On May 31, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported that it has entered into 3 new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of clinical collaborations (Press release, Agenus, MAY 31, 2022, View Source [SID1234615276]). These 6 collaborations span a range of Agenus’ clinical assets, including botensilimab (Fc-enhanced anti-CTLA-4), balstilimab (anti-PD-1), zalifrelimab (anti-CTLA-4), and QS-21 STIMULON.

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Agenus is pursuing partnerships with companies developing agents with complementary mechanisms, paving the way for promising immunotherapy combinations to address immunosuppression in the tumor microenvironment. The combination studies are being sponsored and executed by our collaborators, with drug supply and scientific support provided by Agenus. This strategy, enabled by in-house integrated manufacturing and scientific capabilities, positions Agenus to achieve the insights and advances needed to drive development on accelerated timelines.

"These new collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis are exciting next steps in our partnership strategy to broaden combinations and indications under evaluation with our immunomodulatory antibodies," said Dr. Steven O’Day, Chief Medical Officer at Agenus. "We believe these combinations may unlock the power of immunotherapy more broadly, potentially offering new and promising benefit to patients with treatment-resistant solid tumors."

Agenus’ new and ongoing clinical collaborations are supporting and enabling:

Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102 (oncolytic virus) in patients with PD-1 relapsed/refractory melanoma. ONCOS-102 is designed to induce immune activation and immunogenic cell death to improve response to immunotherapy.

Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076 (CD205-targeting antibody-drug conjugate) in patients with solid tumors, including lung, gastric, and ovarian cancer. OBT076 is expected to deplete CD205+ cancer cells, and immuno-suppressive cells within the tumor microenvironment, leading to T cell activation and increased response to immunotherapy.

Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide (hypoxia-reversal agent) in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer. Evofosfamide is anticipated to reduce tumor hypoxia and restore T cell infiltration and activity within the tumor microenvironment, increasing responsiveness to checkpoint therapy.

Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01 (KRAS vaccine) in up to 3 cancer indications, including multiple myeloma. TG01 is designed to induce T cells that recognize and destroy mut-RAS cancer cells; QS-21 STIMULON is expected to improve immune cell recognition, activation, and TCR diversity of the immune response.

Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer. CR6086 is expected to inhibit the immune suppressive role of prostaglandins in the tumor microenvironment, improving immunogenicity and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.

Nelum is conducting a clinical trial combining zalifrelimab with NLM-001 (hedgehog inhibitor) and chemotherapy in patients with advanced pancreatic cancer. NLM-001 in combination with chemotherapy is anticipated to condition the tumor microenvironment to improve T cell infiltration, activation, and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.

On May 31, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported the completion of a $41 million Series B financing (Press release, Sapience Therapeutics, MAY 31, 2022, View Source [SID1234615275]). The financing was led by new investor NexPoint and included participation from existing investors Bristol Myers Squibb, Eshelman Ventures and Kingdon Capital. As part of the financing, a convertible note provided by NexPoint in December 2021 was converted into Series B shares.

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"We are proud of Sapience’s significant growth toward becoming a leading oncology company. From attracting a quality investor syndicate in our financing announced today to establishing clinical proof-of-concept with a confirmed partial response in Phase 1 with our lead program, ST101, we continue to execute on our corporate goals and deliver on our mission to improve the lives of patients with cancer," said Dr. Barry Kappel, Sapience’s Chief Executive Officer and President.

Marisa Frackman, Sapience’s Chief Financial Officer, added, "We are pleased to have such high-quality investors join us in our pursuit to address difficult-to-treat cancers. The proceeds from this financing will advance our programs through meaningful clinical read-outs and will enable us to expand our pipeline that targets protein-protein interactions, which we believe hold considerable promise in oncology."

Commenting on the investment, Michael Jeong, MD, a Director of Public and Private Investments at NexPoint, said: "This financing is an important step forward to advance Sapience’s next-generation peptide therapeutics that have demonstrated the potential to effectively drug protein-protein interactions, targets that have been largely elusive for the pharmaceutical industry. We are impressed with the strength of the Sapience team, their technologies and their commitment to innovating the oncology field. We are proud to lead this financing and look forward to supporting Sapience through its next phase of growth."

Sapience intends to use the proceeds from the financing to accelerate the advancement of its pipeline of peptide therapeutics designed to disrupt protein-protein interactions and drug well-validated cancer pathways. The proceeds will support the advancement of its lead program, ST101, which is currently in Phase 2 for patients with advanced solid tumors, and progress its second program, ST316, from IND-enabling studies to the commencement of a Phase 1 study. In addition, the financing will support the advancement of Sapience’s platform to discover new therapies against high-value targets for difficult-to-treat oncology indications.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

About ST316
ST316, a first-in-class β-catenin antagonist, is currently being evaluated in IND-enabling studies. β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known development stage pathway that has been considered an "undruggable" cancer target, as small molecules have proven ineffective or toxic. Wnt/β-catenin signaling drives cancer initiation and contributes to tumor growth, angiogenesis and metastasis. ST316 exerts its activity through disruption of the BCL9/β-Catenin interaction to suppress transcription of Wnt target genes regulating proliferation, migration, invasion, and the metastatic potential of tumor cells.

On May 31, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that company management will participate in a fireside chat and one-on-one investor meetings during the 2022 Jefferies Healthcare Conference, which is taking place at the Marriott Marquis hotel in New York, NY from June 8-10, 2022 (Press release, AC Immune, MAY 31, 2022, View Source [SID1234615274]).

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During the fireside chat, AC Immune’s CEO Andrea Pfeifer, will provide an overview of the progress being made across the Company’s development pipeline, which includes both cutting edge-diagnostics and highly selective therapeutics that are collectively designed to shift the neurodegenerative disease treatment paradigm towards earlier diagnosis and disease prevention. Dr. Pfeifer will also outline the five additional clinical milestones the Company expects to achieve by year-end, which includes reporting top line Phase 2 results from an Alzheimer’s disease (AD) prevention trial evaluating the anti-Abeta antibody crenezumab in patients with autosomal dominant AD (expected later this quarter).

The fireside chat will take place on June 9, 2022, at 8:00 am EDT / 2:00 pm CEST. A webcast of the fireside chat will be available on the Events Page of AC Immune’s website. Following the fireside chat, a replay will be archived in the same location.

On May 31, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Biologics License Application ("BLA") for OMBLASTYS (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration ("FDA") (Press release, Y-mAbs Therapeutics, MAY 31, 2022, View Source [SID1234615273]). The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act ("PDUFA"). The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application.

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"We believe that the FDA’s acceptance of our OMBLASTYS BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure. Further, OMBLASTYS has a Rare Pediatric Disease Designation which, if approved, will provide Y-mAbs with a Priority Review Voucher, our second PRV, which would further strengthen our financial position as we would seek to monetize the OMBLASTYS PRV," stated Thomas Gad, Founder, President and Interim CEO. "We look forward to working with the Agency to bring OMBLASTYS to the appropriate patients. We are excited to move forward and plan for a seamless commercial launch of OMBLASTYS, if approved by the FDA."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

On May 31, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published online in The Lancet Oncology suggest that the company’s Immunoscore Immune Checkpoint (IC) assay may identify patients with metastatic colorectal cancer (mCRC) who are likely to benefit from the addition of immune checkpoint inhibitor (ICI) therapy to standard first-line treatment (Press release, Veracyte, MAY 31, 2022, View Source [SID1234615272]). The findings are from the randomized, controlled, phase II AtezoTRIBE trial, a multicenter Italian clinical study, sponsored by GONO Foundation.

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The vast majority of mCRC tumors (approximately 95 percent) have a proficient DNA mismatch repair (pMMR) system and are microsatellite stable. These tumors have low immunogenicity and do not derive benefit from immune checkpoint inhibitors. Previous research suggests that the FOLFOXIRI and bevacizumab combination enhances immunogenicity in pMMR mCRC. In the current study, researchers found a modest benefit of the experimental treatment regimen in this subgroup.

"AtezoTRIBE is the first to show that the addition of the PD-L1 inhibitor atezolizumab to standard first-line treatment (FOLFOXIRI plus bevacizumab) improved progression-free survival in patients with previously untreated mCRC," said Chiara Cremolini, M.D., Ph.D., principal investigator of the trial and oncologist at the Pisa University Hospital in Italy.

Additionally, post-hoc statistical analyses designed to evaluate the association of immune-related biomarkers with treatment outcomes found a meaningful correlation between a "high" Immunoscore IC result and response to the experimental treatment regimen (p=0·003).

"To our knowledge, Immunoscore IC is the first biomarker with potential predictive value in selecting patients with pMMR metastatic colorectal cancer who are likely to benefit from the use of immune checkpoint inhibitors," said Carlotta Antoniotti, M.D., oncologist at the Pisa University Hospital and lead author of the new paper. "These findings must be confirmed in further prospective studies, but are encouraging as a means of addressing a significant unmet need."

"These findings are exciting, as they suggest new potential avenues for the use of the Immunoscore IC assay in identifying patients with metastatic colorectal cancer who may benefit from ICIs," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "We believe the assay could help companies developing ICIs by enabling them to better identify appropriate patients for clinical trials."

About Immunoscore IC

Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells, on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a clinical research service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.