On March 22, 2021 Tavotek Biotherapeutics reported it has raised over $20M in Round A1 and Round A2 financing in the preceding two months (Press release, Tavotek, MAR 22, 2021, View Source [SID1234576982]). YuanBio Venture Capital led the A1 finance round followed by Oriza Holdings, Ming BioVentures, and New Alliance Capital. Series A2 financing was jointly invested by GF Xinde, CTS Capital, and Lanhu Capital. The two rounds of financing will be used to accelerate the CMC production and IND filings of three antibody drugs (Tavo111, Tavo103, and Tavo101) developed by the company based on its TavoPrecise antibody platform. In addition, the funding will also be used to strengthen its bispecific / multispecific antibody pipelines and the development of multicyclic intracellular peptide (MIP) programs.

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Tavotek Biotherapeutics, established in early 2019, received its initial Round A investment from Apricot Capital. Tavotek is committed to using innovation to improve the well-being of patients with unmet medical needs. Presently, the company has two R&D centers: one in Lower Gwynedd, Pennsylvania and another in Suzhou, China. The core team members have decades of successful drug development experiences at multinational pharmaceutical firms (J&J, Abbott, GSK, Eli Lilly) which include many blockbuster drugs with annual sales of more than $1 billion.

Tavotek’s research platforms are built upon three breakthrough technologies: TavoSelect (an innovative Phage Display Library that generates conformational selective human full-length and single domain antibodies); TavoPrecise (a differentiated engineering platform for next generation tissue-specific biologics); and TavoMIP (a multicyclic peptide platform that makes undruggable targets more accessible). With the new infusion of capital, Tavotek is developing novel biologics targeting oncology and autoimmune diseases for patients. The company plans to bring three innovative antibodies into human clinical trials in late 2021 with another three assets to IND in 2022.

On March 22, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the publication of preclinical data in the Journal for ImmunoTherapy of Cancer (JITC) highlighting efficacy of ImmunityBio’s PD-L1 t-haNK natural killer cell-based therapy in combination with T cell-based immunotherapy against heterogeneous tumors (Press release, NantKwest, MAR 22, 2021, View Source [SID1234576948]). ImmunityBio’s novel PD-L1 t-haNKs are derived from a human, allogeneic NK cell line (NK-92) that has been engineered to express IL-2, CD16, and a chimeric antigen receptor (CAR) that recognizes PD-L1.

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Human solid tumors are made of multiple clones of tumor cells, some of which harbor genomic alterations that make them invisible to T cells. These resistant clones accomplish this "cloaking ability" by preventing the presentation of the tumor antigens on MHC-I receptors, thus "hiding" from killer T cells. For these patients, maximum activation of T cells with immunotherapy is unlikely to lead to durable tumor control or a cure. However, when NK cells are activated, tumor recognition and targeting is restored. The study shows that when subpopulations of tumors cells escape T cell detection or killing, they upregulate PD-L1 in the process because of interferon in the tumor microenvironment. This increase in tumor cell PD-L1 expression sensitizes them to killing by PD-L1 t-haNKs.

"Our results suggest that sequential treatment, first with T cell immunotherapy to kill the sensitive tumor cells and upregulate PD-L1 on the remaining cells, followed by PD-L1 t-haNK treatment, may overcome the issue of tumor heterogeneity and enhance rates of durable tumor control in patients with relapsed solid cancers," said Clint T. Allen, M.D., Principal Investigator, Section on Translational Tumor Immunology in the National Institute on Deafness and Other Communication Disorders (NIH) and corresponding author of the publication.

The publication by first author Maxwell Lee et al., "Chimeric antigen receptor engineered NK cellular immunotherapy overcomes the selection of T cell escape variant cancer cells," describes the development of preclinical models with heterogenous cancers containing T cell escape variant tumor cells. T cell-based immunotherapy administered in these preclinical models resulted in IFNγ production that in turn upregulated PD-L1 expression in T cell escape variants. Subsequent administration of irradiated PD-L1 t-haNKs targeted and eliminated the tumor cell populations that had evolved to be resistant to T-cell immunotherapy alone, resulting in synergistic anti-tumor activity.

"We are excited to see this preclinical study that affirms our hypothesis of ‘Quantum Oncotherapeutics,’ which is currently being studied in Phase1/2 QUILT trials across multiple tumor types. The theory we hold is that our treatment itself induces changes in the tumor immune microenvironment. By anticipating these dynamic cellular changes, we can administer and activate NK cells at the optimal time and, ultimately, outsmart the tumor. These spatial-temporal insights informing treatment, have the potential to change the paradigm of cancer care with modernized immunotherapy protocols, beyond the standard-of-care therapy and beyond checkpoint therapy alone. Late-stage, randomized controlled trials in pancreatic and lung cancers that orchestrate NK cells and T cells are underway at ImmunityBio to confirm this hypothesis," said Patrick Soon-Shiong, M.D. Founder and Executive Chairman of ImmunityBio.

On March 22, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Investigational New Drug (IND) application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) by the Company’s partner in China, Qilu Pharmaceutical, was approved ahead of the original timeline of April 2021 (Press release, Sesen Bio, MAR 22, 2021, View Source [SID1234576965]).

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With approval of the IND, Qilu Pharmaceutical is authorized to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive NMIBC in China, at the sole cost of Qilu Pharmaceutical. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022 with potential approval in China expected in 2023.

"The approval of the IND for Vicineum in China represents a significant milestone in realizing our mission to save and improve the lives of patients globally," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Due to more limited use of BCG in China compared to the US, there is an opportunity to transform the treatment paradigm of NMIBC in China. The approval of the IND ahead of the original timeline underscores the strong collaboration between Sesen Bio and our partner, Qilu Pharmaceutical. Given the highly experienced clinical oncology team at Qilu Pharmaceutical, and the Phase 3 trial results achieved in the US, we are optimistic on the prospects for a successful trial and expeditious submission. We look forward to continuing to work with Qilu Pharmaceutical and the NMPA to bring this potentially best-in-class treatment to patients in China."

Sesen Bio is entitled to receive a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments. China represents a large potential market for Vicineum, with peak year sales estimated at $155-$418M. Additionally, the Company anticipates Qilu Pharmaceutical will become a key strategic partner for global supply of Vicineum and the manufacturing technology transfer to Qilu Pharmaceutical is on track to be completed in mid-2021. The completion of the manufacturing technology transfer triggers an additional $2M milestone payment.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On March 22, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for fiscal year 2020 and business update on Tuesday, March 30, 2021 (Press release, Protalix, MAR 22, 2021, View Source [SID1234576983]). The Company’s management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

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Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 22, 2021 Amgen reported that The National Institute for Health and Care Excellence (NICE) has recommended a triple combination therapy comprised of Kyprolis, lenalidomide and dexamethasone for the treatment of previously-treated multiple myeloma patients.

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In final guidance, NICE backed the use of Kyprolis (carfilzomib) plus lenalidomide and dexamethasone for people with multiple myeloma, who have had at least one previous therapy – including targeted therapy bortezomib (Janssen’s Velcade).

In clinical trials of the triple combination, Kyprolis with lenalidomide and dexamethasone was found to extend periods of remission and help people to live longer, compared to the current second-line treatment for multiple myeloma patients – lenalidomide and dexamethasone alone.

In a statement, NICE said that its independent appraisal committee saw evidence that shows the benefit of the triple therapy appears to continue for up to six years.

Following its review, the committee said the most-likely cost-effectiveness estimates for Kyprolis plus lenalidomide and dexamethasone are within what NICE considers a cost-effective use of NHS resources.

"The recommendation of our committee will be welcomed by people with multiple myeloma who have told us of the need of a new second line treatment option that gives longer periods of remission and improves survival," said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE.

"The clinical data shows that the benefits of this triple therapy continue after treatment has stopped. A positive decision has been made possible after the company and NHS England came to a commercial arrangement which allows carfilzomib to be used on the NHS with a confidential discount," he added.