On June 15, 2022 Gnubiotics Sciences, a biotech company pioneering immunomodulatory glycopeptides, reported an agreement with the University of Pennsylvania to explore combining CAR-T therapy with Gnubiotics’ GLAAD technology to enhance efficacy in solid tumors through company-sponsored pre-clinical research studies in the laboratory of Avery Posey, PhD, an assistant professor of Systems Pharmacology and Translational Therapeutics at the Perelman School of Medicine at Penn (Press release, Gnubiotics Sciences, JUN 15, 2022, View Source [SID1234616041]). Gnubiotics presented compelling data recently at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting showing the effect of its glycopeptides platform in driving directed and robust T-cell immune responses against PD-1 resistant solid tumors in a colorectal cancer mouse model.

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While CAR-T has been effective in treating certain blood cancers, numerous studies have shown that many solid tumors do not respond well to CAR-T therapy. "We are excited about the promise of combining CAR-T with glycopeptide strategies like our GLAAD platform which will hopefully lead to the application of new modalities for patients left with few alternative treatments," stated Yemi Adesokan, Ph.D., Gnubiotics’s Chief Executive Officer.

About GLAAD

Glycopeptides are the foundation of Gnubiotics’ GLAAD molecules. GLAAD relies on glycopeptides as providers of antigenicity and adjuvanticity to the immune system. Gnubiotics’ GLAAD candidates are made of a range of glycans uniquely bound to peptides and can act directly on immune cells and modulate the microbiome. Combined, these modes of action influence the immune system responses which opens new ways to address areas where the immune system plays a role, including oncology, inflammatory and infectious diseases.

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.