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SQZ Biotechnologies Reports Third Quarter 2022 Financial Results and Recent Portfolio Updates

On November 9, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported third quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, NOV 9, 2022, View Source [SID1234623583]).

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"I am proud of the SQZ team’s accomplishments this quarter, including our publication showcasing the AAC platform, advancing our autoimmune preclinical work, and progress made developing our integrated point-of-care manufacturing system," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "As we head into the final stretches of the year, we look forward to sharing the latest available clinical data from our three oncology trials."

Third Quarter 2022 and Recent Portfolio Updates

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

Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV-101) trial
Anticipate additional monotherapy data in the highest-dose cohort and initial, interim data for patients in combination with checkpoint inhibitors
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Continued enrollment for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
Anticipate initial cohort 1 data by the end of 2022
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Published comprehensive preclinical research in Frontiers in Immunology
Continued enrollment for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Progressed studies supporting anticipated TAC Investigational New Drug (IND) submission for celiac disease in the first half of 2023
Company’s Point-of-Care (POC) manufacturing system intended to produce clinical batches and be operated outside of an ISO 7 cleanroom
SQZ Point-of-Care Manufacturing

Continued development and testing for utilization in anticipated SQZ TAC IND submission in the first half of 2023
Commenced evaluation of POC to produce additional therapeutic candidates to reduce future manufacturing-related costs; assessing the possibility of allowing access to the Cell Squeeze technology, associated methods and clinical-scale systems for manufacturing uses together with third parties
Recent Corporate Highlights

Elevated Micah Zajic to Chief Financial Officer from Chief Business Officer
Transitioned Chief Scientific Officer (CSO), Howard Bernstein, M.D., Ph.D., to the company’s Board of Directors; announced the division of CSO responsibilities among three experienced internal leaders: Ipsita Roymoulik, Ph.D., SVP, Chemistry Manufacturing and Controls; Scott Loughhead, Ph.D., VP, Translational Research; and Maisam Dadgar, Head of Engineering
Third Quarter 2022 Financial Highlights

Revenue for the quarter ended September 30, 2022, was $3.5 million compared to $4.8 million for the same period in 2021
Research and development expenses for the quarter ended September 30, 2022, were $19.6 million compared to $20.5 million for the same period in 2021; the decrease was primarily due to lower upfront manufacturing, materials and setup costs associated with the SQZ-eAPC-HPV trial
General and administrative expenses for the quarter ended September 30, 2022, were $6.9 million compared to $6.7 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
Net loss for the quarter ended September 30, 2022, was $22.6 million, compared to $22.5 million for the same period in 2021
As of September 30, 2022, the Company had cash and cash equivalents of $84.2 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023

Dong-A ST Signs License-out Deal with Polifarma of Türkiye for NESP® Biosimilar DA-3880

On November 9, 2022 Dong-A ST (Min Young Kim, President and CEO) (KRX: 170900) reported that they signed an exclusive license-out and supply agreement on November 4, 2022, with Polifarma (Mehmet Asri, CEO) for NESP biosimilar DA-3880 (Press release, Dong-A ST, NOV 9, 2022, View Source [SID1234623582]).

According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico to Polifarma. Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. Meanwhile, Polifarma will be responsible for the development and commercialization in Türkiye, Brazil, and Mexico.

The details of the upfront, milestone payments, and supply profit structure remain undisclosed as per the consensus between both parties.

"DA-3880" is an ARANESP/NESP biosimilar for the treatment of anemic patients with chronic renal failure or those undergoing chemotherapy. Dong-A ST signed a license-out agreement with Sanwa Kagaku Kenkyusho in 2014 for the development and commercialization of DA-3880 in Japan. After regulatory approval from PMDA (Pharmaceuticals and Medical Devices Agency, Japan) in 2019, DA-3880 has been successfully commercialized in the Japanese market, making it one of the bestsellers among darbepoetin alfa biosimilar products.

Polifarma is a Türkiye pharmaceutical company with 100% domestic capital and 36 years of experience. It has established actual export records of 586 drugs to over 70 countries, including the US, Europe, Brazil, and Mexico. As the most well-known, and most preferred, hospital products brand in Türkiye, Polifarma’s goal is to maintain its lead in the Türkiye market and become one of the biggest global leaders by sustaining its quality and technological superiority.

Jae Hong Park (President and CSO of Dong-A ST) said, "This agreement provides an opportunity for Dong-A ST to introduce DA-3880 beyond the Japanese market and into the global biosimilar market including Türkiye and South & Central America. Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities."

Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical Scan

On November 9, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported that the clinical trial for Chinese regulatory is back on track after experiencing delays due to Covid-19 lockdowns and is expected to be completed and filed with the Chinese National Medical Products Administration (NMPA) during the first half of 2023 (Press release, Guided Therapeutics, NOV 9, 2022, View Source [SID1234623580]).

According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thus far in China. Hospitals participating in the study include Qilu Hospital of Shandong University, Fudan (Shanghai) University Hospital and Peking University People’s Hospital.

"We are very pleased to hear that the study is progressing well, both in terms of patient recruitment and the performance of LuViva," said Gene Cartwright, CEO of Guided Therapeutics. "Despite sporadic lockdowns due to Covid-19 prevention mandates, study enrollment is now accelerating, and SMI projects that the study results will be filed with the Chinese NMPA sometime in the first half of next year. These events trigger the start of a $2.5 MM purchase order from SMI for LuViva devices and disposables."

According to the World Health Organization, cervical cancer is one of the most frequent cancers worldwide and is the second most common cancer among Chinese women. China has a population of approximately 560 million women above 15 years of age who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China.

Ambrx Announces NovoCodex’s Dosing of First Patient with ARX305, Ambrx’s Investigational Antibody Drug Conjugate Targeting CD70

On November 9, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics (EPBs) platform to create antibody drug conjugates (ADCs), reported the first patient has been dosed by Ambrx’s partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex) in its Phase 1 trial of ARX305 in patients with advanced solid tumors (Press release, Ambrx, NOV 9, 2022, View Source [SID1234623579]). ARX305 is the only anti-CD70 ADC in active development that targets CD70, a protein that is overexpressed in a broad range of solid and hematologic tumors, giving it the potential to treat a range of liquid and solid tumor cancers, where CD70 is overexpressed.

According to their development agreement, NovoCodex and Ambrx will collaborate in the development of ARX305 up until the completion of Phase 1 clinical trials. Under the terms of the development agreement, Ambrx is eligible to receive up to $4.0 million in clinical milestones, as well as tiered royalties in the low teens percentage range of aggregate net sales of ARX305 in China from NovoCodex. As a result of the first patient being dosed in NovaCodex’s Phase 1 clinical trial in China, Ambrx will now receive a significant portion of the $4.0 million milestones payments.

Ambrx plans to leverage the safety data from NovoCodex’s Phase 1 dose escalation clinical trial to inform its own Phase 1a trial, thereby efficiently using the company’s cash and resources. Specifically, using the data gained from NovoCodex’s dose escalation trial, Ambrx can reduce the expense of conducting its own initial dose escalation clinical trial. Building on the NovoCodex Phase 1 data, Ambrx plans to expedite its Phase 1a trial of ARX305 by starting at higher doses (i.e., doses closer to a recommended Phase 2 dose). Following the completion of NovoCodex’s Phase 1 clinical trial, Ambrx’s Phase 1a clinical trial for ARX305 is expected to initiate in the second half of 2023. NovoCodex is also responsible for funding a majority of Ambrx’s development of ARX305 through the end of Phase 1 clinical trials, up to a certain cap, and will be able to leverage Ambrx’s data in its own development of ARX305.

"The dosing of the first patient with ARX305 by NovoCodex represents an important strategic benchmark that will not only advance another Ambrx-generated ADC asset into the clinic, but also will allow us to leverage findings from the study to inform our own clinical trial," said Daniel O’Connor, Chief Executive Officer of Ambrx. "Leveraging partner data will both expedite internal development and cut costs, establishing a strong foundation from which to begin our own Phase 1 trial."

Mr. O’Connor added, "CD70 is highly expressed on the surface of a variety of hematological and solid tumor cells, and I believe the stability of ARX305 conferred by our proprietary EBP platform uniquely positions it as a potential best-in-class treatment for CD70 expressing tumors. I want to thank NovoCodex for continuing our strong partnership and look forward to continued progress as they advance ARX305 through the clinic."

TILT Biotherapeutics Announces Boston Office Opening as it Expands its Clinical Trials in the US

On November 9, 2022 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, reported that the company has opened an office in Boston, to support its increasing US clinical development, partnering and fund-raising activities (Press release, TILT Biotherapeutics, NOV 9, 2022, View Source [SID1234623578]). The current US clinical trials are run in collaboration with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA and the Merck-Pfizer-Alliance.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with earlier versions of oncolytic viruses, said, "Boston is at the heart of one of the world’s biggest biotech clusters, and we’re delighted to become part of that vibrant community as we invest in this infrastructure and accelerate towards Phase 2 trials of our innovative armed oncolytic viruses."

TILT Biotherapeutics’ COO, and President of US operations, Aino Kalervo, who is responsible for initiating the US office operations, said "Our newly established US operations will help to drive our US clinical development in this leading global pharmaceutical market, including lining up several new clinical trial centers, building on our work with the Mayo Clinic, and supporting forthcoming IND filings."

John Goldfinch, TILT Biotherapeutics’ newly appointed US Clinical Lead, with over a decade’s phase I to IV clinical operations and program management experience at US life sciences companies including Athenex, said, "I’m delighted to join TILT to help advance our US program of phase I and II clinical trials. We believe our approach will deliver better outcomes for cancer patients."

TILT Biotherapeutics LLC’s new office is at the CIC in Boston, Massachusetts which has been a home for great entrepreneurs leading fast-growing companies since 1999. This follows its collaborations with US pharma partners and leading cancer centers.

The heart of TILT’s innovative approach revolves around the use of cancer cell specific oncolytic adenoviruses, armed with cytokines and other molecules to boost the patient’s T-cell immune response to better enable it to find and destroy cancer cells.