4D pharma Announces Completion of Merger With Longevity Acquisition Corporation

On March 22, 2021 4D pharma plc (Nasdaq: LBPS; AIM: DDDD) ("4D pharma" or the "Company"), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome – reported completion of its merger ("the Merger") with Longevity Acquisition Corporation ("Longevity")(Nasdaq: LOAC) (Press release, 4d Pharma, MAR 22, 2021, View Source [SID1234576966]).

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4D pharma American Depositary Shares ("ADSs") are expected to begin trading today on the Nasdaq Global Market under the ticker symbol ‘LBPS.’

Warrants of Longevity assumed by 4D pharma in the Merger are currently expected to begin trading on Nasdaq under the ticker symbol ‘LBPSW’ tomorrow, Tuesday, March 23, 2021. Longevity units are expected to be separated and holders thereof are expected receive 4D pharma ADSs and warrants in exchange at the same time as the warrants begin trading.

As a result of the Merger, Longevity shares, warrants, rights and units ceased trading on Nasdaq on Friday, March 19, 2021.

4D pharma ordinary shares continue to be admitted to trading on the London Stock Exchange’s AIM market under the ticker symbol ‘DDDD.’

Sesen Bio and Qilu Pharmaceutical Announce Approval of IND Application in China for Vicineum™

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.

XOMA Announces Approval of First Preferred Stock Dividend

On March 22, 2021 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its Board of Directors approved a dividend of $0.71875 per share to holders of XOMA’s Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) (Press release, Xoma, MAR 22, 2021, View Source [SID1234576964]). The cash dividend will be paid on or about April 15, 2021, to XOMAP holders of record at the close of business on April 2, 2021.

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Anixa Biosciences and Moffitt Cancer Center File IND Application for Ovarian Cancer CAR-T Therapy

On March 22, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that an IND (Investigational New Drug) application for its ovarian cancer CAR-T (Chimeric Antigen Receptor T-cell) therapy has been filed with the U.S. Food and Drug Administration (Press release, Anixa Biosciences, MAR 22, 2021, View Source [SID1234576962]).

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This CAR-T therapy was invented by a team led by Dr. Jose Conejo-Garcia, while he was at the Wistar Institute. Dr. Conejo-Garcia is currently Chair of the Department of Immunology at Moffitt Cancer Center (MCC), where the IND enabling studies were performed, and where the clinical trial will be conducted, under the leadership of Dr. Robert Wenham, Chair of Gynecological Oncology at MCC. Anixa has a worldwide, exclusive commercial license to the technology.

The technology targets the follicle stimulating hormone receptor (FSHR) with engineered T-cells that use the follicle stimulating hormone as a homing mechanism. FSHR is found at immunological levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.

Dr. Wenham stated, "We are pleased to file this IND application, since women who have recurrent ovarian cancer have very few options. We hope the work of our scientific and clinical team at Anixa and MCC yields results that will address a critical unmet medical need."

"We are looking forward to the response from the FDA, and to eventually testing this therapy in humans," stated Dr. Conejo-Garcia. "This is a very high-profile program at MCC, as we believe this could be the first CAR-T therapy that has the potential to achieve clinical success in a solid tumor indication."

"This IND application is a major milestone for Anixa and our partners at MCC," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "This is our second IND application filed within the last few months. Upon clearance from the FDA and commencement of the trial, we expect to have two programs in the clinic."

Enlivex Announces Research Collaboration with Yale Cancer Center to Assess Synergistic Effect of Allocetra™ in Combination with Immune Checkpoint Inhibitors

On March 22, 2021 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, together with Yale Cancer Center, a National Cancer Institute-designated comprehensive cancer center, reported a research collaboration for the assessment of the potential of Allocetra to enhance the activity of checkpoint inhibitors in solid tumors (Press release, Enlivex Therapeutics, MAR 22, 2021, View Source [SID1234576961]). Allocetra is a macrophage-reprogramming immunotherapy product candidate currently in clinical development by Enlivex, as, among other things, a potential therapy in combination with approved immune checkpoint inhibitors for hard-to-treat solid tumors.

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Under the strategic collaboration, the parties intend to develop and execute pre-clinical programs to investigate the potential synergies between Allocetra and commercially-approved checkpoint inhibitor therapies for select solid cancers.

The Principal Investigator for this collaboration is Dr. Vish Muthusamy, PhD, Director of the Yale Center for Precision Cancer Modeling. Dr. Muthusamy is a cancer biologist with expertise in preclinical investigation of candidate cancer therapies. His center has developed in vivo tumor models to investigate pharmacological evaluation of drugs. Recently, Dr. Muthusamy worked in close collaboration several academic investigators and pharmaceutical companies to develop cancer therapeutics that are in various stages of clinical development. The collaboration’s scientific advisor is Dr. Marcus W. Bosenberg, MD, PhD, Co-Leader of the Genomics, Genetics and Epigenetics Program at Yale Cancer Center. On behalf of the Yale team, Dr. Bosenberg said "At Yale we have been interested in trying to understand the process of macrophage reprogramming for some time, and we are excited about studying the effects of Allocetra in potentially recruiting anti-tumor macrophages in the tumor environment and characterize the effects."

Dror Mevorach, M.D., Chief Medical Officer of Enlivex, commented, "We are excited to collaborate with the distinguished research and clinical teams at Yale. Allocetra may have a rebalancing effect on the typically immunosuppressive tumor microenvironment, potentially by facilitating the conversion of pro-tumor macrophage populations to anti-tumor populations. Together, we plan to investigate the potential of AllocetraTM to synergistically combine with commercially available checkpoint inhibitors for the treatment of solid tumors."

Oren Hershkovitz, Ph.D., CEO of Enlivex, stated, "We believe the researchers and clinicians at Yale are world-class and ideal partners as we work to realize Allocetra’s potential. We are pleased to formulate a strategic collaboration with Yale for the development of Allocetra as a potentially key component of combination therapies for solid tumors."

Allocetra is currently in clinical development for acute life-threatening immune-mediated diseases, such as sepsis and COVID-19. Enlivex recently reported positive top-line results in 21 patients from Phase Ib and Phase II investigator-initiated trials in COVID-19 patients in severe/critical condition. The Company has also previously reported positive results from a Phase Ib investigator-initiated trial in 10 sepsis patients and plans to initiate a controlled, randomized, Phase IIb study in sepsis during the first quarter of 2021.