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 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 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 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat a range of cancers, infectious diseases, and immune modulated disorders reported that Chief Executive Officer James Passin has been invited to present live at the Emerging Growth Conference on October 30th, 2024 at 9:40 AM EST (Press release, BioVaxys Technology, OCT 28, 2024, View Source [SID1234647458]). This live interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO in real time.

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Please submit your questions in advance to [email protected] or ask your questions during the event.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source We will release a link to that after the event.

On October 28, 2024 Chime Biologics, a leading global CDMO that enables its partners’ success in biologics, reported a strategic collaboration with MedPacto, a South Korean clinically staged company listed on KOSDAQ (235980) (Press release, MedPacto, OCT 28, 2024, View Source [SID1234647457]).

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MedPacto, known for its focus on cancer therapeutics, will leverage Chime Biologics’ expertise in biologics development to streamline the process from tech transfer to cGMP clinical manufacturing for Investigational New Drug (IND) submissions. Under the agreement, Chime Biologics will advance the Chemistry, Manufacturing, and Controls (CMC) process development for the multiple preclinical drug candidates.

Dr. Jungwon Woo, President of MedPacto, stated," We are highly impressed by Chime Biologics’ development and manufacture expertise, which is crucial helping us expand into major global markets. Their ability to meet international standards will greatly support our efforts to advance our assets into a new stage. This collaboration is a key step forward, and we look forward to a successful and long-term partnership."

Dr. Jimmy Wei, President of Chime Biologics, added, "We are pleased to announce our strategic collaboration with MedPacto, a respected KOSDAQ-listed company with a strong portfolio of first-in-class assets. This partnership marks the beginning of a long-term relationship aimed at advancing pharmaceutical innovation. It aligns with our growth strategy in South Korea and aligns with our commitment to the region’s biopharmaceutical landscape. We look forward to working closely with MedPacto and contributing to the success of their innovative pipeline."

Chime Biologics is expanding its manufacturing capacity to 100,000 liters to solidify its position as a leading global CDMO. As part of this strategy, the company is actively entering the South Korean market and has signed agreements with several South Korean biotech companies to provide development and manufacturing services for antibody drugs and biosimilars.