On September 13, 2023 AbCellera (Nasdaq:ABCL) reported that it has entered into a strategic collaboration with Incyte (Nasdaq:INCY) to discover and develop therapeutic antibodies in oncology (Press release, AbCellera, SEP 13, 2023, View Source [SID1234635154]).

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"We are excited to partner with Incyte, which has a track record of developing first-in-class medicines and bringing them to patients in need," said Murray McCutcheon, Ph.D., Senior Vice President of Partnering at AbCellera. "We look forward to working as an extension of Incyte’s team to address complex antibody discovery challenges and accelerate the development of Incyte’s preclinical pipeline of oncology medicines."

"This collaboration supports our continued commitment to developing new therapeutics that may improve and expand treatment options for patients with cancer," said Patrick Mayes, Ph.D., Vice President, BioTherapeutics at Incyte. "We are excited to partner with AbCellera to initiate this research and look forward to collaborating with them to identify new antibody therapeutics that may address unmet needs in oncology."

Under the financial terms of the agreement, Incyte has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive downstream clinical and regulatory milestone payments and royalties on net sales of products.

On September 13, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported Gabrail Cancer Center (GCC) in Canton, Ohio as the first site activated in the STAR-LLD Phase 1b clinical trial (Press release, Starton Therapeutics, SEP 13, 2023, View Source [SID1234635153]). Dr. Nash Gabrail, medical oncologist and founder of the Center, is the study’s lead investigator.

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"Quality of life is just as important as life itself," said Dr. Gabrail, the author and clinical researcher who believes that involvement in clinical trials, when available, is a fundamental part of patient care and the best option for cancer patients. "I’m thrilled to be the study’s lead investigator and excited about the potential opportunity STAR-LLD can bring multiple myeloma patients."

Since 1990, GCC has built a national reputation for excellence in cancer patient care, management, diagnosis, research, education, and prevention. Due to the expansion of clinical trials and the addition of diagnostic imaging, GCC underwent two expansions to accommodate patients’ needs, and now attracts patients for clinical trials both nationally and internationally.

"We are pleased to be working with Dr. Gabrail and his team at Gabrail Cancer & Research Center again," said Amy Chergey, Executive Director Clinical Operations at Starton. "The clinical and nursing staff are truly remarkable professionals who exhibit unwavering dedication to patient care, consistently going above and beyond to ensure the well-being of their patients. Their expertise, commitment and compassion create an environment of trust and healing for patients."

GCC is open to screen patients and expects dosing to begin in the coming weeks.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% of animals in this cohort were tumor free after 100 days vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of Revlimid.

On September 13, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) to conduct the clinical trial of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor, in China (Press release, InnoCare Pharma, SEP 13, 2023, View Source [SID1234635152]).

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In mid-July, InnoCare and ArriVent announced the clinical development collaboration to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).

Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations and other uncommon EGFR mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Shanghai Allist Pharmaceuticals Co., Ltd, (SSE: 688578) who discovered furmonertinib.

ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In the dose escalation study, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK and safety profile has been demonstrated. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in the 20 mg dose cohort achieved confirmed partial response.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "SHP2 inhibitor is an ideal partner for combination with multiple targeted and immune-oncology therapies in the field of solid tumor. ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRASG12C mutation and EGFR over-expression. We will work with ArriVent to accelerate clinical development of the combination of ICP-189 and furmonertinib, so that this innovative therapy can benefit patients with advanced NSCLC earlier."

NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

On September 13, 2023 Curiox Biosystems, a global leader in providing innovative and automated sample preparation solutions for accurate and reproducible cell analysis, reported its collaboration with Dr. Marco Ruella, an Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania (Penn), to support efforts in the development of next-generation cancer cell therapies (Press release, Curiox BioSystems, SEP 13, 2023, View Source [SID1234635151]).

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The collaboration will focus on leveraging Curiox Biosystems’ next-generation sample preparation platform alongside Dr. Ruella’s pioneering expertise in cell and gene therapies to establish improved metrics of cellular analysis.

"We are excited to embark on this collaboration with Dr. Ruella and Penn," stated the Leadership Team of Curiox Biosystems. "We are collaborating to advance therapeutic development in the field of cell therapy through automation that provides accurate and reproducible cell analytics."

Dr. Marco Ruella, an internationally recognized expert in cellular immunotherapies, brings his extensive experience in the development of innovative treatments, such as chimeric antigen receptor T-cell (CART) to this collaboration. His deep experience, including with industry collaborations, will be instrumental in this partnership to advance automated cell sample preparation in cell and gene therapy workflows.

"We are thrilled to partner with Dr. Marco Ruella and Penn to establish a collaboration around Curiox’s automated cell sample preparation platform," said Dr. Namyong Kim, CEO of Curiox Biosystems. "With this partnership we aspire to improve cell therapies by automating critical steps in the workflow which we hope will ultimately benefit patients worldwide."

On September 13, 2023 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") reported that its independently developed Class I innovative therapeutic biological product, Zuberitamab Injection (trade name: Anruixi), indicated for the treatment of CD20-positive diffuse large B-cell lymphoma (DLBCL), was officially approved for marketing by the National Medical Products Administration (NMPA) (Press release, BioRay Pharmaceutical, SEP 13, 2023, View Source [SID1234635150]).

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In preclinical studies, Anruixi showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state, and more sustained clearance of B cells, demonstrating better efficacy compared to other products. Positive results were observed in a randomized, double-blind, active-controlled phase III clinical trial of Anruixi, conducted in 43 study sites nationwide with 487 subjects enrolled. In the head-to-head study with Rituximab, the overall response rate of Anruixi + CHOP was not inferior to that of R-CHOP in patients with early-stage DLBCL, and it had a significantly higher complete response rate vs. R-CHOP. In terms of long-term survival benefits, the Anruixi group achieved better 1-year, 2-year, and 3-year PFS and OS rates compared with the Rituximab group.

As the first domestically developed Class I anti-CD20 drug in China, Anruixi will become BioRay’s next major product following Anruize. Additionally, clinical research is being conducted to explore the use of Anruixi in the field of autoimmune diseases, such as primary immune thrombocytopenia (ITP).

"As the company’s sixth product on the market and its first new drug in the field of tumor immunology，we are particularly grateful for the tremendous efforts made by the clinical researchers who participated in the product’s clinical study, our partners, and our colleagues at Bioray." said Dr. Haibin Wang, CEO of Bioray. "In the future, Bioray will continue to focus on the field of immunology and the unmet medical needs, providing more clinical treatment options, and bringing more medical solutions to patients."