Kumquat Biosciences and Takeda Enter into Strategic Collaboration and Exclusive Global License Agreement to Advance Novel Oral Immuno-Oncology Drug Candidate

On April 16, 2024 Kumquat Biosciences, a leader in translating breakthrough science into first-in-class therapeutics, reported a strategic and exclusive collaboration with Takeda to develop and commercialize a novel immuno-oncology small molecule inhibitor as a mono- and/or combination-therapy (Press release, Kumquat Biosciences, APR 16, 2024, View Source [SID1234642114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Kumquat granted Takeda an exclusive, global, and royalty bearing license to develop and commercialize a selected small molecule inhibitor. Subject to Kumquat’s option, Takeda will assume and fund all development and commercialization activities beyond the phase 1 trial activities led by Kumquat. Kumquat will receive up to $130 million in near-term payments and potentially more than $1.2 billion if all future clinical, regulatory, and commercial milestones are achieved during the term of the agreement plus tiered royalties on potential net sales of any commercial products resulting from this license.

"The advancement of this immuno-oncology small molecule program speaks to our ability to thrive on the challenges of drugging tough therapeutic targets of great potential," said Yi Liu, Chief Executive Officer of Kumquat. "We are proud of our persistent and innovative breakthrough, and we are thrilled to collaborate with Takeda, who shares our vision and strategy for realizing the benefit of small molecule-based transformative I/O treatments. This collaboration empowers this I/O program to advance to the clinic quickly and holds potential to benefit a broad population of cancer patients."

"We are excited to collaborate with Kumquat, an accomplished team with deep insights into this challenging target and therapeutic space," said P.K. Morrow, the Head of the Oncology Therapeutic Area Unit at Takeda. "This collaboration aligns with our mission to advance a cutting-edge pipeline focused on maximizing the benefit of the immune system to address the continued unmet needs of cancer patients. We look forward to working with Kumquat to accelerate the development of this exciting asset."

Biomica to Present at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting

On April 16, 2024 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported that it will present preliminary data from its Phase 1 study of BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in refractory patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Biomica, APR 16, 2024, View Source [SID1234642113]). The conference will take place at McCormick Place in Chicago, Illinois, and will also be available virtually from May 31 to June 4, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:

Title: Preliminary results from a First-in-Human (FIH), open-label Phase 1 study with BMC128, a rationally designed live bacterial consortium, in combination with nivolumab.
Session Type: Poster Session
Abstract Number: 8631
Date and Time: June 3, 2024, 1:30 PM – 4:30 PM (CDT)

Dr. Elran Haber, CEO of Biomica, stated: "We look forward to presenting our preliminary data at ASCO (Free ASCO Whitepaper), and to provide initial safety and efficacy results from our ongoing Phase 1 POC trial evaluating BMC-128 in combination with nivolumab in refractory patients. These results mark significant progress, laying the groundwork for the next phase in our clinical development process".

Additional information about the trial, can be found at: View Source (ClinicalTrials.gov Identifier: NCT05354102).

About BMC128:
BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI tech-engine.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.
Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

Mabwell Releases Preclinical Study Results of Multiple Innovative Drugs Released at the 2024 AACR Annual Meeting

On April 16, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported the preclinical research findings of three potential novel drug candidates in poster format at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held from April 5 to 10, 2024 (Press release, Mabwell Biotech, APR 16, 2024, View Source [SID1234642111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentation

1. Disrupting IL-11/IL-11R signaling by an efficacious anti-IL-11 antibody 9MW3811 enhances T cell tumor infiltration and synergizes with anti-PD-1 therapies in vivo

Synopsis No.: 2365

The reported 9MW3811 is a high-affinity humanized neutralizing antibody against IL-11 independently developed by Mabwell, and has IND applications approved in China, the United States, and Australia, and its phase I clinical trials are ongoing in Australia and China.

As an important inflammation factor, IL-11 plays a significant role in the development and progression of fibrosis and tumor. Studies have shown that high expression of IL-11 is associated with the prognosis of various tumors such as lung cancer, hepatic cancer, and colorectal cancer. IL-11 not only promotes the growth of tumor cells through the STAT3 pathway but also has a significant impact on immune cells in the tumor microenvironment. 9MW3811 effectively blocks the formation of the IL-11/IL-11Ra/gp130 ternary complex by binding to IL-11, thereby inhibiting the activation of downstream signaling pathways. 9MW3811 has shown good anti-tumor therapeutic effects in multiple preclinical pharmacodynamic models, especially when used in combination with anti-PD-1 antibodies, it significantly promotes lymphocytic infiltration of CD8+ T cells, improves the T cell exhaustion caused by anti-PD-1 antibodies, upregulates the secretion of cytotoxic cytokines, thus exhibiting better combined anti-tumor effects.

2. 2MW4991, a novel ADCC-enhanced integrin αvβ8 blocker, exhibits high anti-tumor potency and was well tolerated in cynomolgus monkeys

Synopsis No.: 6349

The reported 2MW4991 is a high-specificity and high-affinity ADCC-enhanced antibody targeting integrin αvβ8. Integrin αvβ8 is an important activator of TGF-β, and specifically regulates the activity of TGF-β in immune cells. Studies have found that integrin αvβ8 is highly expressed in various tumors, and blocking αvβ8 can completely inhibit the release of TGF-β. 2MW4991 can completely block the release of TGF-β mediated by αvβ8, showing strong anti-tumor activity in various pharmacodynamic models such as CT26 and EMT6, and significantly promotes immune cell infiltration in tumors, greatly increasing the sensitivity of immune-excluded tumors to PD1 inhibitors. 2MW4991 has a significant synergistic effect when used in combination with PD1. The studies conducted in non-primate models have shown that 2MW4991 has good safety and metabolic profiles.

3. 2MW4691, a novel CCR8/CTLA-4 bispecific antibody, displays potent anti-tumor efficacy by specifically depleting tumor-infiltrating Tregs and blocking CTLA-4 signaling on CD8+ T cells

Synopsis No.: 6350

The reported 2MW4691 is an ADCC-enhanced bispecific antibody targeting CCR8/CTLA-4. Targeting CTLA-4 has a strong anti-tumor effect, but its clinical application is limited due to strong side effects. CCR8 is a specific marker of tumor-infiltrating Tregs, and is almost not expressed in other immune cells and peripheral Tregs. Single-cell sequencing analysis of Treg cells infiltrating various tumors found that CCR8 is expressed in a small subset of Treg cells infiltrating tumors, and CTLA-4 is widely expressed in Treg cells and CD8+ T cells. 2MW4691 retains high affinity targeting CCR8 and attenuated CTLA-4-binding and -blocking activity, specifically eliminating Treg cells infiltrating tumors. Due to the lower CTLA-4 expression in the peripheral tissues, 2MW4691 only blocks the immunosuppression mediated by CTLA-4 signaling on peripheral CD8+ T cells. 2MW4691 demonstrates strong anti-tumor activity in preclinical CCR8 single transgenic animal models, CTLA-4 single transgenic animal models, and double transgenic animal models, and has shown good metabolic activity and safety in primate animals.

Volastra Therapeutics Announces First Patient Dosed in Phase Ib Clinical Trial of Sovilnesib

On April 16, 2024 Volastra Therapeutics, a clinical-stage biotechnology company, reported it has dosed the first patient in its Phase Ib clinical trial evaluating sovilnesib in patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC) (Press release, Volastra Therapeutics, APR 16, 2024, View Source [SID1234642109]). This trial (NCT06084416) is a randomized dose optimization study of once-daily oral sovilnesib at different dose levels to establish the recommended Phase 2 dose.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sovilnesib was granted Fast Track designation in this indication by the U.S. Food and Drug Administration (FDA) based on its initial clinical data as well as the high unmet need in this population. Volastra in-licensed sovilnesib (formerly AMG-650) from Amgen in February 2023. The company is also progressing its internally developed KIF18A inhibitor, VLS-1488, in an ongoing Phase 1 clinical trial (NCT05902988).

"Advancing our two chemically differentiated KIF18A inhibitors in parallel Phase 1 clinical trials presents the rare opportunity to efficiently gather comparative clinical data," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "We believe our strategy will allow us to select the first, and potentially best-in-class, medicine for patients to advance to late-stage development for treatment of platinum-resistant or refractory HGSOC."

In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. The majority of these patients will see disease progression on platinum-based therapy.

"Patients with advanced HGSOC have poor treatment response rates after disease progression on platinum-based chemotherapy, and as a result have a significant need for new treatment options," Dr. Joyce Liu M.D., MPH, Associate Chief and Director of Clinical Research in the Division of Gynecologic Oncology at Dana Farber Cancer Institute and a principal investigator on the trial commented. "We are excited to participate in this trial evaluating a unique treatment approach in hopes of advancing new options for patients."

In addition to clinical development of novel therapeutics, Volastra is deploying multiple unique biomarker approaches to measure chromosomal instability and other predictors of response to KIF18A inhibitors through partnerships with companies including Microsoft, Tailor Bio, and Function Oncology.

Veracyte Announces that Nine Studies Reinforcing the Value of Decipher Prostate and Decipher Bladder Testing Will Be Presented at AUA 2024

On April 16, 2024 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that nine abstracts focused on its Decipher Prostate and Decipher Bladder Genomic Classifiers will be presented at AUA 2024, the annual meeting of the American Urological Association, taking place May 3-6 in San Antonio (Press release, Veracyte, APR 16, 2024, View Source [SID1234642107]). Studies to be presented include those that evaluate the clinical utility of the company’s Decipher tests in guiding treatment decisions for patients with prostate or bladder cancer. Other presentations will explore new insights into these cancers’ underlying biology, which researchers derived through use of Veracyte’s whole-transcriptome-based Decipher GRID research tool.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The data being presented at AUA 2024 expands the extensive clinical evidence supporting our Decipher Prostate and Decipher Bladder tests," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "They also highlight Veracyte’s commitment to collaborating with leading researchers to help understand the biological underpinnings of urologic cancers and advance the science around the disease areas we serve."

The following abstracts will be presented in the Henry B. González Convention Center:

Title:


High Decipher score defines the subgroup most at risk of metastatic progression among patients with lower grade tumors classified as NCCN high-risk based on elevated prostate-specific antigen level alone

Presenter:


David Han, M.D., Columbia University Irving Medical Center

Format:


Poster (MP41-14)

Date/Time:


Saturday, May 4, 2024 / 3:30 p.m. to 5:30 p.m. CT

Room #:


304B

Title:


Decipher Predicts Clinically Significant Upgrading on Final Radical Prostatectomy Pathology

Presenter:


John Sheng, M.D., Rutgers New Jersey Medical School

Format:


Poster (MP49-09)

Date/Time:


Sunday, May 5, 2024 / 7:00 a.m. to 9:00 a.m. CT

Room #:


221B

Title:


Genomic Signatures Associated with Adverse Pathologic Features at Radical Prostatectomy Among Active Surveillance Eligible Men

Presenter:


Eric Li, M.D., Northwestern University

Format:


Poster (MP41-09)

Date/Time:


Saturday, May 4, 2024 / 3:30 p.m. to 5:30 p.m. CT

Room #:


304B

Title:


Variation in Prostate Cancer Genomic Subtypes Across Prostate Magnetic Resonance Imaging PIRADS Scores and Race

Presenter:


Nimrod Barashi Gozal, M.D., Washington University in St. Louis

Format:


Podium Presentation (PD42-01)

Date/Time:


Sunday, May 5, 2024 / 9:30 a.m. to 9:40 a.m. CT

Room #:


303A

Title:


Transcriptomic Features of Clinically Localized Prostate Cancer Arising from Distinct Prostate Zonal Regions

Presenter:


Ross Liao, M.D., Cleveland Clinic

Format:


Poster (MP41-13)

Date/Time:


Saturday, May 4, 2024 / 3:30 p.m. to 5:30 p.m. CT

Room #:


304B

Title:


Glucagon-like peptide-1 Expression in Prostate Cancer

Presenter:


Mohammed Shahait, M.D., Private Practice

Format:


Poster (MP05-10)

Date/Time:


Friday, May 3, 2024 / 7:00 a.m. to 9:00 a.m. CT

Room #:


221C

Title:


Molecular subtyping for predicting non-organ confined disease and survival outcomes after radical cystectomy in clinical high-grade T1 and T2 bladder cancer patients

Presenter:


Yair Lotan, M.D., UT Southwestern Medical Center

Format:


Poster (MP15-07)

Date/Time:


Friday, May 3, 2024 / 1:00 p.m. to 3:00 p.m. CT

Room #:


221C

Title:


The stroma-rich consensus bladder cancer subtype correlates with improved prognosis after neoadjuvant immunotherapy and radical cystectomy

Presenter:


Joep De Jong, Ph.D., Erasmus MC, The Netherlands

Format:


Podium Presentation (PD14-05)

Date/Time:


Friday, May 3, 2024 / 4:10 p.m. to 4:20 p.m. CT

Room #:


301A

Title:


A lncRNA-based classifier identifies high grade T1 bladder cancer patients with excellent outcomes after radical cystectomy

Presenter:


Yair Lotan, M.D., UT Southwestern Medical Center

Format:


Poster (MP15-02)

Date/Time:


Friday, May 3, 2024 / 1:00 p.m. to 3:00 p.m. CT

Room #:


221C

Additional information regarding these presentations and Veracyte’s participation at AUA 2024 can be found at the company’s booth (#607).

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, the physician can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in more than 75 studies involving more than 100,000 patients. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More Information about Decipher GRID can be found here.