On December 18, 2024 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS) reported that an abstract highlighting final clinical and biomarker data from its Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-antagonistic antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC), has been selected for a poster presentation at the upcoming 2025 ASCO (Free ASCO Whitepaper) GI Annual Meeting, being held January 23-25, 2025, in San Fransisco, CA (Press release, Coherus Biosciences, DEC 18, 2024, View Source [SID1234649194]).

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!

"Casdozo is a first-in-class antibody, and in oncology, is the first IL-27 cytokine antagonist to demonstrate monotherapy responses and immune activation with a safety profile that lends itself to combination," said Rosh Dias, M.D., Coherus’ Chief Medical Officer. "We look forward to sharing the final data from this Phase 2 combination study of casdozo with standard of care with the medical community at the upcoming 2025 ASCO (Free ASCO Whitepaper)-GI annual meeting. We now have data across several tumor types for casdozo demonstrating clinical activity. We are particularly excited about HCC given the strong preclinical package for targeting IL-27 in liver cancer and now translation to the clinic."

Coherus has initiated a new randomized Phase 2 study (NCT06679985) evaluating casdozo, in combination with bevacizumab and toripalimab, Coherus’ next-generation anti-PD-1 monoclonal antibody, in participants with first-line HCC. This randomized, parallel, open-label Phase 2 study is designed to evaluate the safety, efficacy, and Project Optimus1 dosing of the triplet combination. The study is expected to enroll up to 72 patients, who will be randomized to receive one of two biologically active doses of casdozo with toripalimab plus bevacizumab or toripalimab plus bevacizumab without casdozo.

"Advancing casdozo development in first-line HCC with a randomized Phase 2 combination study marks a significant milestone in our strategic path to progress our clinical pipeline, which is focused on overcoming immune suppression in the tumor microenvironment to extend survival and improve outcomes for patients and pursuing new indications for toripalimab in the U.S.," continued Dr. Dias. "Casdozo has shown encouraging responses in the first line setting when added to the existing standard of care, atezolizumab and bevacizumab, and we’re excited to build upon these data with this new Phase 2 study evaluating casdozo in combination with toripalimab and bevacizumab."

In the Phase 3 HEPATORCH study, conducted by Junshi Biosciences, patients with advanced HCC treated with toripalimab combined with bevacizumab as a first-line therapy showed significantly better clinical efficacy than sorafenib monotherapy.2 HEPATORCH patients showed an objective response rate of 25.3% versus 6.1% in the sorafenib group, a median progression-free survival of 5.8 months, and a median overall survival of 20 months, compared to 4 and 14.5 months, respectively, for the sorafenib group.3 Toripalimab in combination with bevacizumab was well tolerated, with a toxicity profile consistent with the known toxicity profile of each monotherapy, with no new safety signals identified.3 The results of the HEPATORCH study support the clinical study of toripalimab in combination with bevacizumab as a new first-line treatment option for advanced HCC which, along with the results from the Phase 2 casdozo study reported to date, support pursuing a triple combination of casdozo with toripalimab plus bevacizumab in patients with advanced or metastatic HCC.

ASCO-GI 2025 Presentation Details

Title: Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, CHS-388) in combination with atezolizumab and bevacizumab in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC)
Lead Author: Daneng Li, City of Hope National Comprehensive Cancer Center
Abstract #: 605
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date and Time: Friday, January 24, 2025; 11:30 a.m. – 1:00 p.m. PT

Hepatobiliary cancers include a spectrum of invasive carcinomas arising in the liver (hepatocellular carcinoma; HCC), gall bladder, and bile ducts (collectively called biliary tract cancers). The most common type of primary liver cancer in adults is HCC (accounting for ~90%), which is the third leading cause of cancer-related deaths worldwide. According to the NCI Surveillance, Epidemiology and End Results Program (SEER), there will be an estimated 41,630 new cases and 29,840 deaths from liver and intrahepatic bile duct cancer in the US in 2024.4 The U.S. 5-year relative survival rate for liver and intrahepatic bile duct cancer is 21.7%.4 The liver cancer treatment pattern has changed in recent years with the emergence of immunotherapy combinations and will continue to evolve as more treatment options become available for these highly lethal cancers.

On December 18, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, reported that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist (Press release, Merck & Co, DEC 18, 2024, View Source [SID1234649195]).

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!

"We continue to leverage science-driven business development to augment and complement our robust pipeline," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Through this agreement, we aim to build on our experience targeting incretin biology to evaluate HS-10535 and its potential to provide additional cardiometabolic benefits beyond weight reduction."

Under the agreement, Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535. Hansoh Pharma will receive an upfront payment of $112 million and is eligible to receive up to $1.9 billion in milestone payments associated with the development, regulatory approval and commercialization of the candidate, as well as royalties on sales. Hansoh Pharma may co-promote or solely commercialize HS-10535 in China subject to certain conditions. Merck will record a pre-tax charge of $112 million, or $0.04 per share, to be included in GAAP and non-GAAP results in the fourth quarter of 2024.

"We are pleased to announce the in-license of our oral GLP-1 by Merck, a company with established leadership in cardiometabolic diseases," said Ms. Eliza Sun, Executive Director of the Board, Hansoh Pharma. "Hansoh Pharma is becoming an emerging leader in metabolic diseases, and we see Merck’s expertise and capabilities as key to accelerating the development of this promising asset for patients worldwide."

On December 18, 2024 General Proximity reported the company has raised an $8 million seed to grow its drug discovery platform, CEO Armand Cognetta tells Axios exclusively (Press release, General Proximity, DEC 18, 2024, View Source [SID1234649817]).

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!

Why it matters: The company’s approach shows promise in identifying drug candidates for difficult-to-treat conditions like dementia.

How it works: The company’s platform uses proximity therapeutics to take an "undruggable" protein or enzyme and force it in proximity with a drug target.
‍
"Cells can simplistically be thought of as containers to hold things together to drive chemical reactions," he says.
The company’s platform is a tool to discover which of these "proximity events" are the most therapeutically useful. It’s currently focused on cancer, neurodegeneration and longevity.
"These insights then guide our development of precision therapeutics that recapitulate these interactions," he adds.
Zoom in: The round was led by Aydin Senkut, founder of VC firm Felicis.
‍
Other investors include Y Combinator, age1, Modi Ventures and Wilson Sonsini, alongside several angel investors.
Catch up quick: The San Francisco company has received five "Golden Ticket" awards from major pharma pitch competitions, which grant startups access to lab space and mentorship.

Yes, but: General Proximity struggled for years until it found a lead for its seed round and "almost ran out of money a few times," Cognetta says.

What they’re saying: "It happens in biotech — where early on, they don’t get the benefit of the doubt and you really have to grind," says Senkut.

Most VCs looking at Cognetta’s proximity approach might think, "’For 30 years, no one has figured this out, so what makes this different?’ We believe in this method and are willing to take the leap of faith with him," Senkut says.

On December 18, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported the presentation of two data sets through two abstracts showcasing pelareorep’s potential in difficult-to-treat gastrointestinal cancers were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025 (Press release, Oncolytics Biotech, DEC 18, 2024, View Source [SID1234649196]).

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!

Tom Heineman, M.D., Ph.D., Oncolytics’ Chief Medical Officer, said, "We are enthusiastic about pelareorep’s applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer. Pelareorep engages patients’ immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients."

Abstract Number: 6
Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab.
Presentation Type: Poster
Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: January 25, 2025, 7:00 – 7:55 a.m. PT

Abstract Number: 730
Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab.
Presentation Type: Poster
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT

Abstracts will be published on the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025.

On December 18, 2024 TigaTx, Inc., a biotechnology company developing a therapeutic platform technology of engineered Immunoglobulin A (IgA) monoclonal antibodies to address a broad range of diseases, reported that the Advanced Research Projects Agency for Health (ARPA-H) has awarded TigaTx up to $33.5 million in funding (Press release, TigaTx, DEC 18, 2024, View Source [SID1234654374]). Separately, TigaTx was awarded a two-year, $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the U.S. National Institutes of Health under award number R44CA291266.

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!

Many immune cell types, such as T cells, NK cells, and macrophages, are currently engaged by anti-cancer therapies, resulting in successful outcomes for cancer patients. However, neutrophils, the first line of defense in infection and inflammation, are the most abundant immune cells in human circulation and have not yet been harnessed by cancer therapies. Beyond their abundance, neutrophils possess other ideal characteristics as anti-cancer effector cells. They are innate killer cells, and they cross talk with other cells of the innate and adaptive immune system, thereby, further propagating the anti-tumor cascade.

TigaTx’s novel, proprietary platform technology leverages engineered monomeric IgA to bind to and potently activate neutrophils, unleashing their powerful anti-tumor killing ability to treat cancer. TigaTx’s technology yields IgA molecules that have drug-like properties and overcomes historical challenges associated with manufacturing IgA.

The ARPA-H and SBIR funding will allow TigaTx to advance its lead program, TIGA-001, an IgA anti-EGFR neutrophil engager, into the clinic to generate clinical proof-of-concept data for the engineered IgA platform. While anti-EGFR IgGs and tyrosine kinase inhibitors are approved for colon, lung, and head and neck cancers, less than 25% of patients respond, and even for those patients who do respond, their cancer will typically recur. TIGA-001’s distinct neutrophil activation-targeted mechanism of action has the potential to benefit patients with resistance or intolerance to approved anti-EGFR therapies.

In parallel, the ARPA-H award will enable TigaTx to expand its engineered IgA platform to treat infectious diseases. With increasing emergence of antibiotic-resistant strains of bacteria and persistent and emergent viral threats, TigaTx will develop secretory, dimeric IgA as a new therapeutic class for infectious diseases.

"We’re thrilled to announce this funding from ARPA-H and NIH, which provides important external validation of the breakthrough potential of our IgA monoclonal antibody platform and its first-in-class therapeutic applications," said Anne Altmeyer, Ph.D., President and CEO of TigaTx. "This funding will allow us to validate our platform by generating clinical proof-of-concept data for our lead oncology program, TIGA-001. The funding will also enable us to expand our IgA platform technology to other high-unmet-need indications both in oncology and infectious diseases."

Howard Stern, M.D., Ph.D., Chief Scientific Officer of TigaTx, commented, "Engineered IgA neutrophil engagers have the potential to revolutionize the treatment of cancer by harnessing neutrophils’ innate killing power. Further expanding our IgA platform to dimeric IgA opens a new frontier to address the growing threat of communicable diseases."

Under the ARPA-H funding, TigaTx will collaborate with several prestigious academic institutions and world-renowned oncology and immunology researchers to further characterize engineered IgA’s mechanism of action and develop additional proof-of-concept in cutting-edge preclinical models. Collaborating institutions include:

Weill Cornell Medicine

Taha Merghoub, Ph.D., Deputy Director of the Sandra and Edward Meyer Cancer Center; Margaret and Herman Sokol Professor of Oncology Research; Professor of Pharmacology and Professor of Immunology Research in Medicine; Co-Director of the Ludwig Collaborative and Swim Across America Laboratory; Co-Director of the Parker Institute for Cancer Immunotherapy at Weill Cornell Medicine

Jedd D. Wolchok, M.D., Ph.D., FAACR, FASCO, Meyer Director of the Sandra and Edward Meyer Cancer Center; Professor of Medicine; Co-Director of the Ludwig Collaborative and Swim Across America Laboratory; Director of the Parker Institute for Cancer Immunotherapy at Weill Cornell Medicine; Oncologist at New York Presbyterian/Weill Cornell Medical Center

Daniel Hirschhorn, Ph.D., Assistant Professor of Research in Pharmacology

Yale School of Medicine

Richard Flavell, Ph.D., FRS, Sterling Professor of Immunobiology; Investigator, Howard Hughes Medical Institute

Esen Sefik, Ph.D., Assistant Professor, Immunobiology; Howard Hughes Medical Institute Fellow

Hadassah Hebrew University Medical Center (Jerusalem, Israel)

Zvi Fridlender, M.D. M.Sc, Head, Department of Internal Medicine D, Head Laboratory of Lung Cancer Research

The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the Advanced Research Projects Agency for Health (ARPA-H) or the National Institutes of Health.