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ZAP Surgical to Bring Next-Gen Non-Invasive Brain Tumor Treatment to the American Hospital of Paris Group

On October 27, 2021 ZAP Surgical Systems, Inc. reported an agreement to bring its advanced ZAP-X Gyroscopic Radiosurgery platform to the Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC) in Boulogne, France (Press release, ZAP Surgical Systems, OCT 27, 2021, View Source [SID1234592055]). As part of the renown American Hospital of Paris, CCPSC will be the first in France to offer the latest advance in radiosurgical brain tumor treatments. First patient treatments with ZAP-X at CCPSC are estimated to begin the Fall of 2022.

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Stereotactic radiosurgery (SRS) is a well-established procedure for the non-invasive treatment of many primary and metastatic brain tumors, as well cranial functional and vascular disorders including trigeminal neuralgia and arteriovenous malformations. Often considered an alternative to costly and invasive surgical procedures, SRS is a non-invasive outpatient procedure that often provides superior outcomes, yet requires no surgical incision, and little to no patient recovery period.

"A significant percentage of cancer patients develop brain metastases during the course of their disease," said Eric Duret, General Manager of CCSPC. "As this population continues to grow with improving cancer survival, having the most advanced radiosurgery option available to our patients was imperative."

The ZAP-X system uses unique gyroscopic mobility to direct radiosurgical beams from hundreds of angles to precisely concentrate radiation on the tumor target. This pioneering approach supports the clinical objective of protecting healthy brain tissue and patient cognitive function, and when needed, enable future potential SRS re-treatments without the unnecessary risks associated with other radiation delivery techniques.

ZAP-X is additionally recognized for being the first and only vault-free and cobalt-free dedicated SRS delivery system, thereby eliminating the costs to build expensive shielded radiation treatment rooms, and removing the need to maintain, secure and regularly replace live radioactive isotopes.

For more about the ZAP-X Gyroscopic Radiosurgery platform, please visit: View Source Detailed system overview animations can be found at View Source

Sarepta Therapeutics to Announce Third Quarter 2021 Financial Results and Recent Corporate Developments on November 3, 2021

On October 27, 2021 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that it will report third quarter 2021 financial results after the Nasdaq Global Market closes on Wednesday, November 3, 2021 (Press release, Sarepta Therapeutics, OCT 27, 2021, View Source [SID1234592054]). Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2021 financial results and to provide a corporate update.

The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 7131019. Please specify to the operator that you would like to join the "Sarepta Third Quarter 2021 Earnings Call." The conference call will be webcast live under the investor relations section of Sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

Aptevo Therapeutics Presents Promising Clinical Data on Its Lead Leukemia Drug Candidate APVO436 at The Second Virtual Conference on Controversies in Leukemias, Euroleuk2021

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).

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.

Kezar Announces First Patient Dosed in Phase 1 Trial of KZR-261 in Advanced Solid Tumor Malignancies

On October 27, 2021 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that the first patient has been dosed in KZR-261-101, a Phase 1 clinical trial evaluating KZR-261, a novel, broad-spectrum, anti-tumor agent that acts through direct interaction and inhibition of the Sec61 translocon (Press release, Kezar Life Sciences, OCT 27, 2021, View Source [SID1234592052]).

"Dosing the first patient with KZR-261, the first clinical candidate from our novel protein secretion platform, is an exciting milestone for Kezar as we continue to advance our oncology program and mature into a multi-asset therapeutics company," said John Fowler, Co-Founder and Chief Executive Officer of Kezar Life Sciences. "We believe KZR-261 has a differentiated therapeutic profile which could translate into broad potential across the oncology landscape."

KZR-261-101 is a first-in-human, open-label, multicenter, Phase 1 study of KZR-261 in patients with solid tumor malignancies. The study is being conducted in two parts, dose escalation and dose expansion, and is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, as well as to explore the preliminary anti-tumor activity of KZR-261 in subjects with locally advanced or metastatic disease for whom no therapeutics are currently available. Following safety review of all dose escalation cohorts and determination of the maximum tolerated dose or maximum administered dose, KZR-261 will be evaluated for safety and preliminary efficacy in four tumor-specific cohorts and one all-tumor cohort to determine doses recommended for Phase 2 studies.

Additional information about the KZR-261-101 trial is available via Clinicaltrials.gov (NCT 05047536).

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting the protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent, and a Phase 1 trial is underway for the treatment of solid tumor malignancies.

About Inhibition of Protein Secretion

In mammalian cells, the secretion of proteins such as cytokines and growth factors and the expression of cell surface transmembrane proteins such as receptor tyrosine kinases and immune checkpoint molecules involve a process called cotranslational translocation. For most proteins, this process occurs via the Sec61 translocon, a highly conserved multi-subunit protein complex found in the membrane of the endoplasmic reticulum of all cells. Kezar scientists have been researching the protein secretion pathway and ways to drug this important cellular pathway for more than five years and developed novel and robust assays to discover and develop small molecule inhibitors of Sec61. As a result, Kezar has established a broad library of protein secretion inhibitors for potential development across a wide range of diseases.

Perrigo To Release Third Quarter 2021 Financial Results On November 10, 2021

On October 27, 2021 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its third quarter 2021 financial results on Wednesday, November 10, 2021 (Press release, Perrigo Company, OCT 27, 2021, View Source,-2021 [SID1234592051]). The Company will also host a conference call beginning at 8:30 A.M. (EST).

The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 6950324. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Wednesday, November 10, until midnight Wednesday, November 17, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10161334.