On September 3, 2022 Yingli Pharma (the "Company" or "Yingli"), a clinical stage biotechnology company developing oral small molecule drugs for cancers with high unmet need, reported that the first patient has been dosed in a Phase 2 trial evaluating linperlisib, a potent inhibitor of the delta isoform of PI3 kinase (PI3Kδ) in patients with relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL) (Press release, Yingli Pharmaceutical, SEP 3, 2022, View Source [SID1234618977]).

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This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center. Additional trial sites will include medical centers in the United States and Italy.

"We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL," said Michael Hui, MBA, chief executive officer of Yingli. "Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions. We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib’s potential in this Phase 2 study."

"Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we’re excited to continue studying the drug’s potential as we start the Phase 2 study."

Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival. This Phase 2 (NCT05274997), single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with r/r PTCL who have failed at least one prior line of systemic therapy. Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters. An estimated 97 patients will be enrolled in the study.

About Linperlisib

Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, encouraging anti-tumor activities and promising PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A Phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended Phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to a Phase 2 study in follicular lymphoma (FL) that was completed and submitted in 2021 to China marketing authority for approval. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL and T cell lymphoma. Multiple linperlisib clinical trials in FL, PTCL, other lymphomas, solid tumors, combination with gemcitabine/oxaliplatin in r/r DLBC and combination with therapeutic PD1 antibody are underway in China. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma.

On September 2, 2022 Artificial intelligence (AI) biotech company Owkin reported that two first-in-class rapid, affordable AI-based diagnostic solutions designed to improve outcomes for patients with breast cancer and colorectal cancer have been approved for use in Europe (Press release, Owkin, SEP 2, 2022, https://www.fiercebiotech.com/medtech/owkins-ai-identify-breast-colorectal-cancers-scores-eu-approval [SID1234619036]).

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Owkin Dx RlapsRisk BC and Owkin Dx MSIntuit CRC have received CE-IVD approval for diagnostic use in the European Union. By using AI to analyze digital pathology images, they are designed to help clinicians make precision medicine – diagnostic and treatment based on a patient’s individual characteristics – more accessible to more patients at an earlier stage of their disease.

RlapsRisk BC is the first CE-IVD approved digital pathology-based AI diagnostic that predicts the risk that early breast cancer patients will relapse. MSIntuit CRC is the first CE-IVD approved AI solution that enables the identification of microsatellite stable (MSS) patients from routine histology slides, enabling a significant reduction in time and the number of diagnostic tests for detecting MSI in clinical practice.

These are the first approved diagnostics products developed by Owkin, which aims to develop more biomarker pre-screening and outcome prediction diagnostics across a range of disease areas. Owkin’s mission is to join patient care with medical research to discover new mechanisms of diseases and derive better treatments for unmet medical needs.

Meriem Sefta, Chief Diagnostics Officer at Owkin, said:

Our mission is to use AI to find the right treatment for every patient. Novel drugs allow us to personalize treatments to patients’ individual disease characteristics, promising a new era of precision medicine. But one roadblock that doctors face is finding these patients rapidly, accurately and efficiently.

Our first approved diagnostic solutions could help millions of patients with breast or colorectal cancer to receive the therapies they need sooner. This is a crucial moment in Owkin’s mission to use AI to better understand diseases and develop more accurate diagnostics and treatments for patients.

Owkin Dx RlapsRisk BC

RlapsRisk BC is an AI prognostic solution that predicts whether a breast cancer patient (ER+/HER2-) will go on to relapse after treatment, informing oncologists which high-risk patients may benefit from targeted therapies and which low-risk patients could potentially avoid chemotherapy.

The solution aims to revolutionize breast cancer care management by using AI to assess the risk of relapse after treatment from digital images of tissue samples. Currently, breast cancer patients at risk of relapse are identified through expensive, time-consuming molecular or genetic testing. RlapsRisk BC offers doctors a way to identify patients at risk of relapsing by using AI on digital pathology data that will already be held on nearly all breast cancer patients in around 15 minutes.

Dr Magali Lacroix-Triki, MD, PhD, an expert breast pathologist at the Department of Medical Biology and Pathology, Institut Gustave Roussy, Paris, said:

Owkin’s RlapsRisk BC enables pathologists to provide oncologists and patients with insights on the risk of relapse, crucial information for the treatment decision-making to avoid unnecessary chemotherapy. Thanks to RlapsRisk, HER2-, ER+ patients will benefit from an automated and accurate prognosis test using just a simple, standard-stained tumor slide.

AI-based digital pathology diagnostics could help us to provide a comprehensive analysis of each tumor from just one representative standard-stained tumor slide, in a complementary process to the pathologist’ diagnosis. This would democratize access to precision medicine, unlocking a new era of treatment for patients across the world.

Caption: RlapsRisk BC provides an interpretability report to the pathologist with a risk score, derived from the most predictive regions of the histology slide. Image shown may represent the range of the product, or be for illustration purposes only and may not be an exact representation of the product.

It offers comparable performance to standard molecular testing, yet uses far more readily-accessible data, reducing turnaround time and democratizing access to precision medicine.

RlapsRisk BC was developed with Gustave Roussy after winning the 2019 "AI for Health” challenge grant from Region Île de France. Its corresponding research has been presented at ESMO (Free ESMO Whitepaper) 2021 and USCAP 2022.

Owkin Dx MSIntuit CRC

MSIntuit CRC is an AI digital pathology diagnostic solution that pre-screens for a biomarker in colorectal cancer tumors known as microsatellite instability (MSI) – a defect in a cell’s ability to correct mistakes that occur when DNA is copied. This diagnostic rules out microsatellite stable (MSS) phenotypes, allowing pathologists to concentrate their resources on confirming those patients who exhibit MSI.

By using an AI model to analyze digital images of tissue samples, doctors are able to more efficiently screen patients when compared to standard testing techniques, which include time and patient tissue sample-consuming polymerase chain reaction (PCR) testing or immunohistochemistry.

Professor Magali Svrcek, MD, PhD, Sorbonne Université, AP-HP, Saint-Antoine Hospital, Department of Pathology, Paris, said:

As colorectal cancer is the third most common cancer in the world, it is crucial that we are able to screen patients for biomarkers that make them eligible for potentially lifesaving treatments. dMMR/MSI screening should be performed on all colorectal cancer patients, but pathologists’ time and resources are often too stretched.

Owkin’s new AI diagnostic solution MSIntuit CRC will roughly half the number of cases requiring screening. It is designed to help more patients receive treatment sooner. AI-based digital pathology algorithms like these, developed in consultation with pathologists, will soon become an integral part of our daily practice. They will help patients to benefit from the best treatment for them sooner – a new era of personalized medicine.

Patients with MSI-high tumors are eligible for treatment with the novel immunotherapy drug pembrolizumab, which a 2020 clinical trial found led to significantly longer progression-free survival than standard treatment when received as first-line therapy for MSI-H–dMMR metastatic colorectal cancer.

MSIntuit CRC provides an interpretability report to the pathologist, in which the most predictive regions found by the model on the histology slide are outlined.

MSIntuit CRC will help clinicians to gain accurate insights into patients’ individual needs at an earlier stage, enabling a precision medicine approach to treatment. By ruling out those patients who would not benefit from immunotherapy, MSIntuit CRC introduces a pre-screening step which saves pathologists’ and oncologists’ time and resources. Such an optimization supports the scaling of MSI screening for more patient populations and further disease indications.

MSIntuit was created by using deep learning – a type of AI that replicates how the human brain gains knowledge – on hundreds of patient samples until it could accurately detect the presence of MSI on images of tumors. Its accuracy has been validated by a clinical blind validation study on hundreds more patient samples.

On September 2, 2022 Jacobio Pharma (1167.HK) reported it has completed first patient dosage of it’s in-house R&D drug candidate CD73 monoclonal antibody JAB-BX102 in a Phase I/IIa clinical trial for advanced solid tumour patients (Press release, Jacobio Pharmaceuticals, SEP 2, 2022, View Source [SID1234618956]).

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This is a phase I/IIa multi-center, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of anti-tumor activity of JAB-BX102 monotherapy and combination with Pembrolizumab in adult patients with advanced solid tumors.

JAB-BX102 is Jacobio’s first big molecule program entered into the clinical stage. "The landscape of cancer treatment has been more and more complicated, combination therapies between different modalities are needed. Jacobio’s pipeline focuses on the unmet clinical needs and aims to bring hope to more patients through the in-house combination therapies. As an important Immune Oncology target, CD73 has the potential to be used in combination with multiple immuno-oncological therapies, such as PD-1/PD-L1 antibody and STING agonist, so as to relieve the immunosuppression of tumor microenvironment, stimulate the proliferation and activation of immune effector cells, enhance tumor immunity and play a synergistic role. Jacobio is developing CD73 STING iADC JAB-X1800." Said Dr. Yinxiang Wang, Chairman and CEO of Jacobio.

JAB-BX102 is a humanized monoclonal antibody, anti-CD73. CD73 is a protein that plays a key role in the adenosine pathway, and its inhibition has broad therapeutic potential for tumors that are reliant on an active adenosine pathway. Combination treatment of JAB-BX102 with immune checkpoint drugs such as PD-(L)1 (anti-PD-1, or anti-PD-L1) antibodies, can result in synergistic anti-tumor efficacy. There are no anti-CD73 antibodies currently approved for cancer therapy. Pre-clinical data suggest that JAB-BX102 has a dose-activity advantage and has the potential to benefit patients with solid tumors.

On September 2, 2022 Regulus Therapeutics Inc. ( Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that the Company will participate in two upcoming investor conferences (Press release, Regulus, SEP 2, 2022, View Source [SID1234618955]).

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Details are as follows:

Wells Fargo Healthcare Conference taking place September 7-9, 2022, in Boston, MA
H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022, in New York, NY
Jay Hagan, President and Chief Executive Officer of Regulus, will give a live presentation on Monday, September 12, 2022, at 2:30 p.m. ET
A replay of the live presentation will be available under "Events and Presentations" through the investor relations section of the Company’s website at www.regulusrx.com and archived for 30 days following the presentation date.

On September 2, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America ("The RTP GMP Manufacturing Facility") has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials (Press release, Carsgen Therapeutics, SEP 2, 2022, View Source [SID1234618953]).

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The RTP GMP Manufacturing Facility, with a total gross floor area of approximately 3,300 sq.m, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually to support clinical studies and early commercial launch in North America and Europe. "I am very pleased to announce that the RTP Manufacturing Facility has achieved the company’s target of releasing the clinical batches for the U.S. patient use in Q3, 2022," said Mr. Richard Daly, President of CARsgen Therapeutics Corporation. "CARsgen is rapidly expanding the in-house capacity of manufacturing and quality testing in the United States. The company will accelerate the ongoing clinical studies by providing more promising CAR T-cell products to the global patients."

"The successful release of the first U.S. patient product at the RTP GMP Manufacturing Facility is a remarkable milestone for CARsgen and our trusted partners," added by Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited. "By taking the advantage of the vertically integrated production at CARsgen, our world-class CMC team could complete the global technology transfer from our China manufacturing facility and then advance to the clinical manufacturing effectively. The commencement of clinical production at the RTP GMP Manufacturing Facility will greatly reduce current risks of global supply chain shortage and strengthen the value chain of CARsgen."

Apart from several ongoing clinical studies in China, the company has two active INDs, including a Phase 2 pivotal study of CT053 for relapsed/refractory multiple myeloma and a Phase 1b study of CT041 for advanced gastric and pancreatic cancers, both cleared by the U.S. FDA and the Health Canada. In fact, CARsgen is the only CAR T company to have received RMAT and PRIME designations for both heme (CT053) and solid (CT041) tumor therapies.