On January 11, 2022 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on a pivotal Phase 3 clinical study of seviprotimut-L, Polynoma’s melanoma cancer vaccine, for the adjuvant treatment of patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival (Press release, Polynoma, JAN 11, 2022, https://www.prnewswire.com/news-releases/polynoma-receives-special-protocol-assessment-spa-agreement-from-the-us-fda-for-a-pivotal-phase-3-clinical-study-of-seviprotimut-l-a-melanoma-cancer-vaccine-301457618.html [SID1234598604]). Seviprotimut-L previously received Fast Track designation from the U.S. FDA.

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Final analysis of Part B1 data from Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was recently published in the Journal for ImmunoTherapy of Cancer (JITC). A subgroup analysis of patients receiving seviprotimut-L with AJCC Stage IIB/IIC melanoma, under age 60 with a median follow-up time of 45.8 months (3.8 years), showed clinically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 68% (HR=0.32; 95% CI, 0.121, 0.864) compared to patients receiving placebo. Additionally, RFS was more favorable in patients under age 60 with ulcerated melanomas (HR 0.21; 95% CI: 0.065-0.702), and there was a trend toward improved overall survival (OS) (HR 0.34; 95% CI: 0.117, 0.975) for patients that received seviprotimut-L compared to those receiving placebo. Seviprotimut-L was extremely well tolerated, with adverse events (AEs) similar to patients that received placebo; there were no immune-mediated AEs or other treatment-related serious AEs observed.

"Vaccination with seviprotimut- L has an advantage of having very low toxicity, without significant immune-related adverse events and no significant increase in toxicity over placebo," said Craig L. Slingluff, Jr., MD, Professor of Surgery and Director of the Human Immune Therapy Center and lead author of the JITC research paper on MAVIS. "If definitive evaluation of this vaccine therapy confirms clinical benefit in patients with Stage IIB/IIC melanoma, particularly those aged 60 and younger, the low toxicity of this approach will be a valuable option for these patients."

"This SPA agreement with the U.S. FDA for our planned pivotal trial provides important guidance for the regulatory path towards approval of seviprotimut-L as an adjuvant treatment in Stage IIB/IIC melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Executive Officer at CK Life Sciences. "We believe results from this trial will support seviprotimut-L as the first choice in treating younger patients with localized melanoma."

About FDA Special Protocol Assessment
The SPA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for a new drug application. A SPA does not ensure the receipt of marketing approval or that the approval process will be faster than conventional regulatory procedures. Final marketing approval depends on efficacy and safety results and an evaluation of the overall benefits and risks of treatment after review of the data from the development program in its totality. For more information on Special Protocol Assessments, please visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry.

About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase 3 trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. For additional information about the trial, please visit View Source

About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB and IIC melanoma, following definitive resection.

On January 11, 2022 BostonGene Corporation and WellDyne reported a strategic partnership to improve therapeutic decision-making for cancer patients (Press release, BostonGene, JAN 11, 2022, View Source [SID1234598603]). With BostonGene Tumor Portrait Tests, WellDyne will increase efficiency and therapy selection for patients who are candidates for immunotherapy in melanoma, non-small cell lung cancer, gastric, bladder and kidney cancers.

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BostonGene Corporation, a biomedical software company, is committed to defining optimal, precision medicine-based therapies for cancer patients. As a leading pharmacy benefit manager, WellDyne leverages precision medicine’s targeted approach that can predict how a patient will metabolize and respond to specific drugs. The BostonGene Molecular Functional Portrait (MF Portrait) will assist WellDyne in determining patient eligibility for immunotherapy treatment based on its comprehensive analysis of the tumor and the microenvironment. With the implementation of this test, WellDyne will better understand and manage the total cost of care for patients.

The BostonGene Tumor Portrait Test, based on integrated genomic and transcriptomic analysis, reveals key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. The test significantly increases the correct identification of patients who respond to immunotherapy and helps other patients avoid unnecessary adverse events. It combines precise data processing and proprietary algorithms to generate easy-to-understand tumor schematics, including the MF Portrait, a personalized tumor map to guide treatment decision-making that tailors individualized treatments and streamlines treatment costs.

"We focus on smarter, more precise prescribing to determine the best choice of drug and dosage for patients the first time, minimizing side effects and costly trial and error," says Nick Page, Chief Clinical Officer at WellDyne. "Leveraging BostonGene Tumor Portrait Tests to predict treatment response creates a significant opportunity to improve patient outcomes and reduce the cost of overall care."

"While immunotherapy is the most expensive class of drugs for oncology, immuno- and targeted therapies remain the most promising and rapidly developing treatments for cancer patients," says Andrew Feinberg, President and CEO at BostonGene. "We’re pleased to provide WellDyne with our innovative multi-platform analytics to predict prognosis and response to therapy."

On January 11, 2022 Panavance Therapeutics Inc. ("Panavance") is a new clinical-stage pharmaceutical company reported that created to advance and develop GP-2250, a patented, novel therapeutic for the treatment of cancer and other therapeutic indications (Press release, Panavance Therapeutics, JAN 11, 2022, View Source [SID1234598602]).

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GP-2250 is a broadly active, tumor cell selective cancer therapeutic with a unique mechanism of action that, as demonstrated in preclinical research, suppresses cancer cells by disrupting their energy metabolism—bringing about cancer cell death. Panavance’s initial clinical focus is on pancreatic cancer, and the company is conducting preclinical studies to develop GP-2250 for the treatment of other cancers and therapeutic indications.

"Panavance was established by Avensis Pharma AG to pursue the development of GP-2250, a novel compound with great potential. This molecule has demonstrated effectiveness and safety in preclinical studies, and its early clinical results in a Phase 1/2 pancreatic cancer trial across 4 US clinical sites have been encouraging," said Greg Bosch, Chairman & Chief Executive Officer of Panavance.

"We believe in the potential of GP-2250, and the Panavance team is dedicated to realizing its therapeutic possibilities, starting with pancreatic and gynecological cancers, both of which represent areas with unmet clinical need. Ultimately, we hope to improve and extend the lives of cancer patients."

To accelerate its capitalization, development, and success, Panavance has assembled an impressive leadership team, board of directors, and clinical and scientific advisors, which include seasoned leaders with life science backgrounds in pharmaceutical drug development, clinical and medical sciences, commercialization, and capital markets.

Learn more about Panavance and GP-2250 at www.panavance.com.

References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Panavance is not responsible for the contents of third-party websites.

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.

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.