On October 28, 2024 Parabilis Medicines (formerly FogPharma), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer, reported a corporate name change (Press release, Parabilis Medicines, OCT 28, 2024, View Source [SID1234649752]). The company’s new name, Parabilis (pronounced puh-RAH-buh-liss), draws on Greek and Latin etymologies to mean both ‘beyond what’s possible’ and ‘obtainable,’ reflecting the company’s drive to expand what is therapeutically possible for the treatment of serious diseases, and its commitment to ensuring its medicines reach and benefit patients globally.

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Parabilis also unveiled its expanded Helicon platform, which seamlessly integrates highly innovative AI and experimental technologies to discover, optimize, and deliver Helicon peptide therapeutics for not-yet-drugged targets, in addition to cutting-edge data science techniques the company is employing to optimize trial design and guide future clinical strategies.

"The name Parabilis captures the tremendous aspirations of a group of passionate innovators who are grounded in pragmatism. We are combining breakthrough science, industry-leading artificial intelligence (AI) capabilities, and a relentless drive to create real medicines that change what is possible in treating disease," said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. "That clarity of ambition is reflected in the way we approach our work, integrating data science and new product planning throughout the drug discovery and development lifecycle to ensure we’re single-mindedly pursuing only those medicines that anticipate and address profound unmet needs. Our new company name embodies this spirit: break boundaries, crush dogma, operate with the highest ambitions, and focus relentlessly on the patient at all times."

Parabilis’s investigational lead candidate, FOG-001, is the only clinical-stage inhibitor of the interaction of β-catenin with TCF, a known driver of colorectal cancer (CRC) with a significant role in multiple additional cancers. This target has been a towering challenge in the pharmaceutical industry, known for decades to be a key node, yet intractable. Now 16 months into its development, FOG-001 continues to enroll mostly CRC patients in its Phase 1 precision guided program. The company is also advancing its discovery portfolio with applications in protein degraders and radioligand therapies for the treatment of cancer, with four late discovery programs and integration of AI and advanced data science into every aspect of the discovery and development process.

In early 2024, the company raised a $145 million Series E financing to support the ongoing clinical development of FOG-001 and accelerate its broader Helicon peptide portfolio and platform.

On October 28, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,079,784 shares of common stock at a purchase price of $2.259 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, OCT 28, 2024, View Source [SID1234647460]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.51 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $2.44 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund manufacturing of THIO to be used in the Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC) and as working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 28, 2024 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs, including MRT-6160 (Press release, Monte Rosa Therapeutics, OCT 28, 2024, View Source [SID1234647445]). MRT-6160 is currently in an ongoing Phase 1, single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions. Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completion of the ongoing Phase 1 clinical study of MRT-6160.

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We are thrilled to announce this agreement with Novartis, a key player in immune-mediated conditions, and we are excited about the transformative potential it provides for Monte Rosa and MRT-6160. We expect this will accelerate and broaden the scope of clinical development of MRT-6160 to advance this unique, orally bioavailable modality while retaining substantial value for Monte Rosa. We believe the transaction validates our unique and industry leading QuEEN discovery engine, and it further increases our conviction to rationally design and develop highly selective and safe MGDs for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "The financial resources provided by this agreement are expected to extend our operational runway, enable us to advance our pipeline to potential value-creating milestones and anticipated proof-of-concept readouts, and further leverage our QuEEN discovery engine."

"Novartis has had a long-standing interest in molecular glue degraders, which offer the potential to tackle challenging biological targets. We ar excited about their application in immunology and the early progress we have seen by Monte Rosa in this space and with MRT-6160. We look forward to advancing MRT-6160 and learning more about its potential to provide a new therapeutic option for people living with a range of immune-mediated conditions," said Fiona Marshall, President of Biomedical Research at Novartis. "Novartis is committed to bringing forward new therapeutic options for these patients, and we are happy to be working with Monte Rosa to harness the potential of this approach to address unmet medical needs."

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Preclinical studies have demonstrated deep degradation of VAV1, resulting in a significant decrease in cytokines linked to immune-mediated conditions, with no detectable effects on other proteins. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions.

Agreement Details and Financial Terms

Under the terms of the agreement, Novartis has agreed to pay Monte Rosa $150 million up front. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, as well as tiered royalties on ex-U.S. net sales. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S.

The agreement is subject to customary closing conditions including regulatory clearance.

Monte Rosa plans to provide further information regarding its updated cash position and runway in its third quarter 2024 earnings update.

On October 28, 2024 Tempus, a leader in artificial intelligence and precision medicine, reported a collaboration with JW Pharmaceutical, one of the most established pharmaceutical companies in Korea, to leverage both real-world data (RWD) and biological modeling to support efficient hypothesis generation and rapid validation in early therapeutic research in oncology (Press release, JW Pharmaceutical, OCT 28, 2024, View Source [SID1234647461]). JW Pharma is an early adopter of integrating RWD into drug research and development programs, and it is now tapping into Tempus’ rich multimodal dataset and extensive repository of organoid models to accelerate its efforts in multiple indications.

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With this collaboration, JW Pharmaceutical researchers are leveraging Tempus’ biological modeling platform and an extensive panel of pan-indication and richly characterized, patient-derived organoid models to screen early pipeline assets, identify biomarkers of response, and guide asset prioritization decisions. Each organoid model reflects the biology of a distinct patient tumor, and is linked to Tempus’ expansive, real-world, multimodal dataset through the company’s next-generation sequencing assay, xT. This enables projection of organoid screening findings onto real-world patient populations, which has the potential to unlock even richer multimodal insights.

"We are excited to work with a forward-looking collaborator like JW Pharmaceutical, a pioneer in Korea that is embracing the power of RWD and AI to advance the next generation of cancer therapeutics," said Ryan Fukushima, Chief Operating Officer of Tempus. "We are taking it one step further by curating a panel of organoids across specific cancer indications that closely reflect real-world patients to evaluate select preclinical candidates, and we are excited to understand the full potential of this innovative approach to early research."

"We are excited to collaborate with Tempus, a leader in AI and precision medicine, capable of conducting end-to-end translational research from preclinical to clinical stages. As the first in Korea to initiate this partnership, JW anticipates promising outcomes," said Chan-Hee Park, Chief Technology Officer of JW Pharmaceutical. "This collaboration marks a turning point in data-driven drug development using RWD in Korea, aligning with global trends and expected to positively impact the domestic drug development landscape."

On October 27, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus test during the American College of Gastroenterology (ACG) Annual Meeting (Press release, Exact Sciences, OCT 27, 2024, View Source [SID1234647439]). ACG takes place October 25-30, 2024, in Philadelphia, Pennsylvania. Exact Sciences will also present new data on improving adherence to help close the gap in CRC screening. ACG abstracts are available on the meeting website.

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"Exact Sciences is pleased to share new modeling data which demonstrates the Cologuard Plus test as an efficient CRC screening strategy across modeled age ranges and screening intervals, given its high sensitivity and specificity for both cancer and precancer," said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences. "The data demonstrate our commitment to continuous improvement and innovation to deliver best in class, patient-centric cancer screening and diagnostic solutions."

Researchers used a validated simulation model to assess the benefit to burden ratio of the Cologuard Plus test and other established and emerging CRC screening options. Benefit was defined as life-years gained and burden as the lifetime number of colonoscopies.

The efficient frontier abstract summary and presentation details are as follows:

Next Generation mt-sDNA Has the Best Balance Between Benefit and Burden of Age- and Interval-Recommended CRC Screening Among Stool- and Blood-Based Tests (P2119)
Summary: The next-generation mt-sDNA (ng-mt-sDNA) test was the only efficient non-invasive modality for screening over the guideline-recommended age interval of 45-75 years; Blood-based screening strategies were not efficient or near-efficient at any screening interval or age-range.
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
Increasing real-world adherence

The seven remaining abstracts share patient-centric research on improving CRC screening adherence rates, particularly in underserved populations. With industry-leading patient navigation and personalized outreach, these strategies directly impact millions of lives. When modeled against the U.S. general screening population, widespread implementation of the reported strategies could drive as much as a 10% reduction in the CRC screening gap.*

The abstracts at ACG are as follows:

Cross Sectional Adherence with the Multi Target Stool DNA Test for Colorectal Cancer Screening Among Four Largest Payors in the Country (P0437)
Summary: This study demonstrates high adherence rates to mt-sDNA testing across a large, national sample of insured individuals between ages 45-85 years, with an overall cross-sectional adherence of 71.2% and an average return time of 27.3 days.
Session: Sunday, October 27, 2024, 3:30 PM – 7:00 PM EDT
Real-World Multi-Target Stool DNA Longitudinal Adherence for Colorectal Cancer Re-screening in a Large, National Spanish-Speaking Population (P3827)
Summary: The overall adherence rate in this population was 76.7%, with a mean time to test return of 20.2 days; Personalized patient navigation outreach with Spanish language support resulted in adherence rates exceeding 70% for CRC re-screening, across all analyzed age subgroups.
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
Gap Closure Adherence to Multi-Targeted Stool DNA Test for Colorectal Cancer Screening in an Insured Cohort (P0436)
Summary: The gap closure program achieved nearly 50% adherence, with an average of 25.5 days to return the kit; This supports mt-sDNA as an effective modality to enhance CRC screening participation.
Session: Sunday October 27, 2024, 3:30 PM – 7:00 PM EDT
Impact of Personalized Patient Outreach on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2120)
Summary: Personalized patient outreach significantly improved mt-sDNA adherence for CRC screening compared to standard outreach, 63% vs 61.1% respectively.
Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT
Impact of Spanish Language Outreach on Multi-Target Stool DNA Test Adherence in a Spanish-Speaking Population in a Federally Qualified Health Center (P3825)
Summary: Preference-based multichannel navigation with Spanish language outreach significantly improved patient adherence to CRC screening in the FQHC Spanish-speaking population, increasing adherence from 45.10% to 51.60%.
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
Impact of Preference-Based Digital Navigation on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2118)
Summary: Overall mt-sDNA adherence was 63.7% and analysis by communication type revealed that mt-sDNA significantly improved adherence: SMS + email (66.5%), SMS (62.9%), email (64.2%), no digital (57.4%). Additionally, SMS + email demonstrated the shortest average return time (20.1 days).
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
Impact of Spanish Language Patient Navigation on Multi-Target Stool DNA Test Adherence Among Spanish-Speaking Patient Population (P3826)
Summary: Personalized Spanish-language outreach in a predominantly Spanish-speaking Hispanic patient population significantly improved mt-sDNA adherence rates; The Spanish language outreach group exhibited higher mt-sDNA adherence than English language outreach group (62.0% vs. 57.3%), while also exhibiting increased odds of mt-sDNA adherence.
Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT
Meet Exact Sciences Booth Event

Exact Sciences will host two information sessions at the company’s booth (#839), These sessions will be led by Burak Ozbay, PhD, MBA, BPharm, Vice President of Health Economics and Outcomes Research. The sessions will focus on precancer detection and what modeling can inform about CRC screening tests. The booth sessions will take place Sunday, October 27 and Monday, October 28 at 5:30 pm and 10:45 am EDT.

*Estimates based on modeling abstract performance against U.S. based population cohorts of: # of Medicare Advantage members, U.S. Hispanics and unscreened U.S. citizens.

About the BLUE-C Study

BLUE-C was a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design compared next-generation Cologuard and a fecal immunochemical test (FIT). Blood samples were also collected for later evaluation of a blood-based screening test being developed by Exact Sciences. BLUE-C is one of the largest colorectal cancer screening trials ever conducted, and the study population reflects the racial and ethnic makeup of the United States according to the 2020 census.

About the Cologuard Plus test

Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences’ lab and increase the valid result rate. Exact Sciences expects to launch the test with Medicare coverage and guideline inclusion in 2025.

About the Cologuard Test

The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).

The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal phase 3 DeeP-C study. The Cologuard test is easy to use. It can be completed at home and does not require any time off or special preparation. In the initial 10 years since launch, the Cologuard test was used more than 16 million times.

Important Information About the Cologuard Test

Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit Cologuard.com. Rx only.