On May 9, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA) (TSXV: IPA) is pleased to share that IPA’s subsidiary Biostrand, a Belgian end-to-end multi-omics analysis platform provider, reported that it has received a €460,000 round of grant funding from VLAIO (Flanders Innovation & Entrepreneurship), the research fund of the Flemish regional government in Belgium (Press release, ImmunoPrecise Antibodies, MAY 9, 2022, View Source [SID1234613910]). Conditionally awarded in January this year, BioStrand recently satisfied the remaining criteria for the award, which follows an original grant from VLAIO of €235,000 in 2020. Commenting on the latest grant, Dr. Ingrid Brands, General Manager and co-founder of BioStrand, stated, "Thus far, our patented HYFT-based methodology has been applied predominantly to streamline analysis at the syntactic level and combines sequence information with natural language processing. Using the presence, occurrence, and distribution of HYFT patterns, the focus has been on analysis and integration of sequence-based ‘syntactical’ information. We are now extending the methodology to combine syntactical and structural information and to expand our services portfolio with HYFT-based structural and functional modelling functionalities. By linking HYFTs with the 3D structure (and function) of proteins and expanding platform capabilities for AI discovery, we will be able to support an even wider array of applications, including assay development, biomarker discovery, and computer-aided drug design."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The strategic objective driving this HYFT-based synthesis of syntactical and structural information is to extend BioStrand’s technology to encompass the structure of proteins. A key advantage of this blended approach is the detection of protein sequences with similar structures (and function) but without high sequence similarity (distant homologs). A primary application for this approach will be in protein structure prediction, with a particular first focus on antibodies as well as G protein coupled receptors (GPCRs). This will be extended to cover protein-protein interaction prediction (PPI) at a later stage.

BioStrand is also working on an AI Discovery platform that will leverage advanced AI techniques to facilitate integrated protein structure and function analysis. Combined with existing R&R and Variant Analyzer modules, natural language analysis capabilities and the HYFT-based unified syntactical plus structural methodology, BioStrand’s AI discovery platform will empower researchers to fully analyse their data and gain insights across the entire analysis pipeline, from raw sequencing data to biologically relevant aspects such as diagnostics and drug discovery.

The expansion of BioStrand’s omics platform with these advanced functionalities is crucial to become an ambitious market player and position BioStrand as a one-stop-shop for omics analysis," said Dr. Brands. "We believe that integrating sequence and 3D structure analysis in combination with natural language processing will revolutionize protein structure and function prediction and boost developments in biotechnology and precision medicine. Providing a powerful, integrated, and user-friendly data analysis platform for life sciences researchers is our contribution to ramping up the effectiveness of R&D cycles and enabling the real-time analysis of actionable patient data that will bring precision medicine to the next level. It also takes us one step further in our mission to create a truly effective omics data analysis solution."

The Company also announces the departure of Stefan Lang, Chief Business officer of IPA, effective immediately, and wishes him the best in his future endeavors.

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source [SID1234613909]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

On May 9, 2022 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the first quarter ended March 31, 2022 (Press release, Seagen, MAY 9, 2022, View Source [SID1234613908]). During the quarter, the Company continued to engage with the US Food and Drug Administration (FDA) to identify an anticipated regulatory path toward potential resubmission of a Biologics License Application (BLA) for Vicineum for the treatment of non-muscle invasive bladder cancer (NMIBC). The Company has also initiated a process to review strategic alternatives with the goal of maximizing shareholder value.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

US Regulatory Update

On March 28, 2022, Sesen Bio participated in a Type C Meeting with the FDA. During the meeting, the FDA agreed to a majority of the Company’s proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial that it plans to conduct for potential resubmission of a BLA for Vicineum for the treatment of NMIBC. The Company plans to meet with the FDA in mid-2022 to align on the remaining outstanding items related to the additional Phase 3 clinical trial, and intends to request that meeting in the coming weeks.
In addition to working with the FDA to align on a study design, the Company has been addressing comments related to Chemistry, Manufacturing and Controls (CMC) that were included in the Complete Response Letter (CRL) for the BLA for Vicineum for the treatment of bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. The Company has completed technical work on several of the key CMC comments and is continuing to make progress on the remaining items. The Company’s responses to the CMC comments will ultimately be reviewed by the FDA upon a potential BLA resubmission.

Other Business Updates

On January 6, 2022, Sesen Bio disclosed that it achieved a $20 million milestone payment pursuant to the Company’s exclusive license agreement (Roche License Agreement) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Following this milestone payment, Sesen Bio has cumulatively received $50 million in upfront and milestone payments, with an additional $220 million in potential future milestone payments, as well as royalty payment obligations on future sales, remaining under the Roche License Agreement. As part of the Roche License Agreement, Roche also maintains the right to fully acquire the IL-6 technology.
On May 3, 2022, Sesen Bio announced that it had initiated a process to review strategic alternatives with the goal of maximizing shareholder value. Potential strategic alternatives to be explored and evaluated during the review process may include the sale of the Company, a merger, acquisition or other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of some of the Company’s proprietary technologies. The Company is actively working with an investment bank in this process. Pending any decision to undertake any strategic alternative, the Company is continuing its development activities in accordance with its existing business strategy.
On June 22, 2022, Sesen Bio will hold its Annual Meeting of Stockholders, one of the primary purposes of which will be to approve a proposal for a reverse stock split, which includes a proportionate reduction in authorized shares of common stock. The proposed reverse stock split, if approved, should allow the Company to remain listed on the Nasdaq Global Market, which should increase the range and attractiveness of strategic alternatives that the Company is able to consider to maximize shareholder value.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $169.8 million as of March 31, 2022, compared to $110.0 million as of March 31, 2021.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $4.8 million compared to $6.1 million for the same period in 2021. The decrease of $1.3 million was primarily due to lower costs associated with technology transfer and manufacturing ($1.4 million), regulatory and clinical consulting fees ($0.6 million) and license milestone fees ($0.6 million), which were partially offset by increases in employee-related compensation, primarily driven by increased headcount and the retention program implemented in the fourth quarter of 2021 ($1.2 million), and other R&D expenses ($0.1 million).
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $9.0 million compared to $5.3 million for the same period in 2021. The increase of $3.7 million was due primarily to increases in legal expenses related, in part, to the independent internal review completed in February 2022 ($3.0 million), employee-related compensation, primarily driven by increased headcount and the retention program implemented in the fourth quarter of 2021 ($1.1 million), insurance expense ($0.1 million) and other general expenses ($0.2 million). This was partially offset by a decrease in consultant fees incurred in preparation for commercial launch as a result of the subsequent CRL received in August 2021 ($0.7 million).
Net Loss: Net loss was $0.8 million, or $0.00 per basic and per diluted share, for the first quarter of 2022, compared to net loss of $55.5 million, or $0.35 per basic and diluted share, for the same period in 2021. The decrease of $54.7 million in net loss was primarily attributable to the non-cash decrease in fair value of contingent consideration ($61.1 million), partially offset by decreased license and related revenue recognized ($4.3 million).
About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. After meeting with the FDA, the Company plans to conduct an additional Phase 3 clinical trial for Vicineum for the treatment of NMIBC in connection with the potential resubmission of a BLA. The Company plans to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to the additional Phase 3 clinical trial. 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 May 9, 2022 OPKO Health, Inc. (NASDAQ: OPK), a multinational biopharmaceutical and diagnostics company, reported the acquisition of ModeX Therapeutics, Inc. a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases (Press release, Opko Health, MAY 9, 2022, View Source [SID1234613907]). OPKO acquired ModeX for $300 million in OPKO common stock .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Founded in October 2020 with headquarters in Natick, Mass., ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms. The design of these multi-specifics is amenable to gene-based delivery by mRNA or DNA vectors. The ModeX product portfolio includes cancer immunotherapies that combine four specificities into one protein to improve targeting and immune killing, as well as masking or "stealth" technology to improve tumor-specific killing and reduce side effects. For viral diseases, the lead targets of a broad and potent multi-specific antibody portfolio include HIV and SARS-CoV-2. A vaccine for Epstein-Barr virus is also in development.

"The acquisition of ModeX Therapeutics significantly broadens our technology foundation and expands our product pipeline to include multi-specific multi-functional antibodies focused on a range of cancers and infectious diseases, with applicability to other therapeutic areas. We believe the promise of better outcomes for patients treated with these multi-specific antibodies represents a next generation of large molecule therapeutics and the next chapter of OPKO," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "We welcome ModeX’s co-founders Dr. Zerhouni and Dr. Nabel, as well as Alexis Borisy to our Board of Directors, and Dr. Zerhouni and Dr. Nabel to OPKO’s executive management team. The ModeX executive team brings to OPKO a wealth of experience, knowledge and industry contacts, which we expect will have a tremendous long-term positive impact on OPKO as we advance their technology and product pipeline and leverage potential synergies with our current portfolio in diagnostics and therapeutics."

Elias Zerhouni, M.D., Co-Founder and Chairman of the Board of ModeX, has been appointed President and Vice Chairman of the Board of Directors of OPKO. Dr. Zerhouni brings extensive experience in academia, government and industry as a leading authority on emerging trends and issues in medical care and biomedical research and development. A physician scientist with an academic background in imaging and biomedical engineering, Dr. Zerhouni most recently served as President of Global Research & Development and Executive Vice President of Sanofi. Dr. Zerhouni also served as Director of the National Institutes of Health (NIH), Senior Fellow for Global Health Research at the Bill and Melinda Gates Foundation, Presidential U.S. Envoy for Science and Technology, and Professor and Chair of the Russell H. Morgan Department of Radiology and Biomedical Engineering, Executive Vice Dean and Dean for Research at the Johns Hopkins School of Medicine. Dr. Zerhouni was elected to the National Academy of Medicine and to the National Academy of Engineering. He serves on the Board of the Lasker Foundation, the Foundation for NIH, the Davos Alzheimer’s Collaborative and Research!America. He received the 2017 Scripps Executive of the Year Award for the pharmaceutical industry and the French Legion of Honor in 2008. He has been a director of Danaher Corporation since 2009.

"Being part of OPKO represents a transformative opportunity for both companies. We anticipate it will accelerate ModeX’s product pipeline focused on unmet needs in oncology and infectious diseases and the development of our innovative technologies, and also will take advantage of synergies with OPKO’s programs," said Dr. Zerhouni. "ModeX has operated quietly since we were founded 18 months ago on the basis of over 10 years of prior foundational work. We have assembled a world-class executive team with outstanding public and private sector leadership experience to advance our programs. Our lead drug candidate is already in the clinic while several others in late preclinical stages are expected to enter clinical development in 2023. We were enticed to join OPKO by its leadership’s vision and enthusiasm for strengthening our mutual potential for breakthrough innovation."

Gary Nabel, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of ModeX, has been appointed Chief Innovation Officer of OPKO and joins OPKO’s Board of Directors. Dr. Nabel, a renowned virologist and immunologist, served as Chief Scientific Officer and Senior Vice President of Sanofi where he directed the breakthrough laboratory that developed tri-specific products now in early clinical development. He is the founding director of the NIH’s Vaccine Research Center, working on vaccines and broadly neutralizing antibodies against HIV, influenza, SARS, Ebola, Chikungunya and Epstein-Barr virus. He was previously an investigator at the Howard Hughes Medical Institute at the University of Michigan. In recognition of his expertise at the forefront of virology, immunology, gene therapy and molecular biology, Dr. Nabel was elected to the National Academy of Medicine, is a fellow of the American Association of Physicians and the American Academy of Arts Sciences, and was awarded the Geoffrey Beene Builders of Science Award from Research!America.

Alexis Borisy, the Lead Independent Director of ModeX, also joins OPKO’s Board of Directors. Mr. Borisy is a leading biotechnology entrepreneur and investor with more than 25 years of experience, including founding, serving as Chief Executive Officer and/or Chairman of nine NASDAQ-listed companies. He co-founded and served as either the Chief Executive Officer or Chairman of Blueprint Medicines, Foundation Medicine, Relay Therapeutics, Tango Therapeutics, Celsius Therapeutics and CombinatoRx.

With the additions of Dr. Zerhouni, Dr. Nabel and Mr. Borisy to OPKO’s Board, the number of Directors expands to 13.

Conference Call & Webcast Information

Management will discuss this transaction and answer questions during the company’s previously scheduled first quarter 2022 conference call, to be held today at 4:30 p.m. Eastern time. Participants can pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 16, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 6587528. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On May 9, 2022 MobileODT, a leading Israeli FemTech company, reported that it has been selected as the winner of the "Best New Imaging Technology Solution" award in the sixth annual MedTech Breakthrough Awards program conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market (Press release, MobileODT, MAY 9, 2022, https://www.mobileodt.com/press-releases/mobileodt-recognized-for-imaging-technology-innovation-in-2022-medtech-breakthrough-awards-program/ [SID1234613906]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MobileODT is creating a new paradigm in cervical cancer screening and diagnostics at the point of care. MobileODT’s EVA System combines advanced imaging, data, and software applications. EVA is a digital mobile colposcope powered by Artificial Intelligence and telehealth components.

The company’s EVA VisualCheck AI technology is a clinical decision support tool that harnesses the power of artificial intelligence (AI) and Machine Learning (ML) to perform cervical cancer screening at scale. It offers an alternative screening modality to the current standard of care, with significantly improved accuracy and speed – returning results in under 60 seconds.

"It is a great honor to be recognized with this award from MedTech Breakthrough. We are the only company in the world with an AI capability in cervical cancer screening and the only company that can perform screening at scale – and this 2022 MedTech Breakthrough Award is a strong validation of our momentum," said Leon Boston, CEO of MobileODT. "With such unprecedented screening at scale, this can be life-saving for many women around the world. We stand ready to support the World Health Organization’s strategic mission to eliminate cervical cancer by 2030."

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work, and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.

"The unfortunate reality is that many cervical cancer cases occur because of a lack of timely screening. With over 300,000 women dying from cervical cancer each year, timely follow-up and the ability to receive the results immediately at the point of care, represents a complete game-changer," said James Johnson, managing director, MedTech Breakthrough. "The EVA VisualCheck system serves as a "breakthrough" solution that is quick and easy to use, allowing for the ability to screen more patients and predict results with high accuracy. Congratulations to MobileODT on this extremely important win – you’re our choice for ‘Best New Imaging Technology Solution.’"