On January 18, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in the following upcoming conference (Press release, Sorrento Therapeutics, JAN 18, 2021, View Source [SID1234574090]):

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Fireside chat during the B. Riley Securities Oncology Investor Conference being held virtually. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET.
A live webcast of this presentation will be available for registered participants at:

https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup

The fireside chat will be available for 90+ days following the event at:

View Source

On January 18, 2021 Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported that the European Medicines Agency (EMA) has granted PRiority MEdicines (PRIME) designation to the company’s lead autologous CD30 CAR-T therapy for the treatment of relapsed or refractory classical Hodgkin Lymphoma (R/R cHL) (Press release, Tessa Therapeutics, JAN 18, 2021, View Source [SID1234574082]).

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PRIME is a program launched by EMA to optimize development plans and speed up evaluation of medicines that demonstrate major therapeutic advantage over existing treatments, or otherwise benefit patients without treatment options. Through this program, EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency.

"We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma" said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. "Having received RMAT designation from FDA during 2020, we now hope to work closely with regulatory agencies in both the United States and Europe to expedite clinical development and the registration path for this therapy."

The PRIME designation was granted by EMA on the back of promising clinical data from two Phase I/II trials in R/R cHL conducted at Baylor College of Medicine and University of North Carolina Lineberger Comprehensive Cancer Center. These studies showed complete disappearance of tumor in ~60% of patients at the highest dose level with none of the serious toxicities that can be associated with several other CAR-T therapies. These results were published in Journal of Clinical Oncology (Ramos et al., 2020). Based on these data, Tessa plans to commence a multi-center pivotal study in the United States during 2021.

Europe accounts for approximately a quarter of the world’s Hodgkin Lymphoma incidence. Tessa’s pivotal trial will be recruiting patients from more than 20 cancer centers across the US and Europe including sites in Italy, Spain and Sweden. "CD30 CAR-Ts demonstrated excellent safety and efficacy data in heavily pre-treated R/R cHL patients. We look forward to collaborating with Tessa to further validate these impressive results in the pivotal trial." said Dr. Pier Luigi Zinzani, Institute of Hematology "Seràgnoli" University of Bologna, Italy.

Ivan D. Horak, M.D., Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics said "CD30 CAR-T therapy, with its promising efficacy and very limited toxicity, can meaningfully address current gaps that exist in the treatment of R/R cHL. We also are exploring the potential of this therapy in CD30 positive subtypes of Non-Hodgkin Lymphoma (NHL)." Tessa’s Phase 1 clinical study for patients with relapsed / refractory CD30 positive NHL is open for enrollment in the United States.

On January 18, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported an agreement with PT Etana Biotechnologies Indonesia (Etana) to out-license BYVASDA (Bevacizumab Biosimilar)’s development and commercialization rights in Indonesia to Etana (Press release, Innovent Biologics, JAN 18, 2021, View Source [SID1234574081]). Etana is committed to launch BYVASDA in the local market. In return, Innovent will receive milestones for development and commercialization as well as double-digit royalties on net sales. The specific financial terms were not disclosed.

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BYVASDA(Bevacizumab Biosimilar) was firstly approved by China NMPA on June 17, 2020. In January 2020, Innovent entered into an out-license agreement with Coherus BioSciences, Inc. to commercialize BYVASDA (Bevacizumab Biosimilar) in the United States and Canada.

"We are excited to establish a strategic collaboration with Etana. Following BYVASDA (Bevacizumab Biosimilar)’s breaking into the North America market in 2020, this collaboration will enable BYVASDA to penetrate into a Southeast Asian market quickly and marked another solid step toward getting Innovent’s innovative portfolio into the global market," said Blake Salisbury, Vice President of Business Development of Innovent, "We are confident that pairing Etana’s commercial expertise in the local Indonesian market with BYVASDA’s clinical profile will further accelerate our mission, benefitting patients globally."

Mr. Nathan Tirtana, Co-founder and CEO of Etana, stated: " We are excited to enter into the collaboration with Innovent, a premier biopharmaceutical company which has a fully-integrated multi-functional platform. We have been impressed with Innovent’s achievements in its innovation and globalization strategies. Through this collaboration, we hope to make BYVASDA accessible to patients in Indonesia."

This transaction is subject to customary closing conditions.

About BYVASDA (Bevacizumab Biosimilar)
BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

BYVASDA was firstly approved by China NMPA on June 17, 2020. Previous approved indications of BYVASDA include advanced non-small cell lung cancer and metastatic colorectal cancer. In December 2021, it was further approved by NMPA for the indication of adult recurrent glioblastoma.

On January 18, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Vall d’Hebron Institute of Oncology (VHIO), one of Europe’s leading cancer research organizations, reported that have agreed to enter into a partnership to establish in-house liquid biopsy testing services, using Guardant Health’s industry-leading proprietary digital sequencing platform, at VHIO’s facility in Barcelona, Spain (Press release, Guardant Health, JAN 18, 2021, View Source [SID1234574080]).

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The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time.

"We are pleased to announce this partnership with VHIO which will bring liquid biopsy comprehensive genomic testing to more cancer patients in Spain and beyond," said Helmy Eltoukhy, Guardant Health CEO. "Our vision is that all cancer patients globally have access to state-of-the-art diagnostics to enable improved outcomes through earlier, faster, and more accurate diagnosis, therapy selection, and monitoring, and this partnership is an important step toward realizing that vision."

"The opening of this service is expected to significantly increase the number of cancer patients identified as eligible for clinical trials based on available precision medicines, and help accelerate research and development of the next wave of cancer therapeutics," said Josep Tabernero, Director of VHIO and Head of the Medical Oncology Department of Vall d’Hebron University Hospital. "We look forward to working together with Guardant Health to bring clinical-grade liquid biopsy genomic testing services to patients at pace and scale."

Guardant Health’s liquid biopsy tests have been extensively used in clinical trials with over 200 peer-reviewed publications demonstrating its benefits to patients. Guardant360 tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development. Guardant Health has achieved CE mark approval as well as U.S. FDA approval for its Guardant360 CDx assay for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor), and as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).

On January 18, 2021 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company has received expressions of interest to evaluate proenzyme therapy as a method to prevent recurrence and metastasis of solid tumors in pancreatic and ovarian cancers (Press release, Propanc, JAN 18, 2021, View Source [SID1234574079]). The letters of interest were confirmed by Drs Natalia Luque Caro and Fernando Gálvez Montosa, medical oncologists specializing in pancreatic and ovarian cancers, respectively, from the University Hospital of Jaén, in Granada, Spain. The evaluation will most likely be conducted as separate Phase IIa proof of concept (POC), multi-trial center studies for each target indication.

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The expressions of interest were confirmed after evaluation of Propanc’s scientific literature supporting the use of proenzymes in pancreatic and ovarian cancers. The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia.

"Receiving expressions of interest from Drs Caro and Montoya at the University Hospital of Jaén provides important infrastructure to plan our multi-trial center studies, which will likely require up to 60 patients for each study in pancreatic and ovarian cancers, which is why we were thinking of running these trials in Europe, due to the larger patient populations," said James Nathanielsz, Propanc’s Chief Executive Officer. "By running multi-trial centre studies for our Phase IIa studies, we ensure that we have sufficient numbers to complete the trials more efficiently than if we ran the trials in Australia, alone. Furthermore, the University Hospital of Jaén is located in Granada, Spain, and is a well-known biopharmaceutical hub with a strong reputation among multi-national companies. We look forward to a potential collaboration with the clinical trial investigators from this reputable institution."