On January 5, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that it will virtually participate in the 40th Annual J.P. Morgan Healthcare Conference (Press release, Legend Biotech, JAN 5, 2022, View Source [SID1234598124]).
. Ying Huang, PhD, CEO and CFO of Legend Biotech, will deliver the company presentation on Tuesday, January 11, 2022 at 2:15 p.m. (Eastern Time).

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A live webcast of the presentation will be available to investors and other interested parties at the Legend Biotech website at View Source

On January 04, 2022 Wheeler Bio, a biomanufacturing company built to accelerate the translation of therapeutic innovation into clinical impact, reported the closing of a $14M Seed financing round (Press release, Wheeler Bio, JAN 4, 2022, View Source [SID1234642126]). The round was co-led by Echo Investment Capital and Alloy Therapeutics, with participation from Floating Point and Presbyterian Health Foundation.

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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

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The new funding will be used by Wheeler Bio to expand its team and make its Portable CMC solution more broadly available, partnering with more preclinical CROs and antibody drug developers. Through parallel integration with preclinical drug discovery groups, Portable CMC provides a faster, easier, and more predictable discovery-to-IND path for drug developers.

"We are delighted to have the continued support of partners and investors as we work to solve the biggest problems associated with tech transfer," said Dr. Jesse McCool, Co-founder and CEO of Wheeler Bio. "With Portable CMC, we can empower preclinical CROs to halve the time to clinical supply for their customers, while significantly de-risking program onboarding for our CDMO partners. This means more medicines reach more patients faster."

By integrating discovery capabilities with Wheeler Bio’s open source biomanufacturing processes and platforms, preclinical CRO partners can extend their offering beyond drug candidate lead selection, providing drug developers with a clearer path to IND clinical manufacturing. Wheeler’s first partner is Alloy Therapeutics—a Boston-headquartered biotechnology company providing antibody discovery platforms and services to a community of more than 100 developers.

Errik Anderson, Founder and CEO of Alloy Therapeutics, said, "We are very enthusiastic about our partnership with Wheeler Bio because its unique approach and high-quality Portable CMC services address the problems our partners face regularly when moving into the IND-enabling phase. Differentiating speed, predictability, and cost benefits amplify our mission to democratize access to foundational drug development capabilities and reduce barriers in the pursuit of making medicine."

Scientific and operation leadership for the development and implementation of Portable CMC falls to Dr. Stephen Hamilton, Chief Technical Officer of Wheeler Bio, and a veteran of 20 years in industrial R&D and platform engineering. Dr. Hamilton said, "Over the course of my career, I have experienced firsthand the complexities of tech transfer and outsourcing. I am therefore very excited by the unique model that Wheeler Bio is implementing because it provides the next-generation CDMO services that will be critical to the success of emerging biopharma."

More information on Wheeler Bio and Portable CMC can be found on its website at www.wheelerbio.com.

On January 4, 2022 the official website of CDE reported that PI3Kδ inhibitor, SHC014748M Capsules, of Sanhome Pharmaceutical Co., Ltd is proposed to be included in breakthrough therapies for the treatment of relapsed or refractory follicular lymphoma (FL) (Press release, Nanjing Sanhome Pharmaceutical, JAN 4, 2022, View Source [SID1234633518]).

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On January 4, 2022 TCR2 Therapeutics Inc. a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, and Arbor Biotechnologies, a biotechnology company discovering and developing the next generation of genetic medicines, reported that the two companies have entered into a strategic research collaboration and non-exclusive license agreement focused on the further development of a defined set of allogeneic TRuC-T cell therapies (Press release, TCR2 Therapeutics, JAN 4, 2022, View Source [SID1234619527]). The collaboration leverages Arbor’s proprietary CRISPR gene-editing technology, which is tailored to address the underlying pathology of genetic diseases, and TCR2’s’ first-in-class TRuC platform, which has demonstrated clinical activity in multiple treatment-refractory mesothelin-expressing solid tumor indications with its lead autologous program gavo-cel.

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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

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"Our autologous TRuC-T cells have already established clinical activity in multiple difficult-to-treat solid tumors without being dependent on HLA, thus allowing our therapies to be used on the broadest patient population. We believe allogeneic TRuC-T cell therapies will further extend this impact by accelerating patient access while reducing manufacturing cost," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "The collaboration with Arbor enables us to evaluate multiple allogeneic candidates with novel enhancements and advance a lead candidate in 2022, consistent with our vision of continuing to innovate novel therapies for cancer patients suffering with solid tumors."

"The collaboration with TCR2 allows us to leverage Arbor’s proprietary discovery engine and gene editing technologies with an established cell therapy leader developing life-changing treatments for serious cancers," said Devyn Smith, Ph.D., Chief Executive Officer of Arbor. "This agreement reinforces the versatility and strength of Arbor’s platform and furthers our strategic vision of expanding the impact of Arbor’s gene editors through partnerships with leading organizations developing engineered cell therapies."

Under the terms of the agreement, Arbor will receive an upfront cash payment and is also eligible to receive additional milestone payments based upon the successful achievement of development, regulatory and commercial milestones across a selected number of programs. In addition, TCR2 will pay tiered royalties on future net sales on any products that may result from this collaboration.

On January 4, 2022- Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. jointly reported that the IND application for the pivotal clinical trial (KN026-CSP-001) of the anti-HER2 bispecific antibody KN026 combined with chemotherapy was approved by the Center for Drug Evaluation (CDE) of NMPA (Press release, Alphamab, JAN 4, 2022, View Source [SID1234611313]).

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KN026-CSP-001 is a randomized, multi-center, phase II/III clinical study to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastroesophageal junction cancer) who have failed first-line treatment, with Professor Jianming Xu from the Chinese People’s Liberation Army General Hospital as principal investigator.

GC/GEJ is one of the common malignant tumors and there are more than 1 million new cases each year in the world. The incidence of gastric cancer is high in China, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of GC/GEJ worldwide. Gastric cancer in China is characterized by low diagnosis rate of early gastric cancer, high proportion of metastatic stage (>80%) and low 5-year survival rate (about 35.1%), which seriously threatens the life and health of people. HER2 is overexpressed in many tumors, including about 15-20% in gastric cancer. HER2 overexpression is related to tumor aggressiveness and poor prognosis. With the development of targeted therapies, HER2-positive advanced gastric cancer patients have achieved better efficacy compared to traditional chemotherapy when treated with a combination of targeted drugs. However, for patients with HER2-positive gastric cancer who have progressed or recurred after first-line treatment, there is no effective drug approved in China, and there is a huge unmet clinical need.

KN026 is a HER2 bispecific antibody developed by Alphamab Oncology. Data from the Phase II clinical study of KN026, published at ASCO (Free ASCO Whitepaper) in 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, pretreated either with or without anti HER2 treatments. In patients with high expression, the ORR was 55.6% and the DCR was 72.2%, and the 9-month PFS rate was 60.4%. Among patients receiving prior-HER2 treatment, the ORR was 44.4%, and the DCR was 66.7%. The approval of the clinical trial application is a touchstone for the cooperation between Alphamab Oncology and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China. We hope to see more positive data from the study, and bring hope to patients with advanced gastric cancer who are in urgent need of new treatment options.

About KN026
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan).