On September 6, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that BTK inhibitor orelabrutinib has been granted priority review for the treatment of relapsed or refractory Marginal Zone Lymphoma (R/R MZL) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the supplemental New Drug Application (sNDA) of orelabrutinib for the treatment of R/R MZL recently (Press release, InnoCare Pharma, SEP 6, 2022, View Source [SID1234618999]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "We are so inspired by this excited news. This is the third indication of orelabrutinib granted priority review. There are unmet medical needs for patients with R/R MZL. We hope orelabrutinib can bring better treatment options to benefit patients with R/R MZL."

The sNDA of Orelabrutinib for the treatment of R/R MZL was accepted by the CDE on August 12. This NDA was submitted based on data from an open multi-center Phase II clinical study to investigate the safety and efficacy of orelabrutinib for the treatment of R/R MZL.

Current treatment options for R/R MZL are quite limited. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

On September 5, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported the presentation of two new analyses from the Phase 3 Atalante-1 study of immunotherapy Tedopi, in patients with advanced non-small cell lung cancer (NSCLC) in secondary resistance after failure of previous checkpoint inhibitor treatments, at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held September 9-13, in Paris (Press release, OSE Immunotherapeutics, SEP 5, 2022, View Source [SID1234646962]).

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Alexis Vandier, Chief Executive Officer of OSE Immunotherapeutics, commented: "In patients with no treatment option after failure of two therapeutic classes, in particular post-checkpoint inhibitors, Tedopi has shown an overall clinical benefit in this phase 3 study, integrating both efficacy and tolerance compared to chemotherapy treatments. This new specific immunotherapy offers prospects for therapeutic management, both in monotherapy and in combination, and we will do our best to make this treatment available as soon as possible for these patients."

The first analysis compared Tedopi to the Standard of Care (SoC) in patients with advanced NSCLC after secondary resistance to sequential use of chemotherapy followed by immunotherapy (CT-IO).

The results have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival (OS) was longer with Tedopi versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76).

This analysis will be presented by Dr Maria Rosario Garcia Campelo (Head of Medical Oncology Department, Thoracic Tumors Unit, Investigator of Atalante-1 study, University Hospital A Coruña, Spain).

Dr Garcia Campelo said: "There is a strong medical need for a new therapeutic alternative in these heavily pretreated NSCLC patients, aiming not only at a prolonged survival but desiring a maintained global health status."

The second analysis assessed the overall benefit/risk of Tedopi versus SoC chemotherapy in patients with NSCLC who failed therapy with immune checkpoint inhibitors. The Net Treatment Benefit (NTB)*, a new statistical method combining efficacy, safety and quality of life, was assessed in the overall population (n=219). NTB of Tedopi was of 19% and reached statistical significance (p=0.035).

This analysis will be presented by Dr Marc Buyse, (Founder and Chief Scientific Officer, International Drug Development Institute (IDDI), Brussels, Belgium).

Poster presentation details:
Title: Pattern of clinical activity of anticancer vaccine OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1019P
Speaker: Maria Rosario Garcia Campelo (A Coruña, Spain)
Date: Monday, September 12th, 2022

Title: Net Treatment Benefit of OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1024P
Speaker: Marc E. Buyse (Louvain-la-Neuve, Ottignies, Belgium)
Date: Monday, September 12th, 2022

On September 5, 2022 Chiome Bioscience Inc.("Chiome") reported that Chiome will present preclinical data supporting development of its proprietary anti-CDCP1 antibody drug conjugate named PCDC as a therapeutic candidate at the 13th World ADC San Diego 2022 (venue: September 6th-9th, 2022) (Press release, Chiome Bioscience, SEP 5, 2022, View Source [SID1234625708]). As this anti-CDCP1 antibody is characterized for its internalization into cancer cell we have tested several payloads and conjugates in vitro and in vivo. Chiome will present data on anti-CDCP1 antibody conjugated with several payloads such as PBD, MMAE, and amanitin. Each ADC has shown significant anti-tumor activities in vitro and in vivo on multiple models. In addition, Non-GLP toxicity study using cynomolgus monkey showed that amanitin conjugated antibody exhibited tolerability in the expected therapeutics dose.

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➢ Poster Presentation

Date: September 7th, 2022 AM10:00-PM7:00
Place: Sheraton San Diego Hotel and Marina
Title: Anti-CDCP1 antibodies for drug conjugate

➢ World ADC San Diego 2022 Website

View Source
World ADC is one of the most comprehensive conferences in ADC fields from early discovery to clinical and manufacturing. It is held annually, and researchers and pharma companies around the world will participate. This year it is held for the first time in-person since 2019 with 600+ participants at the forefront of ADC R&D.

PCDC is the project on humanized monoclonal antibody that targets CDCP1, highly expresses in broad range of solid tumors, including lung, breast, colorectal, pancreas, prostate, ovarian cancers. Chiome has been studying PCDC as one of our therapeutic pipelines. Patent applications for this antibody has already been submitted.

Information
Chiome is granted access to the ATACⓇ platform, antibody targeted amanitin conjugate technology, developed by Heidelberg Pharma GmbH (Ladenburg, Germany). Amanitin is a toxin found in several species of mushrooms. With ATAC platform, amanitin is conjugated to our anti-CDCP1 antibody. In the preclinical study, the amanitin conjugated anti-CDCP1 antibody has shown significant anti-tumor activities in vitro and in vivo. Chiome is actively working to find a partner.

On September 5, 2022 CellOrigin Biotech (Hangzhou) Co., Ltd. reported that it has made an agreement with Qilu Pharmaceutical on strategic global collaborations to develop, manufacture and commercialize a proprietary ‘off-the-shelf’ iPSC-derived Chimeric Antigen Receptor Macrophages (CAR-iMAC) for cancer immnotherapy (Press release, Qilu Pharmaceutical, SEP 5, 2022, View Source [SID1234619124]).

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This collaboration takes the advantages from both parties by integrating complementary technologies and expertise as well as combining industry-leading R&D, manufacture and marketing capabilities.Both parties will collaborate on new drug development and commercialization, and will push CAR-iMAC pipelines forward to clinical trials.

‘Innovation, and bringing the best products to benefit patients are the core values we both appreciate’, said Dr. Jin Zhang, the co-founder of CellOrigin Biotech and a principle investigator of Zhejiang University, ‘that’s something that brings us together’.

‘We are excited to collaborate with Qilu Pharmaceutical because of its prestige in the Chinese pharmaceutical industry as well as its successful track record in new drug discovery. We (CellOrigin) will keep seeking other potential industry collaborators, jointly exploring and developing innovative anti-tumor drugs, and benefiting more cancer patients’ said Dr. Tong Jiansong, Chief Executive Office at CellOrigin Biotech.

‘CellOrigin is an outstanding startup with a strong research background and valuable industry experience. It has focused on original techniques in cell therapy and gained rich expertise in GMP manufacture. It is an ideal strategic partner for novel cell therapy and it is our pleasure to collaborate with such a great biotech company.’ said Qilu Pharmaceutical.

On September 5, 2022 Vernalis Research ("Vernalis"), a fully owned subsidiary of HitGen Inc., and Unison Medicines Inc. ("Unison") reported a research collaboration on an undisclosed bacterial target (Press release, Vernalis, SEP 5, 2022, View Source [SID1234619120]).

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Under the terms of the agreement, Vernalis will use its expertise in drug discovery to design small molecules against this particularly challenging target, which has long been considered to be undruggable. Unison will finance all activities at Vernalis and Vernalis will be entitled to receive downstream milestones and royalties should the compounds from the collaboration progress further into development and commercialization. As part of the agreement, Vernalis has also invested in Unison’s first round of financing.

Dr. Mike Wood, Managing Director of Vernalis, said: "We are extremely pleased to work with Unison on this promising and difficult bacterial target. This collaboration demonstrates once again that Vernalis is an attractive partner for biotech and pharma companies facing challenges in drug discovery. And the investment in Unison’s financing round demonstrates the flexibility of our business model and the willingness to share the risk with our partners. We are looking forward to a successful collaboration with Unison."

Doug Witt, Founder and Chief Executive Officer of Unison, said: "We are delighted to begin our collaboration with Vernalis. The team at Vernalis has an unmatched track record against difficult targets and we are confident that together we are positioned for success. The investment in this project by Vernalis and others demonstrates the opportunity we see in tackling the Anti-Microbial Resistance problem with highly innovative approaches."

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc., commented: "I am very pleased to see Vernalis and Unison enter this collaboration, which reflects Vernalis’ deep expertise and experience in FBDD/SBDD field to solve challenging problems in drug discovery research. Since Vernalis became part of HitGen at the end of 2020, the research teams from Vernalis and HitGen Chengdu have been working closely to advance the synergistic opportunities of the DEL and FBDD/SBDD technology platforms. I believe that the collaboration between Vernalis and Unison will mark important progress in our concerted efforts, and I wish the collaboration every success in this very important area of healthcare."