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PharmAbcine Announces First Patient Enrolled and Dosed in the Phase II Clinical Trial for the Treatment of mTNBC

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]).

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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

West to Participate in Upcoming Investor Conference

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.

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.

WuXi Biologics and ImmuneOncia Sign MOU for Development and Manufacturing of Anti-PD-L1/CD47 Bispecific Antibody

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]).

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."

Regor Therapeutics Announces U.S. FDA Authorization to Conduct Regor’s First-in-Human Clinical Trial with the Next Generation Targeted Inhibitor RGT-419B for Oncology

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]).

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.

ITM and Grand Pharma Enter into a Commercialization Agreement for Targeted Radiopharmaceuticals in the Greater China Area

On December 27, 2021 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Grand Pharmaceutical Group Limited (GP) a diversified global pharmaceutical company listed in Hong Kong, reported that they have entered into an exclusive licensing agreement for GP to develop, manufacture and commercialize ITM’s oncological radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as the diagnostic TOCscan (68Ga-edotreotide) in the territory of mainland China, Hong Kong, Macau and Taiwan (Press release, ITM Isotopen Technologien Munchen, DEC 27, 2021, View Source [SID1234597770]).

Under the terms of the agreement, ITM grants GP an exclusive license for the named products in the licensed territory and will support the supply of the pharmaceutical materials needed to conduct clinical and commercial activities. GP will be responsible for clinical development, regulatory activities and commercialization of these products in the licensed geographies. ITM is eligible for a significant upfront payment as well as potential aggregate regulatory and commercial milestone payments totalling up to approximately EUR 520 million in addition to tiered royalties.

"In line with our isotope production collaboration with CIRC and the formation of our Shanghai subsidiary (WFOE) in 2021, ITM continues to strengthen its global footprint in Asian regions. This agreement with GP creates a strong partnership that supports the development and future commercial launch of our targeted radiopharmaceutical products with a recognized leader in Asia," commented Steffen Schuster, Chief Executive Officer of ITM. "We look forward to working with GP to develop and provide our radiopharmaceuticals in a region with a growing patient population in need of precision oncology treatments."

"We value our strategic partnership with ITM as we focus on bringing improved precision oncology treatments to Greater China," said Frank Zhou, Chief Executive Officer of GP. "By combining our resources, expertise and patient-centric approach we are confident in our ability to develop, distribute and commercialize innovative and high quality radiopharmaceutical products."

ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s most advanced Targeted Radionuclide Therapy being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM-11 has already demonstrated a favorable safety and efficacy profile in phase II clinical evaluation in GEP-NET patients. ITM-41 (n.c.a. 177Lu-zoledronate) is in preclinical development for in the treatment of osteosarcoma and bone metastases. TOCscan (68Ga-edotreotide) is ITM’s radiopharmaceutical for the diagnosis and staging of neuroendocrine tumors (NETs).

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization potentially enables targeted treatment with minimal impact to healthy surrounding tissue.

About ITM-11 (n.c.a. 177Lu-edotreotide)

ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical trials COMPETE and COMPOSE. ITM-11 consists of the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) linked to the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets receptors that are highly expressed by the tumor. ITM-11 is internalized into the tumor cells and decays, releasing medical radiation (ionizing β-radiation) destroying tumor tissue.

About ITM-41 (n.c.a. 177Lu-zoledronate)

ITM-41 (n.c.a. 177Lu-zoledronate) is a targeted radiopharmaceutical candidate being investigated for the treatment of osteosarcoma or osteoblastic bone metastases. ITM-41 consists of two molecular components: the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu), and the novel bisphosphonate derivate zoledronate. ITM-41 binds to the bone mineral hydroxyapatite, accumulating in bone with malignant bone disease and may demonstrate potential therapeutic benefit.

About TOCscan (68Ga-edotreotide)

TOCscan (68Ga-edotreotide) is ITM’s ready-to-use radiopharmaceutical for diagnosis and staging of neuroendocrine tumors (NETs). TOCscan contains the targeting molecule edotreotide, a somatostatin analogue, labeled with the medical radioisotope Gallium-68 (68Ga). TOCscan is used for PET or PET/CT molecular imaging of neuroendocrine tumors (NETs). In addition to diagnosis and staging of NETs, 68Ga-edotreotide imaging is used for therapy planning and dosimetry in preparation for 177Lu-edotreotide or 90Y (Yttrium-90) DOTA therapy. Administered by injection, TOCscan provides high-quality PET imaging, low radiation exposure and quick procedures with short imaging time. TOCscan is authorized for use in Austria, France and Germany.