On July 12, 2022 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") provides the following update (Press release, Sirona Biochem, JUL 12, 2022, View Source [SID1234616601]):

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Dear shareholders,

We are pleased to provide an outlook of our ongoing corporate development.

On June 13th we announced that we had successfully completed an exclusive global license for TFC-1067 and related family of compounds with Allergan Aesthetics (an AbbVie company). This deal represents a major milestone for Sirona and one we have been working on for some time. While this clearly validates our science and our chemistry platform, the deal also speaks volumes about the team we have here at Sirona. Although we are still a small organization, we were able to rise to the challenge of a long and intensive due diligence process while maintaining operations and moving other projects forward. We will continue to grow our team on the strong base we have built as a group.

The deal will make Sirona a profitable company and the value will be realized. Terms of the agreement were negotiated with the assistance of industry expert Linda Pullan of Pullan Consulting and our legal team from McMillan LLP. The agreement includes a long-term revenue stream in addition to significant upfront and milestone payments. We can now leverage the success of this deal and have already been provided opportunities to meet with institutional investors and analysts. We will continue to build this company and target rapid growth over the second half of 2022 and beyond.

We recently added Dr. Wolfgang Bieber to our strategic advisory board. He has started a review of the company on an operational level and will report on improvements to maximize the talent and value from our team and facilities. He will also assist in any management changes that take place. We plan to have further additions to this new board of advisors in order to improve operations and effectively manage and speed up the development of our promising product pipeline.

TFC-039 Animal Health
Our anti-diabetes drug, TFC-039, is being evaluated as a treatment in companion animals by a number of the top global animal healthcare companies. SGLT2 inhibitors provide an opportunity to treat inflicted animals with a once-daily oral medication as opposed to the traditional method of daily insulin injections. There are currently no alternatives to insulin injections in animal health.

Discussions and due diligence activities with global animal health companies continue to progress. As outlined in our previous CEO update, Wanbang Biopharmaceuticals has signed a binding Letter of Intent and remains committed to providing data and manufacturing information to potential partners. Discussions between Wanbang and a number of these companies are currently ongoing.

TFC-039 Other Indication
Studies on a new indication for TFC-039 have shown promising results and the next steps are being planned. Details of the new indication will not be disclosed until patented, but the opportunity as a valuable therapeutic exists in an area of great need.

Anti-Aging
Batch scale-up and formulation of our lead anti-aging compound are in preparation for a clinical trial. In parallel, we are working with a contract research organization to finalize the trial plan and determine the endpoints that will give us the most commercially viable results. The trial is expected to begin in H2 2022 and will take place in France. We are in discussions with several pharmaceutical / dermatology companies that may participate in the trial for a right-of-first-refusal to license the compound. This compound has the potential to revolutionize the antiaging market as BOTOX did with the antiwrinkle market. After many years of research, we are excited to reach the pivotal milestone of a clinical trial.

Antiviral
As announced on 20 December 2021, our library of 20 antiviral compounds was tested by Utah State University’s Institute of Antiviral Research and results were inconclusive. We have now identified a European institution with the potential to screen the antiviral library through customized development tests. TFChem is preparing the contract for this partnership which will be announced when completed. Testing is expected to start in H2 of 2022. We have expanded this library of compounds through ongoing work at our research facility in France. The need for new antivirals remains incredibly strong as vaccines struggle to combat continually evolving viruses like the SARS-CoV-2 virus. The antiviral market is estimated to reach $64 B US by 2028 .

On July 12, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, reported that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed (Press release, Greenwich LifeSciences, JUL 12, 2022, View Source [SID1234616600]).

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As previously announced, the Phase III clinical trial was placed on clinical hold by the FDA related to manufacturing and the pharmacy process. The Company through discussions with the FDA and testing of GP2 in the pharmacy process has satisfactorily addressed the clinical hold issues. The Company has committed to additional testing of GP2 in the pharmacy process. On July 11, 2022, the FDA formally removed the clinical hold and thus the Flamingo-01 Phase III clinical trial may proceed as planned. The Company has begun site initiation visits and will provide further updates on the progress of Flamingo-01 in the future.

On June 12, 2022 LegoChem Biosciences Inc. (LCB) and Glycotope GmbH (Glycotope) reported that they have signed a Research Collaboration and License Agreement to develop an antibody drug conjugate (ADC) by combining LCB’s proprietary ADC technology with one of Glycotope’s investigational tumor targeting antibodies (Press release, Glycotope, JUL 12, 2022, View Source [SID1234616599]).

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Under the terms of the agreement LCB has the right to exercise its option for worldwide exclusive rights to develop and commercialize the selected antibody as ADC, upon successful completion of a feasibility study. If LCB exercises these rights, Glycotope will receive an upfront payment as well as development and sales milestone payments plus royalties. Specific financial terms have not been disclosed.

"Through this collaboration, once the candidate ADC is discovered and nominated, Glycotope and LCB plan to advance this very innovative program to clinical stage as a competitive cancer therapy," said Dr. Yong-Zu Kim, CEO & President of LCB. "We are very pleased that companies with innovative antibody platforms, such as Glycotope have recognized the advantages of LCB’s linker-payload technology, which has been proven to be plasma stable as well as cancer-selectively activated."

"This exciting collaboration with LegoChem further underlines the value of Glycotope’s unique technology platform and strengthens our leading position in the development of highly specific glyco-epitope targeting antibodies," added Henner Kollenberg, CEO, Glycotope.

"Our antibodies are designed to deliver increased tumor selectivity. Combining these with LCB’s ADC technology platform offers the opportunity to develop ADCs with potential to perform beyond today’s best standard of care," said Patrik Kehler, CSO, Glycotope.

ADCs are a type of targeted cancer medicine that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. LCB’s ADC platform technologies overcome the existing limitations of ADCs by imparting a trinity of improved properties, (1) site-specific stable bioconjugation (2) cancer selective linker activation and (3) cancer-selective activation of potent payload, all of which in a significantly broader Therapeutic Window.

Glycotope’s antibodies target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glyco-epitopes (GlycoTargets). Targeting these specific antigens enables broad indication range, long-term treatment potential and reduced on-target/off tumor toxicity, key elements of highly potent therapies. Based on this unrivalled tumor-specificity, Glycotope’s antibodies are highly suitable for a multi-function platform approach with independent modes of action to provide a tailored therapy format for as many patients as possible.

On July 12, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that Genentech, a member of the Roche Group, has exercised its second option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies (Press release, Bicycle Therapeutics, JUL 12, 2022, View Source [SID1234616597]).

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Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech was granted two collaboration expansion options, each of which gave Genentech the right to add one additional program to the collaboration in exchange for a $10 million payment to Bicycle. In October 2021, Genentech exercised its first expansion option, and has now exercised its second expansion option, triggering an additional $10 million payment. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration.

"We are pleased both with the ongoing progress in our collaboration with the preeminent immuno-oncology team at Genentech, and that Genentech has once again elected to exercise an option to add a new program," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This represents the second expansion option exercised by Genentech under the terms of our collaboration agreement, and we believe this highlights the potential of Bicycles across a wide range of targets. We look forward to our continued collaboration to develop potential new cancer treatments based on Bicycles."

On 11 July 2022 BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a novel approach to develop next generation cancer therapies using insights derived from frontline clinical experience, reported an update on the Company’s recent activities (Press release, BiVictriX Therapeutics, JUL 11, 2022, View Source [SID1234626591]). The Company has made significant progress with its lead candidate, BVX001; expanded its pipeline protection with further patent applications; and broadened its profile with attendance at international conferences and awards.

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BVX001 – LEAD CANDIDATE NOMINATION IN Q4 2022

BiVictriX has made significant progress in the creation and execution of the development plan for its lead product, BVX001, since the company’s Initial Public Offering (IPO) in August 2021. By investing additional time and resources, working closely with regulatory advisors, the Company is actively creating a clear path to Investigational New Drug (IND) status, minimising development risks. Notably, the work performed to date has enabled the Company to better understand the optimum range of target binding affinities for lead declaration – a milestone eagerly anticipated later this year.

BROADENING AND FURTHER PROTECTING THE PIPELINE

BiVictriX continues to expand and strengthen its strategic industrial and academic collaborations, acquiring access to state-of-the-art technical and disease area expertise for new target discovery and product development. This has allowed for the initiation of the Company’s antibody selections and proof-of-concept studies for its two additional therapeutic programmes, BVX002 and BVX003. In addition, BiVictriX is able to progress as planned with the identification of further cancer-specific antigen fingerprints across a wide range of solid and haematological tumour indications.

The Company continues to optimise and invest in BVX001 and, on 29 June 2022, filed a further UK patent application for BVX001, further reinforcing its already robust IP position.

STRENGTHENED TEAM

In line with its planned hiring strategy, BiVictriX has completed the recruitment of a highly talented scientific team establishing a fully functional technical capability within the Company’s labs at Alderley Park to further progress the development of BVX001 and the wider pipeline.

ROBUST CASH POSITION AND PRUDENT COST CONTROL

BiVictriX has a strong cash position and sufficient cash to execute its current strategy. In addition, the Company continues to assess suitable non-dilutive funding opportunities and applies prudent cash control to its operations.

BROADENED NETWORK

BiVictriX is attending major international conferences in order to broaden its network. The Company will present at the 14th Annual PEGS Europe event in November 2022, a prestigious scientific congress well-attended by the life sciences industry and investment spectrum.

The Company has also won and been nominated for a variety of industry awards during the recent quarter including winning ‘Investment Deal of the Year Award’ at BioNow’s 20th Annual Awards. In addition, CEO Tiffany Thorn has been named regional finalist for EY’s 2022 UK ‘Entrepreneur of the Year’.

Tiffany Thorn, Chief Executive Officer of BiVictriX, commented: "We remain focused on developing our lead asset, BVX001, and are making great progress. At the same time, we are exploring the breadth of our Bi-Cygni approach across a wide array of different cancer types through our broad pipeline of anti-cancer therapeutic assets, which includes BVX002 and BVX003, and are applying our learnings to each of our programmes. I am proud of the progress we are making as a rapidly emerging biotech company and the rigour we are applying to our business. I am of course also thrilled that we are being recognised by the industry as such."