On May 15, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported five scientific posters sharing updated preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Annual Meeting, to be held virtually on June 22-24 (Press release, Surface Oncology, MAY 15, 2020, View Source [SID1234558128]).

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The posters include preclinical data from Surface Oncology’s two lead clinical-stage antibody therapies: SRF617 (targeting CD39) and SRF388 (targeting IL-27). Three additional posters containing preclinical data from SRF813 (targeting CD112R) and SRF231 (targeting CD47) will also be presented.

Summaries are provided below; full posters will be placed on Surface Oncology’s website following the presentation.

Details of the AACR (Free AACR Whitepaper) presentations are as follows:

Presentation Type: e-poster (Abstract: 6639)
Title: SRF617, a potent enzymatic inhibitor of CD39, demonstrates single-agent activity and cooperates with various cancer therapies in both solid tumor and hematologic malignancies
Lead Author: Austin Dulak, Ph.D.
Date and Time: Monday, June 22nd, 9:00 a.m. EDT

Summary:

SRF617 is a potent inhibitor of CD39 enzymatic activity both in vitro and in vivo.
Inhibition of CD39 potentiates the activity of chemotherapy and immunotherapy agents to improve tumor growth inhibition and survival in mice.
Differential CD39 expression patterns across tumor types inform clinical indication selection.
These findings support future clinical studies of SRF617 as monotherapy and in combination with other therapeutic agents in treating patients with cancer.
Presentation Type: e-poster (Abstract: 4550)
Title: Increased IL-27 is associated with poor prognosis in renal cell carcinoma and supports use of SRF388, a first-in-class IL-27p28 blocking antibody, to counteract IL-27-mediated immunosuppression in this setting
Lead Author: Matthew Rausch, Ph.D.
Date and Time: Monday, June 22nd, 9:00 a.m. EDT

Summary:

IL-27 is a heterodimeric cytokine consisting of 2 subunits (IL-27p28 and Epstein-Barr virus induced gene 3 (EBI3)) that limits the intensity and duration of T cell-mediated immunity.
High levels of IL-27p28, EBI3, and IL27RA transcript levels are often elevated in renal cell carcinoma (RCC) tumors and are associated with poor clinical outcome.
SRF388 inhibits IL-27 signaling, diminishes inhibitory receptor expression and increases cytokine production. This pro-inflammatory response is enhanced when combined with PD-1 blockade.
Data from these studies indicate that blockade of IL-27 can potentiate anti-tumor responses by counteracting IL-27-mediated immune escape.
Presentation Type: e-poster (Abstract: 4548)
Title: SRF813, a fully human monoclonal antibody targeting the inhibitory receptor CD112R, enhances immune cell activation and anti-CD112R treatment in vivo demonstrates preclinical anti-tumor activity
Lead Author: Jim Mohan, Ph.D.
Date and Time: Monday, June 22nd, 9:00 a.m. EDT

Summary:

SRF813 inhibits the CD112-CD112R interaction and enhances NK cell activation.
CD112R inhibition in mouse tumor models reduced tumor growth and increased tumor-infiltrating lymphocyte activation.
The combination of anti-CD112R with PD-1 blockade leads to greater tumor growth inhibition than either treatment alone.
These preclinical data demonstrate that CD112R is a negative regulator of immune responses and that CD112R inhibition can potentiate anti-tumor responses in cancers that express CD112.
Presentation Type: e-poster (Abstract: 2196)
Title: SRF231, a fully human CD47 antibody, potentiates the effects of opsonizing antibodies and cytotoxic chemotherapies in preclinical cancer models
Lead Author: Marisa O. Peluso
Date and Time: Monday, June 22nd, 9:00 a.m. EDT

Summary:

SRF231 demonstrates anti-tumor activity as a monotherapy in multiple myeloma (MM) and non-small cell lung cancer (NSCLC) models.
SRF231 potentiates the effects of opsonizing antibodies (elotuzumab and daratumumab) in preclinical MM xenograft models.
SRF231 potentiates the effects of taxane and platinum-based standard of care chemotherapies in preclinical NSCLC xenograft models.
Presentation Type: e-poster (Abstract: 4515)
Title: The anti-CD47 antibody SRF231 increases anti-tumor activity of standard of care chemotherapy in platinum-resistant PDX models of ovarian cancer
Lead Author: Joyce Fu Liu, M.D.
Date and Time: Monday, June 22nd, 9:00 a.m. EDT

Summary:

Anti-CD47 directed therapy with SRF231 demonstrates the ability to significantly increase the anti-tumor activity of standard chemotherapies in xenograft and platinum-resistant patient-derived xenograft (PDX) models of ovarian cancer.
In 2018, Surface Oncology deprioritized the SRF231 clinical program and is concluding its Phase 1 study.

On May 15, 2020 Precision BioSciences, Inc. (Nasdaq: DTIL), a life sciences company dedicated to improving life through the application of its pioneering, proprietary ARCUS genome editing platform, reported financial results for the first quarter ended March 31, 2020, and provided a business update (Press release, Precision Biosciences, MAY 15, 2020, View Source [SID1234558127]).

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"So far in 2020, we have continued to make significant progress across our portfolio. This includes advancing the ongoing Phase 1/2a trial of our lead allogeneic CAR T program candidate, PBCAR0191, in relapsed/refractory (R/R) NHL and B-ALL; dosing the first patient in a Phase 1/2a trial of PBCAR20A in R/R NHL, CLL and SLL; and preparing to launch a Phase 1/2a clinical trial of our third allogenic CAR T candidate, PBCAR269A, in multiple myeloma," said Matt Kane, CEO and co-founder of Precision BioSciences. "Amid COVID-19’s impact on the healthcare ecosystem, we believe this progress is not only a testament to our team’s dedication, but also a reminder of the significant disease burden and poor prognosis faced by late-stage cancer patients who have failed previous treatment lines. As evidenced by early data from our Phase 1/2a trial of PBCAR0191, our differentiated, off-the-shelf CAR T approach may offer meaningful clinical benefit for these patients, while potentially avoiding safety and logistical challenges faced by other cell therapies, including autologous CAR T. We continue to look forward to reporting updated data from the PBCAR0191 program later in 2020."

Recent Developments and Upcoming Milestones:

Allogeneic CAR T Portfolio:

PBCAR0191: PBCAR0191 is an investigational allogeneic CAR T candidate targeting CD19, currently being evaluated in a Phase 1/2a study in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The NHL cohort will include patients with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). In the first quarter of 2020, after discussion with the FDA, Precision implemented an amendment to the PBCAR0191 trial protocol designed to further optimize clinical activity. The amended trial design is intended to specifically address key clinical questions, which include assessing the impact of higher total doses of cells on clinical activity and/or the impact of modified lymphodepletion on the ability to achieve durable clinical benefit with

associated CAR T cell expansion and persistence. The PBCAR0191 clinical trial continues to progress, and no dose limiting toxicities or serious adverse events have been observed to date. Precision expects to present updated interim clinical data from both the NHL and B-ALL cohorts of this trial during 2020. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company.

PBCAR20A: PBCAR20A is a wholly-owned investigational allogeneic CAR T candidate targeting CD20 for the treatment of hematological malignancies. In April 2020, Precision dosed the first patient in its Phase 1/2a clinical trial evaluating PBCAR20A in two patient cohorts: R/R NHL, and R/R chronic lymphocytic leukemia (CLL) or R/R small lymphocytic lymphoma (SLL). Similar to the Phase 1/2a study of PBCAR0191, the NHL cohort for PBCAR20A will include patients with MCL, which has also received ODD from the FDA. Based on the safety profile observed from early dose levels in Precision’s ongoing Phase 1/2a study of PBCAR0191, the FDA authorized dosing in this Phase 1/2a study of PBCAR20A to begin at what was originally designed to be Dose Level 2 (1×106 cells/kg), with the subsequent dose level expected to be 3×106 cells/kg.

PBCAR269A: PBCAR269A is a wholly-owned investigational allogeneic CAR T candidate targeting B-cell maturation antigen (BCMA) for the treatment of R/R multiple myeloma, for which Precision has also received ODD. In January 2020, the FDA cleared Precision’s Investigational New Drug (IND) application for PBCAR269A, and the Company expects to begin dosing patients in a Phase 1/2a clinical trial in 2020.

In Vivo Gene Correction Portfolio:

PH1 Program: In January 2020, Precision announced that its first wholly-owned in vivo gene correction program will apply its ARCUS genome editing technology to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disease. In 2020, Precision expects to select a clinical candidate for this program to advance into human trials.

ASGCT 2020: At the American Society of Gene & Cell Therapy 23rd Annual Meeting held May 12-15, 2020, multiple presentations were made by Precision and its collaborators supporting the Company’s ARCUS genome editing platform and emerging pipeline applying this technology in vivo. Posters and talks included:

Engineering a Self-Inactivating Adeno-Associated Virus (AAV) Vector for ARCUS Nuclease Delivery (Abstract #654)

Gene Editing Approach to Eliminate Hepatitis B Virus Using ARCUS Meganucleases (Abstract #1057)

Therapeutic Efficacy of ARCUS Meganuclease Gene Editing – Arrest of Rod Degeneration and Restoration of Rod Function in a Transgenic Pig Model of Autosomal Dominant Retinitis Pigmentosa (Abstract #2)

Evaluation of the Long-term Effects of AAV-Meganuclease Genome Editing of PCSK9 in Macaque Liver (Abstract #518)

Corporate

COVID-19: In April 2020, Precision provided an update regarding its clinical trials and business operations amid the COVID-19 pandemic. This includes steps taken in line with guidance from public

health officials to protect the health and safety of its employees and to ensure continuity of its clinical trials. Precision’s work-from-home policy and restriction of on-site activities to certain manufacturing functions and limited laboratory and support activities remain in effect. To date, Precision has not experienced material delays to its planned or ongoing clinical trials.

Senior Leadership and Board Appointments: Precision further strengthened its senior leadership team with the appointment of Dora Alvarado as Senior Vice President, Human Resources. The Company also recently welcomed Geno Germano, President and CEO of Elucida Oncology, and former head of Pfizer’s Global Innovative Pharmaceutical business, to its Board of Directors.

Quarter Ended March 31, 2020 Financial Results

Cash and Cash Equivalents: As of March 31, 2020, Precision had approximately $154.2 million in cash and cash equivalents. The Company expects that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2021.

Revenues: Total revenues for the quarter ended March 31, 2020 were $7.0 million, compared to $5.5 million for the quarter ended March 31, 2019. This increase was due to increases in both Therapeutic and Food segments.

Research and Development Expenses: Research and development expenses were $24.9 million for the quarter ended March 31, 2020, as compared to $20.0 million for the same period in 2019. This increase of $4.9 million was primarily due to increases in direct research and development expenses, as well as platform development and early stage research expenses, including increases in personnel costs, laboratory supplies and services and expenses to support Precision’s technology platform development and manufacturing capabilities.

General and Administrative Expenses: General and administrative expenses were $9.6 million for the quarter ended March 31, 2020, as compared to $5.0 million for the same period in 2019. The increase of $4.6 million was primarily due to an increase in employee-related costs for additional personnel and facility costs associated with the Company’s growing infrastructure needs.

Net Loss: Net loss was $26.8 million, or $(0.52) per share, for the quarter ended March 31, 2020, compared to a net loss of $31.8 million, or $(1.99) per share, for the same period in 2019.

On May 15, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that new preclinical data on its pipeline programs and technology platform will be presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II to take place June 22-24, 2020 (Press release, Molecular Templates, MAY 15, 2020, View Source [SID1234558126]). All four posters are expected to be available on the AACR (Free AACR Whitepaper) website on June 22, 2020.

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Title: In Vivo Efficacy of a PD-L1 Targeted, Antigen Seeding Engineered Toxin Body
Authors: Hilario J. Ramos, Brigitte Brieschke, Sara LeMar, Joseph D. Dekker, Aimee Iberg, Garrett L. Robinson, Asis Sarkar, Banmeet Anand, Melissa M. Singh, Jay Zhao, Jack P. Higgins, Erin K. Willert. Molecular Templates Inc., Austin, TX
Session:Immunology: Therapeutic Antibodies 2
Abstract # 3366
MT-6402 is a highly differentiated approach to immuno-oncology. MT-6402 target PD-L1 and has been shown in preclinical studies to induce three unique biological effects:

Unlike current checkpoint inhibitors which bind PD-L1 and block interactions, MT-6402 directly destroys PD-L1+ tumor cells
MT-6402 can deliver foreign viral antigens into the target tumors to uniquely alter their immunophenotype to make them visible to CMV-reactive CD8+ T-cells
MT-6402 clears PD-L1+ immune cells and thereby potently activates the immune system
Non-human primate (NHP) data presented at the AACR (Free AACR Whitepaper) meeting show that MT-6402 mediated PD-L1+ immune cell clearance can elicit highly potent monotherapy immune activation in a way that has not been seen previously in NHP models with checkpoint inhibitors.

Title: CTLA-4 Targeted Engineered Toxin Bodies Designed to Deplete Regulatory T Cells (Tregs)
Authors: Aimee Iberg, Edith Acquaye-Seedah, Lilia A. Rabia, Garrett L. Robinson, Hilario J. Ramos, Joseph D. Dekker, Jay Zhao, Erin K. Willert. Molecular Templates Inc., Austin, TX
Session: Immunology: Therapeutic Antibodies 1
Abstract # 2278
Tumor resident regulatory T cells (Tregs) are important mediators of an immunosuppressive tumor microenvironment (TME) promoting tumor immune evasion. The presence of Tregs, and a higher ratio of Tregs to effector T cells in the TME, are associated with poor prognosis. There is concern that antibodies to CTLA-4 are not sufficiently effective at clearing Tregs from the TME. ETBs are being developed to specifically target CTLA-4+ Tregs and clear them from the TME. The clearance of Tregs in the TME is expected to re-expose the tumor to the immune system to allow for tumor control. Because CTLA-4-targeted ETBs preferentially affect Tregs versus CTLA-4+ CD8 T-cells, ETBs may also have a safer profile than CTLA-4 antibodies.

Title: Novel Engineered Toxin Bodies Targeting SLAMF7 (CS1)
Authors: Aimee Iberg, Garrett L. Cornelison, Caleigh Howard, Garrett L. Robinson, Jay Zhao, Hilario J. Ramos, Erin K. Willert. Molecular Templates Inc., Austin, TX
Session: Experimental and Molecular Therapeutics: Antibody Technologies
Abstract # 539
SLAMF7 (CS1) is a clinically validated target of monoclonal antibody therapy for the treatment of multiple myeloma. The approved antibody-based therapeutic, elotuzumab, works indirectly by recruiting effector cells to the tumor but does not show single agent clinical activity. ETBs have the potential to deplete malignant cells by means of potent and direct cell kill through enzymatic ribosomal destruction.

Title: CD45 Targeted Engineered Toxin Bodies Deplete Hematopoietic and Malignant Cells
Authors: Aimee Iberg, Garrett L. Robinson, Sara LeMar, Joseph D. Dekker, Jay Zhao, Hilario J. Ramos, Melissa M. Singh, Erin K. Willert. Molecular Templates Inc., Austin, TX
Session: Experimental and Molecular Therapeutics: Antibody Technologies
Abstract # 521
CD45, the leucocyte common antigen, is a haemopoietic cell-specific tyrosine phosphatase. Targeted and potent ETBs with intrinsically short half-lives are being developed to specifically destroy CD45 expressing cells including malignant cells of B, T and myeloid lineage. A single agent, targeted conditioning method for bone marrow transplant (BMT), employing ETBs, has the potential to increase patient safety and eliminate genotoxic effects that are associated with existing conditioning regimens.

On May 15, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, reported that financial, clinical and operational updates for the first quarter ended March 31, 2020 (Press release, Heat Biologics, MAY 15, 2020, View Source [SID1234558125]).

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Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We continue to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami. We plan to commence preclinical testing for the COVID-19 vaccine this quarter and are finalizing our manufacturing plans, which we believe will help shorten the clinical timeline. Additionally, we are applying for grants to support clinical development of this program and are advancing collaboration discussions. Earlier this year we also announced a collaboration with the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test. We suspended this program due to the progress made by other diagnostic manufacturers utilizing a similar approach, and our desire to focus resources on our highly-differentiated COVID-19 vaccine. Nevertheless, in the process, we developed our own unique diagnostic intellectual property, and plan to opportunistically explore partnership opportunities around this technology."

"We also continue to achieve key milestones related to HS-110 in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC). We recently announced that an abstract has been posted on The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) website. We look forward to presenting additional data at the upcoming ASCO (Free ASCO Whitepaper) Conference on May 29. Importantly, given the strength of the data, we plan to initiate an end of Phase 2 Type B meeting with the FDA to discuss our registrational strategy.

"We ended the quarter with over $26 million of cash and short-term investments as of March 31, 2020, which we believe provides us significant resources to advance each of our programs," concluded Mr. Wolf.

Q1 2020 Financial Results

Research and development expenses decreased approximately 12.5% to $2.8 million for the quarter ended March 31, 2020 compared to $3.2 million for the quarter ended March 31, 2019.
General and administrative expense was $3.3 million for the quarters ending March 31, 2020 and 2019.
Net loss attributable to Heat Biologics was approximately $6.3 million, or ($0.11) per basic and diluted share for the quarter ended March 31, 2020 compared to a net loss of $5.7 million, or ($0.17) per basic and diluted share for the quarter ended March 31, 2019.
As of March 31, 2020, the Company had approximately $26.4 million in cash, cash equivalents and short-term investments.

On May 15, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease reported its financial results for the first quarter ended March 31, 2020 and is providing a business update (Press release, INmune Bio, MAY 15, 2020, View Source [SID1234558124]). INmune Bio will hold a conference call today at 4:30 PM Eastern Time. To participate in the call, please dial 201-389-0923 five minutes before the schedule time.

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The company will review the progress on its clinical programs in areas including Alzheimer’s disease and its recently announced effort in combating complications of COVID-19. The company will also provide guidance for development efforts over the next two quarters based on the ongoing pandemic.

"Since our last earning report, we have been working to put our COVID-19 trial in place," said RJ Tesi MD, Chief Executive Officer of INmune Bio. "Additionally, our Alzheimer’s disease program continues to move forward in Australia. We are comfortable with our goal to have data from the Alzheimer’s program in October if not sooner."

Q1 2020 and Recent Corporate Highlights on the DN-TNF Platform and NK Priming Platform:

DN-TNF Platform Highlights:

Announced combination therapy of Lapatinib with INB03 will be used in the planned Phase II INB03 program in women with brain metastasis from HER2+ breast cancer.
Announced initiation of clinical program targeting soluble TNF (Quellor), one of the key components of the cytokine storm, using its TNF Inhibitor (DN-TNF) Platform to prevent complications of COVID-19 infection.
Expects to submit IND for Quellor in May 2020.
Frontiers in Oncology published an invited review highlighting soluble TNF’s impact on breast cancer.
Awarded a $500,000 grant from The ALS Association to complete IND enabling pre-clinical studies with XPro1595 as a therapy for ALS.
Enrollment continues in the XPro1595 Phase 1 study to evaluate neuroinflammation in patients with Alzheimer’s disease and is on track to report data in October if not earlier.

NK Priming Platform Highlights:

Announced allowance of U.S. Patent covering method for treating cancer by in vivo priming of natural killer cells.
Received notice of allowance in counterpart patent in Australia covering method for treating cancer by in vivo priming of natural killer cells.
"First quarter and year to date, has been a period of considerable progress," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "Our Alzheimer’s trial continues to enroll and we expect to have data in October if not earlier. We received funding to perform pre-clinical proof-of-concept studies in ALS, announced a plan to initiate a multinational clinical program to determine if our DN-TNF platform will help prevent complications of cytokine storm caused by COVID-19 that will enroll patients in the US and Australia and we solidified our unique approach to the treatment of trastuzumab resistant HER2+ breast cancer. Additionally, we received a patent allowance for our NK Priming Platform, and we were published in a Frontiers in Oncology invited review, underscoring sTNF’s effect on breast cancer. In summary, we continue to increase the value of our two platform technologies, with an ever-widening range of applications to advance the breadth and depth of our clinical programs."

Upcoming Milestones:

Report results of Phase 1 XPro1595 in Alzheimer’s Disease, expected to complete 2H 2020.
Submit IND for Quellor for the prevention of complications of COVID-19 infection, expected in May 2020.
Enroll first patient in Phase II Quellor program, targeting COVID-19 patients with complications from COVID19 as soon as possible.
The following milestone timelines have been updated due to the ongoing COVID-19 pandemic.

Enroll first patient in Phase II INB03 program, targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy, expected mid-2021.
Enroll first patient in Phase II LIVNate for NASH, expected mid-2021.
Enroll first patient in Phase I INKmune in High Risk MDS cancer, expected 2H20.
Enroll first patient in Phase I INKmune in Ovarian cancer, expected mid-2021.

Financial Results for the First Quarter Ended March 31, 2020:

Net loss attributable to common stockholders for the first quarter ended March 31, 2020 was $2.1 million, compared to $1.9 million for the quarter ended March 31, 2019.

Research and development expense totaled approximately $0.8 million for the first quarter ended March 31, 2020, compared with approximately $0.6 million for the quarter ended March 31, 2019.

General and administrative expense was approximately $1.3 million in each of the quarters ended March 31, 2020 and March 31, 2019.

As of March 31, 2020, the Company had cash and cash equivalents of approximately $5.9 million with no debt.

As of May 14, 2020, the Company had approximately 10.8 million common shares outstanding.

Earnings Call Information

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

Date: May 14, 2020
Time: 4:30 PM Eastern Time
Participant: 201-389-0923

About XPro1595

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. 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 XPro1595 Clinical Trial

XPro1595 is currently being evaluated in Phase Ib clinical trial in Alzheimer’s disease patients who have biomarkers of neuroinflammation to determine if neutralizing soluble TNF can decrease those biomarkers of neuroinflammation.

Adults (>18 years old) diagnosed with probable Alzheimer’s disease defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association criteria, confirmed with inflammatory biomarkers are being enrolled in this multicenter, Phase Ib open-label study. The study will follow patients during a twelve-week period to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of biomarkers of inflammation. The study will examine inflammatory and disease-related biomarkers before treatment, at the halfway point, and at the end. Cognitive and neuropsychiatric symptoms will be also be measured during the trial. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.

Clinical sites are located in Australia and include KaRa MINDS in New South Wales, Central Adelaide Local Health Network in South Australia, Austin Health and Alfred Health in Victoria, and The Australian Alzheimer’s Research Foundation in Western Australia.