MonTa Biosciences awarded approval from regulatory agencies to start phase I study

On January 18, 2021 MonTa Biosciences reported it was awarded with positive feedback from the regulatory agency in Denmark to initiate phase I study on our lead candidate MBS8. The study will start later in Q1 with dosing of solid tumor patients in a dose-escalation study (Press release, MonTa Biosciences, JAN 18, 2021, View Source [SID1234575255]). The primary endpoint is to establish the recommended phase 2 dose level, for which the second part of the study, the expansion stage, will include a larger group of different solid tumor patients.

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Sana Bio’s $150 Million IPO Expected to Provide Market Valuation of $10 Billion

On January 18, 2021 Sana Biotechnology reported that filed with the U.S. Securities and Exchange Commission (SEC) to launch an initial public offering (IPO) worth $150 million (Press release, Sana Biotechnology, JAN 18, 2021, View Source [SID1234574125]). But that number doesn’t quite reflect the company’s likely market valuation, which is expected to be between $9 billion and $12 billion.

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Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Despite its lofty valuation, the company does not yet have any drugs in the clinic, although it expects to submit Investigational New Drug (IND) applications in 2022 and 2023.

Launched in 2019, the company raised $700 million in June 2020 in its initial financing. Those funds were used to advance its discovery and development programs.

It was founded by the former chief executive officer of Juno Therapeutics, Hans Bishop. Sana’s initial investments came from Flagship Pioneering, ARCH Venture Partners, and F-Prime Capital. In addition to that initial investment, investors included the Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds, Altitude Life Science Ventures, and several unnamed institutional investors.

In a June 2020 statement, chief executive officer Steve Harr said, "Sana is dedicated to modulating genes in cells as well as replacing damaged cells in the body. I am proud of our progress to date in turning our technologies into potential therapies for serious diseases such as cancer, central nervous system diseases, heart disease and various genetic disorders."

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. The technology provides a way of producing hypoimmunogenic stem cells that can be differentiated into any cell type. These cells can then be transplanted into a patient without causing immune rejection. The company’s plans are to take that technology platform and create hypoimmunogenic pluripotent stem cells that it can use to create novel cell therapies.

Sana’s ambitions and broad reach comes with a high burn rate. It currently has $459 million in cash and cash equivalents, but it spent $153 million on R&D in the first nine months of 2020, an increase from $80 million in the same period in 2019.

Of course, this is how biotech investments work. Early-stage companies are often years, often a decade or longer, from a marketable product. And once Phase II and Phase III clinical trials begin, the expenses add up fast and usually require either partnerships, IPOs or continued venture tranches.

The Wall Street Journal notes that Moderna, currently one of two companies to have an authorized COVID-19 vaccine in the U.S., had a trajectory similar to Sana—plenty of investor interest and a sky-high valuation, with no marketable products. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Investors who bought then and held on have seen a sevenfold return on investment in two years.

Harr’s track record undoubtedly gave investors confidence as well. Juno Therapeutics was sold to Celgene in 2018 for $9 billion. Harr was also a director for Loxo Oncology. Loxo sold to Eli Lilly in 2019 for about $8 billion.

On October 30, 2020, Sana acquired Oscine Corp. Oscine focused on developing possibly curative or disease modifying cell therapies for brain and CNS diseases. The combination, they said at the time, would integrate Oscine’s glial progenitor cell program and technologies with Sana’s broader platform. Glial progenitor cells are a major support system of the brain. These cells differentiate into oligodendrocytes, which are the only source of myelin production the adult CNS, and astrocytes, which support neurons and are associated with many neurodegenerative and myelin diseases.

At this time, Sana’s in vivo cell engineering programs, all in the preclinical stage, are focused on non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, ornithine transcarbamylase deficiency (OTC), sickle cell disease and beta-thalassemia. Its ex vivo cell engineering programs, also all preclinical, are focused on NHL, ALL, CLL, multiple myeloma, and type 1 diabetes, Huntington’s disease, Pelizaeus-Merzbacher disease, secondary progressive multiple sclerosis, and heart failure.

Dr. Henry Ji to Participate in a Fireside Chat at the B. Riley Securities Oncology Investor Conference on Jan 20, 2021

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

Tessa Therapeutics Receives PRIME Designation from European Medicines Agency for CD30 CAR-T Therapy

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.

Innovent Announces an Out-license Agreement with PT Etana Biotechnologies Indonesia to Launch BYVASDA® (Bevacizumab Biosimilar) in Indonesia

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.