On July 12, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2022 after the market close on Monday, August 8th, 2022 (Press release, Akoya Biosciences, JUL 12, 2022, View Source [SID1234616604]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On July 12, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, reported that effective August 8, 2022, Jackie Fouse, Ph.D., will transition to the role of chair of the board of directors and Brian Goff will assume the role of chief executive officer (Press release, Agios Pharmaceuticals, JUL 12, 2022, View Source [SID1234616603]). Mr. Goff will also serve as a member of Agios’ board of directors. Current chairman, David Schenkein, M.D., will remain on the board as a director.

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"Throughout our history, Agios has engaged in deliberate and thoughtful long-term planning to drive positive impact for our people and patients. The team’s consistent execution – reflected in the divestiture of our oncology portfolio, the approval of our first genetically defined disease medicine and the initiation of pivotal trials in thalassemia and sickle cell disease – put Agios in a position of strength and great promise for the future," said Dr. Fouse. "The time is right to evolve our leadership and deepen our genetically defined disease skill set to further drive our ability to develop life-changing treatments. Brian’s strong track record of leading rare disease product launches to drive their impact for patients, building and scaling companies’ rare disease capabilities and leading high-performing, diverse teams with strong cultures make him the right next leader for Agios. I look forward to working with him closely as he transitions into his new role and as I continue my commitment to Agios as chair of the board."

"I am delighted and honored to lead Agios at this incredibly exciting time and to have the opportunity to advance its purpose of bringing meaningful new therapies to people with genetically defined diseases," said Mr. Goff. "Rare and genetically defined diseases have been my focus and passion for the past decade, and Agios is well positioned to profoundly change patients’ lives across a variety of diseases with the recent launch of PYRUKYND in adult PK deficiency, a promising clinical and preclinical pipeline based on our expertise in cellular metabolism and our talented and dedicated team. I am grateful to Jackie for serving as our new board chair as we carry forward the momentum and the patient-oriented culture she has strengthened at Agios."

Mr. Goff joins Agios with more than thirty years of experience in the biopharmaceutical industry. Most recently he was executive vice president, chief commercial and global operations officer at Alexion Pharmaceuticals, where he was responsible for leading the global commercial and operations teams prior to the company’s acquisition by AstraZeneca in July 2021. Before joining Alexion, Mr. Goff was chief operating officer and a member of the board of directors of Neurovance. Prior to joining Neurovance, Mr. Goff served as Baxalta’s executive vice president and president of the hematology division. He previously served with Baxter Healthcare Corporation as global hemophilia franchise head. Earlier in his career, Mr. Goff held positions of increasing responsibility in sales and marketing with Novartis Pharmaceuticals and the pharmaceutical division of Johnson & Johnson. Mr. Goff has an MBA from the Wharton School at the University of Pennsylvania and a Bachelor of Arts from Skidmore College.

Dr. Fouse joined Agios as a member of the board of directors in 2017 and has served as chief executive officer since 2019. She led the company’s strategic pivot to focus on developing and commercializing innovative treatments for genetically defined diseases. In February 2022, the U.S. Food and Drug Administration (FDA) approved the company’s first genetically defined disease product, PYRUKYND (mitapivat), for the treatment of hemolytic anemia in adults with PK deficiency, the first disease-modifying therapy for this rare, debilitating, lifelong blood disease. Through Jackie’s orchestration of the sale of the company’s commercial, clinical and research-stage oncology portfolio to Servier, Agios received an upfront payment of $1.8 billion, with $200 million in potential future milestone payments. This transaction strengthened the balance sheet and positioned the company to accelerate and advance its genetically defined disease portfolio.

"At every step of Agios’ journey, our board and leadership team give careful consideration to what should come next for the company. With the appointment of Brian, we are putting in place the right next CEO who possesses the experience in rare and genetically defined diseases, including hematology, to drive our strategy forward and deepen our ability to deliver for patients and shareholders," said Dr. Schenkein, current chairman of the Agios board of directors. "Thanks to Jackie’s leadership, Agios is well positioned for its next chapter. She successfully shifted the company focus to genetically defined diseases, strengthened our balance sheet, achieved our first FDA approval in our hemolytic anemia program, continued to foster a culture of connections and respect and thoughtfully addressed issues of social justice. On behalf of the entire board of directors, I want to thank Jackie for her incredible leadership and commitment to patients; she will undoubtedly continue to provide Agios and Brian with valuable strategic guidance and perspective as she takes on the role of chair of the board of directors."

Conference Call Information
Agios will host a virtual investor webcast today at 4:30 p.m. ET with Jackie Fouse and Brian Goff to discuss Agios’ CEO transition. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On July 12, 2022 CQDM, the Quebec Breast Cancer Foundation and Theratechnologies reported close to CAN $2 million of funding for a collaborative research project that aims to demonstrate the efficacy and safety of a potential innovative treatment for patients affected by metastatic cancer (Press release, Theratechnologies, JUL 12, 2022, View Source [SID1234616602]). This public-private partnership is made possible through a grant of $824,130 from the Ministère de l’Économie et de l’Innovation (MEI) via CQDM, a donation of $186,600 from the Quebec Breast Cancer Foundation and a contribution of $21,000 from Mitacs. It also includes a contribution of $796,610 from Theratechnologies, as part of the company’s annual multi-million-dollar investment in the development of its oncology therapeutic platform using TH1902.

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The project will be led by Professor Borhane Annabi at the Université du Québec à Montréal (UQAM) and builds directly on the success of a previous CQDM-funded study also involving Professor Annabi’s and Theratechnologies’ teams. This earlier work led to the development of TH1902, a new therapeutic approach against cancer that is still in development. TH1902 enables the delivery of the chemotherapeutic agent directly into cancer cells through the recognition and internalizing function of a protein called sortilin, which is overexpressed on the surface of the cells. These major scientific advances have driven the launch of clinical studies in patients suffering from hard-to-treat solid tumors, such as patients with triple-negative breast cancer (TNBC). In order to capitalize on the results obtained to date and as sortilin is also overexpressed on the surface of metastatic cells, the new project will evaluate the therapeutic potential of the compound in several metastatic cancer models. If the hypothesis of the teams is confirmed, the project will increase the spectrum of cancer patients who could benefit from this new therapy.

Today’s announcement will allow Theratechnologies, a Montreal-based company focused on the development and commercialization of innovative therapies, to further cultivate the potential of TH1902 – its main peptide-drug conjugate. As a result of the combined academic and industry expertise, this initiative ultimately could strengthen the therapeutic arsenal available to patients affected by various types of cancers at different stages that too often remain incurable, as is the case in triple-negative breast cancer.

"This research project has the potential to improve the quality of life of many people with cancer and that is no small feat! Much work remains to be done, and we will continue to support the companies and organizations that are working tirelessly to develop new therapeutic avenues to improve the quality of life of Quebecers," said Pierre Fitzgibbon, Minister of the Economy and Innovation and Minister responsible for Regional Economic Development.

"CQDM is very pleased to contribute to the achievement of this new project led by exceptional research teams that have already demonstrated their ability to accomplish and surpass the targeted objectives. We are fully confident that this renewed collaboration will lead to crucial advances in the fight against metastatic cancer, a major step in improving the prognosis of patients with advanced and difficult-to-treat cancers," said Diane Gosselin, President and CEO of CQDM.

"A diagnosis of triple-negative breast cancer can be devastating and comes with many fears and uncertainties about the future – both for the woman diagnosed and for her family and friends – and unfortunately, there have been few treatments available," said Karine Iseult Ippersiel, President and CEO of the Quebec Breast Cancer Foundation. "We are thrilled that this new potential treatment option brings a sense of hope for the future and the prospect of a better quality of life for women living with this disease."

"We are delighted to be part of this innovative partnership with key players in the Quebec life sciences community. Our oncology platform originates from local research and leverages a unique and very promising new receptor called sortilin. The enormous potential of TH1902 to treat several types of cancer motivates us to accelerate its development in metastatic and hard-to-treat cancers. This collaboration will allow us to increase its potential to change the lives of those touched by such a devastating disease," said Paul Lévesque, President and Chief Executive Officer of Theratechnologies.

"It is with great humility and optimism that our team of oncology researchers is committed to meeting this new challenge. A better understanding of the molecular mechanism of action of TH1902 will indeed allow us to evaluate its ability to bypass treatment-resistant properties and eventually contribute to minimizing recurrence in patients," said Borhane Annabi, Professor at UQAM and holder of the Chair in Cancer Prevention and Treatment.

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.