On June 15, 2022 Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, and French pharmaceutical group Pierre Fabre reported that the companies have entered into a manufacturing agreement (Press release, Lonza, JUN 15, 2022, View Source [SID1234616025]).

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This collaboration is aimed at manufacturing W0180, an innovative monoclonal antibody discovered by Pierre Fabre targeting the VISTA checkpoint, currently being investigated as a single agent and in combination with pembrolizumab in a Phase I clinical trial (NCT04564417) in various solid tumors.

Lonza will provide cGMP drug product (DP) manufacturing services for clinical supply from its fill and finish facility at Stein, Switzerland. Lonza’s ability to provide exemplary drug product development and manufacturing services offers customers innovative solutions and the possibility to supply high-quality products for clinical use.

Jean-Luc Lowinski, Pierre Fabre Medical Care CEO, said: "We are delighted to entrust the production of the W0180 Drug Product to Lonza. Its Drug Product Services are well-suited for our innovative therapy manufacturing needs. The W0180 will be manufactured in Lonza’s GS Xceed Expression CHO System, also successfully used for the IGF1R and cMet antibodies discovered by Pierre Fabre."

About W0180

W0180 is a first-in-class antibody targeting VISTA (V-domain Ig suppressor of T cell Activation). VISTA is a negative checkpoint regulator of T cell response. VISTA is expressed within the tumor microenvironment, where its inhibition can enhance antitumor immune responses. Furthermore, an increase in VISTA expression has been reported after treatment with anti-PD1/L1 and anti-CTLA4. This confirms that VISTA may play a key role as a mechanism of resistance to the currently used immunotherapies. W0180 given to patients as a single agent or in combination with anti-PD1/L1 therapy has a potential in multiple cancer indications, including those with myeloid immunosuppressive infiltrates where the VISTA pathway is expressed.

On June 15, 2022 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, reported thyat it has recently dosed the first patients in separate Phase 1 clinical trials evaluating the STAT3 degrader KT-333 and the IRAKIMiD degrader KT-413 (Press release, Kymera Therapeutics, JUN 15, 2022, View Source [SID1234616024]). The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T cell lymphomas and leukemia, and the KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma (DLBCL).

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"These programs demonstrate the potential for targeted protein degradation to target critical nodes that traditional modalities can’t effectively address, offering a precision medicine approach to challenging cancers," said Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera Therapeutics. "The initiation of dosing in these studies represents important progress for Kymera toward understanding the pharmacology and safety of these first-in-class investigational medicines, and we look forward to sharing initial dose escalation clinical data later this year."

About the KT-333 Clinical Program

A target long considered "undruggable," STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. KT-333 is a potent and selective heterobifunctional small molecule protein degrader of the STAT3 protein in development for oncology indications.

The Phase 1 trial will evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 in adult patients with relapsed and/or refractory lymphomas and solid tumors. The first stage of the study will explore escalating doses of KT-333. The second stage will consist of four expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-333 in relapsed and/or refractory peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L), and solid tumors.

KT-333 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of PTCL. This designation provides incentives to encourage the development of medicines for rare diseases.

About the KT-413 Clinical Program

KT-413 is a potent and selective heterobifunctional small molecule protein degrader being developed for MYD88-mutant B cell lymphomas that has the potential to be the first precision medicine for these cancers. KT-413 degrades interleukin-1 receptor associated kinase 4 (IRAK4) and the immunomodulatory imide drug (IMiD) substrates Ikaros and Aiolos. It is being developed initially for the treatment of relapsed/refractory MYD88-mutant DLBCL, with the potential to expand into other MYD88-mutant indications.

The Phase 1 trial will evaluate the safety, tolerability, and PK/PD of KT-413 in patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphomas. The first stage will explore escalating doses of single-agent KT-413. The second stage will consist of two expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-413 in relapsed/refractory MYD88-mutant and MYD88 wild-type DLBCL.

On June 15, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega") reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC) (Press release, Omega Therapeutics, JUN 15, 2022, View Source [SID1234616023]). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

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"This is an important milestone for our Company, an IND achieved in approximately 26 months since we started working on the early constructs in discovery which culminated in OTX-2002. We are excited that this represents the first of many anticipated IND applications and the transition of the company to its next stage," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This also marks a milestone regulatory submission for the first epigenomic controller, a new class of programmable mRNA therapeutics enabled by our OMEGA platform. We believe our approach to engineering epigenomic controllers has immense potential across a broad range of diseases, including HCC, which carries a 5-year survival rate of only 10%. We look forward to advancing OTX-2002 into the clinic and bringing it one step closer to patients in need."

The Company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance.

About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is a mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application has been submitted to the FDA.

On June 15, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology reported that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT886, its anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction (GEJ) and pancreatic cancers (Press release, Phanes Therapeutics, JUN 15, 2022, View Source;an-anti-claudin18-2anti-cd47-bispecific-antibody-being-developed-for-patients-with-gastric-gastroesophageal-junction-and-pancreatic-cancers-301568015.html [SID1234616022]).

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"The clearance of our second IND this year is an important milestone for Phanes and the opportunity to bring this potential first-in-class bispecific antibody to cancer patients who have such a high unmet medical need is what drives us every day," said Dr. Ming Wang, Founder and CEO. "We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file one additional IND with PT217, an anti-DLL3/anti-CD47 bispecific antibody for the potential treatment of small cell lung cancer and other neuroendocrine cancers. This continues to be a transformational year for Phanes as we now progress two programs into the clinic".

PT886 is a native IgG-like bispecific antibody assembled with Phanes’ proprietary PACbody and SPECpair platforms. Its advancement into clinical stage further validates Phanes’ bispecific antibody technology platforms.

Gastric, gastroesophageal junction (GEJ) and pancreatic cancers are considered as some of the most incurable cancers worldwide. In patients with advanced or metastatic gastric or GEJ adenocarcinoma, the median overall survival is no more than 10 months and that for pancreatic cancers is equally dismal with a median overall survival of 6-11 months. The multi-center, Phase I clinical trial of PT886 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT886 in adult patients with metastatic gastric adenocarcinoma, GEJ adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC) that have progressed after available standard therapy or for which standard therapy has proven to be ineffective, intolerable or is considered inappropriate.

On June 15, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing as an alternative to surgical tumor removal, reported ProSense was featured in a categorical course titled "Cryoablation for the Treatment of Breast Cancer: Breast Interventions for the Interventionalist" on Tuesday, June 14, 2022 at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in Boston ("SIR 2022 Conference") (Press release, IceCure Medical, JUN 15, 2022, View Source [SID1234616021]).

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ProSense was well received by physicians, potential U.S.-based customers including medical clinics and hospitals, and international distributors interested in partnerships. The categorical course, which provided information and training on image guided breast cancer cryoablation, came on the same day that IceCure announced its cryoablation system will be distributed in mainland China by Shanghai Medtronic Zhikang Medical Devices Co. Ltd. ("Shanghai Medtronic"), an affiliate of Medtronic plc (NYSE: MDT), and Beijing Turing Medical Technology Co. Ltd. ("Turing"), with the first systems expected to be delivered in 2022.

The categorical course was presented at SIR 2022 Conference by a panel of experts in radiology and breast cancer, including:

Dr. Kenneth Tomkovich, Diagnostic and Interventional Radiologist at Princeton Radiology, Director of Breast Imaging and Interventions at CentraState Medical Center, and Co-lead Investigator of IceCure’s landmark ICE3 study of ProSense in the treatment of small, low-risk, early-stage malignant breast tumors;
Professor Eisume Fukuma, Director of Breast Cancer at Kameda Medical Center, Japan, a pioneer in the study of breast cancer cryoablation, and ProSense user;
Dr. Alexander Sevrukov, Assistant Professor, Director, Women’s Diagnostic Center at Methodist Hospital, a participant in the ICE3 trial, and ProSense user;
Dr. Monica L. Huang, Associate Professor, Department of Breast Imaging, Division of Diagnostic Imaging at the University of Texas MD Anderson Cancer Center;
Dr. Jason Shames, MD, MBS, Assistant Professor of Radiology, Associate Director of Research, Division of Breast Imaging, Co-Director, Breast Imaging Fellowship at Thomas Jefferson University; and
Dr. Gao-Jun Teng, Professor of Radiology at the Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, and former President of the Chinese Society of Interventional Radiology
Dr. Tomkovich commented, "The inclusion of a categorical course on breast cancer cryoablation at the SIR 2022 Conference represents a major shift in the way the interventional and breast radiologist can approach the treatment of small, low-risk, breast cancers and highlights the interest of the professional community about how they can offer such treatments to their patients. The promising interim ICE3 clinical data continues to show that cryoablation for certain types of breast cancers is safe, effective, and is the future of breast cancer care."

IceCure CEO, Eyal Shamir, added, "On the heels of the announcement of our distribution agreement with Shanghai Medtronic and Turing, this is an ideal time for ProSense to be featured at the SIR 2022 Conference as we work toward regulatory approval in early-stage breast cancer following the filing of our pre-submission package to the U.S. Food and Drug Administration in November 2021. We extend our gratitude to the panel of experts who presented ProSense in the categorial course. Several of the doctors have been using ProSense and their perspective is invaluable for IceCure’s potential customers and partners."