On August 4, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported second quarter 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, AUG 4, 2021, View Source [SID1234585752]).

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"This was an exciting quarter for the company as we reported first-in-human data at ASCO (Free ASCO Whitepaper) for our investigational APC cell therapy, which demonstrated an encouraging safety profile, rapid SQZ manufacturing and early signs of immune activity," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "We continue to execute on our APC and AAC clinical programs in oncology, while also making significant strides across our other important therapeutic areas and in developing our manufacturing platform. The quarter’s progress further reinforces the breadth of opportunity for our technology."

Second Quarter 2021 Business and Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Presented initial Phase 1 clinical trial results of SQZ’s engineered APC investigational therapy in patients with advanced or metastatic HPV+ tumors at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper):
SQZ-PBMC-HPV was found to be safe and well-tolerated at all dose levels tested and no dose-limiting toxicity or Grade 3 or higher treatment-related SAEs were observed
Clinical manufacturing feasibility was confirmed with all patient batches produced in less than 24 hours
Analyses of pre- and post-therapy tumor biopsies indicated increased immune activity in select patients. Four out of six patients with less advanced disease achieved stable disease. One patient who achieved stable disease remained on study for over 10 months
Completing fourth Phase 1 monotherapy cohort and progressing towards the combination phase of the study with immune checkpoint inhibitors
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Continued progress on eAPC program supports timeline for year-end IND submission to FDA for first clinical candidate. eAPCs incorporate mRNA, which encode multiple activating signals, as well as antigens to potentially enable a more potent CD8 T cell response
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Initiating multi-center Phase 1 clinical trial of SQZ-AAC-HPV, the company’s red blood cell-derived investigational cell therapy to treat HPV+ tumors
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Preclinical research presented at the Federation of Clinical Immunology Societies demonstrated that the company’s engineered TACs can drive antigen-specific immune tolerance through key mechanisms relevant to many complex autoimmune diseases
SQZ TACs were found to exert potent bystander suppression, showing the ability to suppress pathogenic T cells with different autoantigen specificities. This finding offers a potential pathway to treating autoimmune diseases without inducing broad immunosuppression
SQZ Manufacturing and Potential Pipeline Expansion Research

Manufacturing data presented at the American Society for Gene and Cell Therapy showed that the company’s manufacturing platform can process 10 billion cells per minute with greater than 90 percent cell viability, and results from the Phase 1 APC trial further indicate the feasibility of the company’s core manufacturing platform to support current therapeutic areas
First-generation prototype of our point-of-care manufacturing platform is now undergoing internal non-clinical testing
Preclinical research presented at the International Society for Stem Cell Research demonstrated that the company’s Cell Squeeze technology can rapidly generate neurons with mature markers using optimized, transient mRNA transcription factor expression. Findings indicate potential to direct cell fate for multiple therapeutic applications
Second Quarter 2021 Financial Highlights

Revenue for the second quarter 2021 was $4.5 million, compared to $6.0 million for the same period last year
Net loss for the second quarter 2021 was $19.1 million, compared to $10.0 million for the same period last year
Research and development expenses for the second quarter 2021 were $17.7 million, compared to $12.0 million for the same period last year. The increase was primarily attributable to planned development and manufacturing costs
General and administrative expenses for the second quarter 2021 were $5.9 million, compared to $4.0 million for the same period last year. The increase was primarily due to an increase in personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
As of June 30, 2021, the company had cash and cash equivalents of $185.1 million and expects this will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023

On August 4, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King (Press release, GlycoMimetics, AUG 4, 2021, View Source [SID1234585751]). Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

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Tim Pearson, Chairman of the Board of Directors of GlycoMimetics, said, "On behalf of the entire Board, I offer sincere thanks to Rachel for her leadership of GlycoMimetics and for her commitment to the company’s employees and to patients who will hopefully benefit from GlycoMimetics’ technology. We look forward to her continued contributions as a board member."

Mr. Pearson continued, "Harout is ideally positioned to lead GlycoMimetics into the company’s next phase of growth as we anticipate the completion of our Phase 3 trial and potential commercialization of uproleselan. He possesses the right leadership and operational skills as well as tremendous know-how from his many years at Novartis overseeing several oncology and hematology product launches and from subsequent C-level positions he has held within the industry. I am confident Harout will be an effective leader for GlycoMimetics into the future."

Mrs. King, who has served as CEO for 18 years, has decided to retire for personal reasons and will continue her involvement with the company through her role on the Board of Directors and serving as an advisor during this transition. Mrs. King led GlycoMimetics’ evolution from an early venture-backed company through its initial public offering, strategic partnerships and the advancement of two late-stage clinical candidates. She also shepherded the company’s unique and productive glycochemistry platform to build a multi-faceted pipeline of drug candidates targeting key unmet needs in oncology, sickle cell disease and other indications.

"It has been a privilege and a pleasure to lead GlycoMimetics and to work with such an extraordinary team of colleagues," said Mrs. King. "I am extremely proud of what we have collectively accomplished in the 18 years since the company was founded. When I approached the Board to let them know that I was considering retirement, I committed to do all I can to ensure a smooth transition. I look forward to working with Harout and the team as a board member to continue to advance our programs. My decision to focus on spending more time with my family seems appropriately timed as we near an opportunity to commercialize our first product candidate."

Mr. Semerjian is a global biopharmaceutical veteran. Over the last 25 years, he acquired extensive US, European and international commercialization experience having led multiple successful hematology/oncology product launches, including preparation for the launch of midostaurin in AML. During his 16-year tenure at Novartis, Mr. Semerjian held both strategic and operational leadership roles including US Hematology franchise head. He then served as EVP, chief commercial officer at Ipsen where he was accountable for worldwide commercialization and portfolio strategy. Most recently, he briefly served as CEO of Immunomedics before its sale to Gilead Sciences, Inc.

"I believe GlycoMimetics has exciting opportunities ahead. Uproleselan is a differentiated drug candidate already recognized by both FDA and the Chinese regulatory authority with Breakthrough Therapy Designations and the potential for significant impact across the spectrum of AML. The enthusiasm of independent investigators as well as the clinicians participating in our registration trials provides a foundation for a successful commercialization plan, should the readout and regulatory interactions prove positive. While there are just a few glycobiology-based therapeutics on the market today, the field of glycobiology is rapidly advancing and ripe with opportunity. The expertise resident in GlycoMimetics underlies my confidence in its platform’s productivity. Across the pipeline, I’m seeing novel and potentially game-changing therapies," said Mr. Semerjian. "I look forward to working with the outstanding team at GlycoMimetics as we strive to make a difference in the lives of patients with cancer and other diseases."

On August 4, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing first-in-class oncology drugs, reported that it has appointed Mihail Obrocea, M.D., as Chief Medical Officer and Head of Development, and Charlotte Tsou as an independent member of its board of directors (Press release, MAIA Biotechnology, AUG 4, 2021, View Source [SID1234585750]).

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"We’re thrilled to welcome Mihail and Charlotte to the MAIA team, who bring significant clinical development, financial and leadership expertise that will be important as we advance our cancer pipeline to patients," stated Vlad Vitoc, MD, MAIA’s Chief Executive Officer and President. "Mihail is a distinguished physician scientist and accomplished drug developer who has brought numerous oncology drugs to patients in need. Charlotte is an outstanding business leader who will provide a global perspective to our growth strategies. Both Mihail and Charlotte bring diverse expertise to MAIA and we are eager to benefit from their insights and guidance as we continue to build a world-class biotechnology company."

New Appointment Biographies:

Mihail Obrocea, M.D. is a hematologist/oncologist with over 20 years of experience in drug development in both academia and pharmaceutical/biotechnology industry with expertise in the development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Dr. Obrocea has played an instrumental role in the development and commercialization of numerous drugs, including IMBRUVICA, BESPONSA, and BREYANZI. Prior to joining MAIA, he served as Project and Clinical Lead at Atara Biotherapeutics where he supported the clinical development of the Atara’s allogeneic CAR-T platform. He has held multiple senior level positions over the last two decades including leading the Medical Affairs Oncology group at MedImmune, serving as VP, Clinical Development Oncology at MannKind Corp., Global Project Lead for AbbVie Biotherapeutics, Head, Medical Sciences at Pharmacyclics, VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, US Clinical Lead at Nanobiotix Corp, and clinical Program Lead at Juno Therapeutics Inc. Dr. Obrocea’s research has been published in major oncology peer-reviewed journals, he has co-authored books related to cancer vaccines and immunology, and holds several patents in the biotechnology field.

Dr. Obrocea received his M.D. from the University of Medicine and Pharmacy, Bucharest, Romania and completed an internship and residency program in Internal Medicine at Yale-New Haven affiliated hospitals in Connecticut followed by a fellowship program in hematology/oncology and later appointed as Instructor of Medicine, division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth in New Hampshire.

Charlotte Tsou is a global business leader with several decades of multi-national experience holding leadership positions in the U.S., Asia, and Latin America in the Banking & Financial Service sector. Currently, Ms. Tsou is Head of Marketing Analytics and Insights, overseeing business solutions, consumer research, and experiments driven by AI at Prudential Financial. Prior to joining Prudential Financial, Charlotte spent 17 years with HSBC, held multiple leadership roles in Strategic Planning, Partnerships, Digital & CRM Transformation, and built one of the largest AI-driven Data & Analytics centers in banking.

Ms. Tsou earned a B.A (Hons). in Media Communication from NYU & Shin Hsin University and an M.A. in Integrated Marketing Communication (Specialized in Digital & Database Marketing) from Northwestern University. She is currently a Doctoral Candidate with the SBS Swiss Business School.

On August 4, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that management will present at the 2021 Wedbush PacGrow Virtual Healthcare Conference on Wednesday, August 11, 2021 at 1:45 p.m. Eastern Time (Press release, Arcus Biosciences, AUG 4, 2021, View Source [SID1234585749]).

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A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

On August 4, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported that it has executed a license agreement with Northwestern University for the exclusive commercialization rights to the IND and data generated from Northwestern’s Phase 1 clinical trial treating brain tumor patients with an engineered oncolytic adenovirus delivered by neural stem cells ("NSC-CRAd-S-pk7") (Press release, Calidi Biotherapeutics, AUG 4, 2021, View Source [SID1234585746]). The license is for Calidi’s commercial development of stem-cell based products loaded with adenovirus. A group of prominent neurosurgeons and neuro-oncologists led by Dr. Maciej S. Lesniak, Chair of the Department of Neurological Surgery, at Northwestern University Feinberg School of Medicine, and Dr. Roger Stupp, Chief of Neuro-Oncology in the department of Neurology at Northwestern University, has successfully completed a Phase 1, first-in-human clinical trial with NSC-CRAd-S-pk7, hereafter referred to as NeuroNova-1 (NNV-1), in patients with newly diagnosed malignant glioma. This trial resulted from a 13 year collaboration with Dr. Karen Aboody at the City of Hope Comprehensive Cancer Center, who developed the tumor-tropic neural stem cell line.

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"We share the same excitement and passion of Dr. Lesniak about the potential of NeuroNova-1," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "This exclusive worldwide license and the upcoming Phase 2 clinical trial with NeuroNova-1 will further expand and diversify our product pipeline and portfolio, making Calidi’s solutions more versatile across a variety of cancer indications. We look forward to sharing our cell delivery expertise in future trials with a world-class institution like Northwestern University."

In preclinical models, the neural stem cells were capable of effectively targeting the delivery of the viral payload selectively to glioma cells, warranting the translation of this therapeutic approach to the clinical setting.

"Northwestern University’s neurosurgery and neuro-oncology teams are looking forward to continued collaboration with Calidi Biotherapeutics for the Phase 2 trial of NeuroNova-1," said Maciej S. Lesniak, MD, MHCM, FAANS, Professor of Neurological Surgery and Chair, Department of Neurological Surgery, Northwestern University Feinberg School of Medicine. "We chose to partner with Calidi over other companies, on account of their extensive expertise and proprietary methods in stem cell-based platforms for delivery and potentiation of oncolytic viruses. We will draw from their significant experience and expertise in this field to further enhance the next generation of NeuroNova-1."

"Our team is very pleased to help further development of NeuroNova-1," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "This novel agent has a significant potential for glioma treatment, especially in patients having very difficult to treat gliomas with unmethylated MGMT promoters. These promising findings have been published in the June 29, 2021 issue of the prestigious journal: Lancet Oncology." An article referencing this journal publication was recently published in Apple News: Medical Xpress, entitled: Novel therapy may improve survival for patients with malignant gliomas (Article).

Under the License Agreement, Northwestern granted to Calidi a worldwide, twelve-year exclusivity for use of the clinical data in the commercial development of NSC-CRAd-S-pk7 for therapeutic and preventive uses in oncology and a right of reference to NU IND 17365 which relates to the treatment of newly diagnosed glioma.