On November 1, 2024 Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., reported to have received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration (Press release, Shenzhen Chipscreen Biosciences, NOV 1, 2024, View Source [SID1234647640]). The company’s self-developed original new drug, Chiauranib, combined with PD – (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials.

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Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential.

In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States.

About Chiauranib

Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate.

Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile.

On November 1, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that REFRαME-P1, the registration-directed study of luveltamab tazevibulin (luvelta) for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), has been initiated and is open for enrollment (Press release, Sutro Biopharma, NOV 1, 2024, View Source [SID1234647639]).

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"We are excited to announce the initiation of our second pivotal trial, the registration-enabling clinical trial of luvelta in infants and toddlers with a rare and aggressive form of leukemia," said Anne Borgman, M.D., Sutro’s Chief Medical Officer. "We look forward to bringing this promising targeted therapy to a pediatric patient group with limited effective treatment options."

"Beginning this trial is an important next step in the clinical development pathway for luvelta, as it has the opportunity to address the unmet in many types of cancer that express Folate Receptor-α (FRα) beyond ovarian," said Soheil Meshinchi, M.D., Ph.D. "With my focus on the biology of AML, I am honored to have been a part of making this medicine available to patients in dire need via a compassionate use mechanism sponsored by Sutro, through which we have seen encouraging results in this devastating disease."

In December 2023, Dr. Meshinchi presented data on anti-leukemic activity from the compassionate use of luvelta in 25 pediatric patients with relapsed/refractory CBFA2T3-GLIS2 (CBF/GLIS) acute myeloid leukemia (AML) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Data demonstrated that treatment with luvelta produced meaningful clinical responses, including complete remission in 42% of patients with ≥5% blasts, and prolonged overall survival, enabling some patients to receive hematopoietic stem cell transplant, a potentially curative therapy.

CBF/GLIS subtype AML is a rare and highly lethal form of leukemia found exclusively in infants and young children, with the average age of onset at 18 months1. There are no therapies specifically approved to target this form of leukemia and it is resistant to conventional chemotherapy, with an induction failure rate of over 80%2. Due to a lack of effective treatment, children diagnosed with the disease have a dismal two-year survival rate3. Recent studies have shown that FOLR1, which encodes for FRα, is silent in normal hematopoiesis, but is uniquely induced by the CBF/GLIS gene fusion4.

REFRaME-P1 is a registration-enabling study evaluating the efficacy and safety of luvelta in infants and children under 12 years of age with CBF/GLIS AML. This will be a global study, with the majority of sites planned to be open by the end of the year.

About Luveltamab Tazevibulin
Luveltamab tazevibulin, abbreviated as "luvelta" and formerly known as STRO-002, is a FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. Developed and manufactured with Sutro’s cell-free XpressCF platform, luvelta is a homogeneous ADC with four hemiasterlin cytotoxins per antibody, precisely positioned to efficiently deliver to the tumor while ensuring systemic stability after dosing. REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer is ongoing. The Company has another ongoing registration-directed trial, REFRαME-P1, for patients with CBF/GLIS acute myeloid leukemia, a rare subtype of pediatric cancer, as well as additional ongoing trials in patients with endometrial cancer, non-small cell lung cancer, and in combination with bevacizumab in patients with ovarian cancer. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS Pediatric AML.

On November 1, 2024 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in the following upcoming investor conferences (Press release, Syndax, NOV 1, 2024, View Source [SID1234647638]):

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Guggenheim’s Inaugural Healthcare Innovation Conference in Boston, MA with a fireside chat on Wednesday, November 13, 2024, at 1:30 p.m. ET
UBS Global Healthcare Conference in Ranchos Palos Verdes, CA with a fireside chat on Thursday, November 14, 2024, at 10:15 a.m. ET / 7:15 a.m. PT
Stifel 2024 Healthcare Conference in New York, NY with a fireside chat on Monday, November 18, 2024, at 1:50 p.m. ET
Jefferies London Healthcare Conference in London, UK, November 20-21, 2024
A live webcast of the fireside chats will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

On November 1, 2024 Prokarium, a biopharmaceutical company developing innovative cancer treatments, reported the receipt of two Notices of Allowance from the United States Patent and Trademark Office (USPTO) (Press release, Prokarium, NOV 1, 2024, View Source [SID1234647637]). These patents, covering applications Nos. 17/752,707 and 18/559,543, strengthen Prokarium’s mission to develop innovative, scalable therapies that address critical gaps in cancer treatment.

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Application No. 17/752,707 protects the co-administration of Prokarium’s proprietary Salmonella strains with immune checkpoint inhibitors to enhance the checkpoint inhibitors therapeutic efficacy. "This patent, alongside our granted patent in combination with cell therapies, is a significant step toward scaling our technology’s potential in the oncology space," said Dr. Livija Deban, CSO at Prokarium. "By advancing our technology to amplify the effects of immune checkpoint inhibitors, we’re demonstrating a value proposition that investors and partners can rely on as we work towards scalable, impactful cancer treatments."

Application No. 18/559,543 protects an advanced Salmonella-based method for treating neoplastic diseases by promoting a robust immune response along with targeted anti-tumor action. "This patent bolsters our IP portfolio and, more importantly, creates a stronger foundation for our clinical program in bladder cancer," said Kristen Albright, PharmD, Chief Executive Officer at Prokarium. "Together, these innovations represent a major value driver for the company, strengthening our position to attract strategic partners and investors as we address large, underserved markets in cancer immunotherapy."

On November 1, 2024 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and 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 September 30, 2024 and provides a business update (Press release, INmune Bio, NOV 1, 2024, View Source [SID1234647636]).

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Q3 2024 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● Announced completion enrollment for its Phase 2 Alzheimer’s Disease ("AD") trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the "AD02 trial") is focused on patients with Early AD and biomarkers of elevated neuroinflammation. Enrollment of new patients into the trial was concluded after the Company determined that there are sufficient patients currently in screening to meet the trial’s target of 201 patients. All patients currently in the screening process will remain eligible to participate in AD02, which will likely result in modest over-enrollment.

● Announced that results of interim analysis of blinded data from its AD02 trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), an accepted endpoint for AD trials. Key findings of the analysis included:

● Statistical Correlation: An independent review confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, the secondary endpoint in the AD02 trial. CDR-SB is the clinical rating scale most used in AD registration studies.

● Reliability: The correlation of EMACC when measured during the screening process and again at the first study visit before treatment was found to be 0.93. Higher precision produces results that are more robust and replicable with smaller sample sizes.

● Differentiation Capability: The difference in EMACC performance between patients with CDR global ratings of 0.5 (prodromal AD) and those rated 1.0 (mild dementia) was very large, with an effect size (Cohen’s d) of 0.87 (p<.0001). This demonstrates EMACC’s ability to accurately differentiate between disease stages, highlighting its sensitivity and precision.

● Announced publication in Cell Reports, "Microglia Regulate Cortical Remyelination via ΤNFR1-Dependent Phenotypic Polarization." Myelin is necessary for fast and efficient communication between neurons. Loss of myelin compromises neuron function and communication and is a key step in the neurodegenerative process of many CNS diseases, including Alzheimer’s Disease. Data from the publication identifies soluble TNF as a critical cytokine checkpoint that converts microglia from a reparative, remyelinating cell to a damaging, demyelinating cell. These data suggest that blocking soluble TNF is a promising strategy for treating demyelinating diseases.

● Announced Webinar on Cognitive Testing using EMACC and CSD-SB to be held on November 7, 2024, at 1PM ET. Click Here to Register

INKmune Platform:

● Announced that INKmune demonstrates excellent safety and increased NK-Cell activity in first dosing cohort, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic Castration-Resistant Prostate Cancer (mCRPC). Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK cell activity and function.

● There have been 21 administrations of INKmune in the mCRPC study given on an out-patient basis, with no significant adverse events including zero cases of cytokine release syndrome (CRS). Combining the experience with INKmune from the MDS/AML and mCRPC trials, over 30 infusions of INKmune have been given safely without the need for conditioning therapy, pre-medication, or cytokine support.

● The CaRe PC trial has recently dosed the first patient in the highest dose cohort and opened the phase II enrolment for subjects in the intermediate dose group. The dose of INKmune in the intermediate and high dose cohorts is 3 and 5 times the dose of INKmune in the first cohort. All eight clinical sites are now open and additional results from the trial will be released from the higher dose cohorts as they become available.

● Published landmark paper in Journal Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) led by Mark Lowdell, PhD, INmune’s Chief Scientific Officer, titled, Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmuneTM priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers further supporting INKmune’s in vivo treatment methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and solid tumors.

● Announced new formulation of INKmune that supports highest trial dose with single bag administration and expansion of bioreactor capacity in preparation of scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA that also includes additional validation data supporting an alternative critical reagent used in INKmune manufacturing, improving supply chain redundancy.

Corporate:

● Executed securities purchase agreements with new and existing institutional investors and certain directors and officers and employees of the Company for gross proceeds of approximately $13.0 million.

● Added to the broad-market Russell 3000 Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of Monday, July 1st, 2024.

● Received a $2.5 million research and development rebate from Australia in July.

Upcoming Events and Milestones:

● Top-line data from the Phase 2 Alzheimer’s trial is expected in the second quarter of 2025.

● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression 2H 2024.

● Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial by year-end. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available.

Financial Results for the Third Quarter Ended September 30, 2024:

● Net loss attributable to common stockholders for the quarter ended September 30, 2024 was approximately $12.1 million, compared to approximately $8.6 million during the quarter ended September 30, 2023.

● Research and development expenses totaled approximately $10.1 million for the quarter ended September 30, 2024, compared to approximately $6.0 million during the quarter ended September 30, 2023.

● General and administrative expenses were approximately $2.2 million for the quarter ended September 30, 2024, compared to approximately $2.6 million during the quarter ended September 30, 2023.

● As of September 30, 2024, the Company had cash and cash equivalents of approximately $33.6 million.

● As of October 31, 2024, the Company had approximately 22.2 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 Second Quarter Conference Call when reaching an operator.

Date: October 31, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): 1-203-518-9843
Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link: INmune Bio, Inc. Third Quarter 2024 Earnings Call – 1692115

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11156467.