GlycoNex Announces Manufacturing Agreement with Sterling for GNX102-ADC Clinical Trial Production

On November 12, 2024 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported a manufacturing agreement with Sterling Pharma Solutions, a UK-based CDMO with a specialist Antibody-Drug Conjugate (ADC) division, for clinical trial production of GNX102-ADC in preparation for a planned Phase 1 clinical program investigating the drug technology (Press release, GlycoNex, NOV 12, 2024, View Source [SID1234648227]).

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GNX102-ADC combines GlycoNex’s proprietary monoclonal antibody (mAb), GNX102, and cytotoxic drug therapies to elicit cellular cytotoxicity to target cancer cells with high specificity. GNX102 is a humanized mAb designed to target novel tumor-associated glycans to inhibit tumor growth. GNX102 successfully completed Phase 1 clinical trials with data demonstrating strong safety and tolerability.

"Our GNX102 monoclonal antibody demonstrated superior safety in Phase 1 clinical trials making it an ideal candidate to develop as an ADC," said Dr. Mei-Chun Yang, CEO of GlycoNex. "We are excited to benefit from Sterling’s ADC manufacturing expertise in the production of GNX102-ADC as we seek to investigate the technology’s ability to bind antibodies to cancer cell antigens, initiating apoptotic cell death while directly delivering cytotoxic drugs to the tumor."

Commenting on the partnership, Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions added, "As a company, Sterling continues to invest in capabilities to support ADC innovator companies, in what is a strong and growing area of research. This agreement will leverage the expertise we have in clinical-scale GMP manufacturing at our site in Deeside, UK, and we look forward to building a partnership with GlycoNex to support its ongoing drug development."

Data from the preclinical trials of GNX102-ADC demonstrated safety comparable to approved ADCs with the potential to treat a range of solid tumors, including gastric cancer, colorectal, pancreatic, and lung cancers. In addition, GNX102-ADC has shown strong tumor-suppressing potential in preclinical animal studies. GlycoNex retains full development rights for GNX102-ADC, with patents secured in key global markets, including the U.S., Japan, South Korea, Taiwan, and Russia.

The global ADC market size was valued at USD 11.65 billion in 2023 and is anticipated to reach approximately USD 28.61 billion by 2033, growing at a CAGR of 9.4% from 2024 to 2033.i GlycoNex is well positioned to capitalize on this opportunity with its comprehensive in-house capabilities for end-to-end antibody drug development. GlycoNex’s advanced capabilities supports the full drug development cycle, from monoclonal antibody discovery and preclinical studies to manufacturing and clinical development, ensuring a seamless and efficient transition from laboratory research to clinical trials.

Bexion Pharmaceuticals, Inc. to Participate in the Jefferies London Healthcare Conference

On November 12, 2024 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will participate in the Jefferies London Healthcare Conference (Press release, Bexion, NOV 12, 2024, View Source [SID1234648226]). The conference will be held in London, UK, from November 19-21, 2024.

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Jim Beach, CEO and President of Bexion Pharmaceuticals, and Joyce LaViscount, Chief Financial Officer of Bexion Pharmaceuticals, will attend the conference.

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.

Flare Therapeutics Announces Strategic Discovery Collaboration with Roche to Address Previously Undrugged Transcription Factor Targets in Oncology

On November 12, 2024 Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, reported it has entered into a strategic discovery collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY) (Press release, Flare Therapeutics, NOV 12, 2024, View Source [SID1234648225]). This partnership will leverage Flare Therapeutics’ proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecule drugs aimed at previously undrugged transcription factor targets in oncology.

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"Roche is an ideal partner for Flare Therapeutics because we share a commitment to tackling the most challenging disease areas with novel approaches and overcoming the difficulties of drugging transcription factors. Our platform and expertise have rapidly generated a clinical-stage pipeline, demonstrating the strong potential of our approach. This collaboration will accelerate the expansion of our capabilities, enabling us to develop treatments for transcription factors implicated in indications with high unmet needs. Together with Roche’s expertise, our objective is to successfully pursue challenging transcription factor targets, with the ultimate goal of providing novel interventions for patients who are not currently served by standard-of-care therapies," said Rob Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare Therapeutics.

"We are excited to join forces with Flare Therapeutics, combining our leading expertise and global reach in oncology with Flare Therapeutics’ deep knowledge in drug discovery for difficult-to-drug transcription factor targets. Transcription factors play a crucial role in various oncological diseases and have the potential to address high unmet medical needs. We are looking forward to developing therapeutic options never possible before," said Boris L. Zaïtra, Head of Roche Corporate Business Development.

As part of the collaboration, Flare Therapeutics will receive a US$70 million upfront cash payment and is eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$1.8 billion and royalties. Flare Therapeutics will lead discovery and preclinical activities targeting multiple transcription factor targets in oncology, while Roche will pursue the further preclinical and clinical development and commercialization of potential products from the collaboration, leveraging its industry-leading capabilities in oncology.

Additionally, Flare Therapeutics retains a right to co-fund development for one target under the collaboration in exchange for increased royalties in the United States for this target. Flare Therapeutics will retain ownership of its existing pipeline, including its lead clinical-stage program, FX-909, in advanced urothelial cancer, its prostate cancer program entering IND-enabling studies, and other programs in discovery and early development in oncology and other therapeutic areas.

Servier to Present Data on IDH-mutant Glioma at the 2024 Society for Neuro-Oncology (SNO) Congress

On November 12, 2024 Servier reported that it will present data at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO), November 21-24, 2024, in Houston, Texas (Press release, Servier, NOV 12, 2024, View Source [SID1234648224]). Data presentations will focus on the company’s neuro-oncology development program, including three oral-presentations, and reinforce our understanding of the burdens and experiences of people living with IDH-mutant glioma.

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"At Servier, we are dedicated to delivering transformative, life-changing therapies to patients living with cancer who have little-to-no options available," said Claude Bertrand, Executive Vice President Research and Development, Chief Scientific Officer, at Servier. "Our presentations at this year’s Society for Neuro-Oncology Conference reinforce our commitment to people living with IDH-mutant gliomas, who had, until recently, limited therapeutic options to treat this devastating disease. We look forward to sharing results with the community, including updated Phase 3 data that supports our recently approved medication for Grade 2 IDH-mutant gliomas."

A full list of company-sponsored abstracts can be found here.

About Glioma1

Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:

Astrocytoma, IDH-mutant (CNS WHO grades 2-4)

Oligodendroglioma, IDH-mutant and 1p19q-codeleted (CNS WHO grades 2-3)

Glioblastoma, IDH-wildtype (CNS WHO grade 4)

Koselugo showed statistically significant and clinically meaningful objective response rate vs. placebo in adults with neurofibromatosis type 1 in global KOMET Phase III trial

On November 12, 2024 Astrazeneca reported positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), showed that Koselugo (selumetinib), an oral, selective MEK inhibitor, met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR) versus placebo in these adult patients (Press release, AstraZeneca, NOV 12, 2024, View Source [SID1234648223]).

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NF1 is a rare, progressive genetic condition affecting an estimated 1.7 million individuals worldwide, approximately 70% of whom are adults.1,2 In 30-50% of patients, tumours develop on the nerve sheaths and may cause debilitating symptoms.3-8 NF1 is usually diagnosed in early childhood, however, NF1 often progresses into adulthood.9,10 There are no approved treatments for adults, leaving many to experience disfigurement, dysfunction, persistent pain or endure multiple surgeries.11

Prof. Ignacio Blanco Guillermo, MD, PhD, Chairman of the Genetic Counselling and Clinical Genetics Programme at the Germans Trias i Pujol University Hospital, Chairman of the Spanish National Reference Centre for Adult Patients with Neurofibromatosis and Principal Investigator of the KOMET trial, said: "With limited options to manage NF1 PN in adults, many patients experience functional impairment and symptoms, which can substantially impact their lives. These clinically meaningful data show Koselugo has the potential to make a positive impact in patient care by reducing the size of plexiform neurofibromas."

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: "These promising results demonstrate that Koselugo, the first and only approved targeted therapy for certain children with NF1 PN, now has the potential to benefit adult patients for whom there are no approved targeted therapies. As the largest and only global placebo-controlled Phase III trial in adults with NF1 PN, KOMET reinforces our leadership in advancing potential treatment options for people living with this debilitating disease. We look forward to sharing these findings with regulatory authorities."

Scot Ebbinghaus, MD, Vice President, Global Clinical Development, MSD Research Laboratories, said: "Adults with NF1 are in critical need of treatment options to help manage symptomatic, inoperable plexiform neurofibromas. These positive results from the Phase III KOMET trial demonstrate the potential to expand the use of Koselugo beyond paediatric patients to also treat adult patients living with this rare and challenging genetic condition."

In the trial, ORR was defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume) by cycle 16 (28 days per cycle) as determined by independent central review (ICR) per response evaluation in neurofibromatosis and schwannomatosis (REiNS) criteria.

The safety profile of Koselugo in this study was consistent with that observed in clinical trials among children and adolescents. No new safety signals were identified.

Alexion, AstraZeneca Rare Disease will share these data with regulatory authorities and present at a forthcoming medical meeting. AstraZeneca and MSD are jointly developing and commercialising Koselugo globally.

Notes

NF1
NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene.3,11 NF1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in 30-50% of patients, tumours develop on the nerve sheaths (PNs).4,11 These PNs can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.4-8 PNs begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years.5,8,11,12

KOMET
KOMET is a global Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of Koselugo in adults with NF1 who have symptomatic, inoperable PNs. The trial enrolled 145 adults from 13 countries across North America, South America, Europe, Asia and Australia, with participants’ baseline characteristics, including gender and distribution of PNs, reflective of the global adult NF1 patient population. Patients were enrolled and randomised to receive Koselugo or placebo (1:1) for 12 28-day cycles. Participants were required to have diagnosis of NF1, at least one symptomatic, inoperable PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrolment.13

The primary endpoint is confirmed ORR by cycle 16 as assessed by ICR. ORR is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume).13

After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive Koselugo.13

Koselugo
Koselugo (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumour cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, Koselugo slows down the growth of tumour cells and, therefore, the PN growth.

Koselugo is approved in the US, EU, Japan, China and other countries and has been granted Orphan Drug Designation in the US, EU, Japan and other countries for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN.