On June 22, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported the drawdown of the remaining US$10 million available under its existing US$25 million debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon") (Press release, IMV, JUN 22, 2022, View Source [SID1234616175]). This drawdown has been made available as the Company achieved a predetermined milestone following site activation in its Phase 2b AVALON trial in platinum-resistant ovarian cancer.

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"The execution of our clinical team to launch the AVALON trial has permitted us to access this capital in a timely manner," said Andrew Hall, Chief Executive Officer of IMV. "Our balance sheet has been strengthened by this debt facility. It provides operating cash into the second quarter of 2023, as per our current business plan, to continue to advance the development of our lead compound in Diffuse Large B-Cell Lymphoma (DLBCL) and ovarian cancer, while building incremental value through our DPX technology platform."

"Horizon is pleased to continue supporting IMV as the company makes important progress with the AVALON trial," said Gerald A. Michaud, President of Horizon. "We believe in IMV’s mission of building a new class of effective cancer immunotherapies that preserve patients’ quality of life."

US$15 million of the US$25 million facility was already drawn down in December 2021, of which CAD$4.5 million was used to pay off IMV’s existing term loan with the government of Nova Scotia. The remaining proceeds from this facility are being used to support the ongoing clinical development of key investigational product candidates within IMV’s pipeline and for general working capital purposes.

In connection with this financing, IMV has agreed to issue warrants (the "Loan Warrants") to purchase up to 568,180 common shares of the Company (the "Shares") at an exercise price of US$1.32 per Share until December 17, 2031. 454,544 Loan Warrants were issued on December 17, 2021, and the balance of 113,636 Loan Warrants have been issued in connection with the drawdown of the additional US$10 million available under this facility. The Loan Warrants and the Shares issuable upon exercise thereof will be subject to a statutory hold period of four months following the issuance of the Loan Warrants in accordance with applicable securities laws. For the purpose of Toronto Stock Exchange ("TSX") approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange.

The securities offered have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and all applicable state securities laws, or compliance with an exemption from such registration requirements. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On June 22, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that the company has expanded the European Union (EU) label indication of its Bladder EpiCheck test (Press release, Nucleix, JUN 22, 2022, View Source [SID1234616192]). Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer.

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The technology was initially indicated for use as a non-invasive method for the monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures.

Bladder cancer is the fifth most common cancer in Europe with more than 200,000 new cases of the disease diagnosed annually.1 With bladder cancer, patients typically experience symptoms of traces of blood in the urine, called hematuria, though this is not usually visible to the naked eye.2 Up to 30% of adults will experience hematuria at some point in their life, so it is crucial to quickly and non-invasively determine if the symptom is associated with bladder cancer, to ensure a urological workup is conducted immediately.2 Bladder EpiCheck demonstrated 88% sensitivity in detecting the primary high-risk bladder cancer, with a specificity of 98% or more.

"The current workup of hematuria is invasive, costly and usually performed too late, due to delayed referrals to urologists, all the while symptoms can worsen and diagnosis of the disease is delayed when treatment is critical," said Eli Frydman, Ph.D. MBA, President EMEA of Nucleix. "With this expanded label indication and high specificity of Bladder EpiCheck in this population, we’re able to offer a cost-effective, non-invasive approach to triage hematuria patients and help identify bladder cancer early."

Two recently published studies evaluated the performance of Bladder EpiCheck in the detection of primary and recurrent UTUC including 220 patients.3,4 Bladder Epicheck showed high-grade sensitivity of 96-98% and specificity of 81-100% in urine collected from the ureter. One of the studies also reported high-grade sensitivity of 71% and specificity of 81% in bladder urine. In both studies, test sensitivity was higher than cytology.

"Identifying patients with high-grade UTUC early is critical – if missed, the disease can progress to metastases very quickly and the standard treatment, which is the removal of ureter and kidney, can lead to considerable morbidity," said Aharona Shuali, M.D., Vice President of Medical Affairs at Nucleix. "We are encouraged by this expanded label indication because of its potential impact on patients. Bladder EpiCheck delivers highly accurate results in a non-invasive way and could play an important role in the diagnosis and follow-up of this disease, particularly in ruling-out high-grade disease."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect primary and recurrent bladder and upper urinary tract cancers. The test analyzes subtle disease-specific changes in DNA methylation markers, with sensitivity of 91-96% of high-grade cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-grade cancer is present.5 Overall specificity of Bladder EpiCheck is 84%, 81% and 98% for recurrent bladder cancer, UTUC and primary cancers, respectively, ensuring a low rate of false positive results. Bladder EpiCheck is intended for use as a non-invasive method for detection of urinary tract cancers in conjunction with standard methods. Bladder EpiCheck is CE-marked and commercially available in Europe. The test is not available for sale in the United States.

On June 22, 2022 OCTALFA reported that its subsidiary ORPHELIA Pharma, the French biopharmaceutical company dedicated to the development and commercialization of orphan medicines for the treatment of rare and pediatric diseases, has included the first patient in the KIMOZO French Early Access Program for the treatment of relapsed or refractory neuroblastoma (Press release, ORPHELIA Pharma, JUN 22, 2022, View Source;utm_medium=rss&utm_campaign=octalfa-announces-the-inclusion-of-the-first-patient-in-the-french-early-access-program-granted-to-its-subsidiary-orphelia-pharma-for-the-use-of-kimozo-40-mg-ml-temozolomide-oral-suspension-in [SID1234619551]).

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KIMOZO 40 mg/ml (oral suspension of temozolomide) was granted an early access pre-marketing authorization (Autorisation d’Accès Précoce, AAP) in France on March 31st, 2022 by the Haute Autorité de Santé (HAS) for the treatment of relapsed or refractory neuroblastoma in patients aged 1 to 6 years as well as patients unable to swallow temozolomide capsules.

The goal of Early Access Programs in France is to accelerate access to innovative drugs before or after Market Authorization is granted once all conditions specified in Article L.5121-12 of the French Public Health Code (Code de la Santé Publique) are met:

No appropriate treatment exists;
The treatment’s implementation cannot be postponed;
The efficacy and safety of these drugs are strongly presumed based on therapeutic trials;
These drugs are considered to be innovative, particularly when compared to a possible clinically-relevant comparator.
Full details of the early access program can be found at the Haute Autorité de Santé and the ANSM websites.

About KIMOZO 40 mg/ml

KIMOZO 40 mg/ml is a liquid, taste-masked and ready-to-use oral formulation of temozolomide developed to treat rare pediatric cancers.

In France, KIMOZO has been granted an Early Access Program, to be used as monotherapy or in combination with irinotecan or topotecan in the treatment of pediatric patients aged 1 to 6 years and in patients with incapacity to swallow capsules of temozolomide and who suffer from:

refractory high-risk neuroblastoma or presenting an insufficient response to induction chemotherapy;
relapsed high-risk neuroblastoma after at least a partial response to induction chemotherapy followed by myeloablative therapy and stem cell transplantation.
KIMOZO was developed by ORPHELIA Pharma in collaboration with Gustave Roussy.

On June 22, 2022 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") reported that it has signed an agreement with Contract Manufacturing Organization (CMO) WuXi AppTec ("WuXi"), Shanghai, for the small-scale production of TFC-1326, a powerful active against the aging effects on skin (Press release, Sirona Biochem, JUN 22, 2022, View Source [SID1234616160]).

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Years of groundbreaking research by Sirona’s team of scientists at TFChem has shown in preclinical studies that TFC-1326 has the potential to reverse the effects of aging on skin, including the potential to eliminate fine wrinkles. The scientific data is strong, and we are now preparing for a clinical trial. There are no existing compounds that our scientists are aware of, that have the potential to reverse the effects of the aging process on skin to truly restore its structure and youthful appearance. The anti-aging and anti-wrinkle markets are estimated to be $271 Billion USD globally by 2024.

We are in advanced discussions with a leading clinical trial provider designing the planned clinical trial. Other necessary steps, including formulation and safety work, is being organized. As soon as this is completed and the clinical study starts, we will provide further information on this.

"There are many anti-aging and anti-wrinkle products available on the market currently. But to truly reverse the damage to the skin integrity that occurs naturally with aging is an area of unmet need. Our goal is to demonstrate clinically the potential of TFC-1326 to restore the integrity of the skin and return a more youthful appearance. The treatment of fine wrinkles is also a goal. BOTOX is the most effective on dynamic wrinkles while static wrinkles typically are managed by fillers. TFC-1326 has the potential to replace or supplement dermal filler injections to treat these static wrinkles," said Dr Howard Verrico, CEO of Sirona Biochem. "TFC-1326 with its unique mechanism of action is revolutionary in the aesthetic skin care space. Like our recent success, licensing TFC-1067 and the corresponding compound family globally, we see this as another opportunity to showcase the tremendous potential of our platform technology. And, of course, we are pursuing another lucrative licensing agreement for TFC-1326."

On June 22, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported that the Defense Enclave Services (DES) contract awarded by the Defense Information Systems Agency (DISA) was upheld by the Government Accountability Office (GAO) after a thorough and disciplined review (Press release, Leidos, JUN 22, 2022, View Source [SID1234616176]). The single-award, indefinite delivery, indefinite quantity contract was initially awarded in February 2022 and holds a total estimated value of $11.5 billion if all options are exercised. It includes a four-year base period of performance followed by three two-year option periods.

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"We are pleased the Government Accountability Office has affirmed the Defense Information Systems Agency’s award," said Gerry Fasano, Leidos Defense Group President. "Leidos is deeply committed to DISA’s critical mission, and never stopped preparing for the program’s success. Our robust and continuous preparation has positioned us to start delivering benefits to the user base on or ahead of the current planned schedule, and we look forward to leveraging our decades of technological expertise to support mission success."

Through the DES contract, Leidos will support DISA’s mission by consolidating enterprise IT services at a global scale and by providing standardized, responsive and cost-effective solutions. The program involves a wide range of IT services for more than 370,000 users spanning 22 Department of Defense (DoD) agencies and field activities with over 500 sites both in the U.S. and abroad. This work will focus on mission value and user experience, while improving cybersecurity, network availability, and reliability for Fourth Estate agencies.

DISA is headquartered at Fort George G. Meade in Maryland and supports joint warfighters, national level leaders, and other mission and coalition partners across the full spectrum of military operations with information sharing capabilities, command and control solutions and global enterprise infrastructure.