On November 8, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it will participate in the Stifel 2023 Healthcare Conference (Press release, MEI Pharma, NOV 8, 2023, View Source [SID1234637301]). David Urso, president and chief executive officer, will present a company overview and business update on Wednesday, November 15 at 8:35 AM Eastern Time.

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Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on www.meipharma.com. A replay of the webcast will be made available following the event.

On November 8, 2023 Corner Therapeutics, a biotechnology company exploiting a new scientific paradigm to boost the immune response to disease, reported the first publication detailing their proprietary Catalytic Adjuvant platform that drives strong T cell immune responses to mRNA vaccines (Press release, Corner Therapeutics, NOV 8, 2023, View Source [SID1234637299]). The publication in the journal mBio is titled "mRNAs encoding self-DNA reactive cGAS enhance the immunogenicity of lipid nanoparticle vaccines".

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Lipid nanoparticles (LNPs) have been used to stimulate immunity to mRNA-encoded antigenic proteins from viruses and cancers. However, immune durability is limiting with current LNP vaccines, as the strategies used do not activate T cells robustly, which are key for immune memory. The lack of immune memory from current LNP-mRNA vaccination approaches is linked to a decades-old observation in medical science — antigens are not sufficient to stimulate durable immunity. Durable immunity is only activated when antigens are combined with molecules that mimic an infection. These infection mimics, known as adjuvants, are commonly found in other vaccines, but not current formulations of LNP-mRNA vaccines. This publication describes Corner’s discovery of a new class of immunostimulatory enzymes known as catalytic adjuvants, encoded by mRNAs in LNPs. The mRNA encoded catalytic adjuvant is a variant of the innate immune receptor cGAS, which activates the highly immunostimulatory STING pathway in dendritic cells (DCs), which control durable T cell immunity to cancer and infection. Corner’s catalytic adjuvants induce numerous DC activities that are needed for durable immunity, including the upregulation of chemokine receptors, T cell costimulatory molecules, major histocompatibility complex proteins, cytokines, and type I interferons. This discovery reveals that mRNA-encoded proteins can provide more than antigenic signals to the immune system. Proteins with adjuvant activities can also be encoded on mRNAs, leading to robust immune cell activation.

When co-administered with LNP vaccines encoding antigens, akin to those used clinically, catalytic adjuvants stimulated durable antigen-specific T cell responses that circulated through the lymphatics, blood, and lung. In contrast, antigen-LNPs alone stimulated weak and transient T cell responses. The enhanced T cell immunogenicity of Corner Therapeutics’ Catalytic Adjuvant platform was also observed for antibody production. The unique attributes of catalytic adjuvant vaccines may be particularly effective in vaccines designed to treat or prevent cancers and infectious diseases.

"This publication is an exciting milestone for Corner Therapeutics, offering the first overview of our catalytic adjuvants as tools to stimulate unprecedented vaccine immunogenicity," said Jonathan Kagan, Ph.D., Scientific Co-founder and Advisor at Corner Therapeutics and lead author of the publication. "The 2023 Nobel Prize in Physiology or Medicine was awarded to the researchers whose discoveries enabled the development of mRNA vaccines against COVID-19. This publication highlights Corner’s ambition to further advance this groundbreaking work, providing the first example of a simple and effective adjuvant for mRNA-LNP vaccines. We look forward to making continued breakthroughs in personalized and off-the-shelf vaccines through the development of our Catalytic Adjuvant platform."

"These data present a tremendous opportunity to partner with biopharma companies that share Corner’s commitment to bringing durable immunity to patients living with infectious diseases and cancer," said Steven Altschuler, M.D., CEO of Corner Therapeutics. "As we continue to develop our Catalytic Adjuvant platform, we look forward to exploring its broad potential to generate lifelong immunity for patients young and old."

On November 8, 2023 Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), reported its financial results for the third quarter ended September 30, 2023, and provided a clinical and business update (Press release, Coya Therapeutics, NOV 8, 2023, View Source [SID1234637298]).

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Q3 2023 and Recent Highlights

Completed enrollment in a randomized, double-blind, placebo-controlled Phase 2 study of Low Dose IL-2 in patients with mild-to-moderate Alzheimer’s Disease (AD).
The study is being conducted by Drs. Stanley Appel and Alireza Faridar at the Houston Methodist Hospital and is funded by the Gates Foundation and Alzheimer’s Association.

A total of 38 patients have been randomly assigned to receive subcutaneous Low Dose IL-2 (LD IL-2) at two different dosing regimens, or matching placebo, over 21 weeks. The first patient cohort was randomized to receive LD IL-2 for 5 consecutive days every 4 weeks and the second cohort was randomized to receive LD IL-2 for 5 consecutive days every 2 weeks.

This phase 2 well-controlled study is evaluating the safety and tolerability, biological activity, blood and cerebrospinal fluid biomarkers, neuroimaging, and changes in cognitive function of LD IL-2 compared to placebo at pre-specified timepoints over the course of the 21-week treatment period and at 9 weeks after the last dose of study treatment.
Topline results of the study are anticipated to be reported Summer 2024.

Reported new data supporting the mechanism of action of COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS) at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting on October 4th, 2023.
Details of the study can be found here. Results of this study further support the mechanism of action and potential of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple immune pathways involved in the progression and severity of ALS.

Coya is working expeditiously in the planning and execution of its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS.

Secured the exclusive worldwide licensing rights of a proprietary Exosome Engineering Technology (EET) from Carnegie Mellon University (CMU)

Applications across multiple indications, including neurodegeneration, autoimmune, and oncology.
This proprietary EET platform extends Coya’s pipeline beyond Neurodegenerative disorders to include autoimmune disorders and cancer while expanding Coya’s optionality for potential non-dilutive business development and strategic partnerships with companies seeking ways to deliver cargo/drugs in a targeted fashion.
Announced that Dr. Phil Campbell, Professor of Biomedical Engineering at CMU, presented a proof-of-concept application of the licensed exosome engineering technology, "Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy" at the 5th Exosome Based Therapeutic Development Summit in Boston, MA
The presentation can be accessed here.

Coya and CMU entered into a Research Collaboration Agreement and Option Agreement in 2022 to develop a unique patented technology intended to advance the potential use of exosomes for the treatment of diseases of unmet need.

This proprietary technology expands Coya’s pipeline to include autoimmune disorders and cancer. These engineered exosomes are considered a cell-free drug delivery systems without genetic modification that can travel throughout the body unimpeded, including through the blood brain barrier, to provide specific targeted therapies.
Published a research article entitled "Immunological, Oxidative, and Structural Factors and Their Responses to Regulatory T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis" in the peer-reviewed journal Ageing and Neurodegenerative Diseases.

The publication can be accessed here.

Following these encouraging results, Coya plans to assess blood markers of oxidative stress and inflammation systematically and prospectively in the upcoming well powered placebo controlled clinical study of COYA 302 in patients with ALS.
Published additional AD clinical data for ld-IL-2 at the Alzheimer’s Association International Conference (AAIC).
Showed a significant decrease in biomarker levels known to be associated with neuroinflammation in AD patients, further supporting the initial positive results of the study.
Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG (FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis factor alpha) were consistently lower following administration of ld IL-2.
Announced that Dr. Alireza Faridar, Assistant Professor of Neurology at Houston Methodist and Weill Cornell Medical College, will give an oral presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Disease held in Lisbon, Portugal between March 5-9, 2024.

Details and Registration for the conference are found here.

Appointed Mr. Dieter Weinand, former Chairman and CEO at Bayer Pharma AG, to its board of directors in August 2023.
Coya will continue to leverage Mr. Weinand’s extensive experience, connections, and judgement to guide Coya’s strategic discussions and development programs. Dieter Weinand is an experienced executive with over 25 years of experience in the pharmaceuticals and biotech industries.
Engaged Merit Cudkowicz, MD, MSc as expert clinical advisor.

Dr. Cudkowicz is a world-renowned neurologist who has dedicated her career to improving the life of patients with ALS and other serious neurological conditions. Dr. Cudkowicz brings decades of experience supporting the development of new therapies for ALS.
Appointed Dr. Fred Grossman to its senior management team as President and Chief Medical Officer in July 2023.
Prior to joining Coya, Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. Dr. Grossman will leverage his over two decades of clinical development expertise to guide and oversee all of Coya’s development programs, including its lead asset, COYA 302, for the treatment of ALS.
Howard Berman, Ph.D., Chief Executive Officer of Coya, commented, "During Q3 and year-to-date, we believe Coya has illustrated substantial value demonstrating a commitment to execution and performance.

Coya’s core pipeline is centered around its immunomodulatory biologic drugs, COYA 301 and COYA 302, intended to enhance Treg function and numbers while suppressing other pro-inflammatory pathways. We believe that targeting these critical pathways, both individually and in combination, may provide for an exponential shift in the treatment landscape of neurodegenerative diseases. Focusing our efforts in ALS and AD is warranted given the promising clinical signals that we have observed to date in proof of concept clinical studies. Moreover, running the company efficiently with a careful fiduciary eye to cost containment while delivering significant value to shareholders and patients has been and will continue to be the center of my approach.

We are aiming for a busy end to 2023 and productive 2024 with numerous anticipated catalysts and milestones driving the value of the business. Of importance, we plan to release top-line double-blind, placebo-controlled Phase 2 data of LD IL-2 in AD, expected by summer 2024. We also intend to submit an IND application for a randomized double-blind placebo-controlled Phase 2 trial in ALS in 1H 2024. Further, we anticipate publishing multiple peer reviewed publications during this time related to blood biomarker findings in the prior LD IL-2/CTLA4Ig proof of concept clinical trial, as well as clinical data findings for LD IL-2 in AD," concluded Dr. Berman.

Anticipated Events and Milestones

COYA 302 (ld IL-2 + CTLA4 Ig)

Phase 2 IND Filing in ALS (1H 2024)
Initiate Phase 2 trial in ALS (following IND Filing)
Proof of Concept Phase 1 investigator-initiated clinical study publication (Q1 2024)
Biomarker data and ALS registry publication (Q1 2024)
COYA 301 (ld IL-2)

Topline data of academic investigator Initiated Phase 2 double blind trial in Alzheimer’s Disease (Summer 2024)
Proof of Concept investigator-initiated Phase 1 clinical study publication in Alzheimer’s Disease (Q4 2023 or Q1 2024)
Phase 1 proof of concept investigator-initiated clinical study in Alzheimer’s Disease presentation at 18th annual Alzheimer’s and Parkinson’s Disease Conference (Q1 2024)
Combination LD IL-2 + Undisclosed Drug AD animal data release (2H 2024)
Financial Results (Unaudited)

As of September 30, 2023, Coya had cash and cash equivalents of approximately $10.9 million.

Research and development (R&D) expenses were $1.6 million for the quarter ended September 30, 2023, compared to $1.3 million for the quarter ended September 30, 2022. The Company believes that R&D spending in 2023 will increase over 2022 spending levels and will be focused primarily on advancing COYA 302.

General and administrative expenses were $2.0 million for the quarter ended September 30, 2023, and $1.2 million for the quarter ended September 30, 2022, a change of approximately $0.8 million. The change was primarily due to additional costs associated with being a public company including investor and public relations, director and officer insurance, financial advisory and compliance, as well as an increased headcount. The Company expects general and administrative costs to continue to grow in 2023 as Coya expands its business development activities as well as incur additional public company costs.

Net loss was $3.4 million for the quarter ended September 30, 2023, compared to net loss of $4.0 million for the quarter ended September 30, 2022.

On November 8, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA (EORTC 2129-BCG) (Press release, Natera, NOV 8, 2023, View Source [SID1234637297]). This international, multi-center, randomized, phase III clinical trial is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group in collaboration with Natera and Menarini Group (Menarini), a leading international pharmaceutical and diagnostics company.

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The primary objective of the study is to evaluate whether elacestrant (ORSERDU), a new oral endocrine monotherapy, can delay and/or prevent occurrence of distant metastasis or death compared to standard endocrine therapy in ER+/HER2- early-stage breast cancer patients with molecular relapse, which is defined as the presence of circulating tumor DNA (ctDNA) without clinical or radiographic evidence of recurrence. Over 200 patients who are ctDNA-positive by Signatera will be randomized to continue standard endocrine treatment or switch to elacestrant. Patients in both the control and experimental arms are expected to potentially benefit from timely detection of recurrence.

"We are excited to offer to our high-risk, ctDNA positive, ER+/HER2- early-stage breast cancer patients the possibility to participate in the TREAT ctDNA trial. We aim to study the value of the new selective estrogen receptor degrader (SERD), elacestrant, in reducing the rate of late distant relapses for these patients," said Prof. Michail Ignatiadis, chair of the EORTC Breast Cancer Group and director of the Breast Medical Oncology Clinic and Program at the Jules Bordet Institut.

"We are grateful to partner with EORTC in our efforts to establish the utility of treatment on molecular recurrence, prompted by using Signatera to identify MRD-positive patients before clinically apparent relapse," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "Collaborations with leading clinical trial organizations like EORTC are needed as we seek to demonstrate the power of treatment on molecular recurrence across cancer indications. We believe this represents a paradigm shift in a patient’s cancer journey, wherein ctDNA testing may serve as a critical tool to catch relapse earlier, enable treatment while disease burden is still low, and ultimately improve patient outcomes."

The study will screen approximately 1,900 patients across more than 120 sites in 12 countries throughout Europe and is expected to launch before the end of the year.

About Elacestrant (ORSERDU)

European Union Indication: ORSERDU (elacestrant) was approved by the European Commission in September 2023 as a monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor. More information, including prescribing information and important safety information, is available here.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.

On November 8, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the third quarter ended September 30, 2023 (Press release, Adicet Bio, NOV 8, 2023, View Source [SID1234637296]).

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"Clinical and translational medicine data for our lead asset ADI-001 in NHL has provided us with valuable insights, which has guided us as we initiated the EXPAND cohort in post CAR T LBCL and continue to enroll MCL patients to the clinical study. For patients with these advanced cancers, the prognosis remains poor and patients are in need of new, more effective and better tolerated therapies," said Chen Schor, President and Chief Executive Officer at Adicet Bio.

"In addition, over the past several months, we have conducted a strategic review of our pipeline to focus our resources on programs with the greatest potential for differentiation and long-term value creation," Mr. Schor added. "On the preclinical front, we are prioritizing the development of ADI-270 as our lead preclinical candidate in renal cell carcinoma and other solid tumor indications. ADI-270 has demonstrated a highly differentiated profile stemming from its unique engineering, including targeting via a CAR that incorporates CD27, addition of dominant negative TGF beta receptor armoring, complimentary innate anti-tumor activity of the gamma delta 1 T cells and tissue tropism to solid tumors. We remain on track to file an IND for ADI-270 in the first half of 2024. With a focused organization and clear priority for advancing a pipeline with the highest probability of success, we believe we are well positioned for long-term success as leaders in the allogeneic T cell therapy field."

Recent Operational Highlights:

Advanced ADI-001 Development. The Company is advancing the development of ADI-001, the Company’s investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). In November, Adicet initiated an expansion cohort (EXPAND) to evaluate ADI-001 in patients with post CAR T LBCL and continues to enroll MCL patients in the Company’s ongoing Phase 1 study of ADI-001. Recently, the Company expanded manufacturing capabilities of ADI-001 by transferring the manufacturing process to an additional contract development and manufacturing organization (CDMO) that is capable of operating at a larger scale of production. Subject to data readouts and regulatory feedback, the Company will evaluate options to advance ADI-001 into a potentially pivotal single arm Phase 2 study in post CAR T LBCL and/or MCL patients under an accelerated approval pathway. Adicet continues to expect that it will provide a clinical update from the Phase 1 study in NHL patients in the second half of 2024.

Prioritized ADI-270 Development for Solid Tumors. Adicet has reprioritized its preclinical pipeline to focus on the development of ADI-270 as its lead preclinical candidate for renal cell carcinoma, with potential in other solid tumor indications. The Company has completed a pre-IND meeting for ADI-270 with the U.S. Food and Drug Administration and received positive feedback to support an IND filing in the first half of 2024. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta receptor to address immunosuppressive factors in the tumor microenvironment. The Company expects to file an IND application for ADI-270 in the first half of 2024. Adicet has paused preclinical development of ADI-925 to prioritize corporate resources on IND-enabling activities for ADI-270.

Presented new preclinical data at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In October 2023, Adicet presented new preclinical data building on the potential of Adicet’s allogeneic gamma delta platform as a promising approach to target prostate cancer. Details of Adicet’s lead optimization process and differentiated prostate specific membrane antigen (PSMA) binding moiety were presented at the conference. Data demonstrated intrinsic targeting of patient-derived tumors by gamma delta T cells. Additionally, Adicet’s novel mode of targeting PSMA demonstrated selective binding to conformational epitopes and superior function compared to clinically relevant benchmarks.

Presented three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Earlier in November, Adicet presented three poster presentations highlighting the therapeutic value of its broad pipeline of CAR gamma delta T cell product candidates, including ADI-001, at SITC (Free SITC Whitepaper).
Financial Results for Third Quarter 2023:

Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the three months ended September 30, 2023, compared to $16.6 million during the same period in 2022. The $9.6 million increase is primarily driven by a $4.8 million increase in expenses related to CDMOs and other externally conducted research and development as well as a $2.4 million increase in payroll and personnel expenses resulting from an increase in overall headcount. There was also a $2.0 million increase in allocated facility expenses and a $0.4 million increase in lab expenses.

General and Administrative (G&A) Expenses: G&A expenses were $6.6 million for the three months ended September 30, 2023, compared to $6.4 million during the same period in 2022. The $0.2 million increase is primarily driven by an increase in stock-based compensation of $0.6 million and an increase in contractor fees of $0.2 million. The increase was partially offset by a $0.4 million decrease in allocated facility and other costs.

Goodwill Impairment: Goodwill was impaired by $19.5 million during the three months ended September 30, 2023 following the results of an impairment test conducted during the period. This represented the entire remaining balance of goodwill.

Net Loss: Net loss for the three months ended September 30, 2023 was $49.9 million, or a net loss of $1.16 per basic and diluted share, including non-cash goodwill impairment expense of $19.5 million and non-cash stock-based compensation expense of $5.6 million. Net loss was $22.0 million during the same period in 2022, or a net loss of $0.53 per basic and diluted share, including non-cash stock-based compensation expense of $4.2 million.

Cash Position: Cash and cash equivalents were $183.3 million as of September 30, 2023, compared to $257.7 million as of December 31, 2022. The Company expects that current cash and cash equivalents as of September 30, 2023, will be sufficient to fund its operating expenses into the first half of 2025.