On February 23, 2022 The Life Raft Group reported that we continue highlighting recent clinical trials that are still recruiting in the U.S. which investigate potential treatments for GIST patients (Press release, The Life Raft Group, FEB 23, 2022, View Source [SID1234609028]). Our GIST Trials Database lists over 70 trials that are GIST-related and ongoing around the world . Currently there are 12 GIST-related trials recruiting in the United States. In our last article, we listed several for different types of GIST mutations. You can read the previous clinical trials update (December 2021) here:
View Source

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For further information about GIST trials including international trials, visit: The Life Raft Group Clinical Trials Website: View Source If you want to speak with someone about clinical trials, please contact [email protected].

For patients with advanced KIT/PDGFRa mutant GIST:

THE-630 Phase 1/2 – ""A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)" (View Source)

Site is at Dana-Farber Boston, MA Principal Investigator Suzanne George. Started January 3, 2022. The study will be conducted in two parts: a dose escalation phase, followed by an expansion phase. Plans to recruit 160 over a period of 42 months.

In the Phase 1 dose escalation phase oral THE-630 will be administered once daily in a continuous regimen. Primary objectives during the 28-day dose escalation phase are: 1. Number of patients with dose-limiting toxicities. 2. Determination of the recommended Phase 2 dose. 3. Determination of the maximum tolerable dose. 4. Safety analysis – number of participants with treatment emergent adverse events. For the subsequent expansion Phase 2 the primary objective is confirmed Objective Response Rate over a period of up to 24 months after first dose. In the escalation Phase 1 participants with metastatic or unresectable GIST will be admitted.

During the Expansion Phase 2 unresectable or metastatic GIST patients will be divided into 4 cohorts depending on prior TKI therapy. Cohort 4 will include patients who have progressed on or are intolerant to imatinib including patients in the adjuvant setting. The sponsor is Theseus Pharmaceuticals headquartered in Cambridge, MA. Theseus was founded in 2017 and emerged from stealth mode in 2021. On their web page Theseus describes THE-630 as "Our lead program, THE-630, is a pan-variant KIT inhibitor designed for patients with advanced gastrointestinal stromal tumors (GIST) whose cancer has developed resistance to earlier lines of kinase inhibitor therapy." Patients interested in this clinical trial can contact: Theseus Pharmaceuticals, 857-400-9491, [email protected]. NCT05160168

About Phase 1 trials: It is important to recognize that Phase I studies are held to find the highest dose
of the new treatment that can be given safely without causing severe side effects.

• The first few people in the study get a very low dose of the treatment and are watched very closely. If there are only minor side effects, the next feaw participants get a higher dose. This process continues until doctors find a dose that’s most likely to be and effective treatment while having an acceptable level of side effects.

• Safety is the main concern. The research team monitors participants and watches for severe side effects. Due to the small numbers of people in Phase I studies, rare side effects may not be seen until later phases of the trial when more people are receiving the treatment.

• While some people may benefit from being on one, disease response is not the main purpose of a Phase I trial.

Phase I trials carry the most potential risk, but these studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join Phase I trials when all other treatment options have already been tried.

On February 23, 2022 Simcere Pharmaceutical Group (2096.HK) reported that the phase III clinical registration study of Trilaciclib in patients with extensive-stage small cell lung cancer (ES-SCLC) has met its primary endpoint (Press release, Jiangsu Simcere Pharmaceutical Company, FEB 23, 2022, View Source [SID1234609015]). The drug co-developed in China by Simcere and G1 Therapeutics is the world’s first comprehensive myeloprotective drug in treating ES-SCLC. The latest data has shown a significantly decrease in duration of severe neutropenia of patients receiving chemotherapy in Cycle 1. Further data are scheduled to be presented in academic conferences later this year.

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The principal investigator of the study, Professor Ying Cheng from Jilin Cancer Hospital commented: "Platinum based chemotherapy combined with etoposide is the first-line treatment for ES-SCLC. Chemotherapy-induced bone marrow suppression is an unavoidable toxic side effect of chemotherapy. On the one hand, it can directly lead to the occurrence of adverse events such as infection, sepsis and bleeding, reducing the quality of life of patients and increasing their economic burden; on the other hand, the occurrence of bone marrow suppression will also lead to dose reduction or delay in administration, thereby affecting the anti-tumor effect of chemotherapy. At present, there is no effective prevention therapy to protect bone marrow from chemotherapy. We are happy to see that this study has shown a positive result, confirming that trilaciclib has a bone marrow protection effect in Chinese patients with the potential of filling a clinical gap in the treatment of small cell lung cancer."

Dr. Bijoyesh Mookerjee, Simcere’s Chief Medical Officer in Oncology said: "The latest clinical data supports the safety and effectiveness of trilaciclib in Chinese patients receiving chemotherapy, and hopefully will accelerate the NDA approval of this novel therapy in China. At Simcere, we are committed to accelerating the development of the world’s latest breakthrough therapy to improve the overall benefits and quality of life in patients with small cell lung cancer. "

The Chinese phase III registrational trial of trilaciclib in ES-SCLC was approved in January 2021. Data from the first part of the study for safety and pharmacokinetics evaluation as well as real-world study in the Boao Lecheng International Medical Pilot Zone have supported the NDA submission of the first indication (small cell lung cancer) in China, and the new evidence will be a strong support to the NDA of Trilaciclib in China (myeloprotection for SCLC), which has received Priority Review Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) on Dec 22 2021. The promising evidence obtained from this phase III trial further cofirmed the safety and efficacy of trilaciclib in Chinese patients receiving chemotherapy, and is expected to benefit Chinese small cell lung cancer patients as soon as possible.

About Trilaciclib

Trilaciclib is the world’s first and only anti-tumor drug with comprehensive myeloprotective effect, which can reduce chemotherapy-induced myelosuppression (CIM). In August 2020, Simcere has reached a collaboration agreement with G1 Therapeutics, INC. to be responsible for the development and commercialization of trilaciclib in all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan).The Phase III registration clinical trials of trilaciclib in three indications in China including small cell lung cancer, colorectal cancer, and triple-negative breast cancer have all achieved patient enrollment. The NDA for the first indication (small cell lung cancer) submitted in China has been included in priority review by the State Drug Administration.

Eli Lilly has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 23, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Thursday, March 3, 2022 at 4:30 PM Eastern Time to discuss results for its fourth quarter ended December 31, 2021 and to provide a corporate update (Press release, INmune Bio, FEB 23, 2022, View Source [SID1234608924]).

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Conference 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 Fourth Quarter Conference Call when reaching an operator.

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

On February 23, 2022 Sirnaomics Ltd. ("Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported interim data from a Phase II clinical trial of STP705, a siRNA (small interfering RNA) therapeutic, for the treatment of cutaneous basal cell carcinoma (BCC) (Press release, Sirnaomics, FEB 23, 2022, View Source [SID1234608921]). The interim data, which examines results from three cohorts with 15 total subjects, shows a dose response with complete response, as well as improved or stable cosmetic result with no significant cutaneous skin reactions. Interim data also suggests a favorable safety profile as there are no drug related adverse events (AEs) or serious adverse events (SAEs).

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The Phase II open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with BCC. The primary endpoint is to determine the proportion of participants with a complete response of treated BCC at the end of treatment, which is defined as the absence of detectable evidence of BCC tumor cell nests. The secondary endpoints are to determine the safe and effective recommended dose of STP705, and an analysis of biomarkers common to BCC formation pathway, including TGF-β1 and COX-2.

The interim analysis is comprised of three dose escalation cohorts ranging from 30μg to 90μg with five patients in each group, for a total of 15 patients enrolled in the trial so far. Participants received injections of STP705 once a week for up to six weeks. In cohorts B and C, which received doses of STP705 at 60µg and 90µg respectively, three out of five patients achieved a complete response. Cohort A, which received a 30µg dose, saw a complete response in one out of five participants.

"This interim data indicates that STP705 achieved therapeutic responses from patients with BCC, in addition to the positive readouts from patients with SCC, which further demonstrates our leadership in developing RNAi-based treatments for skin cancers," said Patrick Lu, Ph.D., the founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "We look forward to seeing the results of our next data readout in this Phase II study with the rest of participant cohorts, which will give us more insights into the efficacy of STP705 as we seek to move this important therapeutic candidate forward."

"These encouraging interim results from the Phase II clinical trial of STP705 suggest that we are on a path to potentially offer a treatment for patients with BCC that would be an alternative to surgical excision of these lesions," said Michael Molyneaux, M.D., Executive Director and Chief Medical Officer at Sirnaomics. "There is an unmet need for non-surgical treatments for various types of nonmelanoma skin cancers that reduce scarring and achieve high rates of complete response, which we have begun to see in this arm of the study."

The remaining portion of the Phase II study will include two additional cohorts of five subjects with dosing of 120μg and 180ug, for a total of 25 participants in the clinical trial. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.

About Basal Cell Carcinoma

BCC is a type of nonmelanoma skin cancer (NMSC) that is associated with exposure to ultraviolet radiation from the sun. BCC usually does not spread to other parts of the body therefore the vast majority is pre-metastatic. According to a China Insights Consultancy report, the estimated metastasis rate of BCC ranges from 0.0029% to 0.55%, and common metastatic sites are regional lymph nodes, lungs, bones, skin, and liver. Standard treatments for BCC are standard surgical excision, Mohs micrographic surgery, topical cream treatments, cryosurgery, laser therapy, electro-desiccation and radiation therapy. Various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection, and bleeding. Currently, there are two drugs approved by U.S. FDA for premetastatic BCC patients, which can cause skin reactions in some patients.

Treatment of BCC with STP705 shows benefits in cosmetic appearance, especially for patients with lesions on the head, face or neck, and clinical results demonstrate that STP705 has a high complete response compared with currently available topical treatments.

About STP705

Sirnaomics’ core product candidate, STP705, is a dual TGF-β1/COX-2 inhibitor. TGF-β1 and COX-2 are known as gatekeeper targets for oncology and fibrosis disease drug development. TGF-β1 regulates a broad range of cellular processes, including cell proliferation, differentiation, apoptosis, extracellular matrix production, angiogenesis, inflammation and immune response, while COX-2 is a proinflammatory and proliferative mediator. STP705 leverages our PNP delivery platform in a locally administered formulation for direct administration to diseased tissue. Sirnaomics is developing STP705 for non-melanoma skin cancer, including squamous cell carcinoma in situ (isSCC), skin BCC, dermal fibrosis, and solid liver tumors.