INDUSTRIAL IMPACT, MEDICAL
Molecular Assemblies, Inc. | March 15, 2023
On March 14, 2023, Molecular Assemblies, Inc., a leading life sciences company, made a significant announcement regarding its enzymatic DNA synthesis technology. The company has successfully shipped the first enzymatically synthesized oligonucleotides to leading researchers in biotechnology, academic, and synthetic biology. The capacity to synthesize lengthy, extremely pure DNA promptly utilizing a proprietary Fully Enzymatic Synthesis (FES) technology solves critical unmet demands in DNA synthesis, thus allowing demanding and high-value applications such as CRISPR gene editing.
Long, highly pure single-stranded oligonucleotides are critical in various applications, such as CRISPR gene editing tools used in therapeutic development, research discovery and protein engineering. However, the availability of desired sequences required to make advanced edits has been a significant bottleneck.
Molecular Assemblies' Key Client Program gives chosen researchers priority access to lengthy and customized oligonucleotides synthesized utilizing the company's FES technology. Thanks to this initiative, customers are expected to speed up their research in CRISPR gene editing and other applications needing long oligonucleotides. In addition, key customers can give input to shape the future of enzymatic DNA synthesis. Molecular Assemblies plans to present more details about the technology at the SynBioBeta 2023 conference in Oakland, California, from May 23-25.
Molecular Assemblies' President and CEO Michael J. Kamdar commented, "With the achievement of this significant commercial milestone, we are proving that fully enzymatic synthesis can deliver the DNA that customers want today, without compromise," He further emphasized, "Customers want application-ready DNA, unrestricted by length and sequence-complexity, which we know is essential to power new breakthroughs in scientific research and accelerate innovation for many industries, including next generation medicines and technologies."
(Source – PR Newswire)
About Molecular Assemblies, Inc.
Molecular Assemblies, Inc. is a leading company dedicated to developing enzymatic DNA synthesis technology to address key challenges in DNA synthesis. Its proprietary Fully Enzymatic Synthesis (FES) technology aims to provide an innovative solution to produce long, pure DNA quickly, efficiently, and sustainably. As a result, molecular Assemblies' FES technology has the potential to transform the field of DNA synthesis by enabling the production of high-quality, long oligonucleotides. This development has significant implications for research discovery, therapeutic development, and protein engineering, particularly in the context of CRISPR gene editing. The company was founded in 2013 and is headquartered in San Diego, California. It has received significant funding from various sources, including venture capital firms, angel investors, and government agencies.
Globenewswire | May 26, 2023
Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced preliminary data from its Phase 1 clinical trial evaluating XTX101, an investigational tumor-activated, Fc-enhanced anti-CTLA-4, in patients with advanced solid tumors.
“We are encouraged by the preliminary data from the Phase 1 trial for XTX101 showing evidence of tumor-selective activation,” said Martin Huber, M.D., president and head of research and development at Xilio. “Following treatment with XTX101 monotherapy at the recommended Phase 2 dose of 150 mg once every six weeks, we observed a partial response in a patient with PD-L1 negative advanced non-small cell lung cancer. Importantly, this anti-tumor activity occurred in the absence of meaningful observed activation of the immune system in the periphery, suggesting tumor-selective activation of XTX101. Based on these Phase 1 data, we plan to explore opportunities to evaluate XTX101 in combination with an anti-PD-(L)1 in historically immunotherapy-resistant tumor types.”
Data from the Ongoing Phase 1 Clinical Trial for XTX101
As of a data cutoff date of May 2, 2023, 25 patients had been treated with XTX101, including dose levels ranging from 7 mg to 180 mg administered once every three weeks (Q3W) and one dose level at 150 mg administered once every six weeks (Q6W). Of these patients, 20 patients were dosed in monotherapy dose-escalation (Part 1A) and five patients were dosed in monotherapy dose-expansion (Part 1B).
Patients had a wide range of advanced and treatment-refractory solid tumors, including colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and pancreatic cancer. In addition, 76% of patients had been previously treated with at least three prior lines of anti-cancer therapy, and 44% had been previously treated with at least one immuno-oncology (I-O) agent. As of the data cutoff date, three patients were continuing on treatment with XTX101, and 22 patients had discontinued treatment with XTX101.
Preliminary Safety Data
A recommended Phase 2 dose (RP2D) and schedule of 150 mg Q6W was determined based on the favorable preliminary safety, pharmacokinetic (PK) and pharmacodynamic (PD) data for XTX101. At the RP2D, no dose-limiting toxicities were observed, and there was no reported evidence of immune-related endocrine or skin adverse events (AEs) that are commonly associated with systemically active anti-CTLA-4 agents. In addition, evidence of effective masking of XTX101 was demonstrated by low levels of unmasked drug detected in peripheral circulation, and XTX101 achieved target PK exposure at the RP2D, reaching the targeted area under the curve (AUC) and peak concentration (Cmax).
As of the data cutoff date:
Across all dosing levels and dosing intervals, no Grade 4 or Grade 5 treatment-related AEs were reported by investigators.
Among seven patients who received XTX101 administered at the RP2D of 150 mg on a Q6W dosing schedule, the most common treatment-related AEs (≥10% incidence) of any grade reported by investigators were diarrhea (14%), fatigue (14%) and decreased appetite (14%). In these patients, no treatment-related colitis or infusion related reaction of any grade was observed. Investigators reported only one Grade 3 treatment-related AE of diarrhea, which occurred after two doses and resolved after five days without steroid use. This patient tolerated two additional doses of XTX101 after dose reduction to 75 mg Q6W without any symptom recurrence. At the RP2D of 150 mg Q6W, this was the only patient with a dose reduction due to an AE, and no patients discontinued treatment due to a treatment-related AE.
Among 18 patients who received XTX101 administered on a Q3W dosing schedule, the most common treatment-related AEs (≥10% incidence) of any grade reported by investigators were diarrhea (28%), colitis (28%), infusion related reaction (28%), nausea (17%), vomiting (17%) and abdominal pain (11%). Of these, investigators reported the following Grade 3 treatment-related AEs: diarrhea (6%), colitis (22%) and infusion related reaction (17%). Infusion related reactions were associated with antidrug antibodies. Across all dose levels administered Q3W, two patients had dose reductions due to AEs, and four patients discontinued treatment due to an infusion related reaction.
Preliminary Anti-Tumor Activity
A partial response was observed at nine weeks in one patient with advanced PD-L1 negative NSCLC with hepatic metastases treated with XTX101 at the 150 mg Q6W dose level and confirmed after the data cutoff date at week 27. The only treatment-related AE reported for this patient was Grade 1 fatigue. In addition, PD markers for anti-CTLA-4 reported for this patient showed minimal immune activation in peripheral circulation, demonstrating evidence of tumor-selective activation of XTX101. The patient is currently continuing on treatment with XTX101.
Clinical Development Plan for XTX101
Enrollment in monotherapy dose-expansion (Part 1B) of the Phase 1 trial is currently ongoing, with the goal of further characterizing the safety, PK and PD of XTX101 at the RP2D of 150 mg Q6W. In addition, mandatory tumor biopsies will be obtained from patients in Part 1B to examine intra-tumoral PK and PD for XTX101.
Xilio plans to continue to explore strategic opportunities to advance XTX101 with a partner beyond the current Phase 1 monotherapy cohorts, including in potential Phase 1 dose escalation evaluating XTX101 in combination with a PD-(L)1 and in a potential Phase 2 trial evaluating XTX101 in combination with a PD-(L)1 in patients with microsatellite stable CRC.
About XTX101 (anti-CTLA-4) and the Phase 1 Clinical Trial
XTX101 is an investigational tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody designed to deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX101 for the treatment of patients with advanced solid tumors. The primary outcome measures were the incidence of dose-limiting toxicities (DLTs) and the incidence of treatment-related adverse events, and changes in clinical laboratory abnormalities. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary geographically precise solutions (GPS) platform to build a pipeline of novel, tumor-activated molecules, including cytokines and other biologics, which are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment. Xilio is currently advancing multiple programs for tumor-activated I-O treatments in clinical development, as well as programs in preclinical development. Learn more by visiting www.xiliotx.com and follow us on Twitter (@xiliotx) and LinkedIn (Xilio Therapeutics, Inc.).
INDUSTRIAL IMPACT, MEDICAL
Prnewswire | April 27, 2023
LabCentral Ignite, a platform dedicated to advancing racial, gender and other representation and opportunity within the life sciences field, today launched IgniteVC in partnership with the Bioscience & Investor Inclusion Group (BIIG). BIIG is a grassroots effort driven by leaders from venture capital (VC) firms and startups. The new initiative aims to cultivate a highly inclusive life sciences venture capital community and support the growth of more diverse and inclusive portfolio companies from inception to success.
IgniteVC will provide VC firms and startups with practical tools, best practices, and a community of peers to advance their diversity, equity, and inclusion (DEI) goals. This new initiative will build upon years of work done by hundreds of leaders in BIIG, an unprecedented effort to promote DEI in life sciences innovation and investment.
"We are incredibly grateful for the time and expertise of the BIIG volunteers who have created a strong community and a set of unique resources that are now widely available. We look forward to welcoming them to our team as part of IgniteVC. Their hard work and dedication, along with the support of our sponsors, have been instrumental in launching IgniteVC," said Gretchen Cook-Anderson, LabCentral Ignite Executive Director.
Seed support for IgniteVC comes from founding sponsors Johnson & Johnson Innovation-JJDC, Inc., Mission BioCapital, and Third Rock Ventures. IgniteVC will be managed by LabCentral Ignite, which is set to hire a director this spring to lead VC community engagement, expansion, and planned global impact.
"The work that will be done by IgniteVC is critical to driving underrepresented groups into the life sciences sector as a viable career pathway," said Abbie Celniker, PhD, Partner at Third Rock Ventures. "By cultivating a more inclusive VC community and providing resources to support portfolio companies in implementing DEI best practices, IgniteVC is helping to create a more diverse and equitable life sciences ecosystem. We are proud to continue supporting this important work and look forward to seeing the impact it will have on our industry."
About LabCentral Ignite
The growing Ignite platform is dedicated to developing equity, inclusion, and opportunity within the life sciences field. Through a range of equity-driven programs and a growing member network of industry, startups, higher education, and nonprofits, Ignite connects underrepresented students, talent and innovators to academic, technical skills-building, mentoring, job placement, and board and leadership preparation opportunities that fuel biotech diversity and inclusively transform careers.