On May 10, 2022 Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective oral treatment of cancer, reported that it has strengthened its clinical development team with the appointment of Dr. Brian Schwartz as Chief Medical Officer and Dr. Maureen Higgins as Vice President and Head of Clinical Operations, as it continues to advance STP938, its lead CTPS1 inhibitor, towards clinical studies in haematological malignancies (Press release, Step Pharma, MAY 10, 2022, View Source [SID1234614004]).

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!

Dr. Brian Schwartz brings more than 25 years of experience in drug development in the pharmaceutical and biotechnology industries, in areas including oncology, haematology and rare diseases. Dr. Schwartz previously served for twelve years at ArQule, where he was Chief Medical Officer and Head of Research and Development and led clinical development of the BTK inhibitor ARQ 531 before the company’s $2.7 billion acquisition by Merck in 2020. His previous roles also include CMO and Senior Vice President, Clinical and Regulatory Affairs at Ziopharm, where he oversaw the development of new cancer drugs. Earlier in his career, he held leadership roles at Bayer Healthcare and Leo Laboratories. Alongside his role at Step Pharma, Brian will continue to act as a consultant to other biotech companies, and also serve on the boards of Mereo BioPharma, Enlivex, Cyclacel Pharmaceuticals and Infinity Pharmaceuticals.

Dr. Schwartz, who practiced medicine prior to his career in the biopharmaceutical industry, holds a medical degree from the University of Pretoria, South Africa, and completed a fellowship at the University of Toronto, Canada.

Dr. Maureen Higgins has 30 years of experience in clinical research in project management, clinical operations, and business development within both the pharmaceutical and CRO sectors. Dr. Higgins was previously VP for Project Management at Precision for Medicine. Prior to that, she served as Director for Project Management at Chiltern Oncology, overseeing studies and leading project managers in the conduct and delivery of early phase oncology studies, and as Project Director at PRA Health Sciences, UK, where she project-managed early- and late-phase oncology, and neurology studies. She was also Director for Business Development at CroMedica and an Internal Business Consultant at Quintiles, where she also served as Head of Operations in South Africa.

Dr. Higgins holds a B.Sc. in Biology from Bristol Polytechnic, a Ph.D. in Molecular Developmental Genetics from the University of Edinburgh, where she also completed her post-doctoral fellowship in Molecular Biology and an MBA from Strathclyde Graduate Business School.

Andrew Parker, Chief Executive Officer of Step Pharma, commented: "On the eve of Step Pharma progressing into the clinic with STP938, we are delighted to have made such strong clinical operations appointments in Brian and Maureen. Step Pharma are the world leaders in CTPS1 inhibition, a novel approach that we believe could allow us to selectively target cancer cells, not only in our core focus of haematological cancers but in a combination setting in solid tumours as well."

Dr. Brian Schwartz, Chief Medical Officer, commented: "Researchers have been trying to target pyrimidine synthesis for decades to treat cancer without success, but with Step Pharma’s CTPS1 approach I believe we have the breakthrough. I am delighted to be joining such an experienced team at this pivotal time for the company."

Dr. Higgins, VP, Head of Clinical Operations, commented: "Step Pharma is the world leader in CTPS1 research and with its strong scientific heritage, outstanding team and high-quality investors has the clear recipe for success. I am excited to support the company take the next important clinical step in its development."

On May 9, 2022 Ingenium Therapeutics reported that it has applied to the Ministry of Food and Drug Safety for phase 2 clinical trials of ‘Memory-NK’ cell therapy for relapsed acute myeloid leukemia (AML) (Press release, Ingenium Therapeutics, MAY 9, 2022, View Source [SID1234643521]).

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!

This phase 2 will be conducted at three medical institutions in Korea, including Asan Medical Center in Seoul, Samsung Medical Center, and St. Mary’s Hospital in Seoul. The goal is to complete clinical trials and receive conditional approval in 2024.

According to the company, chimeric antigen receptor T cell (CAR-T) treatment is commercially available for lymphocytic leukemia, but there is currently no specific treatment for relapsed AML. Accordingly, it is expected that Memory-NK treatment will provide an innovative treatment method.
Ingenium’s Memory-NK cell therapy product is expected to have strong anti-cancer properties due to its high expression level of surface-activated receptors and high levels of ‘interferon gamma (IFN-r)’. It was said that cell viability was also high, overcoming the problem of short in vivo survival period, known as a limitation of existing NK cell treatments.

Ingenium said that it confirmed the therapeutic efficacy and safety of Memory-NK cells in a clinical trial conducted by researchers on about 100 patients with recurrent AML. It was said that the anti-cancer treatment potential was also confirmed in animal test models of solid cancers such as lung cancer, liver cancer, and colon cancer. Ingenium plans to formulate and conduct clinical trials of Memory-NK for the treatment of solid tumors in the future.

In addition, basic research on ‘CAR-NK’ and ‘NK engager’ is also being conducted to increase the effectiveness of Memory-NK. Preclinical research is also underway for a self-developed peptide (IGTN13) that has been shown to increase the anti-cancer effect of NK cells. We plan to begin clinical trials of additional candidate substances sequentially within two years.

Ingenium completed ‘Pre-Series A’ funding worth 5.7 billion won in March. We plan to recruit investors for Series A by September.

On May 9, 2022 StromaCare reported a fundraising of €1,500,000 from Sham Innovation Santé (Advised by Turenne Groupe), Kréaxi, and Crédit Agricole Création (Press release, Stroma Care, MAY 9, 2022, View Source [SID1234640990]).

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!

Stromacare is developing a new therapy in oncology based on the immuno-modulation of the tumor stroma using a monoclonal antibody. The tumor stroma is a reaction of the tissue in which the tumor is growing, which inhibits the CD8 T cells and creates a physical barrier preventing access of immune system and therapeutic molecules to the tumor. An overexpressed protein is at the origin of this stromal barrier. Thanks to a specific antibody directed against this protein, we are able to reactivate CD8 T lymphocytes and modulate the stroma stiffness, allowing them to reach and act on the tumor and facilitate the action of other therapies. This new approach opens the way to considerable clinical developments, the stroma being common to all solid cancers.

The company leverages the results of proof of concept in animals carried out by the team led by Dr Ana Hennino, Laureate of the Béatrice Denys Foundation 2021, within INSERM-CRCL, the CNRS, the University of Lyon and the Leon Bérard Center. Her laboratory is internationally recognized for its work on the stroma and is considered as a pioneer in this field. It has been granted with several awards of excellence.

Stromacare has signed an exclusive worldwide license with Inserm Transfert covering a portfolio of three patent families and all the know-how developed.

Ana Hennino, co-founder and CSO announces: "We have shown that the use of this antibody is capable of significantly increasing the survival of animals with solid stromal cancer, alone and in combination with other therapies. Our purpose is now to go to the "First in Human" clinical phase in order to evaluate our product and offer an innovative therapy to cancer patients".

Pierre-Olivier Goineau, co-founder and CEO declares: "The work carried out by Ana is remarkable; it opens up truly innovative therapeutic perspectives in oncology. I would like to thank the funds and the business-angels who trusted us from this stage. Thanks to these new shareholders, this fundraising will be supplemented by "innovation" loans and will make it possible to develop the antibody and refine our regulatory preclinical plan as well as our clinical plan. »

Camille Darcissac (Turenne Groupe) states: "Laureate of our Béatrice Denys Foundation, we were quickly convinced by the relevance and robustness of the approach, targeting the tumor stroma, developed by Ana. The innovation brought by Stromacare is unique and bears considerable therapeutic promises for patients suffering from solid tumors. Combined with Pierre-Olivier’s extensive experience in biotech development, Stromacare has the necessary assets to conduct its preclinical development and prepare its clinical plan. »

Isabelle Bou Antoun (Chief Executive Officer of Kréaxi) adds: "Stromacare opens a promising new therapeutic avenue in the field of oncology, resulting from research work carried out within the Léon Bérard Center (CLB-Lyon). The quality and robustness of the science, supported by a very experienced team, convinced us to support this project with a major societal impact in the treatment of solid tumors".

Contact: [email protected] / www.stroma.care

On May 9, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the San Francisco Business Times and the Silicon Valley Business Journal ranked Allogene as the highest rated biotechnology company – and 12th company overall – on the 2022 Best Places to Work in the Bay Area list in the large company category (200-499 employees) (Press release, Allogene, MAY 9, 2022, View Source [SID1234616276]).

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!

Winning organizations were selected from over 400 competing Bay Area companies that have created exceptional workplaces that their employees value highly. Results were based on a survey of employees measuring engagement and other workplace factors including: communication and resources, individual needs, manager effectiveness, personal engagement, team dynamics and trust in leadership.

"Our people are the heart and soul of Allogene, and this recognition is a testament to the One Allogene company culture we’ve worked so hard to build," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene. "This award is especially meaningful because it stems from honest, voluntary employee feedback and truly illustrates our collective mission of developing life-saving products for patients with cancer."

On May 1, 2022, Allogene celebrated its four-year anniversary with its more than 300 employees who together continue to nurture its One Allogene culture. The Company, which is actively recruiting new employees, was also recently named a 2022 Best Place to Work by BioSpace. For more information, visit the Allogene Careers web site.

On May 9, 2022 (the "Closing Date"), OPKO Health, Inc., a Delaware corporation (the "Company"), reported that entered into an Agreement and Plan of Merger (the "Merger Agreement") with Orca Acquisition Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), ModeX Therapeutics, Inc., a Delaware corporation ("ModeX"), and Gary J. Nabel, solely in his capacity as sellers’ representative (Filing, 8-K, Opko Health, MAY 9, 2022, View Source [SID1234614516]).

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!

Pursuant to the Merger Agreement, on the Closing Date, Merger Sub merged with and into ModeX (the "Merger"), with ModeX surviving the Merger as a wholly owned subsidiary of the Company. On the Closing Date, the Company paid consideration for ModeX of $300.0 million, subject to a customary purchase price adjustment mechanism, including that ModeX be free of debt, as well as deduction for certain equity awards issued on the Closing Date, as described below. The Company paid the entirety of the purchase price pursuant to the issuance of an aggregate of 89,907,310 shares (the "Consideration Shares") of the Company’s common stock, par value $0.01 per share ("Common Stock"), to the former stockholders of ModeX (the "Selling Stockholders"), of which 10% of such shares were deposited in a twelve-month escrow for purposes of satisfying the potential indemnity obligations of the Selling Stockholders under the Merger Agreement. Additionally, the Company issued equity awards to ModeX employees in an aggregate amount equal to $12.4 million, which was deducted from the consideration payable on the Closing Date. If any of such awards are forfeited or otherwise remain unvested on the four-year anniversary of the Closing Date, up to $2.6 million of shares of Common Stock (valued at the same price used for determining the number of Consideration Shares issuable upon consummation of the Merger) may be distributed pro rata to ModeX’s former stockholders in respect of such forfeited or unvested awards. Shares of Common Stock with respect to such potential distribution have been escrowed and will remain escrowed for such four-year period.

In accordance with the Merger Agreement, Dr. Phillip Frost, the Company’s Chief Executive Officer and Chairman of the Board of Directors (the "Board"), Dr. Jane Hsiao, the Company’s Chief Technical Officer and a Director, and Frost Gamma Investments Trust ("FGIT"), a trust controlled by Dr. Frost, entered into a lockup and voting agreement, together with the Company (the "Lockup and Voting Agreement"), pursuant to which: (i) FGIT has agreed that, for a period of four years immediately following the Closing Date, it will not sell or otherwise transfer its shares of Common Stock, subject to certain customary exceptions; and (ii) Drs. Frost and Hsiao agreed that, for as long either Dr. Elias A. Zerhouni or Dr. Gary J. Nabel remains an employee of the Company or ModeX, Drs. Frost and Hsiao will vote, or cause to be voted, all of their respective shares of Common Stock in favor of such person’s election to the Board.
Additionally, in accordance with the Merger Agreement, certain recipients of the Consideration Shares, holding in aggregate approximately 88.0% of the Consideration Shares, agreed not to sell or otherwise transfer their respective Consideration Shares for a period of four years immediately following the Closing Date on the same terms as contained in the Lockup and Voting Agreement.
The foregoing description of each of the Merger Agreement and the Lockup and Voting Agreement is only a summary and is qualified in its entirety by reference to the full text of the Merger Agreement and the Lockup and Voting Agreement, which are filed as Exhibit 2.1 and Exhibit 10.1, respectively, to this Current Report on Form 8-K and incorporated by reference herein.
The Merger Agreement is filed with this Current Report on Form 8-K to provide securityholders with information regarding its terms. It is not intended to provide any other factual information about the Company, ModeX or any other party thereto. The representations, warranties and covenants contained in the Merger Agreement were made solely for purposes of such agreement and as of specific dates, are solely for the benefit of the parties to the Merger Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties to the Merger Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to securityholders. Securityholders should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company, ModeX or any other party thereto. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures, except to the extent required by law.