On November 29, 2022 Eikonoklastes Therapeutics, a preclinical biotech company developing treatments for today’s most challenging diseases, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, reported a manufacturing partnership that will advance Eikonoklastes’ AAV-based gene therapy, ET-101, into clinical trials for the treatment of patients with amyotrophic lateral sclerosis (ALS) (Press release, Eikonoklastes Therapeutics, NOV 29, 2022, View Source [SID1234624562]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Forge will provide adeno-associated viral (AAV) process development and manufacturing services for ET-101. Eikonoklastes will utilize Forge’s platform process including its proprietary HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.

"Eikonoklastes is conducting promising research into treating patients with ALS, and we are honored to work together with them during this critical phase of development to help ET-101 enter clinical trials," said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics. "Our primary goal is to deliver the AAV resources, scale, technology, and expertise for our partners to help patients living with diseases like ALS with no known cure."

ALS is a rare neurological disease with significant socioeconomic impact, whose patients are desperate for novel, safe and effective therapies. ALS is the lead indication for Eikonoklastes’ ET-101, which has just received Orphan Drug Designation from the FDA—an important regulatory milestone reflecting the compelling data underlying the ET-101 program and its potential as a first-in-class treatment option for both familial and sporadic ALS.

"We are excited to advance ET-101, our novel treatment for neurodegenerative diseases, towards a first-in-human clinical trial in ALS patients. Partnering our AAV manufacturing with Forge will further our ability to advance into clinical trials," said Bruce Halpryn, Ph.D., Chair, CEO, and Co-Founder of Eikonoklastes Therapeutics. "With their end-to-end platform supporting AAV therapies, Forge is accelerating our development to reach patients suffering from ALS."

About Amyotrophic Lateral Sclerosis (ALS)

ALS, also known as Lou Gehrig’s Disease, is a rare, progressive, debilitating, and universally fatal neurodegenerative disease affecting the motor neurons connecting the brain and spinal cord. Degeneration of these neurons leads to paralysis as the brain loses its ability to control muscle movement. Most people with ALS succumb to respiratory failure, usually within three to five years from when symptoms first appear. An estimated 10 percent of ALS is familial and caused by genetic mutations that are inherited. The 90%+ of sporadic ALS may be due to a combination of environment and genetic risk factors. There is currently no cure for either familial or sporadic ALS.

On November 29, 2022 Novocure (NASDAQ: NVCR) reported that Health Canada has approved Optune for the treatment of newly diagnosed and recurrent glioblastoma (GBM) (Press release, NovoCure, NOV 29, 2022, View Source [SID1234624561]). GBM is the most common and one of the most aggressive forms of primary brain cancer . Optune is the first treatment for glioblastoma approved in Canada in over 12 years.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are proud to have reached this milestone as a company and are committed to making our therapy available to all the patients who may benefit throughout the world."

Optune is a medical device that works by creating Tumor Treating Fields (TTFields), which are electric fields that disrupt cancer cell division. Optune delivers TTFields therapy to the region of the tumor. Optune is small and light, weighing 2.7 pounds. This makes Optune wearable and portable, so continuous treatment can be received almost anywhere. Globally, more than 25,000 patients have been treated with Optune, to date.

"We’re very happy that Health Canada has approved Optune for the treatment of GBM," said Jovan Antunovic, Country Manager of Novocure Canada. "We are grateful for the rapid and diligent review of our submission and for Health Canada’s approval of Optune. This is an important achievement in order to bring our therapy to more patients throughout Canada who can benefit."

"It is well established that glioblastoma treatment is a high unmet medical need," said Dr. David Roberge, Professor of Radiology, Radiation Oncology & Nuclear at the CHUM Research Centre and Future President of the Canadian Association of Radiation Oncology. "Patients with GBM have very few effective therapeutic options. The approval of Optune can offer a real benefit to Canadian patients."

Each year in Canada, 1,600 people are diagnosed with GBM. Novocure’s phase 3 pivotal EF-14 trial compared Optune plus temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone (HR, 0.63; 95 percent Cl, 0.53-0.76; P<.001). Optune was safely used together with temozolomide with no significant increase in serious adverse events compared with temozolomide alone. The most common side effect related to Optune was mild to moderate skin irritation. Optune is commercially available as a treatment for GBM in multiple countries in North America, Europe and Asia.

"With Health Canada’s approval of Optune, the Brain Tumour Foundation of Canada (BTFC) is excited that another treatment option will soon be available for patients with GBM," said Shannon LaHay, CEO of BTFC. "There are many GBM patients and their caregivers looking forward to the availability of Optune in Canada."

The next critical milestone will be securing reimbursement. Novocure is actively working on this important step in order to ensure that patients have access to Optune for GBM across Canada.

"We are working to ensure that both public and private payers provide access and full reimbursement for Optune as soon as possible," said Pritesh Shah, Novocure’s Chief Commercial Officer. "We are proud to have reached this milestone as a company and are committed to making our therapy available to all the patients who may benefit throughout the world."

About Optune
Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

Tumor Treating Fields therapy uses electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On November 29, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases announces, announces its poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress, being held in Singapore from 2-4 December(Press release, Helsinn, NOV 29, 2022, View Source [SID1234624536]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Helsinn will be presenting a poster on the ongoing MyRisk international trial, assessing whether the administration of a combined treatment of NEPA (Fixed Combination of Netupitant/Palonosetron) and dexamethasone is more effective than the current standard of care prophylaxis1-2-3 (a combination of 5-HT3 receptor antagonist and dexamethasone) in preventing Chemotherapy-induced Nausea and Vomiting (CINV) in patients at increased risk of emesis receiving moderately emetogenic chemotherapy.

Full details of the poster presentation are below:

Title: Assessing the Benefit of NEPA (Fixed Combination of Netupitant/Palonosetron) for Preventing Chemotherapy-induced Nausea and Vomiting (CINV) in Patients at Increased Emetic Risk Receiving Moderately Emetogenic Chemotherapy
Author: Alex Molassiotis, Matti Aapro, Alessandro Alonzi, Marika Chrápavá, Karin Jordan Eric J. Roeland, Lee Schwartzberg, Carole Terrasanta, Silvia Olivari Tilola, George Dranitsaris
Session: Poster session, 03 December, 18:00 – 18:45
Abstract ID: NCT04817189
Dr Silvia Sebastiani, Helsinn Group Head of Medical Affairs, commented: "We are pleased to present the design of this important ongoing study at the ESMO (Free ESMO Whitepaper) Asia congress. Despite the array of effective antiemetics, CINV still represents a huge unmet need in clinical practice. To further the goal of CINV prevention for all patients undergoing emetogenic chemotherapy, it is important to explore ways to optimize antiemetic selection, including exploring factors that may increase CINV risk for patients."

Prof. Alex Molassiotis, Pro Vice Chancellor and Dean, University of Derby, UK and Scientific Lead of the MyRisk study added: "In patients receiving moderately emetogenic chemotherapy (MEC), antiemetic guidelines generally recommend a setron + dexamethasone (DEX). However, one guideline committee (the National Comprehensive Cancer Network ("NCCN")) recognized that this approach is inadequate prophylaxis for many patients and included an NK1 RA-containing option selectively for those with individual emetic risk factors2. MyRisk is the first study prospectively exploring the role of NK1 RA-containing regimen, Akynzeo in this case, in patients receiving MEC who have additional risk factors."

On November 29, 2022 BigHat Biosciences, Inc., a biotechnology company with a machine learning-guided antibody discovery and development platform, reported a collaboration with Merck, known as MSD outside of the United States and Canada, to apply the company’s technology to design candidates for up to three drug discovery programs (Press release, Merck & Co, NOV 29, 2022, View Source [SID1234624560]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BigHat’s design platform, Milliner, integrates a high-speed characterization with ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach could help reduce the difficulty of optimizing antibodies and other therapeutic proteins.

Under the collaboration, BigHat and Merck will collaborate to optimize up to three proteins by leveraging BigHat’s platform to synthesize, express, purify, and characterize molecules. Mark DePristo, co-founder and CEO of BigHat, continued, "We are thrilled to be collaborating with Merck’s world-class drug development teams to design safer, more effective antibodies for these important therapeutic programs."

The teams have initiated work on the first program and are looking forward to using the power of the complementary skills sets within each research team to generate high-quality lead antibodies. "We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients," said Elizabeth Schwarzbach, BigHat’s Chief Business Officer. "This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline."

"This agreement with BigHat expands Merck’s strategy of applying AI/ML across our drug discovery capabilities," said Juan Alvarez, vice president of Biologics Discovery, Merck Research Laboratories. "We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates."

On November 29, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended, for the previously announced license agreement of zanidatamab, a HER2-targeted bispecific antibody, with Jazz Pharmaceuticals has expired (Press release, Zymeworks, NOV 29, 2022, View Source [SID1234624559]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The expiration or termination of the HSR waiting period was a condition to Zymeworks’ receipt of a $50.0 million non-refundable upfront payment from Jazz as part of the agreement. Zymeworks anticipates providing Jazz top-line clinical data from Zymeworks’ HERIZON-BTC-01 study before the end of 2022. Should Jazz decide to continue the collaboration following the data readout, a second, one-time payment of $325.0 million to Zymeworks will be due and payable, which Zymeworks expects to receive before the end of 2022.