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 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence* whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC (Press release, Hoffmann-La Roche, JUN 9, 2022, View Source [SID1234616238]).

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"Today’s approval represents an important advance, as Tecentriq becomes the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Since approximately half of all people with early NSCLC develop recurrence after surgery, which in some cases is no longer curable, treating this cancer at an earlier stage offers the best chance to prevent recurrence."

This approval is based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (hazard ratio [HR]=0.43, 95% CI: 0.26-0.71)** in people with resected Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC).1 A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resected Stage II-III NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a stratified HR of 0.39 (95% CI: 0.18-0.82).2

Follow-up will continue with planned analyses of more mature OS data later this year. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.1

"Today’s approval now offers patients in Europe, whose tumours express high levels of PD-L1, the opportunity to reduce their risk of disease recurrence following surgery and chemotherapy," said Professor Enriqueta Felip, Head of the Thoracic Cancer Unit at Vall d’Hebron Institute of Oncology, Barcelona, Spain. "This milestone reinforces the need for biomarker testing at diagnosis for all people with NSCLC, irrespective of disease stage, to ensure they receive optimal treatment."

To date, Tecentriq has been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥1%. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours have PD-L1 expression on ≥50% of tumour cells.

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced or metastatic NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Roche has an extensive development programme for Tecentriq including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower010 study
IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and intention-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival in the overall study population, ITT Stage IB-IIIA NSCLC.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.3 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.3 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.4 Approximately 50% of patients with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease.4 Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery.5 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with an innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

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.