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.

On October 28, 2024 Oncotelic Therapeutics, Inc (OTCQB:OTLC) reported its fourth publication of its TGFB2 series (Press release, Oncotelic, OCT 28, 2024, View Source [SID1234647454]). Clinical data demonstrated that pancreatic cancer patients with high expression levels of either TGFB2, IRF9, or IFI27 showed improvement of median overall survival from 16-20 months to 72 months for patients with low levels of expression for both TGFB2 and either IRF9 or IFI27 validating that knockdown of IRF9 and IFI27 as therapeutic targets for TGFB2 therapeutics. View Source

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The publications of this series are available at Pubmed as follow:

1) TGFB2 mRNA Levels Prognostically Interact with Interferon-Alpha Receptor Activation of IRF9 and IFI27, and an Immune Checkpoint LGALS9 to Impact Overall Survival in Pancreatic Ductal Adenocarcinoma. Qazi S, Trieu V. Int J Mol Sci. 2024 Oct 18;25(20):11221. doi: 10.3390/ijms252011221. PMID: 39457004

2) Transforming Growth Factor Beta 2 (TGFB2) mRNA Levels, in Conjunction with Interferon-Gamma Receptor Activation of Interferon Regulatory Factor 5 (IRF5) and Expression of CD276/B7-H3, Are Therapeutically Targetable Negative Prognostic Markers in Low-Grade Gliomas. Trieu V, Maida AE, Qazi S. Cancers (Basel). 2024 Mar 19;16(6):1202. doi: 10.3390/cancers16061202. PMID: 38539537 Free PMC article.

3) Transforming Growth Factor Beta 2 (TGFB2) and Interferon Gamma Receptor 2 (IFNGR2) mRNA Levels in the Brainstem Tumor Microenvironment (TME) Significantly Impact Overall Survival in Pediatric DMG Patients. Qazi S, Talebi Z, Trieu V. Biomedicines. 2024 Jan 15;12(1):191. doi: 10.3390/biomedicines12010191. PMID: 38255296 Free PMC article.

4) High Intra-Tumor Transforming Growth Factor Beta 2 Level as a Predictor of Poor Treatment Outcomes in Pediatric Diffuse Intrinsic Pontine Glioma. Uckun FM, Qazi S, Trieu V. Cancers (Basel). 2023 Mar 9;15(6):1676. doi: 10.3390/cancers15061676. PMID: 36980562 Free PMC article.

Additional information on our current phase 3 can be found at: View Source

On October 28, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that new long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published online in the Journal of Urology (Press release, UroGen Pharma, OCT 28, 2024, View Source [SID1234647453]).

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In ENVISION, UGN-102 treatment was associated with an unprecedented 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of response (DOR) by Kaplan-Meier estimate (n=108) in patients who achieved complete response (CR) at three months after the first instillation of investigational drug UGN-102 (mitomycin) for intravesical solution. The DOR Kaplan-Meier estimates at 15 months (n=43) and 18 months (n=9) after 3-month CR were both 80.9% (95% CI, 73.9%, 86.2%). The ENVISION trial previously met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.6% (95% CI, 73.9%, 84.5%) CR rate at three months following the first instillation of UGN-102.

"These data demonstrate that treatment with UGN-102 results in a clinically meaningful CR rate and that the durability of the response in patients with LG-IR-NMIBC is robust," said Sandip Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology, Morristown Medical Center/Atlantic Health System, NJ and Principal Investigator of the ENVISION trial. "This study adds to the mounting evidence supporting UGN-102 as a potentially valuable treatment option for patients with recurrent LG-IR-NMIBC."

UroGen initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102 as a treatment for LG-IR-NMIBC in January 2024 and completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 with a PDUFA goal date of June 13, 2025.

Liz Barrett, President and CEO of UroGen, emphasized the significance of the DOR findings from the ENVISION study, stating, "LG-IR-NMIBC patients are typically elderly and currently treated with repeated surgeries under general anesthesia that are associated with physical and quality of life detriments. These new results continue to strengthen UGN-102’s potential as a treatment option for these patients that extends their recurrence-free interval. The highly recurrent nature of LG-IR-NMIBC underscores the urgent need for innovative options for patients facing this challenging disease."

The most common treatment-emergent adverse events (TEAEs) in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. TEAEs were typically mild-to-moderate in severity and resolved or resolving. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN-102.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

In the U.S., bladder cancer is the second most common urologic cancer in men. LG-IR- NMIBC represents approximately 22,000 newly diagnosed bladder cancer patients each year and an estimated 60,000 recurrences annually among patients diagnosed from previous years. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures.

About ENVISION

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) for intravesical solution as a chemoablative therapy in patients with LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with approximately 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of UGN-102. The primary endpoint evaluated the CR rate at the three-month assessment after the first instillation, and the key secondary endpoint evaluated durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

On October 28, 2024 Odyssey Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that are designed to precisely target disease pathology, and Terray Therapeutics, Inc., a biotechnology company focused on improving human health by transforming the speed, cost, and success rate of small molecule drug development using computation integrated with novel data at scale, reported that they have entered into a strategic collaboration to jointly discover and develop small molecule medicines against transcription factor targets of interest (Press release, Odyssey Therapeutics, OCT 28, 2024, View Source [SID1234647452]). The collaboration combines Odyssey’s expertise in immunology and transcription factor biology with Terray’s complementary expertise in immunology and integrated AI platform, tNova, which leverages proprietary experimental data at scale to power its AI capabilities. Together, the companies will work to develop first-in-class therapeutic candidates for high-interest targets with potential application across inflammatory diseases.

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"We are excited to collaborate with Terray, whose integrated computational and experimental platform offers a powerful complement to our team’s expertise in immunology, and experience in reconstituting functional transcription factors and drug discovery," said Gary D. Glick, Ph.D., founder and CEO of Odyssey Therapeutics. "This collaboration has the potential to create first-in-class therapeutics capable of driving meaningful benefit for patients in inflammatory diseases with high unmet need."

Under the terms of the collaboration agreement, the parties will collaborate to identify one or more development candidates directed at targets of interest. Odyssey will provide enabling background IP and structural and protein biology know-how for use in Terray’s tNova drug discovery platform for initial hit-finding and lead maturation activities. Thereafter, the parties will share responsibilities for the research, development and commercialization of the program pursuant to written plans under the agreement, and share collaboration losses and collaboration profits equally.

Jacob Berlin, Ph.D., Chief Executive Officer, Terray Therapeutics, said: "We are thrilled to collaborate with Odyssey. At Terray, our proprietary ultra-miniaturized chemistry platform enables unique generative AI capabilities for the discovery and development of small molecule therapeutics. This approach is a perfect complement for Odyssey’s transcription factor biology expertise. We believe that our discovery capabilities and combined expertise in immunology affords us the opportunity to solve incredibly hard challenges and bring relief to patients."

On October 28, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR) ("Monopar Therapeutics" or the "Company"), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, reported that it intends to offer to sell shares of its common stock in a best efforts public offering (Press release, Monopar Therapeutics, OCT 28, 2024, View Source [SID1234647451]). All of the shares of common stock are to be sold by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

Monopar Therapeutics intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital.

The securities will be offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 21, 2022, and declared effective on January 4, 2023. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 540-4414. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference into such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.