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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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

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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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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

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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.

On January 25, 2022 Sigyn Therapeutics, Inc. (OTC Markets:"SIGY"), a medical technology company focused on the treatment of pathogen-related conditions that precipitate sepsis, reported that its Chairman and CEO, Jim Joyce, will give a corporate presentation at the upcoming Bullseye Small Cap Virtual Investor Conference to be held on January 27th and 28th, 2022 (Press release, Sigyn Therapeutics, JAN 25, 2022, View Source [SID1234607420]).

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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

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Mr. Joyce’s presentation is scheduled to begin at 3:30 pm eastern on January 27th, 2022. To virtually attend, register at:

View Source

Sigyn management will also be available for online 1×1 meetings with the members of the investment community. To schedule a meeting please visit: View Source or email [email protected].

Mr. Joyce’s presentation will include an update on Sigyn Therapy, a multi-function blood purification technology being advanced to treat a broad-spectrum of pathogen related conditions that precipitate sepsis.

Additional information on Sigyn Therapy, including recent media coverage, can be accessed through the links below:

January 11, 2022 – "Sigyn Therapeutics: Calming and Preventing the Cytokine Storm"

View Source

January 17, 2022 – "A Perfect Storm of Superbugs"

View Source

January 20, 2022 – "How COVID-19 Has Spurred a Shift to Broad-Spectrum Countermeasures Against Viruses"

View Source

On January 25, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in its Phase I clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations (Press release, Biomea Fusion, JAN 25, 2022, View Source [SID1234606765]).

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"We are honored and deeply humbled by this significant milestone, which marks our successful transition to a clinical stage company. Just over four years ago, we took the concept of designing a small molecule that targets menin and brought forward BMF-219 to the clinic to significantly improve the lives of patients," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "I’m incredibly proud of our team for their ability to execute on this aggressive timeline. This signals how we intend to operate as a drug discovery and development organization – advancing world-class science with rapid momentum and driven by an unwavering mission to improve patient outcomes and save lives. We are pursuing a novel approach to developing best-in-class molecules with our FUSION System across multiple indications and anticipate announcing our next pipeline candidate in the first half of 2022."

"Since 2017, we have focused on building a world-class discovery and development team at Biomea Fusion. We have internally developed our FUSION System, which allows us to expeditiously target validated cancer biology with breakthrough covalent chemistry. Our pipeline assets are designed to achieve higher selectivity, deeper target inactivation and thereby afford patients a greater therapeutic window. BMF-219 is just our first asset graduating now into clinical development. Our team has evolved significantly and is set up today not only to explore the full potential of BMF-219 and the inhibition of the menin pathway but also to advance several other programs into the clinic," said Ramses Erdtmann, President of Biomea Fusion. "We are an integrated biotech company engaged in all phases of drug discovery and clinical development. We have come a long way and are now set up to fully explore pre-clinically and clinically innovative therapies for the benefit of patients."

The current Phase I, open-label, multi-center, dose escalation and dose expansion study is designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias, including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). Additional information about the Phase I trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)

AML is the most common form of acute leukemia in adults and is responsible for the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 20,000 people in the U.S. are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29% (Source: NCI SEER Data). Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (e.g., MLL1/KMT2A gene rearrangements or NPM1 mutations). ALL is a less common leukemia, with approximately 6,000 new cases in the U.S. each year and a higher five-year survival rate of nearly 70% (Source: NCI SEER Data). Between 10-15% of adult ALL patients and 60-70% of pediatric ALL patients have MLL1/KMT2A gene rearrangements.