1stOncology™: Cancer Intelligence Service – Page 9883 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Illumina To Webcast Upcoming Investor Conference

On August 30, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that its executives will be speaking at the following investor conference (Press release, Illumina, AUG 30, 2021, View Source [SID1234587019]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Morgan Stanley 19th Annual Global Healthcare Conference on September 13, 2021
Fireside Chat at 11:00 am Pacific Time (2:00 pm Eastern Time)
The live webcast can be accessed under the Investor Info section of the "company" tab at www.illumina.com. A replay will be posted on Illumina’s website after the event and will be available for at least 30 days following.

InnoCare Announces Clearance by U.S. FDA of Clinical Trial of pan-TRK Inhibitor ICP-723

On August 30, 2021 InnoCare Pharma (HKEX: 09969), a commercial-stage biopharmaceutical company, reported the Investigational New Drug (IND) clearance of its second-generation pan-TRK inhibitor ICP-723 by the US Food and Drug Administration (FDA) for starting phase I clinical trial in the United States (Press release, InnoCare Pharma, AUG 30, 2021, View Source [SID1234587018]).

Preclinical studies have shown that ICP-723 has a good safety profile and high activity against a variety of solid tumors, and the potential to provide a broad-spectrum anti-cancer therapy for patients with solid tumors with NTRK gene fusion. The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumors, and evaluate the anti-tumor efficacy of ICP-723 on NTRK fusion-positive cancers.

ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, etc., and for patients resistant to the first generation of TRK inhibitors.

Currently in China, ICP-723 is in the Phase I dose escalation (1mg, 2mg, 3mg and 4mg), ICP-723 showed efficacy in two patients with qualified neurotrophic tyrosine receptor kinase (NTRK) fusion. The NTRK fusion positive patient in 3 mg cohort reached stable disease (>20% tumor reduction) and the patient in 4 mg cohort achieved partial response at the first tumor assessment at the end of cycle 1, or day 28.

"I feel excited that ICP-723 becomes our third innovative drug entering the clinical stage in the United States," said Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, "As a novel small molecule second generation pan-TRK inhibitor, ICP-723 has potent activity and high selectivity in preclinical experiments, which is expected to overcome the resistance to the first-generation TRK inhibitor to better benefit patients. "

Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma

On August 30, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-BCMA-ALLO1, the Company’s first fully allogeneic CAR-T product candidate for patients with relapsed/refractory multiple myeloma (Press release, Poseida Therapeutics, AUG 30, 2021, View Source;investigational-new-drug-application-for-p-bcma-allo1-an-allogeneic-car-t-candidate-for-relapsedrefractory-multiple-myeloma-301364920.html [SID1234587017]).

"We view a fully allogeneic CAR-T product candidate comprised of a high-percentage of desirable stem cell memory T cells (Tscm) as the ‘holy grail’ of cell therapy in oncology," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "P-BCMA-ALLO1 has a very high percentage of Tscm cells with the potential to demonstrate safety in line with our prior P-BCMA-101 autologous approach, allowing for fully-outpatient dosing. The increase in Tscm and a switch to an improved binder also gives P-BCMA-ALLO1 the potential for even better efficacy."

Poseida announces FDA clearance of IND for its first fully #allogeneic CAR-T therapy for patients with multiple myeloma.

"Notably, Poseida’s propriety booster molecule technology gives us the ability to produce up to hundreds of doses of P-BCMA-ALLO1 from a single manufacturing run, thereby dramatically reducing cost and further increasing accessibility for patients who desperately need better and safer cell therapies," Ostertag continued.

With the P-BCMA-ALLO1 IND now cleared, the Company is actively focused on opening clinical sites with the intention to begin dosing later this year. P-BCMA-ALLO1-101 is a Phase 1 study comprised of open-label, dose escalation, multiple cohorts of allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory multiple myeloma. This Phase 1 study follows a 3+3 design of dose-escalating cohorts. After a subject enrolls, allogeneic CAR-T cells will be administered as a single dose, following a standard chemotherapy-based conditioning regimen. Treated subjects will undergo serial measurements of safety, tolerability, and response. The study protocol allows for exploration of additional dosing regimens, including re-dosing, once initial safety has been established.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is Poseida’s first fully allogeneic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. In in vitro and in vivo preclinical studies, P-BCMA-ALLO1 showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy, P-BCMA-101. Inclusion of a proprietary "booster molecule" in the allogeneic manufacturing process further improved expansion of gene-edited cells and enabled production of hundreds of patient doses from a single manufacturing run, thereby reducing the manufacturing cost per dose into the same range as that of a monoclonal antibody.

FDA Grants Lantern Pharma Additional Orphan Drug Designation for Drug Candidate LP-184 in Glioblastoma Multiforme & Malignant Gliomas

On August 30, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation (ODD) for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas (Press release, Lantern Pharma, AUG 30, 2021, View Source;malignant-gliomas-301365111.html [SID1234587015]). This news follows the recent announcement of the FDA granting LP-184 ODD for the treatment of pancreatic cancer.

LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including glioblastoma and pancreatic cancer.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses driven by RADR, Lantern’s proprietary machine learning-based artificial intelligence platform, have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy. According to market analysts at GlobalData, the global GBM market is expected to reach $1.8 billion USD in therapy sales and is growing at a CAGR of 12.8%.

"GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern Pharma. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."

"We recently reported positive preclinical data that demonstrated LP-184 inhibits tumor growth by greater than 106% and improved survival in animal models of GBM," continued Mr. Sharma. "This new data that we reported, in collaboration with the Kennedy Krieger Institute and Johns Hopkins, on the efficacy of LP-184 in GBM cell lines, in-vivo animal models, and in patient-derived neurospheres, validated in-silico predictions generated by our RADR A.I. platform. We believe LP-184’s ability to cross the blood-brain barrier, together with its anti-tumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184’s potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors."

"With our extended and expanded agreement with the Kennedy Krieger Institute and Johns Hopkins, we look forward to further advancing the potential of LP-184 as a new, potent treatment option for GBM, especially in areas of unmet clinical need, including MGMT-unmethylated, temozolomide (TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all of which are often associated with poor prognosis and outcome for patients."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

Therapeutic Solutions International Files Investigational New Drug Application with FDA for Cancer Blood Vessel Targeting Immunotherapy StemVacs-V to Treat Metastatic Breast Cancer

On August 30, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported that filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate a clinical trial of its StemVacs-V immunotherapy in patients with metastatic breast cancer (Press release, Therapeutics Solutions International, AUG 30, 2021, View Source [SID1234587014]).

On May 24th, 2021, the Company announced progress in its preclinical experiments supporting the use of the immunotherapy in human trials. Part of the experiments demonstrated superior activity of StemVacs-V to other immune system-based approaches that were cleared by the FDA to literally "choke" tumors to death by blocking their blood supply1.

"I am honored to be leading medical efforts in bringing this game-changing approach to patients with breast cancer," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The previous efforts to develop an immunotherapy to kill tumor blood vessels have yielded drugs such as Avastin, which despite limitations, possesses multi-billion dollars in annual sales. In my opinion the StemVacs-V approach is superior to others because it induces more potent and more diverse immune responses targeting cancer blood vessels."

"The filing of today’s IND is a significant milestone demonstrating the ability of Therapeutic Solutions International to rapidly move a diverse immunotherapy product pipeline through the drug development cycle," said Famela Ramos, Vice President of Business Development. "We anticipate multiple synergies of our developmental efforts as our candidate’s advance forward, with our lead candidate having been cleared by the FDA to initiate Phase III clinical trials.

"Through working with our advisors such as Dr. Francesco Marincola, Dr. Santosh Kesari, and Francisco Silva, who have all published on utilization of First-Generation tumor angiogenesis blocking immunotherapies2,3, we anticipate learning from previous experiences and to rapidly move forward in taking this approach to patients," said Timothy Dixon, President and CEO of the Company and co-inventor of the StemVacs platform. "We thank our collaborators who have worked tirelessly to make this IND filing a possibility in such a rapid manner."