On August 7, 2023 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 quarter ended June 30, 2023 and provides a business update (Press release, INmune Bio, AUG 7, 2023, View Source [SID1234633975]).

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Q2 2023 Corporate Highlights:

DN-TNF Platform Highlights (XPro and INB03):

● AD02 blinded randomized program in patients with Early Alzheimer’s Disease (AD) continues to enroll in Australia and Canada. The company is actively pursuing other regulatory venues to expand the clinical trial footprint. Discussions with the FDA have provided a clear pathway to lifting the clinical hold before the end-of-year.

● Announced expansion of novel MRI biomarker data to include gray matter. Gray matter, the portion of the brain containing nerve cell bodies, has historically been the focus of Alzheimer’s disease research and drug development. Previous MRI biomarker analysis from patients receiving XPro for treatment of AD has demonstrated early changes in white matter that predict presence of neuroinflammation and response to XPro therapy. The new data, reported at the annual Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands in July, demonstrates improvement in gray matter in patients with AD. The results demonstrate a dose dependent enhancement in gray matter measures in the brain in AD patients treated with XPro. The data confirm that neuroinflammation affects white and gray matter of the brain. Treatment with XPro resulted in improvements in both white and gray matter microstructural elements that may predict improvements in cognition. The data further validate the biomarker package associated with the on-going Phase II trial in patients with Early AD.

● Presented data in early July at the 16th European Meeting on Glial Cells in Health and Disease in Berlin that show that XPro promotes remyelination by affecting astroglial and microglial biology. Myelin is a specialized lipid produced by oligodendrocytes that forms the myelin sheath of axons. Axons are the projections that allow neurons to communicate with each other and with other tissues such as muscle, skin, retina, nose, and the ear for sight, smell, and hearing respectively. An intact and healthy myelin sheath is necessary for axons to allow neurons to communicate with each other and work properly. Drug therapies to prevent demyelination are available, but there are no therapies that promote remyelination. Therapies that promote remyelination will be needed to effectively treat many neurodegenerative diseases and is increasingly recognized as part of the pathology associated with Alzheimer’s disease. The Company plans a webinar on highlighting the importance of remyelination therapy in patients with MS and AD before the end-of-year.

● Presented additional data on combination of INB03 with trastuzumab-deruxtecan (Enhertu, TDxd) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual scientific meeting in April showing that triple negative breast cancer (TNBC) often express MUC4. MUC4-expressing cancers, breast cancer, HER2+ breast cancer, TNBC, gastric, and pancreatic cancer, are candidates for combination therapy with DN-TNF. In pre-clinical models, INB03 reduced MUC4 expression to decrease resistance to immunotherapy including tyrosine kinase inhibitors (TKI), trastuzumab and TDxd. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing in preparation for a strategic partnering program in oncology.

● The polysarcosine (pSar) DN-TNF program converts XPro from a single drug into a DN-TNF drug platform. Polysarcosine is a novel half-life extender that effectively replaces the PEG half-life extender used in XPro. The pSar program is an essential part of INmune Bio’s business development efforts. XPro has been designated for the CNS programs, including AD, TRD, ALS and other neurological diseases. The pSar program provides at least three new DN-TNF biologics that are eligible for composition-of-matter IP and have unique biologic characteristics that allow partnering DN-TNF opportunities beyond CNS, such as oncology (INB03), Duchenne’s Muscular Dystrophy (DMD), and other disease indications. Each drug is a novel DN-TNF compound that will require a unique development program.

INKmune Platform:

● IND cleared by the Food & Drug Administration (FDA) in May for INKmune for a Phase I/II open label trial in metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial is expected to enroll the first of 30 patients in the final quarter of 2023. Patients will receive three infusions of INKmune as out-patient treatment during the six-month trial. Three doses of INKmune are being tested in a modified Bayesian Phase I/II trial to answer four questions:

● Is INKmune safe in patients with mCRPC?

● What dose of INKmune should be used in a blinded randomized pivotal trial in men with mCRPC?

● How long can the effects of INKmune be sustained, (Determined by measuring tumor killing NK cells in the blood called memory like NK cells).

● Is there a tumor response to INKmune therapy? Measures of tumor response include blood PSA and tumor DNA levels in the patient’s blood and PMSA PET scan. The results of the open label study should allow the Company to design a pivotable trial.

● LAUREL, the INKmune trial in high risk MDS and AML has opened a third clinical site in Athens, Greece. The site is screening patients and expects to enroll patients soon. Changing management of high risk MDS patients in the UK has resulted in screen failures. The cause of these screen failures has been identified and addressed to help increase recruiting of patient into LAUREL. The Company is seeking to modify the trial enrollment criteria to increase the pool of potential patients to drive recruitment.

● CSO Dr. Mark Lowdell gave the opening plenary presentation in the Presidential Session at the annual International Society of Cell & Gene Therapy (ISCT) where he presented the scientific discovery of INKmune and development to clinical trials. His talk highlighted that NK cells primed by INKmune have the ability to alter their phenotype to a cancer-killing population of memory-like NK cells that differ from single-cytokine or multiple-cytokine (IL-12, IL-15, IL-18) primed NK cells. This innovation avoids the cost and complications associated with cytokine therapy and produces NK cells ideally suited for attacking cancer.

Upcoming Events and Milestones:

● Top-line results for the Phase II XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease are expected towards the end of 2024.

● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review.

● Webinar on using XPro to promote remyelination in AD and MS before end-of-year.

● Additional open-label Phase I trial data of INKmune in high-risk MDS/AML in 2023.

● Opening of a Phase I/II trial in a prostate cancer in the second half of 2023.

2

Financial Results for the Quarter Ended June 30, 2023:

● Net loss attributable to common stockholders for the quarter ended June 30, 2023, was approximately $6.5 million, compared to approximately $6.8 million during the quarter ended June 30, 2022.

● Research and development expenses totaled approximately $4.1 million for the quarter ended June 30, 2023, compared to approximately $4.2 million during the quarter ended June 30, 2022.

● General and administrative expense were approximately $2.3 million for the quarter ended June 30, 2023, compared to approximately $2.2 million during the quarter ended June 30, 2022.

● Other expense was approximately $0.1 million for the quarter ended June 30, 2023, compared to approximately $0.5 million during the quarter ended June 30, 2022.

● As of June 30, 2023, the Company had cash and cash equivalents of approximately $47.8 million.

● As of August 7, 2023, the Company had approximately 18.0 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching an operator.

Date: August 7, 2023

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-877-404-0784 Participant Dial-in (international): 1-201-689-8560 Conference ID: 13739436

A live audio webcast of the call can be accessed using this link or clicking here:

View Source;tp_key=3e16bba085

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 14 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13739436.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential 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.

On August 7, 2023 Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported that eClinical Medicine(IF:15.1), a sub-journal of The Lancet, recently published the results of a phase II clinical trial of ivonescimab(PD-1/VEGF bispecific antibody) combined with chemotherapy for the treatment of non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, AUG 7, 2023, View Source [SID1234633898]). The study was led by Professor Li Zhang of the Sun Yat-Sen University Cancer Center.

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Full article: View Source

Ivonescimab is the world’s first PD-1/VEGF bispecific antibody for which a New Drug Application (NDA) has been submitted. Based on the published results, the combination of ivonescimab and platinum-doublet showed promising antitumor activity for first-line treatment of advanced NSCLC without driver mutation, as well as for advanced NSCLC patients with EGFR-activating mutation that failed prior EGFR-TKI therapy. Additionally, AK112 in combination with docetaxel has shown favorable antitumor activity in advanced NSCLC patients who failed prior treatments with systemic platinum-based chemotherapy and PD-1/L1 inhibitor.

Following the acceptance of marketing application for an indication of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug and two international multicenter Phase III clinical trials:

An international multicenter Phase III study (HARMONi) of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy. This study was led by Professor Li Zhang. Akeso’s partner, Summit Therapeutics("Summit"), has completed the first patient dosing in the United States.
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC is conducted in the United States (HARMONi-3). Summit intends to dose the first patient in the second half of 2023.
A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression in China is undergoing. The enrollment will be completed soon.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy is undergoing.
It is also notable that owing to its remarkable clinical value, ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications:

Ivonescimab combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who progressed on EGFR-TKI treatment.
Ivonescimab as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression.
Ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.

On August 7, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", Nasdaq: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseases, reported that it has entered into a purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of (i) 138,900,000 ordinary shares of the Company (the "Ordinary Shares") (equivalent to 27,780,000 of the Company’s American depositary shares ("ADSs")), at a purchase price equivalent to $3.60 per ADS, and (ii) warrants to purchase up to 44,802,870 Ordinary Shares (equivalent to 8,960,574 ADSs) (the "Warrants") at an exercise price equivalent to $5.58 per ADS, representing a 55% premium to the purchase price of Ordinary Shares (Press release, Gracell Biotechnologies, AUG 7, 2023, View Source [SID1234633897]). Gracell will receive $100 million in proceeds from the private placement of Ordinary Shares, and up to an additional $50 million if the Warrants are fully exercised. The Warrants will remain exercisable at the election of the investors within 24 months after the closing of the private placement. The financing is expected to close on August 10, 2023, subject to customary closing conditions.

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The oversubscribed transaction includes participation from new and existing institutional investors and is being led by Vivo Capital, with participation from investors including Adage Capital Partners LP, Exome Asset Management, Janus Henderson Investors, Logos Capital, OrbiMed, Pivotal Life Sciences, RA Capital Management and TCGX.

"We are pleased that this high-quality healthcare investor group came together to support Gracell and our innovative and potentially best-in-class CAR-T therapies," said Dr. William Wei Cao, founder, Chairman, and CEO of Gracell. "We thank the investors for their confidence in the broad potential of our FasTCAR-T GC012F candidate for hematological cancers and autoimmune diseases, and their support for our mission to develop revolutionizing cell therapies. These additional funds should allow us to achieve critical milestones in the clinical development of GC012F in multiple myeloma and systemic lupus erythematosus."

Gracell intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and other general corporate purposes. The aggregate proceeds from this proposed financing, combined with current cash, cash equivalents, is expected to be sufficient to fund the current operating plan into the second half of 2026.

The Securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file registration statements with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares issuable in connection with this private placement, including upon exercise of the Warrants.

Jefferies, Evercore ISI and Wells Fargo Securities are acting as the placement agents for the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On August 7, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company’s breast cancer vaccine with Keytruda (pembrolizumab) (Press release, Anixa Biosciences, AUG 7, 2023, View Source [SID1234633896]). An expansion of the ongoing Phase 1 dose escalation trial of Anixa’s breast cancer vaccine, this treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.

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Anixa’s breast cancer vaccine is designed to generate T cells that target triple negative breast cancer ("TNBC"). Keytruda, a therapy marketed by Merck (NYSE: MRK), is approved for use with chemotherapy before surgery and then alone after surgery to treat both high-risk early-stage and advanced TNBC.

Keytruda is a type of immunotherapy known as a checkpoint inhibitor. T cells, a type of white blood cell involved in the body’s immune system, have receptor proteins on their surface called checkpoints. These checkpoints are utilized by other immune cells to modulate the activity of T cells. Cancer cells, such as TNBC cells, have developed mechanisms to target checkpoints to inhibit the activity of T cells, as well as other immune cells. This inhibition enables the cancer cells to escape destruction by cytotoxic T cells. One of these key checkpoint receptors is known as PD-1 (Programmed Cell Death Protein-1). TNBC, like many other cancers, expresses a protein that binds to the PD-1 protein on T cells and essentially turns them "off." Keytruda is a monoclonal antibody, which blocks the ability of the cancer cells to inactivate T cells by shielding the PD-1 receptor.

Dr. Amit Kumar, Chairman and CEO of Anixa stated, "Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect. If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent. We are grateful to the U.S. Department of Defense for providing the funding for this new arm of the trial and look forward to Cleveland Clinic’s presentation of the updated data from this trial at the San Antonio Breast Cancer Symposium (SABCS) in December."

About Anixa’s Breast Cancer Vaccine Clinical Trial
The Phase 1a study is designed to evaluate the safety of the vaccine, identify the Maximum Tolerated Dose (MTD), and monitor the immune response in vaccinated women. All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care. At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence.

About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

On August 7, 2023 Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported the formation of a Scientific Advisory Council as the company intensifies its plans for next phase of development (Press release, Medivir, AUG 7, 2023, View Source [SID1234633895]).

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In February, Medivir announced positive, preliminary results from the dose escalation cohorts of its candidate drug fostrox, in combination with Lenvima and initiated the phase 2a expansion cohort. Fostrox, designed to selectively treat liver cancers while minimizing systemic side effects, has the potential to become the first liver-targeted and orally administered drug for patients with hepatocellular carcinoma (HCC). The Scientific Advisory Council will work closely with Medivir to design the next phase of clinical development.

– "I am truly honored that we have been able to attract some of the world’s leading experts in liver cancer to our Scientific Advisory Council. As underlined by the outcome of the dose escalation cohorts and the swift recruitment in the ongoing dose expansion, it is an exciting time in the development of fostrox. The Scientific Advisory Council, with its expertise and deep clinical experience will be critical in moving the clinical development of fostrox forward," says Dr. Pia Baumann, CMO at Medivir.

– "Despite recent advancements in the treatment of HCC, a significant unmet medical need remains. Patients with advanced HCC have an underlying liver disease that can negatively impact their ability to benefit from systemic, medical treatments. Fostrox, with its unique, liver-targeted mechanism has the potential to minimize the tumor burden locally in the liver and provide synergistic activity with existing medical treatments and improve the anti-tumor activity" says Dr. Richard Finn, Professor of Medicine at the Geffen School of Medicine at UCLA.

The members of Medivir’s Scientific Advisory Council;

Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program.

Dr. Richard Finn is a Professor of Medicine at the Geffen School of Medicine at UCLA Department of Medicine, Division of Hematology/Oncology. Dr. Finn splits his time between patient care and directing the Translational Research Laboratory in the Division of Hematology/Oncology. His research interests are focused on the development of targeted therapeutics for solid tumors across histologies. Dr Finn has been the primary investigator of several, ground-breaking studies in HCC, including the ground-breaking ImBrave 150 study.

Dr. Jeong Heo is a Professor of Internal Medicine at Pusan National University School of Medicine and Director of Gastroenterology and Hepatology at Pusan National University Hospital. During his career, Professor Heo has held a number of academic positions, university and hospital appointments and has been principal investigator in many clinical trials for phase I-IV of hepatitis B, C and hepatocellular carcinoma. He is an investigator in the fostrox clinical program.

Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program.

Dr. Arndt Vogel is managing senior consultant and Professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. He is also head of the GI-Cancer Center and of the Center for Personalized Medicine at Medical School Hannover. His scientific focus is the translational and clinical research in gastrointestinal cancer. Professor Vogel is member and chairman of Hepatobiliary Cancer Study Group of the AIO, a collaborative group in clinical oncology in Germany. Within ESMO (Free ESMO Whitepaper), he is member of the ESMO (Free ESMO Whitepaper) Guidelines Steering Committee. Furthermore, Professor Vogel has responsibilities in the establishment of the national guideline and is the coordinator of the ESMO (Free ESMO Whitepaper) clinical practice guideline on the management of hepatocellular carcinoma and biliary tract cancer.