Asher Bio Appoints Andrea Pirzkall, M.D., as Chief Medical Officer

On June 13, 2022 Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the appointment of Andrea Pirzkall, M.D., as its first Chief Medical Officer (Press release, Asher Biotherapeutics, JUN 13, 2022, View Source [SID1234615941]). Dr. Pirzkall has a multi-disciplinary clinical background and a proven track record in developing cancer therapies from research to commercialization.

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"We are delighted to welcome Andrea to the Asher Bio team at this pivotal time as we transition to a clinical-stage company. Her broad background spans early and late-stage development and includes both small molecule and biologic agents. She has expertise in immunotherapies for cancer and is a successful leader of growing clinical teams. Andrea is an ideal fit to our team as we continue to advance our pipeline," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Her expertise and hands-on style will be valuable assets as we implement clinical strategies to deliver our selective and differentiated immunotherapies for patients with cancer and other diseases."

"I am very excited to join Asher Bio’s highly experienced senior management team and to build and lead the clinical development organization to deliver on the company’s promising pipeline of cis-targeted therapeutics," said Dr. Pirzkall. "I am particularly intrigued by the potential of Asher Bio’s cis-targeting platform approach to overcome limitations and broaden the potential of existing immunotherapy by selectively targeting immune cell subsets, and thereby aiming to improve outcomes for patients. That includes Asher Bio’s lead cis-targeted IL-2 immunotherapy, AB248, which is approaching an IND filing and the start of a Phase 1 clinical trial. AB248 has been designed to selectively activate IL-2 signaling in CD8+ effector T cells, while avoiding systemic toxicities and limiting counterproductive pleotropic signaling that results from IL-2 binding to non-targeted cells. I look forward to working with the team to transition this compound into the clinic."

Most recently, Dr. Pirzkall served as Chief Medical Officer at Replimune Group, Inc., where she was responsible for building, developing, and leading clinical development of the company’s pipeline of next-generation oncolytic immunotherapies. Prior to that, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., where she led and supported the development, startup and execution of several pivotal studies in lung cancer and head and neck cancers, which successfully led to approvals of tislelizumab (anti-PD1) in China and ongoing filings in other jurisdictions. She also served as the global clinical development lead on the BeiGene, Inc./Celgene Corporation joint development committee. Earlier in her career, Dr. Pirzkall spent 10 years at Genentech, Inc., where she held roles of increasing responsibility, including Principal Medical Director and Clinical Development Team Leader. In this role, she worked with cross-functional teams on therapeutics including Avastin, Tarceva, Perjeta, Cotellic and Tecentriq supporting these novel biologic agents through early to late stages of development in oncology as well as through exploratory and combination studies.

Prior to moving to industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University of Heidelberg and the German Cancer Research Center. She completed a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (UCSF) and held academic positions as Associate Adjunct Professor of Radiation Oncology, Radiology, and Neurosurgery at UCSF. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.

TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Previously Untreated Metastatic Triple Negative Breast Cancer

On June 13, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient was dosed in the global TROPION-Breast02 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy (Press release, Daiichi Sankyo, JUN 13, 2022, View Source [SID1234615940]).

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Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

"Patients with metastatic triple negative breast cancer who are not able to receive PD-1/PD-L1 inhibitor treatment often experience recurrence following chemotherapy, so additional options in the first-line treatment setting are needed," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting."

"Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple negative breast cancer, a group with a significant unmet need, have been encouraging," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "We are building on these early results by moving forward with the TROPION-Breast02 trial, the second pivotal trial of datopotamab deruxtecan in breast cancer, to determine if this antibody drug conjugate may potentially be used earlier in the treatment of metastatic triple negative breast cancer."

About TROPION-Breast02
TROPION-Breast02 is a global, randomized, open-label, two-arm, multicenter study assessing the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC. TNBC is defined as HR negative, meaning tumors test negative for estrogen and progesterone hormone receptors, and HER2 negative, determined by an IHC test and/or an ISH test.3,5 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.5 Patients must not be candidates for PD-1/PD-L1 inhibitor therapy and must be eligible for one of the investigator’s choice of chemotherapy options.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 will randomize approximately 600 patients with TNBC at sites in Asia, Africa, Europe and North America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.6 TROP2 expression has been detected in a wide range of breast cancer subtypes, including approximately 80% of patients with TNBC.7,8,9 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.7

About Datopotamab Deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three leading ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including TNBC, HR positive/HER2 negative breast cancer, non-small cell lung cancer, small cell lung cancer, urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

Guardant Health Completes Purchase of Guardant Health AMEA Joint Venture

On June 13, 2022 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, reported it has purchased the remaining shares of Guardant Health AMEA, Inc., held by SoftBank and its affiliates, giving the company full control over operations throughout the Asia, Middle East and Africa region (Press release, Guardant Health, JUN 13, 2022, View Source [SID1234615939]).

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More than half of the world’s estimated new cancer cases come from Asia, Middle East and Africa (AMEA).1 This acquisition will allow Guardant Health to directly address the growing cancer burden in the region by accelerating the adoption of the company’s blood tests and services used by healthcare providers to detect and manage cancer across all stages of the disease.

Guardant Health AMEA operations support 41 countries across the region. Near term, the company will prioritize bringing blood-based testing to healthcare providers and to patients with advanced cancer in Japan, where, in March 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling in patients with advanced solid tumors.

"By acquiring the remaining shares of Guardant Health AMEA, we can focus on creating a unified and centralized global organization that delivers on our promise to help conquer cancer and improve patient outcomes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We believe our blood-based tests can play a significant role in helping address the growing incidence of cancer in the region, and we look forward to continuing to support patients facing cancer diagnoses as we expand our operations in these markets."

In May 2018, Guardant Health and SoftBank Vision Fund established the Guardant Health AMEA joint venture to expand commercialization of Guardant Health’s industry-leading liquid biopsy technology across the region. Under the terms of the parties’ joint venture agreement, Guardant Health paid approximately $177.8 million to acquire the Guardant Health AMEA equity interest held by SoftBank and its affiliates.

PharmaCyte Biotech to Attend 2022 BIO International Convention in San Diego

On June 13, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Chief Executive Officer, Kenneth L. Waggoner, will represent PharmaCyte at the 2022 BIO International Convention (BIO) being held at the San Diego Convention Center in San Diego, California, June 13-16 (Press release, PharmaCyte Biotech, JUN 13, 2022, View Source [SID1234615938]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We look forward to meeting a host of industry leaders, investors and organizations as we introduce and advance the Cell-in-a-Box technology and the therapies we are developing using this technology. BIO offers a unique opportunity to showcase our novel therapies for cancer, diabetes and malignant ascites to world-class clinicians and scientists who work in our field of endeavor."

The 2022 BIO convention is the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. The host, the Biotechnology Innovation Organization, is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. The convention will feature 100+ interactive sessions over four days covering a variety of therapeutic areas, business development, digital health, patient advocacy, public policy and next generation biotherapeutics.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at: View Source

Mustang Bio Announces Updated Interim Results from Follicular Lymphoma Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted CAR T Therapy

On June 13, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that updated interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, show a favorable safety profile, high overall response ("ORR") and complete response ("CR") rates, and CAR T persistence in patients with follicular lymphoma ("FL") (Press release, Mustang Bio, JUN 13, 2022, View Source [SID1234615937]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch") to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL").

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The updated results presented during an on-site oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress ("EHA2022") by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, included interim safety and efficacy data from the cell manufacturing process that was modified to combine the culture of CD4+ and CD8+ cells. CAR-T cells were administered at one of 5 dose levels: 1×105, 3.3×105, 1×106, 3.3×106 and 1×107 CAR T cells/kg. Treatment for all patients was infused in the outpatient setting except for the first patient of each dose cohort, each of which was kept for overnight observation.

In the 18 treated patients with FL, ORR and CR were 94% (17/18) and 78% (14/18), respectively. Additionally, 17% experienced a partial response (3/18) and 5% experienced disease progression (1/18). One patient experienced pseudo-progression followed by a spontaneous CR documented at 207 days and has remained in remission since. Additionally, one patient with prior CD19 CAR-T failure experienced a CR and also remains in remission. From a safety profile perspective, cytokine release syndrome occurred in 5 patients: 4 patients with grade 1 and one patient with grade 2. No patients with FL experienced immune effector cell associated neurotoxicity syndrome of any grade. Although the persistence of CAR T cells was seen at all dose levels and was comparable by day 28, the expansion was faster at the higher dose levels.

"We continue to observe a favorable safety profile and high rate of complete response with MB-106 as exhibited by this follicular lymphoma cohort and within a wide range of other hematologic malignancies including CLL, diffuse large B-cell lymphoma ("DLBCL") and Waldenstrom macroglobulinemia ("WM")," said Dr. Shadman. "Based on the ongoing progress, MB-106 may be a suitable outpatient treatment for these patients and another immunotherapy option for patients for whom CD19-directed CAR T cell therapy is not effective. Enrollment in this study remains open to patients with CD20+ B-NHLs and CLL, including patients with prior CAR T treatment."

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Given the ongoing positive progress presented by Dr. Shadman, we look forward to evaluating MB-106 to treat relapsed or refractory B-NHL and CLL in the multicenter clinical trial under Mustang’s IND which is now open to enrollment. MB-106 continues to demonstrate its potential as a safe, effective CAR T therapy that can address the unmet needs of a range of patients with relapsed or refractory B-NHLs, including WM and DLBCL, with outpatient administration. It is especially gratifying to see that the DLBCL patient previously reported as a PR has now improved to a CR, which therefore represents a second CR in DLBCL and a second CR in a patient previously treated with CD19-targeted CAR T therapy."

For more information on the clinical trials, please visit www.clinicaltrials.gov using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and was exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter Phase 1/2 clinical trial that is now open to enrollment under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trials can be found at View Source using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.