On October 18, 2023 SOPHiA GENETICS (Nasdaq: SOPH), a category-defining software company and a global leader in data-driven medicine reported a collaboration with Memorial Sloan Kettering Cancer Center (MSK), a top cancer treatment and research institution, and AstraZeneca (LSE/STO/Nasdaq: AZN) to bring high quality, comprehensive cancer testing to a global scale (Press release, AstraZeneca, OCT 18, 2023, View Source [SID1234636123]). With this collaboration, the three leading organizations will further their shared goal to advance health equity on a global scale by providing inclusive access to comprehensive cancer testing worldwide.

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Cancer is the second leading cause of death worldwide. In 2020, 10 million deaths were attributed to cancer, 70 percent of which occurred in low- and middle-income countries.1 While there are multifaceted reasons for this disparity, a top contributor is the lack of adequate testing, which can lead to prevention, early detection, and advanced treatment. Through the newly announced partnership, SOPHiA GENETICS, MSK, and AstraZeneca will create a decentralized global network for cancer testing, including underserved regions where access to testing remains scarce.

The partnership will provide MSK’s proprietary liquid biopsy and solid tumor cancer tests – MSK-ACCESS and MSK-IMPACT – to organizations via the decentralized, technology-agnostic SOPHiA DDM Platform. This offering will be rapidly deployed by SOPHiA GENETICS with support from AstraZeneca’s global footprint. Through SOPHiA GENETICS’ cloud-based platform, which provides highly accurate and reliable data and insights, institutions around the world – and in traditionally under-resourced and under-served areas – will have the power to make data-driven decisions.

"The power of a decentralized network like the SOPHiA DDM Platform is that diverse data inputs are continuously added to the network to fuel and teach our artificial intelligence algorithms, helping to produce stronger data outputs each time," said Jurgi Camblong, PhD., CEO and Co-founder, SOPHiA GENETICS. "The diverse data that will be unlocked through the partnership between SOPHiA GENETICS, AstraZeneca, and MSK will undoubtedly contribute to the collective intelligence needed on a global scale to revolutionize the future of cancer research and treatment."

"MSK is excited to collaborate with SOPHiA GENETICS and AstraZeneca to bring our advanced genomic testing to new populations," said Anaeze Offodile II, MD, MPH, Chief Strategy Officer, MSK. "We believe that this collaboration will enable patients from around the world to better understand the genomic profile of their cancer. Expanding this to a global population generates a more diverse data set to help develop treatments that could benefit different and often underserved populations."

This collaboration aims to generate an unparalleled and comprehensive dataset sourced from diverse populations to provide invaluable insights and knowledge that could shape the future of global healthcare.

"While cancer continues to be a leading cause of death worldwide, we know that a key barrier for cancer patients and their physicians is a lack of access to high-quality comprehensive genomic testing. Broad access to quality testing can vastly improve cancer diagnosis and physicians’ treatment decisions," said Kristina Rodnikova, Head of Global Oncology Diagnostics, AstraZeneca. "We believe that our collaboration with MSK and SOPHiA GENETICS will provide physicians and patients with the reliable data that they need to better diagnose their disease."

The first iterations of this program are expected to be available for healthcare institutions before the end of 2023.

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.COM, or connect on X (formerly known as Twitter), LinkedIn, Facebook, and Instagram.

On October 18, 2023 Actym Therapeutics, pioneering a new drug modality to treat solid tumors, reported that it has extended its Series A financing round with an additional close of $25.5 million, bringing the total Series A amount raised to $59.5 million (Press release, Actym Therapeutics, OCT 18, 2023, View Source [SID1234636122]). The extension was co-led by existing investors Boehringer Ingelheim Venture Fund and Illumina Ventures, with GKCC LLC as a new investor joining the round with Actym’s other current shareholders, Panacea Ventures and JLo Ventures.

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Actym’s proprietary platform, S. Typhimurium-Attenuated Cancer Therapy (STACT), represents a new approach to achieving a comprehensive immunological re-activation of the Tumor Microenvironment (TME) for the treatment solid tumors. By leveraging a genetically modified bacterial vehicle, STACT-based therapeutics transport therapeutic payloads to initiate a selective immune response within the TME. Actym’s lead candidate, ACTM-838, safely introduces optimized IL-15 and STING, two highly potent and synergistic payloads, directly into the TME. In preclinical studies, ACTM-838 is effectively enriched within the TME, unlocking a comprehensive and durable innate and adaptive anti-tumor immune response. The Series A extension will support the company’s entry into a Phase 1 clinical trial. This trial is designed to achieve proof of mechanism for ACTM-838, demonstrating its ability to selectively enrich in tumors, deliver payload combinations there, and positively re-activate the immuno-compromised TME. In addition, the trial is designed to assess the dose selection, safety, efficacy and pharmacokinetics of ACTM-838.

"We have advanced the STACT platform and defined a value-building clinical pathway that will allow us to translate our deep understanding of the tumor microenvironment into a novel approach to an effective and safe cancer treatment," said Christopher Thanos, Ph.D., CEO and Co-founder of Actym Therapeutics. "We value the continued commitment from our current investors and welcome GKCC LLC into the syndicate. Through their combined support, we aim to bring innovative therapies to patients across multiple solid tumor indications."

"Illumina Ventures is committed to driving innovation by supporting companies dedicated to using breakthrough science to transform the healthcare landscape. Actym’s pioneering approach to cancer treatment aligns perfectly with our vision," said Ron Mazumder, Ph.D., Partner at Illumina Ventures. "We are convinced that the Actym team is well-positioned to deliver on the promise of its platform and its new drug modality."

"Actym Therapeutics is pushing the boundaries of cancer immunotherapy with an adaptable platform that precisely targets the TME and can deliver a wide array of therapeutic payloads to treat solid tumors," added Julie Cherrington, Ph.D., Executive Chair of the Actym Board of Directors. "We are excited by the transformative potential of ACTM-838 and look forward to the company’s next phase of clinical and corporate development."

On October 18, 2023 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, reported that it will be presenting at the following upcoming scientific conferences (Press release, Inhibrx, OCT 18, 2023, View Source [SID1234636121]):

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Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting
November 1st – 4th, 2023 – Dublin, Ireland

Title: The Tetravalent Death Receptor 5 Agonist INBRX-109 Combined With Chemotherapy in Ewing Sarcoma: Preliminary Data From A Phase 1 Study
Lead Author: Rashmi Chugh, MD
Poster presentation on Thursday, November 2nd, 2023 from 5:30 PM – 6:30 PM Irish Standard Time
Location: The Liffey Convention Centre in Dublin, Ireland

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting
November 3rd – 5th, 2023 – San Diego, California

Title: Phase 1/2 Study of the Bispecific 4-1BB and PD-L1 Antibody INBRX-105 Alone and in Combination With Pembrolizumab in Select Solid Tumors
Lead Author: Jong Chul Park, MD
Abstract: 742
Trial-in-progress poster presentation on Saturday, November 4th, 2023 from 9 AM – 8:30 PM Pacific Standard Time
Location: San Diego Convention Center, San Diego, CA – Hall A

Presentation Title: Phase 1/2 Study of the Hexavalent OX40 Agonist INBRX-106 Alone and in Combination With Pembrolizumab in Select Solid Tumors
Lead Author: Rachel E. Sanborn, MD
Abstract: 748
Trial-in-progress poster presentation on Saturday, November 4th, 2023 from 9 AM – 8:30 PM Pacific Standard Time
Location: San Diego Convention Center in San Diego, CA – Hall A

The posters will be accessible through a link on the investors’ section of Inhibrx’s website at View Source upon commencement of each respective presentation.

On October 18, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 (Lutetium (177Lu) rosopatamab tetraxetan) for prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) (Press release, Telix Pharmaceuticals, OCT 18, 2023, View Source [SID1234636120]).

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The purpose of the SELECT study (ClinicalTrials.gov ID: NCT04786847) was to evaluate the utility of PSMA imaging to select patients for rADC-based PSMA therapy and to confirm the biodistribution of the rADC investigational therapy. The primary clinical objective was to determine whole body distribution and organ radiation and assess the safety and tolerability of TLX591, when administered in combination with SoC in second-line mCRPC.

The evaluable population was 28 patients (of a total 30 enrolled in the study). Patients received two (2) single intravenous (IV) infusions of TLX591, fourteen (14) days apart. Cohort 1 (5 patients) received a 27mCi dose followed by a 76 mCi dose for accuracy of biodistribution determination. Cohort 2 (23 patients) received two 76mCi doses.

The study achieved its primary objectives, confirming the safety and tolerability profile of TLX591 administered in two cycles,14 days apart (total cumulative dose 152mCi). The results reinforce the clinical utility of the short, fractionated dosing regimen.

Key results and observations

Dosimetry and biodistribution

Consistent lesion delineation between TLX591 and 68Ga-PSMA-11 imaging, within the detection sensitivity and resolution limits of SPECT[4]
Excellent uptake and retention in tumour and metastases up to 14 days post injection
Radiation exposure to key organs is well within prescribed safety limits
The highest absorbed dose was in the liver (clearance organ), with minimal uptake in exocrine (salivary) glands
Long retention period is evidence of internalisation and ability to efficiently deliver payload to tumour
Hematologic profile and adverse events

Grade 3 thrombocytopenia (25%) and neutropenia (38%) events in line with profile expected for this class of therapy. Similarly for Grade 4 hematologic events – thrombocytopenia (25%) and neutropenia (4%)
Serious adverse events (SAEs) observed were generally lower than in earlier studies conducted at the same dose level, reflective of the SELECT study being conducted in a healthier patient population
Hematologic events were transient and reversible
Four patients (17%) received intervention in the form of platelets, growth factors or both
All treatment related non-hematologic events were Grade 1 or Grade 2 and generally mild
Preliminary anti-tumour activity

64% of patients (baseline PSA and full dose) had a PSA reduction, with 27% demonstrating a 30% reduction and 18% demonstrating a 50% reduction. PSA and rPFS monitoring is ongoing
Scott T. Tagawa, MD, Professor of Medicine and Urology in New York said, "Preliminary results from the ProstACT SELECT study build on prior studies of TLX591 and underline the potential advantages of an antibody-based approach. Latest data provides further evidence of the long retention and internalisation of TLX591 in the tumour (and metastases), which may maximise the cell-killing effect of the 177Lu radioisotope at the site of the tumour."

Nat Lenzo, MD, GenesisCare Group Clinical Director Theranostics and top recruiter onto the ProstACT SELECT study commented, "It is really exciting to see development of this next-generation PSMA-targeting radiotherapeutic progressing. This study confirms the suitability of the short, simple treatment duration with two doses administered two weeks apart which is attractive to physicians and patients. The safety and tolerability data also demonstrates the potential for this therapy to reduce undesirable side effects, while delivering a hematologic toxicity profile that is both tolerable and manageable."

Colin Hayward, Telix Chief Medical Officer, added, "TLX591 is being designed to integrate with current standard of care, demonstrative of Telix’s continued innovation in prostate cancer treatment. The SELECT study provides further validation of the potential of TLX591, a first-in-class rADC therapy and the use of PSMA imaging with small molecules to select patients for antibody-based PSMA therapy."

Investigation of TLX591 is continuing in the Phase III ProstACT GLOBAL study (ClinicalTrials.gov ID NCT04876651), open for enrolment in Australia and expected to commence in the United States in 2024.

On October 18, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the grant of stock options to purchase 60,000 shares of its common stock to one new employee (Press release, Verastem, OCT 18, 2023, View Source [SID1234636119]). The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employee’s acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $7.65 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on October 12, 2023. The stock options to purchase 30,000 shares of common stock that were granted to the one new employee will vest at a rate of twenty-five percent (25%) on the one-year anniversary of the employee’s date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date. The stock options to purchase 30,000 shares of common stock that were granted to one new employee will vest upon the achievement of a certain commercial milestone, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on such vesting date.

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