On June 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM) (Press release, Kintara Therapeutics, JUN 15, 2022, View Source [SID1234615995]).

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Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Some of the significant benefits of FTD include:

Enhanced access to the FDA, including opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083.
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
FTD also allows for ‘rolling review’, whereby Kintara may submit completed sections of the VAL-083 NDA as they become available, rather than at the end of development.
"We believe Fast Track Designation is indicative of VAL-083’s potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer," stated Robert E. Hoffman, President and CEO of Kintara. "We look forward to announcing top-line data from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023. Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved."

On June 15, 2022 Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum physics reported that it has entered a new research collaboration with Sanofi (Press release, Aqemia, JUN 15, 2022, View Source [SID1234616012]).

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This new agreement is a follow-up to a Research Collaboration initiated at the end 2020 by Sanofi to bring the unique technologies of Aqemia to the design and discovery of novel molecules in several projects in oncology, a priority therapeutic area for Sanofi.

This initial collaboration resulted in promising molecules for an oncology program, for which Sanofi and Aqemia decided to pursue joint efforts.

Aqemia will take responsibility for the AI-based design of optimized molecules that fulfill several small molecule design goals among which potency and selectivity in a priority project in oncology. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the drug discovery project by generating its own data with quantum and statistical physics-based calculations.

This collaboration includes an undisclosed upfront payment from Sanofi.

Maximilien Levesque, CEO and co-founder of Aqemia, commented, "We are really proud of the results obtained in the first Sanofi-Aqemia oncology collaboration and are very excited to continue working together to accelerate important projects in oncology." He added, "This follow-up of our first collaboration project with Sanofi, a global leader in the Pharmaceutical industry, demonstrates our ability to quickly generate novel potent and selective compounds for a given target, and we can’t wait to scale it up to dozens of drug discovery projects."

"We are also extremely excited by the promising results obtained by Aqemia using their proprietary and disruptive technology to design potent inhibitors on given targets. We are eager to prolong our collaboration to speed up our candidate finding process for the sake of patients suffering from cancer," said Laurent Schio, head of Integrated Drug Discovery of Sanofi France,

On June 15, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that its clinical study collaborator Hospices Civils de Lyon in France ("HCL") has surgically excised the first ovarian cancer tumors from cancer patients to be used by BioVaxys for process development and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production of the Company’s ovarian cancer vaccine (Press release, BioVaxys Technology, JUN 15, 2022, View Source [SID1234615997]).

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BioVaxys recently entered collaborations with HCL and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used by BioVaxys’ Lyon-based manufacturing partner, BioElpida ("BioElpida"), to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU.

Donors of ovarian cancer tumors are required to sign a patient consent form, with the tumor extraction, storage, and shipping logistics following a strict protocol developed by Biovaxys, and subjected to institutional and regulatory approval.

BVX-0918 produced from the surgically removed tumor cells from HCL will be screened using the identity assays derived from the OVCAR-3 cell line recently completed by BioElpida. The identity assay will be performed on every batch of autologous ovarian cancer vaccine, and is mandatory for regulatory bodies in the EU and United States.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated that "The production of BVX-0918 is a process that built on the prior successful execution of sequential steps, such as the bioproduction technology transfer to BioElpida, development of validation procedures needed to support GMP manufacturing, sterility testing for transport, hapten fixation, cryopreservation methods, antibody generation, bioburden screening, endotoxin assays, and most recently, the development of the identity assays from the OVCAR-3 cell line. With the surgically excised tumors we can now begin the final stages of the vaccine production protocol and GMP validation."

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

On June 15, 2022 Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide reported that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market LLC ("Nasdaq") on Thursday, June 16, under the new ticker symbols "ALVO" and "ALVOW", respectively (Press release, Alvotech, JUN 15, 2022, View Source [SID1234616013]). This follows the successful completion of the company’s business combination with Oaktree Acquisition Corp. II ("OACB"), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"). The merger, which was approved on June 7 by OACB shareholders, creates a publicly traded, pureplay company focused on the growing global biosimilar market.

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The public listing is expected to be the largest debut on a U.S. exchange by an Icelandic company. Ordinary shares of the company are also expected to trade on the Nasdaq First North Growth Market in Iceland commencing on June 23, 2022. Alvotech is expected to be the first dual-listed Icelandic company on both a U.S. and Icelandic stock exchange.

"Becoming a public company is a historic milestone on Alvotech’s growth journey," said Robert Wessman, founder and Executive Chairman of Alvotech. "We expect that becoming a listed company will allow us to continue strengthening our position in the biosimilar space while delivering value to our partners and patients across the globe."

"Oaktree is proud to be associated with Alvotech, a world-class biosimilar platform with a mission-critical focus on providing important drugs at a reduced cost," said Howard Marks, Co-Founder and Co-Chairman of Oaktree. "We look forward to the continuation of our relationship as the company enters its next phase of growth."

Since its inception a decade ago, Alvotech has built a vertically integrated, state-of-the-art platform for developing and manufacturing biosimilars at scale. Biosimilars are therapeutic equivalents to biologics, a rapidly growing category of highly efficacious medicines, that provide lower-cost alternatives to higher-priced originator medicines. Biologics represent over 40% of all pharmaceutical spending in the U.S. and over 30% of spending on medicines in Europe at list prices1. Alvotech’s current portfolio of eight products and product candidates targets multiple therapeutic areas and represents an estimated total addressable market of over $85 billion based on estimated peak sales of the reference products2.

Alvotech’s lead product, AVT02 (adalimumab), a biosimilar to Humira, has launched in Canada and Europe and is expected to launch in the U.S. on July 1, 20233. For the U.S. market, Alvotech is pursuing an interchangeability designation for AVT02 (adalimumab) and has previously announced FDA acceptance of Alvotech’s BLA supporting interchangeability for the company’s high-concentration, citrate-free biosimilar candidate. More recently, the company has announced positive topline results for AVT04 (ustekinumab), Alvotech’s proposed biosimilar to Stelara, for both the confirmatory clinical, safety and efficacy study and a pharmacokinetic (PK) study.

In order to give its products global reach with local expertise, Alvotech has formed strategic commercialization partnerships with leading pharmaceutical companies spanning global markets. These include partnerships with Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) for the US market; STADA Arzneimittel AG for EU and select other territories; and Fuji Pharma Co., Ltd (TSE: 4554) for Japan, among others.

The transaction is supported by a PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. The PIPE was backed by top-tier investors such as Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

To celebrate the public listing, Mr. Wessman will ring the opening bell at NASDAQ with live ceremonies beginning at 9:15 ET on June 16 at the Nasdaq Market Site in New York City. The event will be livestreamed and can be viewed at View Source

On June 15, 2022 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, JUN 15, 2022, View Source [SID1234615998]). The dividend is payable on August 1, 2022 to stockholders of record at the close of business on July 1, 2022.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2022, to stockholders of record at the close of business on August 9, 2022.