On December 27, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved I-Mab’s IND submission for the initiation of a phase 2 trial in China for enoblituzumab (also known as TJ271) in combination with pembrolizumab (Keytruda) in patients with solid tumors, including non-small cell lung cancer (NSCLC), urothelial carcinoma (UC), and other selected cancers (Press release, I-Mab Biopharma, DEC 27, 2021, View Source [SID1234597775]). I-Mab has acquired exclusive rights to develop and commercialize enoblituzumab in Greater China from MacroGenics (Nasdaq: MGNX).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Enoblituzumab is a highly differentiated humanized monoclonal antibody directed against the immune regulator B7-H3, which plays a key role in regulating immune response against cancers and is widely expressed in multiple cancers. The presence of B7-H3 in tumors is associated with the poor efficacy of neoadjuvant therapies. Enoblituzumab enhances the antibody-dependent killing of cancer cells and has demonstrated strong anti-tumor activity in preclinical studies. Additional preclinical data generated by I-Mab and preliminary clinical evidence from MacroGenics support increased efficacy for the combination of enoblituzumab and a PD-1 antibody against cancers.

The phase 2 clinical trial in China will evaluate the efficacy of the combination of enoblituzumab and pembrolizumab. The trial is designed as a "basket" clinical trial in patients with NSCLC, UC, and other selected cancer types based on previous studies conducted by MacroGenics. These previous studies have indicated that combination therapy resulted in anti-tumor activity in recurrent or metastatic NSCLC and squamous cell carcinoma of the head and neck (SCCHN).

"The initiation of the phase 2 clinical trial will accelerate the clinical development of enoblituzumab in China," said Dr. Andrew Zhu, President of I-Mab. "Enoblituzumab has become a key player against various advanced cancers and one of the Company’s core clinical assets. We are excited about the initiation of this clinical study and expect to bring this valuable compound to cancer patients with critical unmet medical needs."

Currently, MacroGenics is conducting a phase 2 study of enoblituzumab in combination with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART molecule) for first-line treatment of patients with recurrent or metastatic SCCHN.

About Enoblituzumab

Enoblituzumab is an investigational Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of immune regulator proteins. B7-H3 is widely expressed by many different tumor types and may play a key role in regulating the immune response to various types of cancer. Enoblituzumab has been or is currently being evaluated in clinical trials as a monotherapy or in combination with anti-PD-1-based therapies in patients with B7-H3-expressing cancers. I-Mab acquired the development and commercial rights from MacroGenics for Greater China.

On December 27, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported it has dosed the first patient in its Phase II clinical trial evaluating the combination of olinvacimab, PharmAbcine’s anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors) antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia (Press release, PharmAbcine, DEC 27, 2021, View Source [SID1234597774]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Phase II clinical trial is currently open and actively recruiting patients. It is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study is designed to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR2. The enrolled patients will be treated with 16mg/kg of olinvacimab every week and 200mg of pembrolizumab every 3 weeks for up to 35 cycles (approximately 2 years).

Both companies decided to initiate this study based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at SABCS (San Antonio Breast Cancer Symposium) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and encouraging efficacy data, including 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike other breast cancers, mTNBC does not express estrogen or progesterone receptors or HER2 (human epidermal growth factor receptor 2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

Olinvacimab is the Company’s leading pipeline and is undergoing multiple global clinical trials. Other than the ongoing Phase II olinvacimab and pembrolizumab combo trial in mTNBC, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is ongoing at multiple sites in both US and Australia. Also, two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

"We are pleased to have commenced the first enrollment and dosing in this important study," said Professor. Arlene Chan, the principal investigator of this study and a medical oncologist at Hollywood Private Hospital in Western Australia. "The encouraging clinical results and the excellent safety profile from the previous Phase Ib trial gave us huge confidence in the Phase II study. We hope to see this combination therapy rise up as a promising treatment option for mTNBC patients in which current treatment options are limited."

"It is thrilling to have reached this important milestone as this study is critical towards offering a potential new treatment for the mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "PharmAbcine is grateful for the collaborative work with MSD, and we are glad that the recruitment process remains on track. We all look forward to generating another encouraging data in a larger population setting."

For more information about the Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC, please visit clinicaltrials.gov and search for the reference identifier NCT04986852

On December 27, 2021 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will participate in the 40th Annual J.P. Morgan Healthcare Conference taking place virtually on January 10, 2022 (Press release, West Pharmaceutical Services, DEC 27, 2021, View Source [SID1234597773]). Management will present at 11:15 a.m. EST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live audio webcast will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the events.

On December 27, 2021 WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and ImmuneOncia Therapeutics, Inc., a clinical-stage, immuno-oncology company in South Korea, reported that a Memorandum of Understanding (MOU) was signed to form a strategic partnership in the development and manufacturing of IOH-001, ImmuneOncia’s therapeutic bispecific antibody targeting PD-L1 and CD47 (Press release, WuXi Biologics, DEC 27, 2021, View Source [SID1234597772]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Within the partnership, ImmuneOncia will have access to WuXi Biologics’ integrated services in cell line development, cell culture development, biologics manufacturing and bioassay development. WuXi Biologics will support ImmuneOncia on the whole CMC studies of IOH-001 for Investigational New Drug (IND) application.

Heung Tae Kim, CEO of ImmuneOncia, commented, "We are excited to collaborate with WuXi Biologics. WuXi Biologics’ comprehensive capabilities on bispecifics development and manufacturing will enable us to focus on realizing the therapeutic potential of IOH-001. More importantly, access to WuXi Biologics’ world-leading technologies will help ensuring its efficacious and sustainable development. We look forward to expanding collaboration in the future to bring more innovative biologics for patients in South Korea. "

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are glad to partner with ImmuneOncia to proceed its first bispecific antibody into clinical development through our integrated services and know-how. At WuXi Biologics, we have demonstrated our extensive capabilities for CMC development, analytical method, and quality control by enabling over 60 bispecific projects. We are committed to providing innovative technical solutions, reliable and sustainable manufacturing supply chain for our global partners to benefit patients worldwide."

On December 27, 2021 Regor Therapeutics, a clinical-stage biotech company, reported that authorization from the US Food and Drug Administration (FDA) to proceed with Regor’s Phase 1 clinical development plans for RGT-419B (Press release, Regor Therapeutics, DEC 27, 2021, View Source [SID1234597771]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of and combat the resistance to currently approved CDK4/6 inhibitors that are given in combination with endocrine-based therapy for treatment of pre/perimenopausal or postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.

In cell model experiments, RGT-419B has demonstrated single agent activity with greater suppression of ER+ tumor cell growth when compared to abemaciclib and palbociclib. In ER+ breast cancer cells with acquired resistance to currently approved CDK4/6 inhibitors, RGT-419B has demonstrated full suppression of cancer cell proliferation. In these experiments, RGT-419B’s tumor cell suppression was further augmented when combined with a selective estrogen receptor degrader or a PI3K signaling pathway inhibitor.

As a single agent and in combination with other approved therapies, RGT-419B will initially be developed for the treatment of patients with HER2-, ER+ breast cancer who have primary or acquired resistance to currently approved CDK4/6 inhibitors. As CDK4/6 inhibitors are widely adopted in clinical practice, refractory and relapsed patients previously treated by CDK4/6 inhibitors are becoming a greater and clinically significant unmet medical need. RGT-419B’s clinical development programs will address this resistance to CDK4/6 and other hormone receptor modulation therapy, providing a new opportunity to improve the survival and quality of life in breast cancer patients with advanced disease.

RGT-419B is the first of many innovative oncology drugs being developed by Regor. Dr. Xiayang Qiu, Founder and CEO of Regor Therapeutics, said, "This milestone marks Regor’s success in entering into the area of oncology therapeutics. Achieving an optimal selectivity profile against several CDKs by leveraging Regor’s proprietary CARD platform, this innovative drug is entering clinical stage development in the U.S. We are excited by this opportunity to bring new and differentiated treatment options to the many patients suffering from breast cancer worldwide.

About breast cancer

HER2-, HR+ breast cancer is the most common type of breast cancer. Globally, breast cancer is one of the most common cancers affecting approximately 2.3 million women in 2020 and is the leading cause of death due to cancer in women. In China breast cancer ranks 4th amongst solid tumor types with over 400,000 new cases annually. Breast cancer poses a tremendous healthcare burden in China and across the world as well as having a significant negative impact on patients and their families.