On October 28, 2021 BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, reported the appointment of Philippe Drouet as President and Chief Executive Officer of BioTheryX (Press release, BioTheryX, OCT 28, 2021, View Source [SID1234592158]).

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"Philippe is an extremely talented biopharma executive with more than two decades of global experience in commercializing blockbuster oncology therapeutics. He has worked to advance products through clinical development, successfully launched them, and most importantly made them available to patients. His proven track record in building effective high performing teams will position us well to advance our pipeline of protein degraders and modulators to create life-saving medicines for patients," said David Stirling, Ph.D., Executive Chairman of BioTheryX. "The Board and I welcome him as CEO, and we are excited to have him lead our company as we build on our expertise in protein modulation-based drug development."

Prior to joining BioTheryX, Mr. Drouet served as Chief Commercial Officer at CRISPR Therapeutics where he shaped the strategy for the launch of the company’s first allogeneic CAR-T therapies and helped lead the clinical development strategy for the company’s phase I clinical assets. Previously, Philippe served as Senior Vice President, Global Oncology at Merck & Co. where he launched and commercialized Keytruda, drove substantial global oncology revenue and built and led the company’s Global Oncology Marketing, Access and Pricing organization. Prior to that, he served as President of Hospira’s U.S. division before Hospira’s acquisition by Pfizer in 2015. Philippe also held roles of increasing responsibility at Novartis Pharmaceutical Corporation, including Vice President U.S. Hematology, General Manager Oncology in Turkey, Global Brand Leader for Gleevec and Head of Oncology Marketing in Canada. Philippe received an MBA from INSEAD in France and a Master of Science and Bachelor in Chemical Engineering from McGill University, Canada.

"I am excited to join BioTheryX and lead the company through its next stage of rapid growth as it expands its programs in the fast-paced category of protein degradation," said Mr. Drouet. "BioTheryX has built one of the leading scientific teams and most promising pipelines in the protein degradation space. I look forward to working alongside this outstanding team to build our clinical-stage program for liquid and solid tumors and develop first-in-class therapies in areas of high unmet medical need in oncology and other diseases."

On October 28, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company has scheduled the release of its third quarter 2021 financial results on Thursday, November 4, 2021 (Press release, Sangamo Therapeutics, OCT 28, 2021, View Source [SID1234592196]). The press release will be followed by a conference call at 9:15 a.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide business and clinical updates.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5178059. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5178059.

On October 27, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported the issuance of U.S. Patent No. 11,155,872 for digital polymerase chain reaction (dPCR) technique for molecular detection of solid organ allograft rejection (Press release, Oncocyte, OCT 27, 2021, View Source [SID1234592010]). The new patent strengthens Oncocyte’s intellectual property portfolio in the blood-based monitoring market including the transplant setting, enabling Therasure Transplant Monitor, its donor-derived cell-free DNA (dd-cfDNA) test, access to the $2 billion U.S. transplant market. Therasure Transplant Monitor is a blood-based solid organ transplantation monitoring test that is designed to be used in lieu of a tissue biopsy in kidney, liver and heart transplant patients, minimizing the need for these invasive and costly procedures.

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"Our newest patent will play an important role in strengthening our IP portfolio as we establish a robust pipeline of blood-based monitoring tests to democratize monitoring tests in both the transplant and oncology markets, helping to ensure that patients and their doctors get the right insights at the right time to make the best decisions," said Ron Andrews, President and CEO of Oncocyte. "The issuance of our second U.S. patent, building upon our prior U.S. and EU patents, gives us a protected path to launch an LDT in the U.S. to complement our current efforts in Germany and the EU. Our U.S. LDT is now expected to be validated and ready for CMS submission by the end of the first quarter in 2022 and with the broad LCD coverage for molecular testing of organ rejection from CMS in place, which cited our technology, we believe we will have a solid path to reimbursement."

Mr. Andrews continued, "Our future development beyond the LDT will include partnering with a technology platform and channel partner to initiate a clinical trial effort for a kitted product with an FDA submission planned in the first half of 2023. We believe our strategy to launch as a LDT and move to a kit business in the U.S. and Europe, will allow us a rapid path to market and revenues in 2022, with the ultimate goal of democratizing this new technology. Importantly, this differentiated approach that is more specific, quantitative for longitudinal follow up, cost effective and provides same-day turnaround time of important information for patient management has the potential to improve patient care and accelerate patient access to this essential insight in an estimated $2B U.S. market."

The patent granted delivers Oncocyte the right to exclude others from using the claimed methods in the United States and the European Union (where an earlier patent, EP3004388 was granted), strengthening the broader transplant IP portfolio which also covers methods of absolute quantification of dd-cfDNA through dPCR in both the U.S. and EU (US10,570,443 / EP3201361). Oncocyte is currently validating the Therasure Transplant Monitor in its Nashville CLIA lab and is on track for a lab developed test (LDT) launch in the first half of 2022. The Company is also planning a clinical trial program to support an In Vitro Diagnostic Regulation submission to the U.S. Food and Drug Administration (FDA) in early 2023.

Ekkehard Schütz, M.D., Ph.D., FAACC, Managing Director of Oncocyte GmbH and Head of Blood Based Monitoring Program at Oncocyte, said, "As a biomarker, dd-cfDNA can enable cost-effective, precise surveillance of transplant recipients to decrease premature graft loss resulting in the need for re-transplantation. Quantitative dPCR assays, like Therasure, should be considered the gold standard to monitor this biomarker and give care teams the early information as fast as needed to adjust and optimize a patient’s treatment. On top of the test itself, our IP portfolio together with the newly granted patent also protects its highly precise absolute quantification, which outperforms the standard percentage values for dd-cfDNA. We are thrilled to expand into this market with a proven technology which we believe will enable improved patient care and cost efficiencies across the globe."

To date, over 20 clinical studies and numerous peer reviewed publications have validated the usefulness of dd-cfDNA tests as non-invasive biomarkers to assess rejection, cell death, and under-immunosuppression – all signs that a transplant is or is soon to be rejected. However, the technologies in use differ in effectiveness, accuracy, and speed of turnaround. Data published to date identifies dPCR as the fastest and least-expensive technique as compared to other methods that measure dd-cfDNA, such as next-generation sequencing. With widely published results in high impact medical journals such as PLOS Medicine, American Journal of Transplantation, Transplantation and Clinical Chemistry, Oncocyte’s now-patented Therasure test is the only test on the market of this kind clinically validated for liver transplants, and for kidney and heart transplantation in large clinical cohort studies.

On October 27, 2021 Sesen Bio, Inc.’s (the "Company") reported that it Phase 3 VISTA trial for Vicineum arising from a 2021 FDA inspection related to the review of the Company’s Biologics License Application ("BLA") for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") (Press release, Sesen Bio, OCT 27, 2021, View Source [SID1234592027]). Sesen Bio discontinued use of the clinical site and the study investigator over four years ago when the Company learned of professional misconduct by the study investigator that was unrelated to the Phase 3 VISTA trial.

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The FDA Warning Letter indicates that the study investigator did not comply with applicable statutory requirements and applicable regulations regarding conduct of clinical investigations. The study investigator operated a clinical site that was previously part of the VISTA trial, which was closed by the Company on May 26, 2017. The study investigator’s medical license was temporarily suspended on May 29, 2017 due to inaccurate recordkeeping, which was unassociated with Sesen Bio and the patients in the VISTA trial. The Company notified the FDA of the misconduct at that time.

When the clinical site was closed, five patients had completed treatment and were in post-treatment follow-up. There was no evidence found that patients were harmed by the study investigator’s actions. The Company included the corresponding patient data from the clinical site in its BLA submission to the FDA, which were thoroughly analyzed and discussed during the BLA review.

The Company did not receive any Warning Letters or Discipline Review Letters during the FDA’s review of the BLA for Vicineum from the Company’s initiation of the submission of its BLA under rolling review in December 2019 through the Company’s receipt of a Complete Response Letter from the FDA in August 2021. Sesen Bio looks forward to continuing to work collaboratively with regulators to determine the appropriate path forward for Vicineum.

On October 27, 2021 Aptevo Therapeutics Inc. ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that it will participate at the 2nd Virtual Congress on Controversies in Leukemias (EuroLeuk), an international leukemia symposium which is being held October 28-29, 2021, with a Poster Presentation (Press release, Aptevo Therapeutics, OCT 27, 2021, View Source [SID1234592053]). The poster abstract was selected as one of the best abstracts and included into the Congress program as an oral presentation as well. Euroleuk2021 will provide clinicians and biologists with state-of-the-art recommendations regarding patient care and insights into controversies and new therapeutic perspectives in the field (View Source).

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The Aptevo presentations will focus on the clinical safety, pharmacodynamics, and efficacy signals obtained so far during the ongoing multi-institutional Phase 1B clinical study of Aptevo’s lead leukemia drug candidate APVO436 in 46 adult patients with relapsed or refractory acute myelopid leukemia (AML) or myelodysplastic syndrome (MDS). Both the oral slide presentation and the poster presentation will be delivered by the lead author Dr. Fatih Uckun, the leukemia expert and Chief Clinical Advisor of Aptevo. The shared title of the talk and poster is: CD3xCD123 Bispecific Antibody APVO436 for Biotherapy of Relapsed/Refractory AML/MDS. Dr. Uckun’s co-authors are Dr. Justin Watts (University of Miami), Dr. Tara L. Lin (University of Kansas), Dr. Alice Mims (The Ohio State University), Dr. Prapti Patel (University of Texas Southwestern Medical Center), Dr. Paul Shami (University of Utah), Dr. Elisabeth Cull (Greenville Health System), Dr. Christopher R. Cogle (University of Florida), Dr. Cynthia Lee (Aptevo Therapeutics), and Dr. Eunice Wang (Roswell Park Comprehensive Cancer Center).

"We are very excited about the APVO436 data, demonstrating that our lead drug is generally well tolerated and showing preliminary signs of efficacy in the treatment of patients with relapsed or refractory AML and MDS who are in urgent need for new therapeutic options," said Marvin White, CEO of Aptevo. "Our work on APVO436 is on-going and we look forward to sharing new outcomes, as they become available."

About APVO436

Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo’s lead proprietary drug candidate, APVO436 is a bispecific CD3xCD123 ADAPTIR that is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger the destruction of leukemia cells. APVO436 has been engineered using Aptevo’s proprietary and enabling bioengineering methods and is designed to reduce the likelihood and severity of CRS. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.