On November 15, 2022 Ablexis, LLC ("Ablexis"), a biopharmaceutical company focused on licensing its AlivaMab Mouse technology for antibody drug discovery, and AlivaMab Discovery Services, LLC ("ADS"), a leader in the discovery of superior antibody-based therapeutics, which together are leading providers of solutions for the discovery of superior antibody-based therapeutics, reported an expansion of platforms and capabilities in antibody drug discovery and engineering (Press release, AlivaMab Discovery Services, NOV 15, 2022, View Source [SID1234624118]). These innovative new offerings include:

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Molecularly diverse panels of lead-quality antibodies ready for reformatting into multispecific formats of the partner’s choice, including a large panel of T-cell-engaging CD3 antibodies that potently eliminate cancer cells with minimal cytokine release.
New strains of AlivaMab XKL Mice offered by Ablexis that further expand the molecular and epitope diversity of the immune response to promote even broader responses against the increasingly complex types of antigens at the cutting edge of antibody drug discovery.
NGS-based hit-expansion capabilities that expand upon ADS’ existing advanced hybridoma-based approaches, increasing captured diversity.
Immune repertoire display technology offered by ADS, which enhances the capture of alternative diversities of the immune response, downstream screening, and antibody drug engineering.
"Ablexis and AlivaMab Discovery Services continue to invest in new technologies that maximize value and flexibility for our partners," said Larry Green, PhD, Chief Executive Officer of Ablexis and AlivaMab Discovery Services. "Our partners enjoy an edge on their competition, not only through access to the expanding suite of AlivaMab Mouse transgenic mice for antibody drug discovery and ADS’ expanding offerings of validated technologies in antibody discovery and engineering, but also through the intellectual contributions of our scientific leadership team and deep bench of scientists. The result is that we outperform with unsurpassed speed and efficiency in the delivery of molecularly diverse, drug-quality human antibodies, even for the most challenging drug targets, enabling our partners to discover and advance better antibody drug candidates faster."

Data on these new capabilities will be highlighted in two presentations by Jane Seagal, PhD, Vice President of Antibody Discovery at ADS, at PEGS Europe, to be held at the InterContinental Barcelona from November 14 to 16, 2022.

A Platform for Tuning Therapeutic Efficacy of T-Cell-Engaging Bispecific Antibodies – November 15 at 3:35 pm CET.
Discovery of Diverse Antibody Panels Using AlivaMab Mouse: The Foundation for Successful Antibody Therapeutics – November 16 at 12:15 pm CET.

On November 15, 2022 DermTech, Inc. (NASDAQ: DMTK) ("DermTech" or the "Company"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported an agreement with Sonora Quest Laboratories (Sonora Quest), Arizona’s leading diagnostic laboratory, to expand access to enhanced melanoma detection (Press release, DermTech International, NOV 15, 2022, View Source [SID1234624117]). As a result of the agreement, Sonora Quest will be the exclusive laboratory in Arizona to offer the DermTech Melanoma Test to its vast network of healthcare providers.

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The DermTech Melanoma Test uses a non-invasive Smart Sticker to lift skin cells from the surface of a patient’s skin to be tested for select genomic markers associated with melanoma. It rules out melanoma with over 99% reliability. The agreement between DermTech and Sonora Quest will increase the availability of the DermTech Melanoma Test to Arizonans through a visit to their healthcare providers within the Sonora Quest network. Not only will this provide additional patient populations with heightened access to the DermTech Melanoma Test, but it could also reduce the number of unnecessary biopsies and referrals to specialists and reduce costs to the healthcare system.

"This agreement with Sonora Quest is a testament to our continued commitment to helping end deaths from melanoma," said John Dobak, M.D., CEO of DermTech. "Given the frequency of patients asking their healthcare providers about suspicious moles, introducing a simple way for providers to rule out melanoma with confidence is key. We look forward to working with Sonora Quest to reach more patients who visit their healthcare providers as a first line of defense."

"Arizonans spend significant time outdoors, potentially putting us at higher risk of skin cancer," said David A. Dexter, president and CEO for Sonora Quest. "Early detection is key and our agreement with DermTech will provide greater access to this innovative testing method to detect melanoma. We’re dedicated to continually investing in innovative technology like this to make health care more convenient and provide better outcomes to all Arizonans."

One of the deadliest forms of skin cancer, melanoma is most treatable when diagnosed early – in fact, the survival rate is 99% when detected early and only 27% once it spreads distantly.

On November 15, 2022 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported a significant expansion of its business platform with the formation of a new, patient-focused Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit (Press release, NorthStar Medical Radiostopes, NOV 15, 2022, View Source [SID1234624116]). Based on the success of its diagnostic imaging and therapeutic radioisotope production programs, NorthStar has created the services unit to further advance development and commercialization of radiopharmaceuticals to treat patients who have cancer and other serious diseases. The CDMO will provide collaborator companies with a full range of customized radiopharmaceutical development and commercialization services, and serve NorthStar in progressing its own radiopharmaceutical programs. Ground has been broken on a new facility, located alongside production facilities on the Company’s Beloit, Wis. campus. Upon completion, NorthStar will be the first and only U.S. company housing commercial-scale, multi-radioisotope production and radiopharmaceutical development services on the same campus, enabling collaborator companies to realize logistical, regulatory and cost benefits.

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"Establishing this new radiopharmaceutical CDMO services unit at NorthStar marks an important inflection point in our growth plan to facilitate efficient patient supply of game-changing radiopharmaceuticals," said Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar’s industry-leading reputation is grounded in technological innovation, successful execution and proven expertise. Our track record of success includes production and expanded capacity of U.S.-produced, non-uranium based molybdenum-99 (Mo-99) for use in diagnostic imaging. We are poised to be the first commercial-scale producer of non-carrier added (n.c.a.) therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67) using advanced, environmentally preferable electron accelerator technology. With our depth and breadth of technical knowledge in the development and production of medical radioisotopes, we are now expanding to help companies progress their own radiopharmaceutical development programs. NorthStar’s CDMO will enable us to share our radiopharmaceutical development and commercialization expertise with pharmaceutical or biotechnology companies that may require additional infrastructure, resources or the specialized knowledge required for complex radiopharmaceutical development, to help them develop and deliver products with the potential to improve care for even more patients with serious disease."

"We are excited that NorthStar will be able to offer a full spectrum of radiopharmaceutical CDMO services to facilitate the radiopharmaceutical drug development process," said Frank Scholz, Ph.D., President and Chief Operating Officer of NorthStar Medical Radioisotopes. "We plan to collaborate with pharmaceutical and biotechnology companies to provide customized input and support across all phases of program development, from early stage through commercialization and product life cycle management. NorthStar’s radiopharmaceutical CDMO services will be customized to accommodate each customer’s needs and in compliance with rigorous regulations and attention to safety. They will include radionuclide procurement and formulation, dedicated suites for compounding and filling operations, quality assurance and quality control, analytical services, regulatory support, scale-up and commercialization activities and logistical support with packaging and shipping. NorthStar’s highly talented workforce possesses the specialized expertise to help support our radiopharmaceutical CDMO activities, and we plan to hire additional employees in association with this expansion. We have begun design, construction and fitting-out of clean rooms, laboratories and other required infrastructure for the dedicated 36,000 square foot facility, and expect that it should be available to deliver services in late 2024, pending appropriate licensure and regulatory approvals."

On November 15, 2022 CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, reported the close of an oversubscribed $120 million Series E financing round, co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital (Press release, CG Oncology, NOV 15, 2022, View Source [SID1234624115]). The company has secured a total of over $200 million in funding to date. In connection with the financing, Brian Liu, M.D., Principal from Longitude Capital, will join the company’s board of directors.

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The proceeds from the Series E financing will be used to advance the company’s lead clinical programs in bladder cancer towards FDA approval as well as broaden the scope of its pipeline to address unmet medical needs in urologic cancer, such as the first-line setting in Bacillus Calmette-Guérin (BCG)-naïve, intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients.

"We are delighted by the support from leading global investors to help us accomplish our mission of developing innovative therapeutics for patients suffering from urologic cancers," said Arthur Kuan, Chief Executive Officer, CG Oncology. "Our continued clinical progress in bladder cancer is a testament to our lead candidate CG0070 in both monotherapy and combination therapy studies, setting the stage to further expand development across additional urologic oncology indications."

CG0070 is an intravesically delivered oncolytic immunotherapy agent in an ongoing Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a fully enrolled combination Phase 2 study (CORE1) of CG0070 with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in the same indication. CG Oncology has a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of CG0070 with pembrolizumab in CORE1. Interim Phase 2 data for CORE1 announced at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting on November 10, 2022, continue to show both strong anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.

"We have strong conviction in CG Oncology which continues to generate compelling data to develop potential bladder-sparing innovative therapeutics for patients suffering from bladder cancer," said Simone Song, Founder and Senior Partner of ORI Capital. "We’ve been strong supporters of the CG Oncology team from an early stage by leading the Series C round, and we are particularly proud to co-lead this round with Longitude Capital and Decheng Capital, as we see tremendous potential for CG0070 to be a game changer for patients with NMIBC."

"In advanced clinical studies CG0070 has continued to demonstrate potentially transformational results in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population," said Brian Liu, M.D., Principal, Longitude Capital. "I am excited to join CG Oncology’s board of directors during this significant expansion trajectory for the company and am looking forward to working with the leadership team to bring this therapy to patients in need."

CG0070 has been administered to over 200 patients for the treatment of bladder cancer. The investigational therapy has exhibited potential best-in-class efficacy and safety in monotherapy as well as strong response rates when combined with checkpoint inhibitors. Given CG0070’s combination results with strong complete response rates in heavily pre-treated BCG-unresponsive, high-risk NMIBC patients, there has been significant demand within the urologic community for CG0070 to also be investigated in the BCG-naïve NMIBC setting, where limited treatment options have been exacerbated by the global BCG shortage impacting both providers and patients. In response, CG Oncology has decided to investigate the activity of CG0070 as a first-line treatment of BCG-naïve, intermediate-risk NMIBC in a Phase 2 study to expand clinical development for additional patients with bladder cancer.

About CG0070

Our lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO (nivolumab).

On November 15, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the results of a pre-clinical study of the Company’s lead drug candidate, THIO, in hepatocellular carcinoma (HCC) in vitro and in vivo models. MAIA presented the data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held Nov. 8-12 virtually and in Boston (Press release, MAIA Biotechnology, NOV 15, 2022, View Source [SID1234624114]).

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The results indicate that THIO, a first-in-class telomere-targeted agent may enhance the overall therapeutic efficacy of current immune checkpoint inhibitor-based treatments for HCC. In April, MAIA received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for THIO for the treatment of HCC.

Before the study, the researchers hypothesized that telomere-targeting agents may be effective in HCC. The study evaluated the activity of THIO and second-generation analogues in vitro using telomerase-positive HCC cells and in vivo using syngeneic mouse models of aggressive HCC.

The study found that THIO treatment:

Directly killed cancer cells, as it induced replicative stress, followed by cell cycle arrest and apoptosis in telomerase-reactivated HCC cells.
Stimulated anti-tumor immune response, as it activated pathways associated with innate and adaptive immunity and altered the immune-suppressive tumor microenvironment in syngeneic mouse models of aggressive HCC.
Enhanced the response to immune therapy checkpoint inhibitors, yielding complete responses in some HCC model systems with no dose-limiting toxicities.
"In addition to observing complete responses with no recurrence after THIO treatment, we identified immune memory, meaning that the body was able to autonomously target cancer cells when challenged with an influx of even more cancer cells," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are thrilled with this latest set of data as all models treated with THIO exhibited curative properties. The projected growth of liver cancer cases illustrates an increasing unmet global medical need for effective HCC therapies and this latest data reaffirms our belief in THIO’s potential to address it. We also strongly believe that the U.S. FDA’s Orphan Drug Designation of THIO for HCC further validates the quality of our data, and we look forward to continuing its clinical development."

About the SITC (Free SITC Whitepaper) 37th Annual Meeting

The SITC (Free SITC Whitepaper) 37th Annual Meeting provides a multidisciplinary educational and interactive environment focused on improving the outcome for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy. The Annual Meeting consists of cutting-edge research presentations by experts in the field, oral and poster abstract presentations and ample opportunity for structured and informal discussions, including important networking opportunities. In addition, the meeting includes updates on major national and international initiatives coming from academia, government and industry, as well as important society projects. Additional meeting information is available on SITC (Free SITC Whitepaper)’s website.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with cemiplimab (Libtayo), a PD-1 inhibitor developed by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.