On October 28, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE275 (GSK959), a potential first-in-class and best-in-class Werner Helicase (WRN) inhibitor (Press release, Ideaya Biosciences, OCT 28, 2024, View Source [SID1234647459]). IDE275 (GSK959) has demonstrated robust and selective synthetic lethality preclinically in the high microsatellite instability (MSI-High) biomarker setting, and the Phase 1 clinical trial will enroll patients having tumors characterized by MSI-High.

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"IDE275 represents IDEAYA’s fifth potential first-in-class clinical program in our precision medicine oncology pipeline and has a potentially differentiated best-in-class profile that we are targeting to present at a future medical conference with GSK. The robust preclinical efficacy observed by IDE275 selectively in the MSH-High biomarker setting, including monotherapy regressions, provides a double-digit % prevalence target patient population across several major solid tumor types, including endometrial, colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE275 (GSK959) is a potential first-in-class small molecule inhibitor of Werner Helicase that was discovered by IDEAYA in collaboration with GSK. In preclinical studies, IDE275 has demonstrated robust and selective synthetic lethality in the MSI-High biomarker setting, including single-agent tumor regressions in-vivo in MSI-High CDX and PDX models derived from colorectal, endometrial and gastric cancers. Initiation of the Phase 1 trial for IDE275 is projected in the fourth quarter of 2024. GSK is the sponsor of the IND application and plans to develop IDE275 (GSK959) as both a monotherapy agent and in combination with a PD-1 inhibitor in a Phase 1 clinical trial for patients having MSI-High tumors. The percent prevalence of MSI-High in solid tumors, including endometrial, colorectal, and gastric cancers, has been reported at approximately 31%, 20%, and 19%, respectively (JCO Precision Oncology, September 2017).

GSK is responsible for 80% of global research and development costs for IDE275 (GSK959) and IDEAYA is responsible for 20% of such costs. IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion. IDEAYA may potentially also receive up to $465 million in further later-stage development and regulatory milestones. Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of IDE275 (GSK959) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.

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 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.