On January 25, 2022 48Hour Discovery and Fusion Pharmaceuticals to Develop Radiopharmaceuticals for the Treatment of Cancer Tumours (Press release, 48Hour Discovery, JAN 25, 2022, View Source [SID1234606763]).

48Hour Discovery Inc. (48HD), a biopharmaceutical company specializing in peptide-derived drug discovery reported that the company has entered into a strategic research collaboration with Fusion Pharmaceuticals. This is 48HD’s first collaboration with a Canadian company. The goal of the collaboration is to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumours.

"We are excited to work with a dynamic oncology company like Fusion Pharmaceuticals" said Ratmir Derda, CEO of 48Hour Discovery "In this collaboration, 48Hour Discovery will identify potent ligands for targets selected by Fusion. This project will further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline to accelerate the advance of peptide drug candidates in the radiopharmaceutical field."

"Fusion’s versatile platform, supported by our internal research capabilities, allows us to create targeted alpha therapies (TATs) using different classes of targeting molecules, tailoring the approach based upon the disease target," said Fusion Chief Executive Officer John Valliant, Ph.D. "With our antibody, bispecific, and small molecule programs in the clinic or progressing through investigational new drug-enabling studies, we are excited to announce our work with peptides. Partnering with a global leader like 48Hour Discovery in peptide discovery further diversifies our capabilities and assets needed to create differentiated TATs in multiple areas of high unmet medical need."

On January 25, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported an exclusive supply and technology agreement with Corning Incorporated (NYSE: GLW) (Press release, West Pharmaceutical Services, JAN 25, 2022, View Source [SID1234606779]). The new collaboration includes a multimillion-dollar investment to expand Corning’s Valor Glass technology to enable advanced injectable drug packaging and delivery systems for the pharmaceutical industry with the goal of advancing patient safety and expanding access to life-saving treatments.

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By combining West’s industry-leading NovaPure components, with Daikyo Flurotec coating technology, and Corning’s Valor Glass and Velocity Vials, the strategic collaboration will enable new, advanced pharmaceutical packaging solutions. The collaboration optimizes the materials science and manufacturing expertise of both companies to help bio-pharma producers navigate the complex regulatory environment and mitigate risk in bringing drugs to market.

"West and Corning have developed this exceptional collaboration to offer leading elastomer-glass system solutions for the containment and delivery of injectable medicines," said Eric M. Green, President and Chief Executive Officer, West. "At West, we value the state-of-the-art products offered by Corning and are excited to build together the next generation of integrated packaging and delivery innovations."

This portfolio of new elastomer-glass system offerings and supportive data services will utilize West’s NovaPure components along with Corning’s Valor Glass technology. West’s NovaPure components adhere to Quality by Design principles and processing, representing the highest standards in pharmaceutical components. For customers, it provides the assurance of components with the tightest specifications applicable within today’s formulation and manufacturing process capabilities at West. Corning’s Valor Glass is intended to enhance the storage and delivery of drugs, providing more reliable access to state-of-the-art medicines essential to public health. Valor Glass packaging can enable increased throughput and offers high chemical durability, strength, and damage resistance.

"This partnership and investment enable the development and industry-leading solutions that enhance patient safety, increase quality and reliability in highly regulated markets, and ensure greater capacity for life-saving drugs. West is a great partner. The combination of Corning’s Valor Glass, along with West’s NovaPure components, is a win-win for customers and patients all over the world," said Wendell P. Weeks, Chairman and Chief Executive Officer, Corning.

On January 25, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it has scheduled its fourth quarter and year-end 2021 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) on Friday, February 11, 2022 (Press release, Neurocrine Biosciences, JAN 25, 2022, View Source [SID1234606796]).

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The schedule for the press release and conference call / webcast is as follows:

Q4 & Year-End 2021 Press Release:
February 11, 2022 at 4:30 a.m. PT / 7:30 a.m. ET

Q4 & Year-End 2021 Conference Call:
February 11, 2022 at 5:00 a.m. PT / 8:00 a.m. ET

Domestic Dial-In Number:
800-895-3361

International Dial-In Number:
785-424-1062

Conference ID:
NBIX

The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On January 25, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Japanese Patent Office has issued a Decision to Grant of a patent to Cleveland Clinic titled, "Ovarian Cancer Vaccines (Press release, Anixa Biosciences, JAN 25, 2022, View Source [SID1234606764])." The technology was invented by Drs. Vincent K. Tuohy, Suparna Mazumder and Justin M. Johnson at Cleveland Clinic. Anixa is the worldwide licensee for the vaccine technology. Patents for the technology were issued in the U.S. and Europe in 2021.

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"We’re pleased to announce this additional intellectual property protection of Anixa’s novel ovarian cancer vaccine, which was developed at Cleveland Clinic and is being studied at NCI. This unique technology has the potential to be the first vaccine to prevent ovarian cancer, which remains one of the most devastating and difficult-to-treat cancers," said Dr. Amit Kumar, CEO, President and Chairman of Anixa Biosciences. "If successful, this vaccine could prevent ovarian cancer from ever occurring and spare patients from undergoing chemotherapy and extensive surgical treatments, and potentially save lives. We look forward to continuing our preclinical work in the hope that this vaccine will add to the arsenal needed to target this challenging cancer and ultimately make a difference for many patients."

The ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. Of note, the majority of ovarian cancer diagnoses occur after menopause, and AMHR2-ED is expressed again in the majority of ovarian cancers. By receiving a vaccine such as Anixa’s that targets AMHR2-ED after reaching menopause, ovarian cancer, historically one of the most aggressive gynecological cancers, could be prevented from ever developing.

Preclinical work to advance the vaccine is ongoing through the PREVENT Program at the National Cancer Institute (NCI), which supports preclinical innovative interventions and biomarkers for cancer prevention and interception. Preclinical data published in Cancer Prevention Research in 2017 supports ongoing advancement toward clinical studies.

On January 25, 2022 MiNA Therapeutics Limited ("MiNA" or the "Company"), the pioneer in small activating RNA (RNAa) therapeutics, reported that it has dosed the first patient in a global Phase 2 clinical trial (OUTREACH-2) of MTL-CEBPA in combination with second line standard of care sorafenib (a tyrosine kinase inhibitor (TKI)) in advanced hepatocellular carcinoma (HCC or liver cancer) (Press release, MiNA Therapeutics, JAN 25, 2022, View Source [SID1234606780]).

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OUTREACH-2 is a multi-centre, open-label, randomised study of MTL-CEBPA in combination with sorafenib, compared to sorafenib alone, in TKI-naïve advanced pre-treated HCC patients with viral hepatitis etiology. The study will recruit up to 150 patients globally from centres in the US, Europe, and Asia. OUTREACH-2 is designed to assess further to what extent the MTL-CEBPA and sorafenib combination offers therapeutic advantage compared to sorafenib alone for the treatment of advanced HCC. The study’s primary endpoint is progression-free survival by blinded radiological assessment and the study is expected to complete in the first quarter of 2024. If the data from this Phase 2 OUTREACH-2 study are satisfactory to the US Food and Drug Administration (FDA), this could enable an Accelerated Approval of MTL-CEBPA in combination with sorafenib soon thereafter.

Professor Tim Meyer, Professor of Experimental Cancer Medicine at University College London, and Chief Investigator of the study, commented:
"Advanced liver cancer remains a significant unmet medical need, in particular for those patients who are resistant to front line systematic therapy. This combination treatment demonstrated intriguing signals of activity in a Phase 1b trial, including durable and complete tumour responses. We believe that MTL-CEBPA’s immunological activity in the tumour microenvironment enables a greater effectiveness of sorafenib and we are excited to seek to validate those early findings in this Phase 2 clinical trial."

Robert Habib, CEO of MiNA Therapeutics, commented:
"We are very excited to dose our first patient in the OUTREACH-2 study, which is the first Phase 2 clinical trial of a RNAa therapeutic. MTL-CEBPA has demonstrated its potential to make tumours more susceptible to established anti-cancer therapies, which can significantly improve treatment outcomes for patients. We look forward to building on data from our successful Phase 1b study of the sorafenib combination and to developing MTL-CEBPA more broadly for the benefit of patients."

The study builds on the successful proof-of-concept data from MiNA’s first-in-human, Phase 1b clinical trial (OUTREACH) evaluating the safety and tolerability of the therapeutic combination in patients with advanced HCC. The clinical activity observed in OUTREACH, which included durable and complete tumour responses not common with sorafenib alone, suggested that MTL-CEBPA may increase the effectiveness of sorafenib as a second line standard of care for HCC. The OUTREACH study showed that MTL-CEBPA plus sorafenib achieved a complete response rate (CRR) of 13% and an overall response rate (ORR) of 27% in the target population. By comparison sorafenib alone achieved a CRR of <1% and an ORR of 5-11% in recent published studies. The trial protocol has been accepted in an investigational new drug (IND) application by the FDA. The FDA has also granted Orphan Drug Designation for MTL-CEBPA in combination with sorafenib for the treatment of HCC of viral hepatitis etiology who have progressed following prior therapy. As a monotherapy, MTL-CEBPA achieved a CRR of 2% and an ORR of 6%, despite not being intended to target the tumours directly.

As the first ever RNAa therapy to enter the clinic, MTL-CEBPA is being studied as a combination therapy in cancer. The mechanism of action of MTL-CEBPA is to reduce or remove one of the main defence mechanisms by which tumours can resist the immune system, thereby opening the tumour to attack by the immune system and tumour-targeting drugs. In combination, data suggests that the drug can significantly improve the effectiveness of established cancer treatments by altering the tumour microenvironment in favour of those treatments. It achieves this by using the RNA activation mechanism to boost and restore expression of the C/EBP-α protein to normal levels which, in turn, reduces immune suppression by myeloid cells in which this protein has been down-regulated by the tumour. The drug candidate is also being investigated in an investigator-sponsored Phase 1a/1b study in first-line HCC in combination with first-line standard of care combination atezolizumab and bevacizumab in collaboration with F Hoffman-La Roche Ltd, as well as in an ongoing multi-centre Phase 1b clinical trial in patients with a variety of advanced solid tumours in combination with pembrolizumab, a PD-L1 inhibitor.

About MTL-CEBPA
MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and in solid tumour cancers these cells have been identified as a critical barrier to induction of clinical response for many therapies. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing or eliminating their suppressive effect on immune response and therapies in the tumour micro-environment. MTL-CEBPA is currently in clinical development in three different studies as a combination therapy for the treatment of both first- and second-line advanced liver cancer and for a variety of other advanced solid tumour malignancies.