel, M.D., Ph.D., as chief medical officer (Press release, eFFECTOR Therapeutics, OCT 15, 2020, View Source [SID1234568518]). Dr. Patel will lead the clinical development of the company’s pipeline of cancer product candidates. He will also be a member of eFFECTOR’s executive management team.

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"Dr. Patel is an accomplished physician-scientist who has demonstrated expertise in developing oncology products across a number of mechanisms, including targeted agents, immuno-oncology and cell-based therapies," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "His experience will be invaluable as we evaluate tomivosertib combined with pembrolizumab in a randomized Phase 2 study in non-small cell lung cancer and advance zotatifin into expansion cohorts targeting specific patient populations."

Dr. Patel brings to eFFECTOR more than 15 years of healthcare industry experience in medical oncology drug development, thoughtfully combining clinical strategy with adept biomarker approaches. Most recently, Dr. Patel was chief medical officer at Lyell Immunopharma. Previously he served as senior vice president, head of early clinical drug development at Juno Therapeutics, where he led CAR-T efforts in multiple myeloma and all solid tumor CAR-T and TCR efforts. He has also served as vice president, head of early clinical development and translational research at Pfizer, where he led the allogenic CAR-T effort, along with immuno-oncology assets. Dr. Patel spent over seven years at Genentech, Research and Early Development leading clinical development for several agents, including atezolizumab + Avastin in renal cell carcinoma, and the AKT inhibitor ipatasertib across indications from inception to successful proof-of-concept at end of Phase 2.

Dr. Patel completed residencies in internal medicine at University of Washington and adult medical oncology at Memorial Sloan Kettering Cancer Center, where he researched targeted therapies for renal cell carcinoma. Dr. Patel received his M.D. and Ph.D. degrees at University of Washington and a B.S. in pharmacy from Rutgers University.

About Selective Translation Regulator Inhibitors

Selective Translation Regulator Inhibitors (STRIs) target the eukaryotic initiation factor 4F (eIF4F) complex and its activating kinases, MNK1/2. eIF4F is a key node where the RAS and PI3K pathways converge and controls production of multiple oncoproteins that are validated therapeutic targets, including several RTKs, RAS, Cyclin D, CDK4/6, estrogen receptor (ER) and Myc. Inhibiting eIF4A or eIF4FE, the catalytic subunits of eIF4F, leads to apoptosis in select cancer models. MNK inhibition delays T cell exhaustion while enhancing T cell central memory pool.

On October 15, 2020 Genmab A/S (Nasdaq: GMAB) reported that it will hold a Capital Markets Day for analysts and investors on November 13, 2020 from 8:30 AM EST / 2:30 PM CET to 11:00 AM EST / 5:00 PM CET (Press release, Genmab, OCT 15, 2020, View Source [SID1234568517]). The event will be webcast live from Genmab’s state-of-the-art R&D Center in Utrecht, the Netherlands, and from its new offices and laboratory facilities in Princeton, NJ, US. The Capital Markets Day will feature Genmab’s Executive Management Team and a variety of high-level Genmab speakers who will provide updates on Genmab’s business and the ways in which we are delivering on our commitments and evolving into a fully integrated biotech innovation powerhouse.

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Topics to be discussed include an overview of our robust product pipeline with a focus on our exciting epcoritamab, tisotumab vedotin and DuoBody-PD-L1x4-1BB programs, a deep dive into our proprietary DuoBody technology and a look at how we are growing our capabilities across the company.