On February 22, 2023 AstraZeneca and KYM Biosciences Inc. reported that it have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer (Press release, AstraZeneca, FEB 22, 2023, View Source [SID1234627550]). Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.

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CMG901 is currently being evaluated in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumours, including gastric cancer. Preliminary results from the Phase I trial have shown an encouraging clinical profile for CMG901, with early signs of anti-tumour activity across the dose levels tested.

Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, "We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers. CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform outcomes for patients with gastrointestinal cancers."

Dr Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM Biosciences, said, "We are pleased to announce our agreement with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies. This is not only a recognition of CMG901, a potential first-in-class Claudin 18.2 ADC, but also Keymed’s internal discovery and development capabilities. The global scope of this agreement has the potential to benefit patients in China, and throughout the world."

Financial considerations
AstraZeneca will make an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn to KYM Biosciences as well as tiered royalties up to low double digits.

The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2023.

i. KYM Biosciences is a joint venture established by affiliates of Keymed Biosciences and Lepu Biopharma.

Notes

CMG901
CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, and consists of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and a cytotoxic small molecule monomethyl auristatin E (MMAE). CMG901 is being developed for the treatment of solid tumours that express the cell surface protein Claudin 18.2, including gastric cancers. CMG901 is owned by KYM Biosciences Inc. (KYM), a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership).

AstraZeneca in gastrointestinal cancers

AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.1

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

Imfinzi (durvalumab) is approved in the US in combination with chemotherapy (gemcitabine plus cisplatin) for advanced biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma. Imfinzi is being assessed in combinations, including with Imjudo in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is approved in HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib), a first-in-class PARP inhibitor, is approved in BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On February 22, 2023 Ordaōs, a biotechnology company designing novel mini-proteins to help drug hunters deliver life-saving treatments, reported a collaboration with FatiAbGen, a South Korea-based biopharma company developing monoclonal antibody-based therapies (Press release, Ordaōs Bio, FEB 22, 2023, View Source [SID1234627549]). As a part of their partnership, Ordaōs will use their in silico Design Engine to optimize antibodies for several oncology conditions including pancreatic and ovarian cancer, of which there is a high unmet need.

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"Ordaōs is pleased to be collaborating with FatiAbGen to optimize their monoclonal antibodies for the treatment of these debilitating cancers," said Ziwei Liang, CSO of Ordaōs. "Together in partnership, we can address many of the challenges faced in difficult-to-treat diseases and help develop therapeutics for those patients who currently have limited options."

As part of this collaboration, Ordaōs will employ their proprietary in silico Design Engine to optimize the overall safety and efficacy of FatiAbGen’s existing monoclonnal anitbodies. The Ordaōs Design Engine, which leverages the power of multitask, metalearning AI, can rapidly enhance FatiAbGen’s existing antibodies indicated for a number of oncology conditions. FatiAbGen will then be responsible for developing these antibodies in pre-clinical study.

"We remain committed to meeting the unmet needs of patients by exploring new and challenging technologies and markets," Said JayJay Lee, CEO of FatiAbGen. "Combining our capabilities with Ordaōs and their proprietary Design Engine will further our efforts in creative research, development and delivery to patients in need of a treatment."

FatiAbGen will utilize their capabilities in manufacturing antibodies in therapeutic markets in tandem with their fusion protein antibody drug conjugate(ADC) platform technology. FatiAbGen currently has developed novel antibodies for treating autoimmune diseases that cause allergies, and has previously used their proprietary technology to develop treatments for Mesothelioma and pancreatic cancer.

To learn more, visit the Ordaōs website, or email [email protected].

On February 22, 2023 ARS Pharmaceuticals, Inc. (the "Company") reported that it has entered into a Termination Agreement (the "Termination Agreement") with Recordati Ireland, LTD. ("Recordati"), pursuant to which, among other things, the Company and Recordati agreed to terminate that certain License and Supply Agreement, dated September 21, 2020, by and between the Company and Recordati (the "License and Supply Agreement") (Filing, 8-K, ARS Pharmaceuticals, FEB 22, 2023, View Source [SID1234627548]).

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Pursuant to the Termination Agreement, the Company will reacquire from Recordati all of its rights in and to an exclusive, royalty-bearing, sublicensable license under its patents relating to neffy to (i) perform Recordati’s development activities on the epinephrine compositions ("Licensed Compositions") and related products ("Products") for commercialization in the E.U., United Kingdom, and certain countries in the Middle East, Africa and Eurasia (the "Territory"), (ii) manufacture (or have manufactured) the Products for commercialization in the Territory, (iii) file and hold regulatory approvals for the Products in the Territory, and (iv) commercialize the Products in the Territory.

Under the Termination Agreement, the Company agreed to pay Recordati a one-time upfront payment of €3.0 million and Recordati is eligible to receive (i) an European Medicines Agency regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Product in the Territory, and (iii) milestone payments of up to €5.0 million in the aggregate from sales of Product(s) in the Territory.

The foregoing summary of the Termination Agreement does not purport to be a complete description of the document and is qualified in its entirety by the Termination Amendment, which the Company intends to file as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

Item 1.02
Termination of a Material Definitive Agreement.

On February 22, 2023, the Company entered into the Termination Agreement with Recordati, pursuant to which, among other things, the Company and Recordati agreed to terminate the License and Supply Agreement, effective immediately.

A description of the material terms of the License and Supply Agreement was included under the heading "License and Supply Agreement with Recordati Ireland" under Item 1.01 of the Current Report on Form 8-K filed by the Company on November 8, 2022 (the "2022 Form 8-K"), which is incorporated herein by reference. A description of the material terms of the Termination Agreement are included under Item 1.01 of this Current Report on Form 8-K and is incorporated herein by reference.

On February 22, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT (Press release, Poseida Therapeutics, FEB 22, 2023, View Source [SID1234627547]).

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"R&D Day is our annual showcase for the innovative and exciting science we are advancing at Poseida that continues to drive our leadership in the field of cell and gene therapies," said Mark Gergen, Chief Executive Officer of Poseida Therapeutics. "Today, we will announce our second liver-directed preclinical gene therapy program partnered with Takeda: P-PAH-101 for the in vivo treatment of Phenylketonuria, or PKU. We are excited to share the progress we have made with our site-specific Super piggyBac platform to enable highly targeted site-specific editing and insertion, one of the most sought-after characteristics of genetic engineering. Finally, in our cell therapy portfolio, we continue to differentiate ourselves, expanding our capabilities for our allogeneic T cell platform to deploy TCRs in combination with CARs in solid tumors. We are thankful for the continued dedication of our scientists, partners and collaborators as we work together to unlock the potential of our technologies to treat patients with cancer and rare genetic diseases."

The Company’s third-annual R&D Day will feature its executive leadership and scientists for a morning of presentations and fireside chats with special guest speakers exploring the future of cell and gene therapy. The program will highlight the Company’s proprietary genetic engineering platform technologies, differentiated allogeneic CAR-T programs, and novel approaches to gene therapy as well as ongoing collaborations with Roche and Takeda.

External speakers will include:

George M. Church, Ph.D., a pioneer in the fields of genetics and synthetic biology and Chair of the Company’s Gene Therapy Scientific Advisory Board;

Madhu Natarajan, Ph.D., Head of the Rare Diseases Drug Discovery Unit at Takeda;

Christine Brown, Ph.D., Professor, City of Hope, a CAR-T cell expert and member of the Company’s Immuno-Oncology Scientific Advisory Board.

Key R&D Day Topics and Highlights

In Vivo Gene Therapy Programs

The Company will present advancements in hybrid technology highlighting the potential for single treatment cures across multiple diseases.

P-OTC-101 is the Company’s liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by a deficiency in the ornithine transcarbamylase (OTC) enzyme, a defect that impairs the body’s ability to detoxify ammonia, a byproduct of protein metabolism. The Company will show data highlighting disease correction and evaluation in non-human primates, with the Company’s lead lipid nanoparticle formulation that has demonstrated favorable tolerability.

The Company will announce P-PAH-101, its second Takeda-partnered gene therapy program. P-PAH-101 is a liver-directed gene therapy to treat PKU, an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in buildup of phenylalanine in the body. If left untreated, PKU can affect a person’s cognitive development. P-PAH-101 utilizes Super piggyBac technology combined with a hybrid adeno-associated virus (AAV) and nanoparticle delivery system. Preclinical data has demonstrated the potential to resolve phenylalanine to normal levels following a single treatment in juvenile and adult mice.

Emerging Technologies in Gene Therapy

The Company will highlight its continuing focus on innovation in its emerging platform technologies at today’s event.

Site-specific Super piggyBac DNA Delivery, first unveiled at the Company’s R&D Day in February 2022, has continued to advance. The Company has made significant enhancements to efficiency and site-specific transposition, with up to 60% of haploid genomes modified.

The Company has made key enhancements to its non-viral gene delivery system resulting in nearly 10-fold improvements in DNA expression in the past 12 months on a pathway towards realizing the full potential of non-viral gene delivery.

Allogeneic Cell Therapy Programs

The Company will recap early clinical data presented at the European Society for Medical Oncology Immuno-Oncology Annual Congress in December 2022 (ESMO I-O) on both of its Phase 1 allogeneic cell therapy programs: P-MUC1C-ALLO1, a wholly-owned CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers, and P-BCMA-ALLO1, a CAR-T product candidate partnered with Roche targeting relapsed/refractory multiple myeloma. The Company plans to present additional updates on both trials at a medical conference in 2023.

The Company will present preclinical data on additional emerging allogeneic CAR-T programs including P-CD19CD20-ALLO1, P-CD70-ALLO1 and P-ckit-ALLO1.

Emerging Technologies in Cell Therapy

The Company will share early preclinical data highlighting progress made towards developing dual-targeting CAR-TCR-T therapies capable of recognizing extracellular and intracellular solid tumor antigens for potential improved clinical outcomes.

R&D Day Webcast Information

Registration for this virtual event and access to the live webcast will be available on the Investors & Media section of the Company’s website, www.poseida.com. A replay of the webcast will be available for 90 days following the presentation.

On February 22, 2023 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it is reducing its workforce by approximately 57 percent (Press release, Jounce Therapeutics, FEB 22, 2023, View Source [SID1234627545]). The decision to reduce its workforce was made as Jounce believes advancement of its clinical programs, JTX-8064 and vopratelimab, requires funding and a scope that the Company cannot pursue on its own and will be seeking business development opportunities for both programs.

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"We believe data in both the SELECT and INNATE clinical trials is intriguing, but to date neither study has demonstrated clinical activity sufficient to create the value necessary for Jounce to independently advance these programs to the next stage of development. We believe a company with additional resources and a longer value creation timeline could potentially advance these programs, for the benefit of cancer patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Although reducing our workforce was a difficult decision, we are incredibly proud of the work of the entire Jounce team and would like to thank our talented employees impacted today for their dedication and contributions in support of our mission to benefit cancer patients."

Jounce expects to incur a non-recurring charge of approximately $11.2i million in the first quarter of 2023 related to the restructuring announced today. The workforce reduction will be substantially completed by March 31, 2023.