On April 22, 2021 MonTa Biosciences, a Danish clinical stage biotech company located in Copenhagen, reported the first patient has been dosed with Monta Bioscienes MBS8 in a Phase I clinical trial (Press release, MonTa Biosciences, APR 22, 2021, View Source [SID1234578399]). Patients with solid tumors are enrolled at two danish hospitals in Copenhagen, Rigshospitalet and Herlev Hospital. 30-50 patients will be enrolled over the next 18 months.

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MonTa Biosciences lead candidate MBS8 was administered intravenously to the first patient in the trial at Rigshospitalet in Copenhagen on Wednesday, April 21. The primary objective of the trial is to evaluate the safety of multiple escalating doses of MBS8 for patients with advanced solid tumours and to establish the maximum tolerated dose (MTD/recommended Phase 2 dose (RP2D). The effects on biomarkers and objective tumor response in the patients will also be assessed.

MBS8 treatment is an innovative way to stimulate the immune system to help the body fight cancer. MBS8 is a nanoparticle that contains an immune stimulating compound called a TLR7 agonist that activate certain types of immune cells which are able to enter tumor tissue from the blood and kill tumor cells. After weeks of treatment MBS8 is also able to stimulate immune memory T-cells to recognize and eliminate cancer cells, which is of particular interest to cancer patients with metastatic disease, where there is a huge unmet medical need for better treatment.

MonTa Biosciences’ CEO, Simon S Jensen said "We are very excited to have the first patient dosed with MBS8 and hope the drug will demonstrate to be safe for the patients, and even more important also have an impact on their cancer. With the new mode of action for MBS8, which has never been seen for any cancer drug before, we have high expectations to MBS8 and hope we already in this phase I will be able to help patients in need. It is quite rare to see drugs acting as monotherapy on the immune system as efficiently as MBS8, often cancer immunotherapy treatments are combined with other treatments to enhance their therapeutic activity."

On April 22, 2021 Case Western Reserve University reported that The U.S. Food and Drug Administration has approved human clinical trials to test the safety of cancer-detection technology developed at Case Western Reserve University: a tumor-targeting contrast agent that accurately detects aggressive prostate cancer in a magnetic resonance imaging (MRI) scan (Press release, Case Western Reserve University, APR 22, 2021, View Source [SID1234578350]).

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The molecular-targeted imaging agent is licensed to Molecular Theranostics LLC, a Cleveland based startup company, and its partners U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd. of China.

The agent will undergo a clinical trial at Ohio Clinical Trials Inc. in Columbus through a contract with U.S. Motek. Patient recruitment is expected to start in early May and the trial later in the month.

The imaging agent, known as MT218, was invented in the lab of Case Western Reserve researcher Zheng-Rong Lu, who has been developing the tumor-specific MRI contrast agent for nearly 15 years.

Lu, a co-founder of Molecular Theranostics, and his partners believe the agent could someday allow clinicians to non-invasively and accurately diagnose the malignant prostate cancer in a common MRI scan.

A more precise MRI scan of prostate cancer—and possibly other cancers—could benefit patients who are sometimes needlessly treated with aggressive interventions, or conversely, better identifying those who need the treatments, said Lu, the M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering at the Case School of Engineering.

Zheng-Rong Lu
"We are very excited about this phase one clinical trial because it means that our research product is now under clinical development to help people," Lu said. "Our agent has the promise to detect the aggressive solid tumors to provide imaging guidance for precision healthcare of cancer patients."

The key to this more precise diagnosis of the tumor is using Lu’s patented gadolinium-based MRI contrast agent that binds to a molecular marker, called extradomain B fibronectin, a cancer-associated subtype of fibronectin.

The gadolinium agent is a paramagnetic substance that can enhance MRI signals of aggressive tumors to improve the accuracy of cancer diagnosis.

The clinical trials at Motek will assess whether the agent can be safely administered to humans—the first step in the clinical development for detecting the tumors in patients as it has done successfully in animal models, Lu said. The trial participants are expected to be 30 healthy Black and white males between age 18 and 55, he said.

A second trial is being pursued to test the agent’s effectiveness in detecting aggressive tumors and differentiating the types of tumors, Lu said.

Lu’s patented technology was jointly developed by Molecular Theranostics and its affiliates (U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd). Jiangsu Motek Pharmaceuticals announced the FDA approval in March.

Current prostate testing

Prostate cancer is the most common non-skin cancer in the United States: one in eight men nationally will be diagnosed with prostate cancer in his lifetime, according to the Prostate Cancer Foundation.

MRI provides high-resolution, three-dimensional tissue images and is widely used to diagnose prostate cancer.

However, the current technologies—especially MRI contrast agents added to tissues to reveal tumors—are limited. An imprecise diagnosis can lead to either over- or under-treating a tumor, Lu said.

Jiangsu Motek Pharmaceuticals officials said "the gold standard" for clinical diagnosis of prostate cancer is a 12-needle puncture biopsy guided by rectal ultrasound. However, sampling errors in the biopsy—and the fact that various levels of tumors may coexist in the prostate—can lead to a false-negative diagnosis rate of up to 30%, according to the company.

On the other hand, extensive blood tests for prostate cancer and a subsequent biopsy can sometimes lead to overdiagnosis and overtreatment. That overtreatment can lead to

serious infections and reproductive and urinary side-effects, Lu said.

"That’s why this is so important," said Lu. "Research shows that only 20% of patients diagnosed will develop aggressive tumors—so we could spare the other 80% from aggressive over treatment."

On April 22, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received two milestone payments under MediciNova’s assignment agreement with Genzyme Corporation, a subsidiary of Sanofi (Press release, MediciNova, APR 22, 2021, View Source [SID1234578366]). The milestone payments, which total $4 million, are a result of the successful achievement of two clinical development milestones for a gene therapy product based on AAV (adeno-associated virus) vector technology that is covered under the assignment agreement.

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On April 22, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (the "Company" or "Jazz") reported the pricing of the previously announced offering (the "Offering") of $1.5 billion in an aggregate principal amount of 4.375% senior secured notes due 2029 (the "Notes") by Jazz Securities Designated Activity Company, a direct wholly owned subsidiary of the Company (the "Issuer") (Press release, Jazz Pharmaceuticals, APR 22, 2021, View Source [SID1234578382]). The Notes will mature on January 15, 2029 and will bear an interest rate of 4.375%. The Notes will be guaranteed by the Company and certain of its subsidiaries. The Offering is expected to close on April 29, 2021 subject to customary closing conditions.

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The aggregate principal amount of the Notes to be issued in the Offering decreased to $1.5 billion from the anticipated $2.7 billion announced on April 20, 2021, a decrease of $1.2 billion. This reduction corresponds to the equivalent anticipated increase in term loan borrowings under our new senior secured credit facilities (the "New Senior Secured Credit Facilities") in connection with the previously announced proposed acquisition of GW Pharmaceuticals plc ("GW") (the "Acquisition") from $2.65 billion to approximately $3.85 billion.

The Company expects to use the net proceeds from the Notes and Acquisition date borrowings under the new senior secured credit facilities, together with cash on hand to fund the cash consideration payable in connection with the Acquisition of GW, the refinancing of certain of the Company’s indebtedness (including the Company’s existing senior secured credit facility) and fees and expenses in connection with the foregoing. The Offering is not conditioned on the closing of the Acquisition. If (1) the Acquisition is consummated without the Company entering into the New Senior Secured Credit Facilities, (2) the Acquisition has not been consummated on or before August 3, 2021 (or such later date to which such date may be extended pursuant to the terms of the Transaction Agreement, dated February 3, 2021, among the Company, GW and Jazz Pharmaceuticals UK Holdings Limited (the "Transaction Agreement") or (3) the Transaction Agreement is terminated in accordance with its terms, the Issuer will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount plus accrued and unpaid interest to, but excluding, the redemption date.

The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act") that are located in the United States, Canada, France, Ireland, Luxembourg, the United Kingdom, and Bermuda and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act that are located in Canada, France, Ireland, Luxembourg, the United Kingdom, and Bermuda. The Notes have not been registered under the Securities Act or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to purchase the Notes or any other securities and does not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

On April 22, 2021 Vyant Bio, Inc. ("Vyant" or the "Company") (Nasdaq: VYNT), an emerging leader in novel drug discovery techniques, reported a collaboration that will seek to de-risk the development of small protein therapeutics (Press release, Cellaria, APR 22, 2021, View Source [SID1234578443]). In partnership with Ordaōs Bio ("Ordaōs") and Cellaria, Inc. ("Cellaria"), the Company is unveiling a model for rapid iteration of therapeutic design using artificial intelligence and in vitro ‘avatar clinical trials’ that will enable the design, development, and testing of potential therapeutics on specific patient populations, during preclinical development. The goal is to provide an early detection system of a drug’s efficacy in different patient cohorts, prior to clinical trials.

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The collaboration capitalizes on the unique capabilities of each company to design, manufacture, and test small-protein therapeutics that target multiple biomarkers derived from whole genome sequencing of patient populations. Using proprietary AI, Ordaōs will generate in silico protein sequences, designed to bind specific disease targets, and will serve as a blueprint for the collaborative team’s experts in in vitro and in vivo preclinical drug discovery, to produce the protein and rapidly iterate the structure using a highly efficient expression system. Using Cellaria’s Patient Specific Cell Model Cohorts, the purified protein will be critically evaluated for target binding and further optimized to improve performance across an array of disease-specific genetic biomarker expressing cells. Once fully optimized by the team, Vyant Bio’s objective will be to deliver regulatory readiness and a maximally de-risked drug candidate. The combined solution will provide data and human-based insights not usually available until after a costly clinical trial.

"Vyant Bio is committed to transforming the way that drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our collaboration with Ordaōs and Cellaria allows us all to work together to design and develop superior therapeutics and position them to be as successful as possible before they get into the clinic."

Cellaria Inc. uses cell biology in novel ways to provide insights into how a therapeutic may perform in specific patient populations, prior to clinical trials. In this collaboration, Cellaria provides the means for scientists to test how a drug will perform in a range of patient cohorts. The Cellaria in vitro and 3-D Models of tumor and metastatic niches are directly linked to a patient’s disease state and enable multiple parametric deep data sets in genomics, proteomics, and combinatorial analysis.

"Working with the Ordaōs and Vyant Bio teams has been incredibly important for us. Seeing the wealth of patient data and cells used so seamlessly to inform and guide the design of a therapeutic is highly rewarding," stated David Deems, President and Founder of Cellaria Inc. "We are developing a repeatable process that leverages well defined patient cohorts to learn as much as possible prior to embarking on a clinical trial."

Ordaōs uses generative AI technology to accelerate the mini protein drug discovery and development process. In this collaboration, Ordaōs provides a pipeline of digitally optimized therapeutics for further development. The company was founded by David Longo, a Stanford and Harvard-trained AI and biotech scientist, and Ulo Palm, MD, PhD, a 30-year veteran of clinical drug discovery and development at Allergan, Novartis, and Schering Plough.

"We are very excited about working with Vyant Bio and Cellaria to further our vision for transforming the way we bring therapeutics to patients. At Ordaōs, we believe that designing, rather than discovering, drugs is now possible with AI and will allow us to think bigger when we envision the impact we can have on people’s lives." said David Longo, CEO of Ordaōs.

Ülo Palm, Ordaōs’ Chief Medical Officer, added that "the ultimate goal is to use modern AI to design the next generation of highly effective and safe biologics for treating cancer and inflammatory diseases thereby creating transformative treatment options for potentially millions of patients worldwide. We expect that this new approach will significantly accelerate drug R&D overall and get the new drugs to patients much faster than with the traditional drug development approach. Patients who suffer from chronic and life-threatening diseases cannot wait. That is why this new collaboration is so important."

The three companies will continue to refine their strategies for drug design and development through a series of projects targeting cancer, pancreatic, and autoimmune disorders. As the project evolves, the therapeutic de-risking strategy will further incorporate the human-based biology and analytical software of StemoniX, a wholly owned subsidiary of Vyant Bio.