On January 11, 2022 iTeos Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, iTeos Therapeutics, JAN 11, 2022, View Source [SID1234598580]).

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On January 11, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported 2022 corporate priorities and anticipated clinical development and research milestones (Press release, Xencor, JAN 11, 2022, View Source [SID1234598598]).

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"The plug-and-play nature of Xencor’s XmAb Fc domains and our protein engineering expertise have enabled a broad portfolio of bispecific antibody and engineered cytokine drug candidates, as well as a multitude of partnerships, which have thus far produced three marketed products," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In 2022, we expect emerging clinical data to continue to support our own mid-stage development plans for vudalimab and plamotamab, and we will continue to initiate new studies with potential to present new data that may define a path to registration for these programs. Additionally, we remain excited by the opportunities to use our technological competitive advantage to address challenging areas of biology and continually grow our portfolio, now with multiple reduced-potency cytokines and CD3 and CD28 T cell engagers in development, both internally at Xencor and with our partners."

Execute on development plans for mid-stage XmAb bispecific antibody programs

Vudalimab (PD-1 x CTLA-4), designed to activate intra-tumoral T cells
Xencor presented updated Phase 1 expansion cohort data in November 2021 and is enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), where vudalimab is being evaluated as a monotherapy or in combination depending on the tumor’s molecular subtype. Xencor plans to:

Initiate a second Phase 2 study, evaluating vudalimab in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
Present initial data from the Phase 2 study in mCRPC, in the second half of 2022.
Plamotamab (CD20 x CD3), for B-cell malignancies
Xencor presented updated Phase 1 dose-escalation data in December 2021 and is currently recruiting non-Hodgkin lymphoma patients in expansion cohorts of plamotamab monotherapy at the Phase 2 recommended dose. Xencor entered a global collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to expand the Company’s strategy to develop plamotamab as part of multiple highly active chemotherapy-free regimens across B-cell cancers. Xencor plans to:

Initiate potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab and lenalidomide, in patients with relapsed or refractory DLBCL.
Incorporate subcutaneous administration into the ongoing Phase 1 monotherapy study.
Present data from Phase 1 expansion cohorts, in the second half of 2022.
Develop B-cell targeted CD28 bispecific antibodies to selectively enhance T-cell cytotoxic activity in combination with plamotamab.
Advance multiple potency-reduced XmAb cytokine programs in oncology and autoimmune disease

Xencor’s engineered, potency-reduced cytokines are designed to expand select immune cell populations, to have longer circulating half-life and to be tolerable, active and easy to administer. XmAb cytokines incorporate Xtend extended half-life technology.

XmAb306, potency-reduced IL15/IL15Rα-Fc fusion protein
Recently, Xencor announced encouraging initial dose-escalation data from an ongoing Phase 1 study in patients with advanced solid tumors, in which the preliminary safety profile, biological activity and signs of anti-tumor activity provide initial validation for the Company’s approach to engineering cytokine therapeutics. Xencor plans to:

Announce new clinical studies of XmAb306 in combination with other agents, such as NK- or T-cell recruiting therapies in collaboration with the Company’s co-development partner.
XmAb564, potency-reduced IL2-Fc fusion targeting regulatory T cells in autoimmune disease
Xencor plans to:

Present tolerability, durability and biomarker data from the ongoing Phase 1 single-ascending dose study in healthy volunteers.
Identify development indications and initiate a multiple-ascending dose study in select patient populations.
XmAb662, potency-reduced IL12-Fc fusion protein designed to increase tumor immunogenicity
Xencor plans to:

Submit an investigational new drug (IND) application in 2022, and initiate a Phase 1 study in patients with advanced solid tumors in 2023.
Xencor plans to present preclinical data from additional cytokine-Fc programs in 2022.

Expand the Company’s portfolio with the first internally developed XmAb 2+1 CD3 and XmAb CD28 bispecific antibodies advancing into Phase 1 clinical studies

XmAb819 (ENPP3 x CD3), XmAb 2+1 bispecific antibody for renal cell carcinoma (RCC)
The multivalent XmAb 2+1 bispecific antibody format enables greater selectivity for tumor cells compared to normal cells, which also express ENPP3 at lower levels. Xencor plans to:

Initiate a Phase 1 study evaluating XmAb819 in patients with RCC in the first half of 2022.
XmAb808 (B7-H3 x CD28), tumor-selective, co-stimulatory CD28 bispecific antibody
CD28 is a key immune co-stimulatory receptor on T cells; however, the ligands that activate T cells through CD28 are usually not expressed on tumor cells. Targeted CD28 bispecific antibodies may provide conditional co-stimulation of T cells, for example, to T cells recognizing neoantigens or in concert with CD3 T-cell engaging bispecific antibodies. XmAb808 targets the broadly expressed tumor antigen B7-H3. Xencor plans to:

Submit an IND application in the first half of 2022, and initiate a Phase 1 study in patients with advanced solid tumors in the second half of 2022.
Cash Position and Financial Guidance

Xencor ended the fourth quarter of 2021 with unaudited cash, cash equivalents, receivables and marketable debt securities totaling approximately $660 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2025.

On January 11, 2022 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and Antion Biosciences, a Swiss cell and gene engineering company, reported that they have entered into an exclusive collaboration and global license agreement for Antion’s miRNA technology (miCAR) to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products (Press release, Antion Biosciences, JAN 11, 2022, View Source [SID1234629137]).

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Antion is an early-stage research company with foundational miRNA technology. In preclinical studies, Antion has demonstrated proof-of-concept for multiplex gene silencing in an allogeneic CAR T cell model. These studies demonstrated the ability of miCARTM technology to silence multiple gene targets in a single step and indicate this technology has broad application within cell and gene engineering. Allogene plans to deploy miCARTM with other technologies to develop next-generation strategies for immune evasion and other advances in allogeneic CAR T therapy.

"We believe that Antion has one of the few technology options capable of delivering multiplex gene silencing with a high degree of specificity and potency," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We are excited to be working with Antion to explore how their miCAR technology may advance and accelerate Allogene’s research efforts aimed at creating best in class allogeneic cell therapies."

As part of this agreement, Antion will exclusively collaborate with Allogene on oncology products for a defined period. Allogene will also have exclusive worldwide rights to commercialize products incorporating Antion technology developed during the collaboration. Allogene will provide Antion an upfront cash payment and a preferred equity investment. Allogene will pay Antion developmental and commercial milestones and a single-digit royalty on any product sales. Allogene will also take a seat on Antion’s Board of Directors.

"This collaboration represents an exciting validation of the power and flexibility of our miCAR platform." said Sven Kili, M.D., Chief Executive Officer. "We are extremely enthusiastic to be working with Allogene, as the world leader in Allogeneic CAR T therapies to bring next-generation life changing therapies to patients"

On January 11, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2021 financial results on Thursday, February 3, 2022, before the market opens (Press release, Quest Diagnostics, JAN 11, 2022, View Source,-2022 [SID1234598581]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-839-9317 for domestic callers or 203-369-3605 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 3, 2022 until midnight Eastern Time on February 17, 2022.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 11, 2022 Dren Bio, Inc. ("Dren Bio" or the "Company") reported it has entered into a research collaboration and license agreement with Pfizer Inc (Press release, Dren Bio, JAN 11, 2022, View Source [SID1234598599]). The strategic collaboration will focus on the discovery and development of therapeutic bispecific antibodies for select oncology targets using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform.

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Under the terms of the agreement, Pfizer made an upfront cash payment of $25 million to Dren Bio, with the Company eligible to potentially receive more than $1 billion of cash in total, including payments for the achievement of future development, regulatory, and commercial milestones. Dren Bio and Pfizer will work together to advance the selected oncology target programs through clinical candidate selection, at which point Pfizer will assume full responsibility for all remaining development, manufacturing, regulatory and commercialization activities. For each target-specific product that is globally licensed by Pfizer, Dren Bio will be eligible to receive tiered royalties on all future net sales during the term of the Agreement. Additionally, under the terms of the agreement, Pfizer also has the right to reserve and subsequently nominate additional oncology targets to license from Dren Bio, subject to additional cash payments and future royalties. Excluding products developed for targets licensed to Pfizer, Dren Bio will retain exclusive global rights for the platform including all other therapeutic targets currently in development as part of its own internal pipeline.

"This agreement highlights Dren Bio’s expertise in therapeutic antibody development and marks the first collaboration using our proprietary platform to harness myeloid cells in disease, offering a differentiated approach with the potential to provide revolutionary therapies to patients across a broad array of therapeutic areas, starting with cancer," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "Pfizer’s unwavering commitment to deliver innovative therapies makes them an ideal strategic partner to help us achieve this vision."

"Building on Pfizer’s established leadership position in oncology research, we are excited to work alongside Dren Bio on a novel strategy focused on the engagement of myeloid cells to treat cancer," said Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer. "Together we hope to develop potential breakthrough treatments for cancer patients."

The Company’s proprietary Targeted Myeloid Engager and Phagocytosis Platform is a bispecific antibody-based technology that engages a receptor selectively expressed on myeloid cells, including monocytes, macrophages, and dendritic cells. Certain myeloid cells, such as Tumor-Associated Macrophages (TAMs), are part of the tumor microenvironment where they can be immunosuppressive and are therefore often associated with poorer clinical outcomes. By repolarizing TAMs and engaging them together with dendritic cells to execute targeted phagocytosis, antigen presentation, and subsequent T cell activation, the Company’s platform antibodies may expand the therapeutic benefit of immunotherapy while also potentially promoting durable clinical responses.

Data generated to date using platform antibodies from the Company’s pipeline demonstrate a differentiated, multi-pronged mechanism of action that encompasses (i) direct coupling of myeloid cells with tumor cells, (ii) stimulation of myeloid cells causing the release of key cytokines responsible for repolarizing TAMs in order to mitigate the immunosuppressive tumor microenvironment, (iii) targeted phagocytosis of tumor cells and (iv) cross-presentation of tumor neoantigens to promote the future activation of tumor-specific T cells to potentially promote a long-lasting immunological memory response. The unique biology of the novel phagocytic receptor targeted by the Company’s platform antibodies enables controlled myeloid cell activation only in the presence of the target antigen, resulting in localized cytokine release for potentially greater therapeutic indexes and safety profiles. In addition to the pharmacodynamic effect demonstrated in preclinical non-human primate studies to date, the observed tolerability and safety profile support the potential utilization of future platform candidates at higher or broader dose levels, which may provide an important benefit when compared to competing technologies such as T or NK cell engagers and antibody drug conjugates.

Dren Bio’s internal development pipeline for the platform currently includes multiple antibodies targeting both liquid and solid tumor types. In addition to the initial focus on developing therapies for the treatment of cancer, the Company has also generated data using platform antibodies against targets associated with non-oncology indications, including forms of amyloidosis and Alzheimer’s disease. This data further supports the vast potential of the platform for developing multiple successful product candidates.