On March 3, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the fourth quarter and full-year ended December 31, 2021, and provided updated clinical data from the ongoing Phase 1b trial of ATRC-101 in select solid tumors (Press release, Atreca, MAR 3, 2022, View Source [SID1234609452]).

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"Last year was a highly productive year for Atreca with regard to both clinical development of ATRC-101 and the generation and advancement of other pipeline assets," said John Orwin, Chief Executive Officer. "We are pleased to report additional results from the ATRC-101 program today. The data continue to show a significant association between activity and target expression, and we’ve now observed a partial response in monotherapy along with a complete response in the pembrolizumab combination cohort. Given the relationship between activity and target expression, we are preparing to integrate a diagnostic for participant selection. We believe these data demonstrate that ATRC-101 has clinical activity, validating our platform and our approach to identifying potentially valuable therapeutic antibodies against novel targets in oncology. On the preclinical side, we look forward to presenting more information on our EphA2 program and other pipeline assets at an R&D day in April."

ATRC-101 Update

The Phase 1b trial is a first-in-human, open-label study of ATRC-101 in patients with select solid tumor cancers. The trial began with a dose escalation portion of five dose levels from 0.3 mg/kg to 30 mg/kg, which was completed last year with no dose-limiting toxicities observed. Patient enrollment is ongoing in a once-every-three-week (Q3W) monotherapy dose cohort, a once-every-two-week (Q2W) monotherapy dose cohort and combination dose cohort with pembrolizumab. Enrollment in the monotherapy cohorts is limited to patients with tumor types displaying greater than 50% immunoreactivity to ATRC-101 in preclinical studies, and greater than 30% in the combination cohort. The objectives of the study are to characterize safety, determine a maximum tolerated or recommended dose for future studies, measure initial anti-cancer activity, and characterize potential biomarkers of activity in tumors, plasma, and peripheral blood mononuclear cells (PBMC).
As of the data cut-off date of February 15, 2022, a total of 47 participants have been dosed in the trial and evaluated for safety, including 36 participants treated in the Q3W arm, 8 in the Q2W arm, and 3 in the combination arm. Thirty-eight of 47 participants were treated with doses of 3 mg/kg, 10 mg/kg or 30 mg/kg, which we believe are pharmacologically relevant. Participants enrolled in the study had received a median of five prior lines of treatment, and participants in the combination arm are required to have had prior anti-PD-1 or anti-PD-L1 therapy.
ATRC-101 has been generally well-tolerated, with no dose-limiting toxicities in the monotherapy or combination dose-escalation cohorts. Among the 47 participants enrolled, 16 (34%) had at least one grade ≥ 3 adverse event (AE). Only two grade 3 AEs were considered potentially treatment-related, which were headache and a small intestinal obstruction. The most common treatment-related AEs were fatigue (n=15, 32%) and nausea (n=12, 26%).
Target expression in tumor biopsies obtained at screening was significantly associated with anti-tumor activity in the 3,10 and 30 mg/kg cohorts. Among participants treated at the higher dose levels who were evaluable for target expression and response, stable disease (SD) (n=6), PR (n=1) or CR (n=1) was observed in 8 of 12 (66%) with a screening H-score ≥ 50 (high). By comparison, in such participants with a screening H-score < 50 (low), SD was observed in 2 of 12 (17%), and none achieved PR or better.
A confirmed CR was observed in a melanoma participant (H-score high) in the pembrolizumab combination cohort who had progressed on prior anti-PD-1 and combined BRAF/MEK inhibitor therapy. In the monotherapy cohorts, a participant with non-small cell lung cancer (H-score high) achieved PR with 48% reduction in tumor burden, and a participant with colorectal cancer (H-score unknown) experienced a 29% reduction. All three participants remain on study.
Enrollment is ongoing in the Q3W and Q2W monotherapy cohorts and in the pembrolizumab combination cohort. Atreca has now completed validation of the target diagnostic and is planning to begin participant selection based on target expression in 2Q22. Atreca expects to report additional monotherapy and combination data in 2H22.
"We are very encouraged by the safety profile and evidence of the anti-tumor activity of ATRC-101, both as a single agent and in combination with a checkpoint inhibitor," said Jonathan Benjamin, M.D., Ph.D., Senior Vice President, Clinical Research. "We are pleased to see stable disease with tumor burden reduction in several trial participants and are especially gratified that two participants achieved objective responses, including a 78-year-old participant with melanoma who had progressed on a prior anti-PD1 agent yet achieved a complete response with the combination of ATRC-101 and pembrolizumab. ATRC-101 recognizes a previously unknown ribonucleoprotein complex that is expressed selectively in tumor tissue of many different cancer types. Among participants with evaluable baseline tumor biopsies, tumor burden reduction was achieved exclusively in those with high ATRC-101 target expression. Selection of trial participants based on target expression will be important in further evaluation of ATRC-101 and is expected to begin by mid-year."

Other Recent Developments and Highlights

Atreca presented two posters on ATRC-101 at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Atreca disclosed data on its anti-SARS-CoV-2 antibody discoveries, originally planned for presentation at the Keystone Symposia Conference: Antibodies as Drugs, which was postponed. By applying its proprietary IRC technology, the company discovered antibodies from the immune responses of patients infected with the original SARS-CoV-2 virus, two of which were determined to be pan-neutralizing against a panel of SARS-CoV-2 variants, including Delta and more recently, Omicron.
Atreca will be hosting a pipeline-focused virtual R&D Day on April 5th, 2022. Topics to be covered include our EphA2 program, as well as other previously undisclosed antibodies against new targets in ADC, T cell engager and other weaponized formats, in addition to our non-oncology programs.
Fourth Quarter and Year End 2021 Financial Results

As of December 31, 2021, cash and cash equivalents and investments totaled $148.1 million.
Research and development expenses for the year ended December 31, 2021, were $78.3 million, including non-cash share-based compensation expense of $8.6 million. Research and development expenses for the three months ended December 31, 2021, were $22.2 million, including non-cash share-based compensation expense of $2.5 million.
General and administrative expenses for the year ended December 31, 2021, were $32.0 million, including non-cash share-based compensation expense of $8.3 million. General and administrative expenses for the three months ended December 31, 2021, were $7.3 million, including non-cash share-based compensation expense of $2.2 million.
Atreca reported a net loss of $109.3 million, or basic and diluted net loss per share attributable to common stockholders of $2.95, for the year ended December 31, 2021. The Company reported a net loss of $29.5 million, or basic and diluted net loss per share attributable to common stockholders of $0.79, for the three months ended December 31, 2021.
Conference Call and Webcast Details

Atreca will host a live conference call and webcast today at 4:30 p.m. EST. To access the conference call by telephone, please dial (800) 373-6606 (Domestic) or 409-937-8918 (International). The conference ID number is 5089907.

The live audio webcast and accompanying slide presentation can be accessed via the Events section of the Company’s investor relations website at View Source An archived replay of the webcast will be available on the Company’s website for 90 days following the live event.

On March 3, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a business update (Press release, Immunocore, MAR 3, 2022, View Source [SID1234609468]).

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Immunocore’s recent and fourth quarter highlights include the approval from the United States Food and Drug Administration (FDA) of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). The U.S. approval of KIMMTRAK establishes many firsts: the first TCR therapeutic to receive regulatory approval; the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor; and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

In 2021, Immunocore continued to advance its ImmTAC clinical candidates IMC-C103C and IMC-F106C targeting cancer-testis antigens MAGE-A4 and PRAME, respectively. At ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 (ESMO-IO), the Company presented initial clinical activity in ovarian and head and neck cancer from its MAGE-A4 program. An expansion arm in high grade serous ovarian carcinoma at 140 micrograms was initiated in the fourth quarter of 2021. Immunocore will continue to explore the optimal dose and evaluate clinical activity in multiple solid tumors as part of the IMC-C103C program, with data planned during the fourth quarter of 2022. PRAME is a negative prognostic marker in solid tumors and is heavily expressed amongst multiple solid tumors. As of year-end 2021, there were 39 patients enrolled in the dose escalation PRAME study and the Company plans to present Phase 1 data in the third quarter of 2022.

Bahija Jallal, Chief Executive Officer of Immunocore, said: "Reflecting on what has been a momentous period for Immunocore, I am tremendously proud of what we have been able to achieve in recent years, culminating in the FDA approval and positive CHMP opinion of our lead product KIMMTRAK for the treatment of metastatic uveal melanoma. This historic milestone for patients, and for Immunocore, was made possible through years of hard work by our team and healthcare partners. Furthermore, KIMMTRAK’s approval provides an important validation of our ImmTAX platform and opens doors to the development of further ground-breaking discoveries in cancer and other diseases with high unmet need."

Dr. Jallal, continued "We go forward into the new year with energy and optimism that builds on the amazing progress we have made. We continue to focus on the commercial roll-out of KIMMTRAK, striving to ensure that all patients who need treatment with this medicine have access to it. Additionally, we will continue to accelerate our ImmTAX technology platform through our clinical programs, with updates from both our PRAME and MAGE-A4 programs planned for later this year."

Fourth Quarter 2021 Highlights (including post-period)

KIMMTRAK (tebentafusp-tebn)

In February 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending KIMMTRAK (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). The CHMP opinion will now be reviewed by the European Medicines Agency, which will provide a final decision on Immunocore’s Marketing Authorisation Application. The United Kingdom’s Medicines and Healthcare Products Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have each accepted the submission of the Company’s Marketing Authorisation Application. Additionally, Immunocore launched a global early access program to make KIMMTRAK readily available to mUM patients. Subject to receipt of regulatory approval from the EMA, Immunocore anticipates launching KIMMTRAK for the treatment of mUM in Europe in the second quarter of 2022.

In January 2022, the United States Food and Drug Administration (FDA) approved KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). The FDA approval of KIMMTRAK is based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. The randomized pivotal trial evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment.

In November 2021, the Company presented new clinical data from the Phase 1b trial of tebentafusp in combination with durvalumab (anti-PDL1) and/or tremelimumab (anti-CTLA4) in metastatic cutaneous melanoma (mCM) in poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting. In a phase 1b trial in mCM of tebentafusp in combination with checkpoint inhibitors, in which the majority of patients had previously received prior anti-PD(L)1 treatments, the maximum target doses of tebentafusp (68 mcg) plus durvalumab (20 mg/kg) with and with/out tremelimumab (1 mg/kg) were tolerated in both doublet and triplet arms of the study. Preliminary evidence of tebentafusp clinical activity in mCM patients who had prior anti-PD(L)1 therapy, currently an unmet medical need, included 1-year overall survival (OS) rate of 76%. The Company plans to initiate a randomized trial in the fourth quarter of 2022.

In addition, the Company presented a new analysis of baseline gp100 protein tumor expression by immunohistochemistry of tumor biopsies from the Phase 2 and Phase 3 tebentafusp monotherapy mUM trials, where OS benefit was observed for both high and low gp100 protein tumor expression.

In October 2021, the Company announced an exclusive multi-regional agreement for Medison Pharma Ltd. to help seek regulatory authorization and commercialize Immunocore’s tebentafusp (IMCgp100), for the treatment of patients with mUM, in Canada, twenty markets across Central Eastern Europe and Israel. Under the agreement, Medison Pharma would also assist with commercialization activities, assuming regulatory approval is received.

IMC-C103C targeting MAGE-A4

In December 2021, the Company reported initial Phase 1 data from the IMC-C103C dose escalation trial at the 2021 ESMO (Free ESMO Whitepaper)-IO Congress. IMC-C103C, an ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, is currently being studied in a first-in-human, Phase 1/2 dose escalation trial in patients with solid tumor cancers including non-small-cell lung cancer (NSCLC), gastric, head and neck, and ovarian. IMC-C103C demonstrated a manageable safety profile and clinical activity with confirmed durable responses in ovarian cancer and a confirmed durable response in head and neck squamous cell carcinoma (HNSCC). We initiated an expansion arm in high-grade serous ovarian carcinoma at 140 micrograms/weekly. The Company plans to report data from the MAGE-A4 program in the fourth quarter of 2022.

IMC-F106C targeting PRAME

In 2021, the Company continued to dose escalate IMC-F106C, an ImmTAC molecule targeting an HLA-A*02:01 PRAME antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma and breast cancers. As of December 16, 2021, the company has enrolled 39 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report the initial Phase 1 data in the third quarter of 2022.

IMC-I109V targeting HBV

In 2021, the Company continued to enroll patients in the IMC-I109V global Phase 1 single ascending dose trial. IMC-I109V is the first product candidate in development using the Company’s immune‐mobilizing monoclonal T cell receptors against virus (ImmTAV) platform to enter clinical trials. IMC-I109V targets a conserved Hepatitis B virus (HBV) envelope antigen and is being developed as a potential functional cure.

IMC-M113V targeting HIV

In December 2021, the Company received acceptance of a clinical trial application (CTA) in the UK for IMC-M113V, an ImmTAV molecule targeting an HIV gag antigen. The Company plans to dose the first patient in the single ascending dose portion of the study in the second quarter of 2022.

Financial Results

Basic and diluted loss per share was £0.90 (or $1.21) and £3.10 (or $4.19) for the quarter and year ended December 31, 2021, respectively, as compared to an adjusted basic and diluted loss per share of £0.69 and £2.79, respectively, for the same periods in 2020. Total operating loss for the quarter and year ended December 31, 2021, was £37.8 million (or $51.1 million) and £135.2 million (or $182.5 million), respectively, as compared to £20.2 million and £86.2 million respectively for the same periods in 2020. The increases in operating loss were driven by increases in employee costs associated with a non-cash share-based payment charge and pre-commercial expenditure relating to tebentafusp.

Revenue for the quarter and year ended December 31, 2021, was £6.6 million (or $8.9 million) and £26.5 million (or $35.8 million), respectively, as compared to £7.4 million and £30.1 million, respectively, for the same periods in 2020. Revenue consisted of collaboration revenue, and, starting in 2021, also consisted of pre-product revenue under a compassionate use program in France. The decrease in revenue in both periods was primarily due to a reduction under our collaboration agreements, which was partly offset by pre-product revenue. Pre-product revenue was £3.0 million (or $4.1 million) in the year ended December 31, 2021.

For the quarter and year ended December 31, 2021, research and development ("R&D") expenses were £20.1 million (or $27.1 million) and £73.2 million (or $98.9 million), respectively, as compared to £17.2 million and £74.8 million, respectively, for the same periods in 2020. There was a reduction in clinical trial activity for tebentafusp in the year ended December 31, 2021, as we transitioned to pre-commercial activities, which was partly offset by increases in headcount-related expenses and costs in connection with our IMC-F106C (PRAME) program.

For the quarter and year ended December 31, 2021, administrative expenses were £24.4 million (or $32.9 million) and £88.4 million (or $120.0 million), respectively, as compared to £14.2 million and £45.7 million respectively for the same periods in 2020. The increases in both periods were driven by increases in the non-cash share-based payment charge (which increased by £23.8 million in the year ended December 31, 2021) and pre-commercial expenditure relating to tebentafusp (which increased by £17.4 million in the year ended December 31, 2021).

Cash and cash equivalents were £237.9 million or approximately $321.1 million as of December 31, 2021, as compared to £129.7 million as of December 31, 2020.

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About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

Please see full Prescribing Information, including BOXED WARNING for CRS.

About KIMMTRAKConnect
Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

On March 3, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported a two-day summit hosted by the B. Riley Securities’ Healthcare Equity Research team, that will feature multiple programs from Fortress’ diversified pipeline (Press release, Fortress Biotech, MAR 3, 2022, View Source [SID1234609483]). The events will be held virtually on Tuesday, April 5, and Wednesday, April 6, 2022, beginning at 1:00 p.m. ET each day.

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Registration links and more details will be provided approximately two weeks prior to the summit.

Following each event, the webcast will be available on the News / Events page, located within the Investors section of Fortress’ website, View Source, for approximately 30 days.

On March 3, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that the Company will participate at two upcoming investor conferences (Press release, Bausch Health, MAR 3, 2022, View Source [SID1234609499]).

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Joseph C. Papa, chairman and chief executive officer; Sam Eldessouky, executive vice president and chief financial officer; and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the virtual Cowen & Co. 42nd Annual Health Care Conference on March 8, 2022 at 12:50 p.m. ET and at the Barclays Global Healthcare Conference 2022 in Miami on March 15, 2022 at 11:15 a.m. ET.

A live webcast and audio archive of the conferences will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source

On March 3, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the year ended December 31, 2021 and provided a business update (Press release, INmune Bio, MAR 3, 2022, View Source [SID1234609522]).

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In December, the Company reported data from the first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days after the course of INKmuneTM therapy, 60% of the patient’s NK cells showed the activated, tumor killing memory like NK cells phenotype, a fourfold increase from pre-treatment. The patient’s memory like NK cells killed >70% of NK resistant tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally, two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy was well tolerated, safe and was given without any type of pre-medication or cytokine therapy.

"These patients demonstrate the unique attributes of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient’s resting NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay. Both these attributes lasted four months, a trait we are calling therapeutic persistence." stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We are continuing to screen patients for enrollment into the trial and are in process of expanding the number of clinical trial sites."

The Phase II clinical trial using XProTM to treat patients with AD and elevated biomarkers of neuroinflammation (ADi) is open, screening patients and seeking to enroll the first patient. A second Phase II trial in patients with Mild Cognitive Impairment (MCI) should begin enrolling patients soon. Patients must have ApoE4 to be included in the MCI trial. INMB is treating MCI and Mild AD in separate clinical trials due to differences in disease severity with the potential for different rates of response to therapy. The MCI trial is a three-month trial designed to determine the extent to which XProTM has an impact on biological and cognitive biomarkers in MCI patients. The mild AD trial is a six-month trial with EMACC as the primary endpoint and secondary endpoints of CDR, ADL, NPI, MRI, and blood biomarkers of neurodegeneration. Top line data is expected in the first half of 2023 from the MCI trial and the second half of 2023 from the mild ADi trial. A video released today can be found on the company’s website which explains our rationale for XPro in treating neuroinflammation to potentially reduce white and gray matter degeneration which can be found by clicking here.

Q4 2021 and Recent Corporate Highlights

IINKmuneTM Platform Highlights:

The Phase I program has been peer-reviewed by the UK National Cancer Research Institute (NCRI) – Myelodysplastic Syndrome Expert Group and has been accepted for listing on their national MDS trials site. This is unique to the UK; no equivalent system is present in the US. This allows specialist MDS trials centers to refer patients to the current UK clinical trial sites for treatment under the clinical trial protocol or to request to become an additional trial site. We hope this added validation of the trial and exposure to additional expert centers will provide more patients for enrollment into the Phase I MDS program and facilitate future phase II trials.
Presented 119-day data on first patient in company’s ongoing Phase 1 clinical trial of its Natural Killer (NK) cell priming platform, INKmuneTM, as a potential treatment for high-risk myelodysplastic syndrome (MDS). A single course of INKmuneTM has benefited the course the patient’s disease for more than 6 months. The data were presented at the 2021 British Society of Immunology Congress.
Announced a pre-clinical research collaboration with the Chinese University of Hong Kong to evaluate INKmuneTM, the company’s pseudokine NK cell priming platform, in nasopharyngeal cancer (NPC), a type of head and neck cancer. The project provides INMB scientists working at University College of London with access to the only three proven NPC cancer cell lines to test the ability of INKmuneTM-primed NK cells to kill NPC tumors. This pre-clinical work, if successful, will provide data for a future clinical trial in NPC.
DN-TNF Platform Highlights (XProTM and INB03TM):

Opened the Phase II trial using XProTM to treat patients with mild ADi for enrollment. The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition will also be measured, including CDR-SB, ADAS-COG13 and other endpoints. Data is anticipated in the second half of 2023.
Delivered multiple oral and poster presentations at the AAIC 2022 (Alzheimer’s Association International Conference) and the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting.
Presented new breast cancer data at the 2021 San Antonio Breast Cancer Symposium. A significant percentage of women with triple negative breast cancer (TNBC) express MUC4. MUC4 expression predicts a worse survival and increased risk of developing metastatic disease. In addition, MUC4 expressing patients have "cold" tumors with fewer tumor infiltrating lymphocytes. These data suggest the use of INmune’s DN-TNF candidate, INB03TM, may help reverse resistance to immunotherapy women with TNBC.
Upcoming Milestones:

Initiate XProTM Phase II program for Mild Cognitive Impairment (MCI) in patients with APOE4 allele 1H 2022.
Initiate XProTM Phase II program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Initiate INKmune Phase I program in ovarian cancer in 2H 2022.
Additional open-label Phase 1 trial data of INKmuneTM in high-risk MDS.
Report top-line data from Phase 2 trial of XProTM in MCI patients in 1H 2023.
Report top-line data from Phase 2 trial of XProTM in mild Alzheimer’s patients in 2H 2023.
Present INKmuneTM clinical data and new pre-clinical data on mechanism of action at the Innate Killer Summit conference in San Diego in March.
Report pre-clinical INKmuneTM data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
Oral and Poster presentations at AD/PD 2022, the largest European AD meeting. The meeting will be held in Barcelona in March.
Financial Results for the Year Ended December 31, 2021:

Net loss attributable to common stockholders for the year ended December 31, 2021 was approximately $30.3 million, compared to approximately $12.1 million for the year ended December 31, 2020.

Revenues were approximately $0.2 million for the year ended December 31, 2021, compared to $0.0 million for the year ended December 31, 2020.

Research and development expense totaled approximately $20.5 million for the year ended December 31, 2021, compared to approximately $5.9 million during the year ended December 31, 2020.

General and administrative expense was approximately $8.8 million for the year ended December 31, 2021, compared to approximately $6.3 million during the year ended December 31, 2020.

Other expense was approximately $1.2 million during the year ended December 31, 2021 compared to other income of approximately $0.1 million during the year ended December 31, 2020.

As of December 31, 2021, the Company had cash of approximately $74.8 million.

As of March 3, 2022, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

A live audio webcast of the call can be accessed using this link: View Source;tp_key=636ec61ab2

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13726701.

About XProTM

XProTM is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XProTM could have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmuneTM

INKmune is a pharmaceutical-grade, replication-incompetent derivative of our proprietary INB16 cell line, a human tumor cell line, which conjugates to resting NK cells and delivers multiple essential priming signals akin to treatment with a combination of at least three cytokines. INKmuneTM is stable at -80 °C and is delivered by a simple IV infusion. The INKmuneTM:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated tumor lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors, including: leukemias, lymphomas, myeloma, ovarian cancer, and breast cancer.