The Buzz Surrounding: INmune Bio Inc. (NASDAQ: INMB)

INmune Bio Inc. is a clinical stage immuno-oncology company focused on harnessing the patient’s immune system to treat cancer. INKmune, the company’s lead product, primes patient’s NK cells (natural killer cells) to kill cancer.

About INmune Bio

INmune Bio Inc. is a clinical stage immuno-oncology company focused on harnessing the patient’s immune system to treat cancer. INKmune, the company’s lead product, primes patient’s NK cells (natural killer cells) to kill cancer. INmune is targeting residual disease, the cancer cells that survive initial treatments that return to cause the cancer relapse. 

“By controlling residual disease, patients may live longer. Using a novel mechanism of action and a precision medicine approach, INKmune therapy should enhance NK cells’ ability to eliminate residual disease.”

Our Behind the Buzz Show Featuring INmune Bio Inc.

Investor Recap

The Innate Immune System

The innate immune system is one of two limbs of the human immune system. It is comprised mainly of natural killer cells (NK cells), macrophages and eosinophils. The other limb, the adaptive immune system, is comprised of T and B cells. Dendritic cells and T cells, which reside between the two limbs, facilitate cross-talk between the innate and adaptive immune system. Both the innate and adaptive immune system are important in controlling cancer; however, the interplay between the two is very complicated and not completely understood.

The Problem

The problem with relapsers’ cancer cells is they evade patients’ NK cells by making themselves effectively invisible. Because the patient’s immune system cannot see them, it cannot kill them. Understanding the problem requires a deeper understanding of NK cell biology. 

The Solution

The solution is to replace or artificially provide patients’ NK cells with priming signals. This converts an NK cell that needs two signals from a cancer cell to an NK cell that needs only triggering signals to initiate cancer killing. We call this product INKmune™. 

INmune Bio Platform and Pipeline

INKmune – Cancer

INKmune™ is a biologic delivery system that allows for the delivery of essential priming signals to patients’ resting NK cells. INKmune™ is delivered by a simple IV infusion. Once in the patient’s system, INKmune™ comes in contact with resting NK cells. The interaction converts NK cells to “primed NK cell” (PiNK) similar to an “on-off” switch. PiNK then remain primed until they contact and kill cancer cells.

INKmune Primed NK Cells Kill Cancer

Human ovarian cancer cells plus
patient’s own NK cells

Human ovarian cancer cells with patient’s NK cells after INKmune treatment

INB03 – Cancer

INB03 is a protein biologic that could have many beneficial effects in patients with cancer. Our initial focus is on its ability to inhibit proliferation and function of Myeloid-Derived Suppressor Cells (MDSC). By preventing the proliferation and function of MDSC, we believe patients will have a stronger immune response to cancer cells and may respond better to other cancer treatments including immunotherapy.

The innate immune system is one of two limbs of the human immune system. It is comprised mainly of natural killer cells (NK cells), macrophages and eosinophils. The other limb, the adaptive immune system, is comprised of T and B cells. Dendritic cells and T cells, which reside between the two limbs, facilitate cross-talk between the innate and adaptive immune system. Both the innate and adaptive immune system are important in controlling cancer; however, the interplay between the two is very complicated and not completely understood.

XPro1595 – Alzheimer’s

XPro1595 is a protein biologic that targets soluble TNF (sTNF) and may have many beneficial effects in patients with Alzheimer’s disease by decreasing neuroinflammation. We believe that decreasing neuroinflammation may slow or stop the progression of the cognitive and psychiatric symptoms of Alzheimer’s patients and improve in the overall quality of life of the patient and their care-givers.

“awards INmune Bio Part the Cloud Grant – $1M USD translational funding to study XPro1595 in Alzheimer’s disease”

Recent Developments

Oct. 17, 2019 - INmune Bio, Inc. Announces Presentation of Data Related to its Lead Compound XPro1595 at the Society for Neuroscience’s Annual Meeting

INmune Bio, Inc. (NASDAQ: INMB), an immunotherapy company developing treatments that harness the patient’s innate immune system to fight disease, announced today a poster presentation related to the company’s program in Alzheimer’s disease at the upcoming Society for Neuroscience (SfN) 49th Annual Meeting, to be held Oct. 19–23 at McCormick Place in Chicago. In addition, INmune Bio announced that this presentation has been selected for presentation during the meeting’s press conference.

Presented in a poster by Malú Tansey, Ph.D., Professor of Neuroscience and Director of the Center for Translational Research in Neurodegenerative Disease at the University of Florida College of Medicine, the data from studies involving the use of INmune Bio’s XPro1595 demonstrate the critical role of the immune system on an individual’s genetic risk in the context of environmental exposures, such as a diet high in fat and sugar, for neurodegenerative diseases such as Alzheimer’s.   The Company believes that  XPro1595 is a next generation anti-inflammatory that crosses the blood-brain barrier to affect neurodegenerative diseases by selectively inhibiting soluble tumor necrosis factor.

“It’s become clear that neurological disorders can arise from or be exacerbated by innate immune dysfunction and chronic inflammation resulting from both genetic and environmental factors such as diet,” said Dr. Tansey. “Harnessing the power of the immune system could potentially delay or perhaps even prevent some of these neurological disorders. Our results provide a compelling rationale for moving forward with a clinical trial in early Alzheimer’s disease patients.”

The SfN Annual Meeting is the premier venue for neuroscientists to present emerging science, learn from experts, forge collaborations with peers and explore new tools and technologies related to the brain and the nervous system.

Poster Details

Session: Alzheimer’s Disease and Other Dementias: Therapeutic Strategies III

Poster number: 564

Presentation Title: Soluble tnf mediates obesogenic diet‑induced alterations in peripheral and brain immunophenotype in a model of Alzheimer’s disease

Time and Date: 1:00 PM, Oct. 22

Location: McCormick Place, Chicago, Illinois

The presentation abstract can be accessed on the SfN website. The above listed date may be subject to change. Details on presentation times or changes to presentation dates can be found on the SfN website. Please check https://www.sfn.org/ for the latest information.

About the Society for Neuroscience (SfN)

The Society for Neuroscience is the world’s largest organization of scientists and physicians devoted to understanding the brain and the nervous system. SfN’s mission is to advance the understanding of the brain and the nervous system by bringing together scientists of diverse backgrounds, by facilitating the integration of research and by encouraging translational research and the application of new scientific knowledge to develop improved disease treatments and cures. SfN is also committed to provide professional development activities, information, and educational resources for neuroscientists at all stages of their careers, to promote public information and general education about the latest neuroscience research and inform legislators and other policymakers.

For Full Press Release – https://www.globenewswire.com/news-release/2019/10/17/1931279/0/en/INmune-Bio-Inc-Announces-Presentation-of-Data-Related-to-its-Lead-Compound-XPro1595-at-the-Society-for-Neuroscience-s-Annual-Meeting.html

Oct. 08, 2019 - INmune Bio Inc. to Present at Advances in Immuno-Oncology USA Congress and at World Immunotherapy Congress in October

INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today that RJ Tesi, M.D., Co-Founder and CEO, will present at the 2nd Annual Advances in Immuno-Oncology USA Congress in San Diego taking place on Oct. 8 and Oct. 9. Dr. Tesi and CJ Barnum, Ph.D., Director of Neuroscience, will also present at the World Immunotherapy Congress taking place in Basel, Switzerland from Oct. 15 through 17.

“The immuno-oncology field is rapidly growing, and emerging new therapies are at the center of attention,” said Dr. Tesi. “With 30% of breast cancer patients being HER2+, trastuzumab has made significant strides in the treatment of breast cancer. Yet, many HER2+ breast cancer patients have shown resistance to the drug. In my presentation during the Advances in Immuno-Oncology USA Congress, I will address one of the reasons for the resistance – specifically the presence of the MUC4 biomarker – and how we may be able to use a soluble TNF inhibitor, such as our drug candidate INB03, to increase the efficacy of trastuzumab in those women who have shown resistance.”

Advances in Immuno-Oncology USA Congress brings together global pharmaceutical organizations, leading biotech companies and presents a unique chance to connect scientists on the latest innovations in immuno-oncology therapy development, research and more.

“Our approach to treating patients with Alzheimer’s disease is focused on targeting the root of the disease, chronic inflammation and how we can leverage biomarkers,” said Dr. Barnum. “It’s an honor to have the opportunity to present alongside some of the most prominent leaders in the immunotherapy community to approach the field from a non-oncology perspective.”

The World Immunotherapy Congress is one of four conferences coordinated by the Festival of Biologics. The vision of the World Immunotherapy Congress is to bring together the full community and provide a single meeting point for where science meets business to make immunotherapy the cornerstone of the fight against cancer and other diseases.

For Full Press Release – https://www.globenewswire.com/news-release/2019/10/08/1926521/0/en/INmune-Bio-Inc-to-Present-at-Advances-in-Immuno-Oncology-USA-Congress-and-at-World-Immunotherapy-Congress-in-October.html

Sept. 24, 2019 - CEO of INmune Bio Inc. Discusses Company Accomplishments at Nasdaq’s MarketSite and Announces Presentation at World Immunotherapy Congress

 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced that RJ Tesi, M.D., Co-Founder and CEO will be featured in an interview with multimedia financial reporter, Jason Lin discussing the company’s accomplishments. The interview can be found by clicking here.

“Nasdaq’s MarketSite is a premiere platform for INmune Bio to share our story with investors and to discuss recent developments in our programs for cancer, Alzheimer’s disease and nonalcoholic steatohepatitis (NASH) liver disease,” said Dr. Tesi. “We hope to continue reaching new milestones in the development of therapies that target the innate immune system.”

INmune Bio has four drug development programs: two that are designed to treat cancer, INKmune™ and INB03 — with recently reported positive preliminary data from the Phase 1 trial in patients with advanced cancer; XPro1595 for the treatment of neuroinflammation and Alzheimer’s disease; and NeuLiv™ for the treatment of NASH.

Additionally, CJ Barnum, Ph.D., Director of Neuroscience, will present on “Approaching Alzheimer’s disease as an immunological disease: role of biomarkers” at the World Immunotherapy Congress on Oct. 16 in Switzerland.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/24/1920074/0/en/CEO-of-INmune-Bio-Inc-Discusses-Company-Accomplishments-at-Nasdaq-s-MarketSite-and-Announces-Presentation-at-World-Immunotherapy-Congress.html

Sept. 23, 2019 - INmune Bio to Present XPro1595 for Treating Neuroinflammation in Alzheimer’s Disease at 2019 Alzheimer’s Association International Conference (AAIC) Satellite Symposium

INmune Bio, Inc. (NASDAQ: INMB), an immunotherapy company developing treatments which harness the patient’s innate immune system to fight disease, announced today that the company will be presenting at the upcoming Alzheimer’s Association International Conference (AAIC) Satellite Symposium held Sept. 25 – 27 in Sydney, Australia.

C.J. Barnum, Ph.D., Director of Neuroscience at INmune Bio, will present the company’s strategy for treating Alzheimer’s disease at a panel session, along with other global researchers and leaders in the latest therapeutics and developments in Alzheimer’s clinical research.

“Neuroinflammation is now widely recognized as a key therapeutic target in Alzheimer’s disease,” said Dr. Barnum. “ We believe that neuroinflammation plays a critical role in neurologic disorders like Alzheimer’s and our drug candidate, XPro1595 is starting clinical trials to test this hypothesis.”

AAIC is the premier annual conference for presentation and discussion of the latest Alzheimer’s and dementia research. The AAIC Satellite Symposium is part of the events organized by the Alzheimer’s Association and gathers researchers from around the world to discuss scientific advances in the understanding and treatment of Alzheimer’s disease and other related dementias. Dr. Barnum will present during a panel session moderated by Malú Tansey, Ph.D., Professor of Neuroscience and Director of the Center for Translational Research in Neurodegenerative Disease at the University of Florida College of Medicine.

Session 3:  Therapeutics: State of the Field

Presentation Title: A Biomarker-Directed Approach to Targeting Inflammation in Alzheimer’s Patients

Time and Date: 5:10 PM – 5:30 PM, Sept. 25

Location: Hyatt Regency Sydney, Australia

Alzheimer’s disease is a progressive neurodegenerative disease that is the most common cause of dementia and is characterized by the decline in cognitive function and neuronal loss. Sustained activation of the brain’s resident macrophages (microglia) and other immune cells have emerged as the underlying pathological condition that facilitates and exacerbates the progression of the disease. 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 the Alzheimer’s Association

The Alzheimer’s Association is the leading voluntary health organization in Alzheimer’s care, support and research. Its mission is to eliminate Alzheimer’s disease through the advancement of research; to provide and enhance care and support for all affected, and to reduce the risk of dementia through the promotion of brain health. Its vision is a world without Alzheimer’s. Visit the Alzheimer’s Association website or call 800.272.3900.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/23/1919220/0/en/INmune-Bio-to-Present-XPro1595-for-Treating-Neuroinflammation-in-Alzheimer-s-Disease-at-2019-Alzheimer-s-Association-International-Conference-AAIC-Satellite-Symposium.html

Sept. 17, 2019 - INmune Bio Invited to Speak on Company’s Advancements in Cancer Treatments at the Targeting Innate Immunity Congress and MarketsandMarkets Next Gen Immuno-Oncology Congress

 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced that RJ Tesi, M.D., Co-Founder and CEO, and Mark Lowdell, Ph.D., Co-Founder and Chief Scientific Officer, will present at the first ever Targeting Innate Immunity Congress, taking place in the biotech hub of Cambridge, Mass. from Sept. 23 through 25.

The conference is an opportunity for INmune Bio to showcase its two leading innate compounds in the hopes of improving the treatment of cancer to industry leaders, experts, academic researchers and clinicians in the field of innate immunity. In addition to presenting at the conference, Dr. Tesi and Dr. Lowdell will be instructing a course on the role of the tumor microenvironment (TME) in immunosuppression.

“This panel will bring together other experts from industry and academia to explore the role of the innate immune system in the TME and in cancer drug development,” said Dr. Tesi.

In addition to speaking at the Targeting Innate Immunity Congress this month, Dr. Tesi will also take part in a speaking engagement at the second annual MarketsandMarkets Next Gen Immuno-Oncology Congress on Sept. 19 in Philadelphia.

Below is a schedule of upcoming presentations:

MarketsandMarkets Next Gen Immuno-Oncology Congress
Thursday, September 19 at 11:40 a.m.
“Reversing Trastuzumab Resistance in HER2+ Breast Cancer”
Dr. Tesi will discuss Mucin 4 (MUC4) protein and how it predicts trastuzumab resistance in HER2+ breast cancer, the role of soluble tumor necrosis factor (TNF) in MUC4 expression and how INmune Bio’s drug candidate, INB03 works in combination with trastuzumab to reverse resistance in MUC4/HER+ breast cancer.

Targeting Innate Immunity Congress
Monday, September 24 at 3:30 – 6:00 p.m.
Short Course: “Understanding and Modulating Tumor Microenvironment for Immunotherapy”
Dr. Tesi and Dr. Lowdell will instruct an interactive short course on the role of the tumor microenvironment (TME) in immunosuppression. They will discuss strategies to change the immunosuppressive nature of the TME to one that supports immune responses and enhances the impact of tumor immunotherapy. Those who attend will walk away with an understanding of the following:

  • Role of the TME in immunosuppression
  • Checkpoint inhibitor optimization
  • Targeting of regulatory cells
  • Reprogramming of immunosuppressive cells
  • Modulation of chemokines and cytokines in the TME
  • Modification of tumor-reactive lymphocytes to evade the TME

Wednesday, September 25 at 11:40 a.m.
“Myeloid Derived Suppressor Cell (MDSC): The Queen Bee of the Tumor Microenvironment (TME)”
As part of the “Modulating Macrophages in the Tumor Microenvironment” panel, Dr. Tesi will discuss targeting myeloid derived suppressor cells (MDSCs) as an efficient way to reverse tumor microenvironment (TME) immunobiology. His discussion will address the complexity of TME and how it contributes to failure of therapy, as well as understanding how targeting soluble tumor necrosis factor (TNF) offers a solution to the resistance to therapy when part of combination therapy. Dr. Tesi will also discuss the results of the Phase I trial for INmune Bio’s drug candidate, INB03 in patients with advanced cancer.

Wednesday, September 25 at 1:45 p.m.
“What do Tumor Cells do to NK Cells? – Harnessing the Tumor-NK Interaction for Clinical Benefit”
Dr. Lowdell will participate in the “Advancing Innate Cell Therapies to the Clinic” portion of the conference to discuss how relapsed cancer cells evade natural killer (NK) cells, and how priming NK cells could effectively kill these cancer cells. Dr. Lowdell will also discuss INmune Bio’s INKmune™ drug candidate.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/17/1916773/0/en/INmune-Bio-Invited-to-Speak-on-Company-s-Advancements-in-Cancer-Treatments-at-the-Targeting-Innate-Immunity-Congress-and-MarketsandMarkets-Next-Gen-Immuno-Oncology-Congress.html

Sept. 12, 2019 - INmune Bio Inc. Announces USPTO Allowance of Key Patent Covering Its DN-TNFa Platform Technology for Treating Cancer

INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that reprogram the patient’s innate immune system to fight disease, announced today that the United States Patent and Trademark Office (USPTO) has given formal notice of allowance to Patent Application Serial No. 15/776,061, titled “CANCER PREVENTION AND THERAPY BY INHIBITING SOLUBLE TUMOR NUCROSIS FACTOR”, which covers INmune’s INB03 Program utilizing dominant negative TNFα (DN-TNFα) technology for treating cancer.

“This is an important patent for INmune Bio, Inc. and provides exclusivity for use of our DN-TNFα technology for the treatment of cancer,” said Joshua Schoonover, Assoc. General Counsel of INmune Bio. “With the approval from the USPTO, and the positive indication of allowable subject matter in the international preliminary report on patentability for the corresponding international PCT patent application, published as WO/2017/106278, we expect this patent family should develop into global intellectual property rights.”

INMB has presented preliminary data from the Phase I trial using INB03 in patients with advanced cancer. The study demonstrated the safety of INB03 in cancer patients and showed that INB03 lowered IL6 levels – a biomarker that correlates with neutralization of soluble TNF.

“The inventors of this patent have made an important contribution to the field of cancer biology and cancer therapy,” said RJ Tesi, MD, CEO of INmune Bio. “With the successful completion of the Phase I trial, the company has already begun planning of a Phase II clinical trial in cancer patients where INB03 is used as part of combination immunotherapy.”

The allowed patent application is owned by the University of Pittsburgh and is licensed exclusively to INmune Bio, Inc.

About INB03

INB03, a novel dominant-negative TNFα inhibitor, is a selective second-generation TNFα inhibitor that neutralizes soluble TNFα (sTNFα) without blocking the function of trans-membrane TNFα or TNFα receptors. In animal studies, INB03 neutralization of sTNFα alters the immunobiology of the tumor microenvironment (TME) to improve tumor killing by decreasing populations of cells in the TME that protect the tumor from the patient’s immune system and immunotherapy – myeloid derived suppressor cells, T regulatory cells and tumor activated macrophages. The unique mechanism of action suggests INB03 may have safety and efficacy advantages over currently approved non-selective TNFα inhibitors in the treatment of cancer and other diseases.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/12/1914771/0/en/INmune-Bio-Inc-Announces-USPTO-Allowance-of-Key-Patent-Covering-Its-DN-TNFa-Platform-Technology-for-Treating-Cancer.html

Sept. 05, 2019 - INmune Bio to Present at the H.C. Wainwright 21st Annual Healthcare Conference on Tuesday, September 10th at 2:10 p.m. ET

INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is pleased to announce that R.J. Tesi, M.D., the Company’s Co-founder and CEO, is scheduled to present at the H.C. Wainwright 21st Annual Healthcare Conference in New York City to introduce the NeuLiv™ program for treatment of NASH.

Date: Tuesday, September 10, 2019
Time: 2:10 p.m. – 2:35 p.m. Eastern Time
Location: Lotte New York Palace Hotel in New York City
Room: Louis, 4th Floor
Live webcast: https://inmunebio.com/index.php/en/investors-2/ir-events

Management will be available for one-on-one meetings with investors throughout the event. To schedule a meeting, please contact KCSA Strategic Communications at Inmune@kcsa.com.

An audio webcast of the presentation will be available in the events and presentations section of the Company’s investor relations website.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/05/1911506/0/en/INmune-Bio-to-Present-at-the-H-C-Wainwright-21st-Annual-Healthcare-Conference-on-Tuesday-September-10th-at-2-10-p-m-ET.html

Sept. 04, 2019 - INmune Bio Inc. to Introduce NeuLiv™ Program for Treatment of NASH at H.C. Wainwright 21st Annual Global Investment Conference

INmune Bio, Inc. (NASDAQ: INMB), an immunotherapy company developing treatments that harness the patient’s innate immune system to fight disease, will introduce its NeuLiv™ development program for the treatment of nonalcoholic steatohepatitis (NASH) as part of a presentation at the H.C. Wainwright 21st Annual Global Investment Conference. 

Presentation Details:

Location: The Lotte New York Palace Hotel, NY
Date: Monday, September 9, 2019 at 2:10 p.m. ET
Presentation Room: Louis, 4th Floor

The presentation will be webcast live on September 9 and will remain available for 90 days through the Investor Relations section of INmune Bio’s website.

“NASH presents a significant unmet medical need.  We believe NeuLiv™ may enable us to target the underlying cause of NASH, to help stop the disease and allow the liver to heal,” said RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “NeuLiv precisely targets soluble TNF, a key cytokine driving pathologic chronic inflammation. Unlike treatments focused on addressing fibrosis directly, we believe NeuLiv™ targets peripheral, regional and local causes of innate immune dysfunction that lead to chronic inflammation in patients with NASH. We hope this strategy will prevent progression of the disease and allow hepatic repair mechanisms to function.”

Innate immune dysregulation, also called chronic inflammation, is a low-grade inflammatory state that, over time, has detrimental effects on organs, including the liver and brain. NeuLiv™, which is the third drug development program originating from INmune Bio’s DN-TNF platform, is a next generation TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors.  By targeting soluble TNF, NeuLiv may alter the complex immunobiology that causes the development and progression of NASH. 

NASH is a progressive disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in fibrosis that can lead to cirrhosis, liver failure, cancer and death. By 2020, NASH is projected to become the leading cause of liver transplants in the U.S. No medications are currently approved for the treatment of the disease.

About INmune Bio’s DN-TNF Clinical Development Programs

INmune Bio has active development programs in Alzheimer’s disease and oncology originating from the DN-TNF platform. XPro1595 is set to begin this quarter a Phase I clinical trial in patients with mild-to-moderate Alzheimer’s disease who have biomarkers of neuroinflammation to determine if neutralizing soluble TNF can decrease those biomarkers. In addition, INB03 just completed a Phase I open label, dose escalation trial in patients with advanced cancer and will move to Phase II studies in the first half of next year.

For Full Press Release – https://www.globenewswire.com/news-release/2019/09/04/1910877/0/en/INmune-Bio-Inc-to-Introduce-NeuLiv-Program-for-Treatment-of-NASH-at-H-C-Wainwright-21st-Annual-Global-Investment-Conference.html

Aug. 12, 2019 - INmune Bio Reports Second Quarter 2019 Financial Results and Provides Shareholder Update

 INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today reported its financial results for the second quarter ended June 30, 2019 and is providing a business update for the year-to-date.

2019 Year-to-Date Corporate Highlights:

  • INmune Bio’s management team rang the NASDAQ closing bell on Tuesday, April 9, 2019, to celebrate the Company’s successful initial public offering (“IPO”) in February 2019.
  • In May, the Company closed a private placement of approximately $4.7M of Common Stock priced led by Insiders and existing shareholders.
  • The Company published data on INmune Bio’s INB16 (INKmune) cell line in peer-reviewed journal PLOS ONE.
  • Reported positive preliminary data from INB03 Phase I clinical trial in cancer followed by a final report later this year as the Company advances the program into a Phase II study.
  • Edguardo (Ed) Baracchini a biotech business development veteran joined the board of directors.

“This year we remained focused on advancing our pipeline,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “More recently we announced we have begun planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study.  This preliminary data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate our full data set to be reported later this year followed by a Phase II study.”

Our clinical programs continue to advance:

  • Received preliminary positive data on INB03’s Phase I study in patients with advanced solid tumors. The trial was successful in determining, in order of priority, the safety of INB03 in cancer patients, the adequate dosage of INB03, and evidence of a biologic effect, as the Company begins planning a Phase II trial in cancer patients using INB03 as part of their combination immunotherapy. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03. 
  • INmune anticipates it will start patient enrollment in the Phase I study of XPro1595 for the treatment of Alzheimer’s disease and INKmune, INmune Bio’s NK cell therapy focused on eliminating residual disease after cancer therapy, in the second half of 2019.

Financial Results for the Second Quarter Ended June 30, 2019:
Net loss attributable to common stockholders for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially offset by noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30, 2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer’s Association which the Company recognized as contra research and development expense.

General and administrative expense was approximately $1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018.  The $4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including investor relations and payroll expense.

At June 30, 2019, the Company had cash and cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.

As of August 9, 2019 the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.

For Full Press Release – https://www.globenewswire.com/news-release/2019/08/12/1900480/0/en/INmune-Bio-Reports-Second-Quarter-2019-Financial-Results-and-Provides-Shareholder-Update.html

Aug. 08, 2019 - INmune Bio Appoints Biotechnology Executive Edgardo Baracchini as New Board Member

INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is pleased to announce that Edgardo (Ed) Baracchini, Ph.D., has joined the company’s board of directors.

“Ed is a fantastic addition to our board of directors,” said RJ Tesi, MD, INmune Bio’s Chief Executive Officer and Chief Medical Officer. “He brings extensive business development and deal-making experience to the company, which is a critical skill set, as we continue to advance our three drug candidates through clinical trials.”

Dr. Baracchini has an impressive biotech business development background with over 25 years of experience in structuring and negotiated research and development partnerships, mergers, acquisitions and licensing agreements.  He has negotiated over 80 business transactions with multinational pharmaceutical firms, biotechnology companies and prominent universities which resulted in transactions valued in excess of $5.3 billion.  He currently serves on the board of 4D Pharma PLC, as was previously Chief Business Officer of Xencor, Inc. (Nasdaq: XNCR), a biopharmaceutical company focused on autoimmune diseases. Prior to this, Dr. Baracchini was associated with Metabasis Therapeutics, where he quickly moved from the role of Vice President to Senior Vice President of Business Development.

“INmune Bio has very exciting clinical trials in cancer and Alzheimer’s disease,” said Baracchini. “I am looking forward to working closely with its seasoned leadership team, each of whom have demonstrated their own track record of success.”

For Full Press Release – https://www.globenewswire.com/news-release/2019/08/08/1899220/0/en/INmune-Bio-Appoints-Biotechnology-Executive-Edgardo-Baracchini-as-New-Board-Member.html

Aug. 05, 2019 - INmune Bio Reports Positive Preliminary Data from INB03 Phase I Clinical Trial in Cancer

 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported positive preliminary data today during a presentation at Cambridge Healthtech Institute’s 7th Annual Immuno-Oncology Summit in Boston. INB03 is being developed as part of combination immunotherapy to potentially reverse resistance to treatment.

The Phase I trial is an open-label, dose-escalation trial in patients with advanced solid tumors. Patients received INB03, a novel, second-generation soluble TNF (tumor necrosis factor) inhibitor that works by a dominant-negative technology. Today, positive preliminary data from the first two cohorts were released. These data will be followed by a final report later this year as the company advances the program into a Phase II study. 

“The goal of the Phase I study is to determine, in order of priority, the safety of INB03 in cancer patients, the dose of INB03 to take into the Phase II trials in cancer, and evidence of a biologic effect of INB03,” said RJ Tesi, MD, Chief Executive Officer and Chief Medical Officer of INmune Bio. “All of these goals have been met. Using data from this trial, we have begun planning a Phase II trial using INB03 as part of combination immunotherapy in patients with cancer.” 

To date, 11 of 12 patients have been enrolled in one of three dosing cohorts of INB03 (0.3, 1.0 and 3.0 mg/kg). Participants were a mix of patients with advanced solid tumors that have progressed after multiple previous lines of therapy. INB03 was given once a week by subcutaneous injection. Safety, INB03 pharmacokinetics and inflammatory biomarkers were followed in all patients. 

Preliminary data from patients treated in the first two cohorts are available. Patients included two males and four females, and the average age was 63-years-old. Patients in the study had prostate cancer, ovarian cancer, colon cancer (two), cholangiocarcinoma and lung cancer, with an average of three previous lines of therapy (range: two to four). INB03 was given for a median of 74 days (range: 12 to 119 days). No drug-related serious adverse events have been reported, and INB03 was well tolerated. Discontinuation of INB03 was due to tumor progression in all patients. INB03 trough drug levels were obtained before each INB03 dose. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

About INB03
INB03, a novel dominant-negative TNF inhibitor, is a selective second-generation TNF inhibitor that neutralizes soluble TNF (sTNF) without blocking the function of trans-membrane TNF or TNF receptors. In animal studies, INB03 neutralization of sTNF alters the immunobiology of the tumor microenvironment (TME) to improve tumor killing by decreasing populations of cells in the TME that protect the tumor from the patient’s immune system and immunotherapy – myeloid derived suppressor cells, T regulatory cells and tumor activated macrophages. The unique mechanism of action suggests INB03 may have safety and efficacy advantages over currently approved non-selective TNF inhibitors in the treatment of cancer and other diseases.

For Full Press Release – https://www.globenewswire.com/news-release/2019/08/05/1896903/0/en/INmune-Bio-Reports-Positive-Preliminary-Data-from-INB03-Phase-I-Clinical-Trial-in-Cancer.html

11 Comments
  1. Samantha Barrios 3 weeks ago
    Reply

    Proper exercise, It is already known that exercise boosts your brain’s ability to make more neurons, this research shows it is mediated by a factor(s) that is present in blood #Alzheimers #brainhealth

    “Runner Plasma” Jogs Neurogenesis, Quells Neuroinflammation in Mice

    • Peter Ma 3 weeks ago
      Reply

      making sure the cancerous cells don’t come back is the most important thing for those that have beat cancer

    • Wyatt Stovall 5 days ago
      Reply

      what about Bitter Melon. Its been showing promise in the treatment of cancer. Studies showing a 51% reduction in cancer cell proliferation.

  2. Haumin Lum 3 weeks ago
    Reply

    picked up a starter, I’d like to see it hold $5.5, plenty of room to bounce from here back to August price levels

  3. John Reznick 3 weeks ago
    Reply

    strengthening the immune system is one of the most natural and optimal ideas to fight cancer, but you also have to cut out foods that are high in carcinogens

  4. Jaydee Chen 3 weeks ago
    Reply

    What is the price point of Inkmune if it were available to the masses?

  5. Gurjant Singh 2 weeks ago
    Reply

    When #DNA in our cells gets damaged, our body uses DNA Damage Response (DDR) to fix it. But what if it could also patch up broken #cancer cell DNA?

  6. Kevin Hincks 1 week ago
    Reply

    $INMB sub $4, a technical rebound could bounce this nicely.

    • Carmen Liu 1 week ago
      Reply

      picked up some below $3.6, wish me luck. Looking for a bounce

      • Watson Chen 6 days ago
        Reply

        Would like a hold above $4, a V bounce over $6 would be ideal.

        • Fernando Hernandez 9 hours ago
          Reply

          Over 1 Point reversal so far on $INMB, looks like it can go more, not so sure about reaching the PT of $6 though.

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