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Triore, an ADC platform owner, raises 12 billion KRW in Series A investment

On May 25, 2023 Triore, a new drug development venture, reported that it has completed a Series A investment of 12 billion won through the issuance of convertible preferred shares (CPS).

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This Series A investment was led by LSK Investment, a venture capital firm specializing in biotech. Enlight Ventures, Kiwoom Investment, Meditox Venture Investment, and Shinhan Capital participated as new investors. KB Investment and Bokwang Investment joined as follow-up investors following their participation in the Pre-Series A round. This investment comes one year after the Pre-Series A round in 2022. The total amount of investment raised reaches 19 billion won.

Triore, established in 2021, possesses a technology (ReleaDom) that improves the drug delivery limitations of existing antibody therapeutics and antibody-drug conjugates (ADCs), and a linker-payload system (TROSIG) that can enhance the efficacy of ADCs.

Triore’s platform technology can be applied to various applications, including ADCs, multispecific antibodies, immune checkpoint inhibitors, and tumor microenvironment activators. Triore explains that when this platform technology is combined with existing drugs, it is expected to enhance efficacy and reduce toxicity. With this investment, Triore plans to secure even more refined platform technologies and novel drug candidates.

Yoon Doo-cheon, Director at LSK Investment, stated, "Triore’s ADC platform is a highly scalable technology applicable to various antibody targets," adding, "We determined that it has the potential to grow into a commercially viable new drug development platform company through partnerships with global big pharma firms."

Woo Seong-ho, CEO of Triore, stated, "This investment holds great significance considering the global biotech investment environment has been frozen since the COVID-19 pandemic," adding, "It is the result of recognition for Triore’s core platform technology, human resource expertise, and systematic commercialization strategy."

(Press release, TriOar Biotechnology, MAY 25, 2023, View Source;idx=3 [SID1234664806])

Oxford BioTherapeutics and Boehringer Ingelheim Agree on 2 Year Extension to their Second Multi-Year Collaboration in Cancer Immunology

On May 25, 2023 Oxford BioTherapeutics Ltd. (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, reported that it has extended its second multi-year collaboration with Boehringer Ingelheim for an additional two years (Press release, Oxford BioTherapeutics, MAY 25, 2023, View Source [SID1234656436]). With this extension further programs will be added into the existing collaboration, with the goal to enable the development of novel cancer immunotherapies in areas of high unmet patient need.

The two partnerships between OBT and Boehringer Ingelheim were initiated in April 2013 and October 2020. They are both focused on the discovery of novel tumor targets enabled by OBT’s proprietary OGAP discovery platform for Boehringer Ingelheim’s unique immuno-oncology and ADC platforms, contributing to the company’s aspiration of transforming the lives of people living with cancer with the ultimate goal of curing a range of cancers.

Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: "Last month marked the 10-year anniversary of our partnership with Boehringer Ingelheim and it is fitting to mark this anniversary by extending our collaboration both in time and in value. Over the past decade, we have built a successful relationship with Boehringer Ingelheim’s cancer research, now in its third phase, through high-quality outputs enabled by our proprietary OGAP discovery platform. Since 2013, the company has selected three targets discovered using OGAP, of which two programs have led to therapeutic assets in Phase 1 clinical development. We look forward to the next phase of our highly successful partnership and to continuing to work together to develop innovative first-in-class treatments for patients with difficult to treat cancers."

A major differentiator between OBT’s discovery platform and other approaches is the retention of the link between individual patient samples through to the design of therapeutic antibodies and diagnostic patient selection tools, which increases the overall success rate of these novel compounds transitioning into clinical development.

Under the terms of the extended agreement, Boehringer Ingelheim is responsible for the development and commercialization of treatment candidates that interact with the novel targets identified by OGAP. OBT will receive research funding as well as success-based development and regulatory milestone payments and royalties on potential future product sales.

Erasca to Present Promising Preliminary HERKULES-3 Phase 1b Data at the 2023 ASCO Annual Meeting

On May 25, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported preliminary Phase 1b data for ERAS-007 combinations in patients with GI malignancies from two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Erasca, MAY 25, 2023, View Source [SID1234639355]). The posters will be available online at Erasca.com/science/presentations.

"Early clinical data from HERKULES-3 continue to reinforce the potential to combine ERAS-007 with multiple agents and its potential as a backbone therapy to treat patients with GI malignancies. Importantly, these preliminary findings support a data-driven approach to refine the focus of our initial clinical development efforts on indications holding significant promise," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Our initial evaluation of the ERAS-007 + EC combination in patients with BRAF-mutated metastatic CRC will focus on EC-naïve patients based on the preliminary activity observed in HERKULES-3. By evaluating efficacy and safety in a larger sample size of patients treated at the 100 mg BID-QW dose of ERAS-007 with EC, we believe we will be able to better assess whether the promising response rate and duration of treatment observed with the triplet can be maintained."

Poster Presentation Highlights

Abstract 3557 – Preliminary results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with metastatic BRAF V600E-mutated colorectal cancer (CRC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)

ERAS-007 in combination with encorafenib (BRAFTOVI) + cetuximab (ERBITUX) demonstrated promising preliminary clinical activity in EC-naïve patients with metastatic BRAF V600E-mutated CRC. EC is currently approved for the treatment of patients with metastatic BRAF V600E-mutated CRC, as detected by an FDA-approved test, after prior therapy; however, only approximately 20% of patients experience an objective response in the second and later line of treatment setting. Downstream ERK inhibition through ERAS-007 may prevent resistance to upstream BRAF/EGFR inhibition when combined with EC. As of the data cutoff date of March 23, 2023:

40% (2/5) response rate and 60% (3/5) disease control rate (complete response + partial response + stable disease) in EC-naïve response evaluable patients at the highest dose of ERAS-007 tested (100 mg BID-QW), with duration of exposure for both responders > 34 weeks as of the data cutoff date; across all dose levels in EC-naïve response evaluable patients, 29% (2/7) response rate and 57% (4/7) disease control rate
ERAS-007 + EC was generally well-tolerated with mostly low-grade adverse events at all combination doses tested
One dose-limiting toxicity (DLT) was reported for ERAS-007 100 mg BID-QW + EC (Grade 3 macular edema)
Pharmacokinetic (PK) exposures of ERAS-007, encorafenib, and cetuximab were comparable to monotherapy values, suggesting no clinically significant PK drug-drug interactions between the study drugs
Additional HERKULES-3 Phase 1b combination data in EC-naïve patients with BRAF-mutated CRC expected between H2 2023 and H1 2024

Abstract 3558 – Preliminary results from ERAS-007 plus palbociclib (palbo) in patients (pts) with KRAS/NRAS mutant (m) colorectal cancer (CRC) or KRASm pancreatic ductal adenocarcinoma (PDAC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)

ERAS-007 in combination with palbociclib (IBRANCE) demonstrated a lack of clinical activity in patients with KRAS/NRAS mutant CRC and KRAS mutant PDAC. Palbociclib is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy or with fulvestrant in patients with disease progression following endocrine therapy. Based on these data, the combination of ERAS-007 and palbociclib will not be pursued further in this patient population.

Dr. Lim continued, "Our pioneering efforts exploring the potential of targeting adjacent pathways with terminal node inhibition of the RAS/MAPK pathway (ERAS-007) and cell cycle inhibition (palbociclib) did not demonstrate clinical activity in the initial evaluation. While we will not pursue further development of this combination in this patient population, it has contributed to our understanding and characterization of ERAS-007."

The Investigator Initiated Phase II Trial at MD Anderson Cancer Center combining CB-103 and Venetoclax for the treatment of rr/r-T-ALL patients is now open for recruitment

On May 25, 2023 Cellestia Biotech reported that the Investigator Initiated Phase II Trial at MD Anderson Cancer Center combining CB-103 and Venetoclax for the treatment of relapsed-refractory T cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL /LBL) is now open for recruitment (Press release, Cellestia Biotech, MAY 25, 2023, View Source [SID1234632333]).

CB-103 is a small molecule transcriptional pan-NOTCH inhibitor with a novel mechanism of action. A Phase I clinical trial has shown promising safety and tolerability, proof of biological activity, and signs of efficacy. A new investigator- initiated trial (IIT) is starting at The University of Texas MD Anderson Cancer Center, in the departments of Pediatrics and Adult Leukemia, to combine the potential of NOTCH and BCL2 inhibition considering the biological synergies between the two pathways. CB-103, in combination with Venetoclax, will be tested for the treatment of relapsed-refractory T cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL in patients 12-40 years old). Added to the ongoing anti-leukemia treatment, CB-103 administration to a r/r T-ALL patient under a compassionate use program resulted in a complete response making the patient eligible for Hematopoietic Stem Cell Transplant. The IIT trial at MD Anderson is now open for patient recruitment.

Sermonix Pharmaceuticals to Share Longer Patient Follow-up Results for ELAINE-2 in Poster Presentation at ASCO 2023

On May 25, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, reported an abstract to be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting detailing the results of its ELAINE-2 clinical study with longer patient follow-up (Press release, Sermonix Pharmaceuticals, MAY 25, 2023, View Source [SID1234632148]). ASCO (Free ASCO Whitepaper) 2023 will be held June 2-6 at McCormick Place in Chicago.

ELAINE-2 (NCT04432454), an open-label, Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study of Sermonix’s lead investigational drug, lasofoxifene, in combination with Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib, evaluated 29 women with ER+/HER- metastatic breast cancer and an ESR1 mutation. The primary endpoint was safety/tolerability, with secondary endpoints including progression-free survival (PFS) and overall response rate (ORR). Earlier ELAINE-2 results were shared at ASCO (Free ASCO Whitepaper) 2022.

With patient follow-up through Jan. 31, 2023, the combination of lasofoxifene and abemaciclib continued to be well-tolerated, with clinically meaningful efficacy in women with ER+/HER- metastatic breast cancer and an ESR1 mutation. The previously reported PFS, a median of 13 months, and ORR of 50% were promising, with longer term follow-up to be provided at ASCO (Free ASCO Whitepaper) 2023. Encouraging Phase 2 monotherapy and combination results in ELAINE-1 and ELAINE-2 respectively led Sermonix in March to initiate ELAINE-3, a confirmatory Phase 3 randomized study. Enrolling 400 patients, ELAINE-3 will again assess the efficacy of the combination of lasofoxifene and abemaciclib compared to the combination of fulvestrant and abemaciclib.

"Sermonix is pleased that the combination of lasofoxifene and abemaciclib, which demonstrated compelling anti-tumor activity in ELAINE-2, continued to be well-tolerated when observed through a longer patient follow-up," said Dr. David Portman, founder and chief executive officer of Sermonix. "The results solidify our team’s excitement for ELAINE-3 enrollment and continue to point to a potential therapy with a favorable safety profile and the ability to address a critical unmet need for women confronted with metastatic breast cancer. We look forward to further discussing the results at ASCO (Free ASCO Whitepaper) 2023."

Details of Sermonix’s ASCO (Free ASCO Whitepaper) 2023 poster presentation are as follows:

Abstract Title: Lasofoxifene (LAS) plus abemaciclib (Abema) for treating ESR1-mutated ER+/HER2- metastatic breast cancer (mBC) after progression on prior therapies: ELAINE 2 study update.

Session Title: Breast Cancer—Metastatic
Session Date and Time: June 4, 2023, 8-11 a.m. CT
Sermonix will also convene meetings of its ELAINE-3 Steering Committee and ELAINE-3 Translational Committee while at ASCO (Free ASCO Whitepaper).

To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit View Source

About Lasofoxifene
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.