On November 13, 2023 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its third quarter 2023 financial results and provided a corporate update (Press release, Instil Bio, NOV 13, 2023, View Source [SID1234637540]).

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Recent Highlights and Anticipated Milestones:

▪Presented novel preclinical data at SITC (Free SITC Whitepaper) 2023 Annual Meeting demonstrating that its CoStimulatory Antigen Receptor (CoStAR) enhances activity of CD4+ T cells in multiple ways to broaden anti-tumor response and support CD8+ T cells

▪Publication of ITIL-306 manuscript in Frontiers in Immunology (https://www.frontiersin.org/articles/10.3389/fimmu.2023.1256491/full), demonstrating that CoStAR enhances T cell activity and augments tumor reactivity of TILs in preclinical studies

▪Initial data from ITIL-306-202, a Phase 1 clinical trial of ITIL-306 in non-small cell lung cancer, anticipated in 2024

▪Cash runway expected beyond 2026

Third Quarter 2023 Financial and Operating Results:

As of September 30, 2023, Instil had cash, cash equivalents, restricted cash and marketable securities of $184.5 million, which consisted of $9.1 million in cash and cash equivalents, $1.0 million in restricted cash and $174.3 million in marketable securities, compared to $260.9 million in cash, cash equivalents and marketable securities as of December 31, 2022, consisting of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities. Instil expects that its cash, cash equivalents and marketable securities as of September 30, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $8.5 million and $37.6 million for the three and nine months ended September 30, 2023, respectively, compared to $39.7 million and $120.3 million for the three and nine months ended September 30, 2022, respectively.

General and administrative expenses were $11.9 million and $36.7 million for the three and nine months ended September 30, 2023, respectively, compared to $17.0 million and $49.3 million for the three and nine months ended September 30, 2022, respectively.

Restructuring and impairment charges were $46.3 million and $71.8 million for the three and nine months ended September 30, 2023, respectively. There were no restructuring and impairment charges for the three and nine months ended September 30, 2022.

On November 13, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the quarter ended September 30, 2023 (Press release, IGM Biosciences, NOV 13, 2023, View Source [SID1234637539]).

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"During the third quarter, we continued to execute across our clinical development pipeline," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We have significantly expanded the number of active sites for our aplitabart randomized study, including multiple international sites, begun our Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis and received FDA clearance of our IND application to begin a third Phase 1b autoimmune clinical trial of imvotamab. Our progress in the clinical development of these pipeline product candidates reinforces our commitment to the broad development of our Death Receptor 5 agonist platform and our T cell engager platform for autoimmune diseases."

Pipeline Progress

Aplitabart (DR5 agonist)

Clinical development of aplitabart advances.
Enrollment ongoing in the randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a Death Receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer, with a goal of enrolling approximately 110 patients by the end of the first quarter of 2024. In addition to clinical sites in the United States, this study will include multiple sites in Asia and Europe. This randomized trial is designed to assess the additional benefit of 3 mg/kg of aplitabart to the current standard of care treatment arm of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival and secondary endpoints of overall response rate and overall survival.
Dosing at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial. The Company continues to treat later line colorectal cancer patients in its single arm combination clinical trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination study in the first half of 2024.
Ongoing venetoclax combination. The Company continues to treat patients in its initial Phase 1 single arm study of aplitabart in acute myeloid leukemia in combination with venetoclax and azacytidine.
Ongoing birinapant combination. The Company continues to treat patients in its aplitabart plus birinapant Phase 1 combination cohort.
Imvotamab (CD20 x CD3)

Two autoimmune clinical trials ongoing. Following the clearance of the Company’s two Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) for imvotamab, an IgM-based CD20 x CD3 bispecific antibody T cell engager, the Company has begun two Phase 1b clinical trials, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA).
FDA clearance to begin third autoimmune clinical trial. In the third quarter, the Company received clearance from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis).
Imvotamab preclinical data. In November 2023, the Company presented preclinical data for imvotamab at the American College of Rheumatology Annual Meeting. The results were featured in a poster presentation titled "Therapeutic Potential of Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, for the Treatment of Refractory Autoimmune Disease Patients", which highlighted the ability of imvotamab to effectively deplete CD20+ B cells in tissue as well as to deplete low expressing CD20+ cells. These preclinical results support the advancement of imvotamab into Phase 1b clinical trials in autoimmune disease and may indicate differentiated activity as compared to anti-CD20 IgG1 antibodies.
IGM-7354 (IL-15 x PD-L1)

Phase 1 trial continues. The Company continues to treat patients in a Phase 1 clinical trial exploring the safety, efficacy, and biomarker activity of IGM-7354, an IgM-targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
IGM-2644 (CD38 x CD3)

Phase 1 trial continues. The Company continues to treat patients in a Phase 1 clinical trial exploring the safety and efficacy of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma.
Third Quarter 2023 Financial Results

Cash and Investments: Cash and investments as of September 30, 2023 were $387.0 million, compared to $427.2 million as of December 31, 2022.
Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.
General and Administrative (G&A) Expenses: For the third quarter of 2023, G&A expenses were $12.5 million, compared to $12.7 million for the same period in 2022.
Net Loss: For the third quarter of 2023, net loss was $62.0 million, or a loss of $1.04 per share, compared to a net loss of $58.0 million, or a loss of $1.32 per share, for the same period in 2022.
2023 Financial Guidance

The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2023 with more than $325 million in cash and investments, and the Company expects its existing cash and investments and anticipated collaboration payments to fund operations into the second half of 2025.

On November 13, 2023 GSK plc (LSE/NYSE: GSK) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of momelotinib for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib (Press release, GlaxoSmithKline, NOV 13, 2023, View Source [SID1234637538]).

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The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission. If approved, momelotinib would be the only medicine in the European Union (EU) specifically indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia that addresses splenomegaly and symptoms.

Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: "Momelotinib has a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with moderate to severe anaemia. The vast majority of myelofibrosis patients will develop anaemia, causing them to require transfusions and leading a notable proportion to discontinue treatment. This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer."

The positive CHMP opinion is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with moderate to severe anaemia (haemoglobin <10 g/dL) from the SIMPLIFY-1 phase III trial.1,2 MOMENTUM was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population. SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy.

In these clinical trials, the most common adverse reactions were diarrhoea, thrombocytopaenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain and cough.1,2

If approved in the EU, momelotinib will be available under the proposed trade name Omjjara. This opinion follows the September 2023 approval of momelotinib under the brand name Ojjaara by the US Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Momelotinib is not approved in any other market.

About momelotinib

Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly. Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia benefit.

About myelofibrosis

Myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), progressive anaemia and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.6

About 40% of patients have moderate to severe anaemia at the time of diagnosis and nearly all patients are estimated to develop anaemia over the course of the disease.7,8,9,10 Myelofibrosis patients with anaemia require additional supportive care, including transfusions, and more than 30% will discontinue treatment due to anaemia.11 Patients who are transfusion dependent have a poor prognosis and shortened survival.

On November 13, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the third quarter of 2023 ended September 30, 2023 (Press release, Enveric Biosciences, NOV 13, 2023, View Source [SID1234637537]).

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"The third quarter of 2023 was a period of significant progress for our team as we completed several initiatives that served to enhance the value of our differentiated neuroplastogenic small-molecule therapeutics as we advance towards the clinic," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Key to this effort, we significantly strengthened our IP estate across our development portfolio, highlighted by new patents from the United States Patent and Trademark Office (USPTO) for our EVM301 Series of novel non-hallucinogenic molecules and for EB-373, our lead EVM201 Series prodrug product candidate. The patents encompass composition of matter and pharmaceutical drug formulations related to the EVM301 Series and composition of matter and pharmaceutical drug formulations pertaining to EB-373. Additionally, we filed six non-U.S. applications related to the EVM301 Series, received several U.S. Notices of Allowance for claims related to the EVM301 Series and EB-373, and filed a new application for our AI-based computational methods for identifying and optimizing novel tryptamine derivatives. Our expectation is the USPTO will grant patents based on the Notices of Allowance, which would continue to increase the value of our technologies and further distinguish Enveric’s science as groundbreaking and unique."

Dr. Tucker added: "Through the third quarter of 2023 and into Q4, we have showcased the leading drug discovery and research engine behind our EVM301 Series of compounds, with several publications and presentations in academic settings, establishing a leading position in the psychedelic and psychedelic-inspired drug development industry to deliver next-generation treatments, with low- and non-hallucinogenic compounds. We look forward to several key milestones during the remainder of 2023, including identification of a lead candidate from the EVM301 Series by year-end. With this lead candidate identified, we anticipate initiating a thorough and expedited preclinical development program in 2024 in preparation for an Investigational New Drug application."

"As part of our objective to ensure clinical readiness, the third quarter was also characterized by completing key manufacturing and preclinical activities needed to file for regulatory clearance to begin a first in human clinical trial of EB-373. We announced favorable results from exploratory animal studies, which demonstrated oral bioavailability and well-tolerated side effects for EB-373. The outcome of these animal studies indicated potential for EB-373 to reduce GI upset and vomiting as well as rapid onset of action and systemic clearance, improving on the pharmacokinetic characteristics of psilocybin. Additionally, further preclinical work assessing absorption, distribution, metabolism, and excretion (ADME) assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin," concluded Dr. Tucker.

THIRD QUARTER AND RECENT PROGRAM UPDATES

Presented and published leading scientific research describing development and screening methods for non-hallucinogenic, neuroplastogenic drug candidates in Enveric’s EVM301 Series of candidates targeting the treatment of mental health disorders
Showcased drug candidate generation engine surpassing 1000 compounds discovered and analyzed in Psybrary Portfolio of psychedelic-inspired therapeutic candidates
Published research describing a key cane toad enzyme and its application to the biosynthesis of novel indolethylamine-type drug candidates with potential use in psychiatric medicine
Reported results from preclinical studies exploring the metabolic profile and the safety of lead candidate EB-373, a next generation psilocin prodrug targeting psychiatric disorders. Reported favorable preclinical absorption, distribution, metabolism, and excretion (ADME) and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin
Completed manufacturing of EB-373 to supply drug material for completion of preclinical program with resulting high purity of prodrug product that allows Enveric and partners to ship EB-373 without being subject to restrictions required for controlled substances
Continued to drive value with growing IP portfolio across therapeutic pipeline and filed provisional patent application to support AI-based computational methods for identifying and optimizing novel tryptamine derivatives
Granted USPTO No. 11,707,447 encompassing compositions of matter and pharmaceutical drug formulations for prodrugs utilizing C4-substituted tryptamine derivatives and C4-carbonothiate-substituted tryptamine derivatives
Granted USPTO No. 11,752,130 providing claims to novel composition of matter and pharmaceutical drug formulations for a family of carboxylated derivatives of tryptamine-based drug candidates
THIRD QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $2.82 million for the third quarter ended September 30, 2023, including $0.16 million in net non-cash income, with a basic and diluted loss per share of $1.30, as compared to a net loss of $2.60 million and non-cash income of $2.29 million, with primary and diluted loss per share of $1.46 per share for the quarter ended September 30, 2022.

Net cash used in operations for the quarter ended September 30, 2023, was $2.98 million, consisting of a $2.82 million net loss, adjusted by a net of $0.16 million in non-cash income and changes in asset and liability balances of $0.23 million.

As of September 30, 2023, the Company had cash and cash equivalents of $4.27 million.

On November 13, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that it will present updated efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (the EOGBM1-18/ROSALIE study), in an oral presentation at the Society for Neuro-Oncology (SNO) 28th Annual Meeting which will be held in Vancouver, British Columbia, Canada on November 15-19, 2023 (Press release, Enterome, NOV 13, 2023, View Source [SID1234637536]).

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Oral presentation details – Abstract CTIM-25

Title: EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the phase 1/2 EOGBM1-18/ROSALIE study (NCT04116658)

Presenting Author: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School, and Clinical Director for Dana Farber Cancer Institute

Session Name: Abstract Concurrent Session: Clinical Trials – Immunologic

Session Date and Time: Friday, November 17, 2023, at 8:35 AM PST

Location: Room 109-110

Link to abstract published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, can be found here. The slides from the oral presentation will be available on Enterome’s website after the Meeting.

About ROSALIE

ROSALIE (EOGBM1-18) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US.
For more information on the Phase 1/2 trial of EO2401 in recurrent glioblastoma, please refer to ClinicalTrials.gov Identifier: NCT04116658

About OncoMimics

OncoMimics immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer.