On June 9, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported data from a preclinical combination study of SON-1010 with a commercially available anti-PD1 compound (Press release, Sonnet BioTherapeutics, JUN 9, 2022, View Source [SID1234615826]). These results suggest that dosing of SON-1010 (IL12- FHAB) in combination with anti-PD1 demonstrated strong efficacy in the B16F10 mouse melanoma model, historically known as an immunologically insensitive model to anti-PD1.

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Checkpoint inhibitors provide viable treatment alternatives to chemotherapy and/or radiation for patients with solid tumors, but there remains a robust need for more effective combination treatment regimens. With the objective of improving the checkpoint inhibitor response rate, Sonnet BioTherapeutics is developing a targeted approach using the company’s Fully Human Albumin binding (FHAB) platform. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only Interleukin 12 (IL-12), but a variety of synergistic and potent immunomodulators. SON-1010 is currently undergoing Phase 1 clinical study in cancer patients and this preclinical study was designed to explore the combination potential with a checkpoint inhibitor (anti-PD1).

"We are excited to see that the combination of SON-1010 with an anti-PD1 antibody yielded compelling data in this preclinical model" said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer, and further added that, "These data support our strategy of pairing SON-1010 with a checkpoint inhibitor, with the goal of developing an improved treatment option for cancer patients."

Experimental Study Design: Three randomized cohorts of nine mice (n = 27), each with 150 mm3 B16F10 melanoma tumors, were dosed with 3µg IL12-FHAB and/or 10µg anti-PD1 antibody on days 0, 4 and 8 while the placebo cohort was not treated. Mean tumor volumes were measured every two or three days through an 18-day period.

Table 1: Mean Comparisons of Tumor Volume Growth Inhibition

Test Article

Mean Tumor
Volume (mm3) – Day 14

Tumor Growth Inhibition Ratios
( % Inhibition )

Placebo (n = 9)

2260

–

Anti-PD1 antibody (n = 9)

2016

10.7%

Anti-PD1 + IL12-FHAB (n = 9)

472

79.1%

Compared to the tumor-bearing placebo group at day 14, the treatment groups administered three doses of anti-PD1 antibody or three doses of the IL12-FHAB + anti-PD1 antibody combination resulted in 10.7% and 79.1% tumor growth inhibition, respectively.

Survival data for study mice at 18 days further supports the efficacy synergy of IL12-FHAB co-injected with anti-PD1 by improving the survival rate: (i) for anti-PD1 administration, only one mouse survived out of a total of nine, and (ii) for anti-PD1 + IL12-FHAB administration, seven mice survived out of a total of nine. Additionally, the mice cohorts used in the preclinical efficacy study did not show any weight loss during the study in either the single agent or combination dosing arms.

"We are excited to have demonstrated these important data in an immunologically distinct animal model when IL12-FHAB was dosed in combination with an anti-PD1 antibody," said John Cini, Ph.D., Sonnet’s Chief Scientific Officer. "Further, this study evaluated the sequence of test article administration, whereby co-injection of IL12-FHAB and anti-PD1 antibody was optimal when compared to administration of either anti-PD1 or IL12-FHAB first. Targeting the tumor by linking IL-12 to an albumin-binding domain extends the cytokine half-life in the body, and we believe that is the key to inducing a successful local immune response in the tumor microenvironment."

On June 9, 2022 NEXT Bio Research Services LLC (www.nextmolecular.com), dba NEXT Molecular Analytics reported that the New York State Department of Health (NYSDOH) has accredited the Company’s L-Asparaginase enzyme activity assay platform (Press release, NEXT Molecular Analytics, JUN 9, 2022, View Source [SID1234615842]). This means that NEXT is now able to receive clinical test samples from New York State institutions without waiver and also means that NEXT is now accredited in all 50 states to process asparaginase test samples.

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Dr. Robert B Harris, the original developer of the Laboratory Derived Test for asparaginase, the holder of the Certificate of Quality from the NYSDOH, stated, "Reaching this milestone is a tremendous accomplishment for our Company and is testament to the diligent and precise work of our dedicated employees." He added, "The NYSDOH standards are among the most rigorous in the country for testing labs to meet, and we take great pride in the fact that NEXT has met these standards."

L-asparaginase chemotherapy is integral in the treatment of pediatric patients with acute lymphoblastic leukemia (ALL). Its incorporation as part of a multi-agent chemotherapy regimen has resulted in improved, event free survival in childhood ALL. NEXT’s test measures asparaginase levels in patients being treated with any of the current therapeutic biologics used in ALL patients including Oncaspar, Asparlas, Erwinaze, and Rylaze. NEXT has assayed more than 16000 patient samples from well over 250 institutions worldwide, including hospitals and clinics in Canada, Switzerland, Hong Kong, Singapore, and the United Arab Emirates. Assay results are returned by the close of business the same day that the sample is received, thereby providing the clinician real-time therapeutic monitoring of his patient with respect to asparaginase activity levels. In addition to providing results to ordering physicians, NEXT is also partnering with the different drug manufacturers of asparaginase to help propagate the usefulness of real time therapeutic monitoring of asparaginase levels, NEXT is actively using its assay to support several human pre-clinical and clinical trials.

On June 9, 2022 Alloy Therapeutics, a biotechnology ecosystem company, reported a collaboration and licensing agreement with Sudhir Agrawal’s Arnay Sciences to advance new RNA-based drug discovery platforms and novel chemistries spanning the fields of antisense therapeutics to immunomodulating therapeutics (Press release, Alloy Therapeutics, JUN 9, 2022, View Source [SID1234615811]). The collaboration demonstrates Alloy’s dedication to expanding its ecosystem offerings into genetic medicines. In collaboration with Dr. Agrawal, Alloy will advance the core technology platforms developed by Arnay into a multitude of new applications, which will initially be available to new companies formed within its Venture Studio, 82VS. Dr. Agrawal will also serve as the Scientific Advisory Board chair of Alloy’s genetic medicine platform technologies.

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For over three decades, Dr. Agrawal has spent his career innovating in RNA therapeutics spanning antisense and immune modulation, starting in the laboratory of the "father of antisense," Paul Zamecnik. Dr. Agrawal has published over 300 research papers and has co-authored over 400 patents worldwide, including the invention of gapmer antisense technology widely employed in antisense candidates and approved drugs. He also serves as an affiliate professor at UMass Chan Medical School, as a business advisor to Harvard Medical School’s Initiative for RNA Medicine, and is on the scientific advisory boards of Dyne Therapeutics, QurAlis, Q-State Biosciences, Lytix Biopharma, Envisagenics, HAYA Therapeutics, Bolden Therapeutics, Maze Therapeutics, the Dan Lewis Foundation for Brain Regeneration Research, and two ASO-focused 82VS companies, Aldebaran Therapeutics and Restoration Biosciences.

The licensing agreement with Arnay will enable Alloy to provide the drug discovery community non-exclusive access to RNA-based drug discovery platforms and chemistries through the successful democratization model already deployed for antibody therapeutics, through Alloy’s ATX-Gx mouse and its DeepImmune fully integrated Antibody Discovery Services. Alloy’s expansion into genetic medicines is specifically designed to meet the increased interest and momentum in the RNA therapy industry by enabling drug discovery teams to innovate efficiently through unparalleled access and generous terms.

"Working with Alloy represents an opportunity to make genetic medicines available to the widest possible community of innovators and drug developers around the globe, all thanks to Alloy’s model of democratizing access to foundational discovery tools," said Dr. Agrawal. "It has been my unique pleasure to work with Alloy, and I look forward to further advancing the new platforms with the Alloy team and leveraging their expertise in providing the community access to technology platforms. The cohesive integration of platform licensing, Discovery Services, and Venture Studios that Alloy has created will enable industry collaborators to more rapidly advance innovative therapeutics that ultimately benefit patients."

Alloy was founded in 2017 by Errik Anderson—co-founder of Adimab, Compass Therapeutics, Alector, Avitide, and Arsanis, among other companies—to minimize the intense capital requirements and timelines of biotech company formation and discovery campaigns. He recognized the need to democratize foundational platforms and tools typically made inaccessible through high-access fees and cumbersome development milestones and royalties. Through accessible licensing activities with its flagship ATX-Gx mouse, a transgenic humanized mouse that produces fully human antibodies, the company has amassed more than 130 partnerships across academia, biotech, and large biopharma. It continues to expand its technology portfolio and service offering to support a broader range of drug discovery and development teams.

"We have seen the impact of disruptive access in our antibody discovery offering and are thrilled to build upon this model to serve developers of genetic medicines better," says Errik Anderson, Alloy CEO and founder. "We were delighted to learn a seminal figure in genetic medicine therapies like Sudhir was aligned with our mission to democratize enabling, pre-competitive technologies. We look forward to seeing the therapeutic innovation this collaboration spurs across the global scientific community."

Dr. Agrawal has leveraged his decades of experience to develop novel chemistries and structures for RNA therapeutics. These breakthrough platforms are designed to address limitations of currently used chemistries, such as specificity, off-target effects, delivery, and unintended inflammatory responses. Dr. Agrawal’s RNA-based drug discovery platforms have broad applications in developing antisense therapeutics by targeting RNA, including mRNA, pre-mRNA, microRNA, and ncRNA, and for immune-modulation therapeutics. These platforms strengthen Alloy’s ability to help its partners address a vast range of drug discovery challenges in creating genetic medicines. Alloy intends to provide broad access to these technologies and platforms as part of their larger Innovation Subscription offerings and through individual, non-exclusive licensing activities. Initially, the new genetic medicines platforms and services will be exclusively available through company collaborations within 82VS portfolio companies.

"Our Venture Studio model facilitates Alloy’s expansion of new modalities by enabling our portfolio companies to access and de-risk new technologies, yet not be beholden to using an unproven approach," said Dr. Chris Pacheco, General Partner at 82VS. "This work provides our 82VS portfolio companies the upside of accessing new, cutting-edge technologies at the earliest stage of the company development. This access is unprecedented in the industry and gives our companies a significant advantage in developing the best medicines. Inside the ecosystem, we have created win-win scenarios for Alloy, 82VS companies, technology developers, and, in the end, patients. And isn’t that what we are all trying to do in the end?"

Arnay has pending patent applications claiming these technologies. Alloy has gained exclusive rights to these patents for internal use and for sublicensing. Under the licensing agreement, Alloy will pay an upfront fee and will share sublicensing income with Arnay.

On June 9, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Wednesday, June 15th at 8:40 a.m. PT / 11:40 a.m. ET (Press release, SpringWorks Therapeutics, JUN 9, 2022, View Source [SID1234615827]).

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To access the live webcast please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On June 9, 2022 SpectronRx, a leading contract development and manufacturing organization (CDMO) for the life sciences industry that specializes in radiopharmaceuticals, reported that it will showcase its new Actinium-225 production facility during this year’s annual Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting being held June 11-14 in Vancouver, British Columbia, Canada (Press release, SpectronRx, JUN 9, 2022, View Source [SID1234615843]). SpectronRx has secured more than 10-acres in Bunker Hill, Indiana, where it is building a facility that will produce Actinium-225 for the clinical trial and commercial supply of cancer-fighting therapies.

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"Although there’s currently no Food and Drug Administration-approved treatment using Ac-225, it’s showing great promise when it comes to the treatment of certain types of cancer, including prostate, breast, colon, brain and neuroendocrine," said John Zehner, CEO of SpectronRx. "Researchers have been studying the radioisotope’s cancer-fighting potential for decades and are on the cusp of several new breakthroughs. Our goal is to support these new therapies as they are approved."

Actinium-225 is an exceptional cancer fighter. It can be attached to a molecule that delivers the radionuclide to a selectively targeted cancer site, where the Ac-225 alpha-emission can destroy the cancerous tissue with minimum damage to healthy cells. And the high-energy alpha particles Ac-225 releases can interrupt DNA processes, keeping cancer cells from replicating or even killing them altogether. This makes Ac-225 one of the most promising candidates for targeted alpha therapy.

"Unfortunately, there is a limited supply of the Ac-225 radionuclide globally," said Anwer Rizvi, president of SpectronRx. "This limits the ability of pharmaceutical companies to perform the drug trials needed in order to advance the use of this crucial radionuclide. That’s why building up production of Ac-225 is so important."

Currently, only small amounts of Ac-225 are being produced by various government entities. To enhance the available supply, SpectronRx will produce Ac-225 through methods including the use of particle accelerators. The company will invest several million dollars to install multiple particle accelerators at its new site near Grissom Air Reserve Base in Indiana, which will produce the much-needed medical isotopes to treat cancer. The project is expected to take two years to complete.