BeyondSpring R&D Day Highlights New Plinabulin Development Strategy for Cancer and Updates for SEED Therapeutics
BeyondSpring hosted an R&D Day on May 15, 2024, spotlighting their lead asset Plinabulin, which shows promise in treating cancer patients who have failed prior PD-1/PD-L1 inhibitors. Plinabulin has demonstrated significant efficacy in extending overall survival (OS) in phase 3 NSCLC studies and shows potential in combination therapies with chemotherapy or radiation.
SEED Therapeutics, BeyondSpring's subsidiary, focuses on developing molecular glues for undruggable targets using their proprietary TPD platform. SEED plans to file an IND for an oral RBM39 degrader in early 2025 and has a robust pipeline with collaborations, including a partnership with Eli Lilly, which has led to multiple milestone payments.
- Plinabulin showed a significant extension in overall survival (OS) in phase 3 NSCLC studies.
- >50% disease control rate in phase 1 study with radiotherapy and PD-1 inhibitor.
- Strong potential for Plinabulin in combination therapies, addressing unmet needs in cancer treatment.
- SEED Therapeutics' proprietary TPD platform shows promise for undruggable targets.
- SEED's collaboration with Eli Lilly involves milestone payments up to $780 million.
- Plans to file IND for oral RBM39 degrader in early 2025.
- 60% of patients ultimately fail PD-1/PD-L1 therapies, indicating significant unmet needs.
- Pending clinical validation for Plinabulin’s unique mechanism of action.
- No concrete revenue or profit data provided; the focus is on future potential.
Insights
Plinabulin's development strategy and its promising combination with PD-1/PD-L1 inhibitors is noteworthy. The agent's potential to offer benefits to patients who have failed other therapies presents a substantial clinical advantage. The dendritic cell maturation mechanism highlights a unique approach to cancer immunotherapy, which could translate to significant improvements in patient outcomes.
The positive phase 3 studies, particularly in non-small cell lung cancer (NSCLC), where the combination of plinabulin and docetaxel showed a significant extension in overall survival (OS) rates, are promising. The ability to double 2-year and 3-year OS rates in these patients is exceptional and suggests a robust therapeutic benefit. Additionally, the phase 1 study at MD Anderson showing >50% disease control rate in multiple cancers that had progressed during PD-1/PD-L1 therapy underscores plinabulin's potential versatility across various cancer types.
However, the transition of plinabulin into earlier lines of treatment will require further validation from ongoing studies. The preliminary data expected in the second half of 2024 will be important in determining its future role in cancer therapy landscapes. This development should be closely watched by investors as it could significantly impact BeyondSpring's market position.
From a research and development perspective, the updates on SEED Therapeutics' target protein degradation (TPD) platform are intriguing. SEED's focus on molecular glues, which have the potential to target proteins that are considered undruggable by conventional methods, stands out in the biopharma space. Their RITE3 platform presents a novel approach by being 'target centric,' which could lead to higher hit rates in high throughput screenings.
The partnership with Eli Lilly, involving significant milestone payments and royalties, validates the commercial potential and scientific ingenuity of SEED's approach. Achieving three milestones in this collaboration further reinforces the credibility and progress of SEED's initiatives.
The upcoming IND filing for RBM39 and the focus on orally delivered molecular glues for CNS indications are critical components of their pipeline. If successful, these developments could open new therapeutic avenues, particularly in cancer and neurodegeneration, providing a significant competitive edge.
However, it's essential to monitor the actual clinical outcomes and regulatory progress of these initiatives to gauge their true impact on BeyondSpring's financial and market performance.
FLORHAM PARK, N.J., May 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that it hosted a virtual Research and Development (R&D) Day to discuss its lead asset Plinabulin, a dendritic cell (DC) maturation agent, in drug combinations to potentially address the current unmet medical needs in cancer indications where patients failed prior PD-1/PD-L1 inhibitors, as well as updates for SEED Therapeutics which focuses on target protein degradation (TPD) platform for innovative molecular glue drug discovery on May 15, 2024.
The R&D Day was led by Key Opinion Leaders (KOLs) Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), Alberto Chiappori, M.D. (Moffitt Cancer Center), and Steven Lin, M.D., Ph.D. (MD Anderson Cancer Center), as well as BeyondSpring and SEED Therapeutics management.
Invited KOLs shared their latest insights on plinabulin’s durable anti-cancer benefit, mechanism-of-action (MOA), and its unique potential as an I/O combination agent with chemotherapy or radiation, in patients that have progressed on PD-1/PD-L1 therapy. Over time, plinabulin may have the potential to move into earlier lines of treatment in combination with I/O:
- As a unique tubulin binder, plinabulin drives dendritic cell (DC) maturation/T-cell activation by effectively liberating the immune defense protein GEF-H1 from microtubules.
- Plinabulin alone or in combination has been well-tolerated in >700 cancer patients in two positive phase 3 studies.
- In a phase 3 study with EGFR wild-type 2L/3L NSCLC, the combination of plinabulin and docetaxel significantly extended OS in all subgroup analyses and doubled 2-year and 3-year OS rates compared to docetaxel alone.
- In an MD Anderson phase 1 study, in combination with radiotherapy and a PD-1 inhibitor, plinabulin demonstrated its DC maturation MOA in responding patients (PR+SD) in multiple cancers that had progressed during PD-1/PD-L1 inhibitor therapy with >
50% disease control rate (PR+SD). The most responding cancers include NSCLC, HNSCC and Hodgkin’s lymphoma.
- PD-1/PD-L1 inhibitors have been approved in approximately 20 cancer indications with >
$40 billion annual sales, and yet around60% of patients eventually fail, leaving them with limited treatment options.- Plinabulin’s potent DC maturation effect, in combination with PD-1/PD-L1 and radiation or chemotherapy, may address unmet medical needs across numerous patient settings following progression from PD-1/PD-L1 inhibitor therapy.
- Plinabulin has the potential to fill a substantial gap in cancer treatment for precisely the same patient settings that have been found elusive to other mechanisms or combinations.
“Additionally, significant headway is being made through various Investigator-Initiated Trial (IIT) studies of plinabulin at leading institutions in the U.S. and China. Preliminary results are expected to be reported in 2H 2024, that are expected to reinforce our unique MOA and lead to a transformative year for BeyondSpring. If interim clinical data from our ongoing studies further validates our unique MOA, then we will look for opportunities to extend and accelerate plinabulin’s outreach through third-party partnerships,” said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring.
Following the plinabulin presentations, Dr. Lan Huang discussed how BeyondSpring’s majority-owned subsidiary, SEED Therapeutics, uses its proprietary TPD platforms to develop “molecular glues” for undruggable targets. Different from PROTAC platforms, molecular glues have the potential advantage of targeting un-ligandable proteins, including proteins without ligandable pocket, and unfolded protein, such as Tau. The SEED TPD platform referred to as RITE3, has translated the scientific breakthroughs and insights of its co-founders, including a Nobel Laureate and two Howard Hughes Medical Institute investigators, into a diversified and fast-evolving drug development pipeline:
- Differentiated from other molecular glue companies, which are mainly “E3 centric”, SEED’s RITE3 platform is “target centric” and uses novel E3 ligases for protein targets. With detectable weak basal interaction between selected E3 and protein target, the binder hit rates from its high throughput screening is higher.
- 6 internal pipeline assets and 2 partnered assets, in oncology, neurodegeneration, immunology, and virology used 5 novel E3 ligases.
- SEED expects to file an IND in early 2025 for its IND Candidate oral RBM39 degrader, for the treatment of rationally selected cancer indications.
- SEED R&D has a focus on the development of orally delivered molecular glues for CNS indications, with a lead internal program against Tau.
Eli Lilly is a current investor and R&D collaborator with upfront and milestone payments up to
“I'm delighted to announce SEED's substantial progress in advancing internal initiatives, including an oncology asset advancing towards first human dose in the first half of 2025, Tau degraders for neurodegeneration advancing towards lead molecule status towards the end of 2024. In addition, we have a synergistic collaboration with Eli Lilly, which achieved multiple milestone payments. In the recent “Nature Biotechnology” review article on molecular glues, it was truly a privilege for SEED Therapeutics to be recognized alongside other prominent companies employing groundbreaking TPD molecular glue strategies. Leveraging our unique and proprietary RITE3 platform that focuses on predicting, detecting, and utilizing a pre-existing weak interaction between an E3 ligase and the target disease-causing protein, SEED consistently garners growing interest for additional partnerships and investment,” said Dr. James Tonra, President and CSO of SEED Therapeutics.
An archived replay of the webinar will be available on BeyondSpring’s website www.beyondspringpharma.com under “Events and Presentations” in the Investors section.
Trevor M. Feinstein, M.D.
Dr. Feinstein is board certified in medical oncology and hematology. He joined Piedmont Cancer Institute in 2011 and is the Director of Research at Piedmont Fayette Hospital. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers. He is a member of Georgia CORE’s research committee along with Georgia Society for Clinical Oncology Clinical Practice Committee. He also chairs the Lung Disease Group for the entire OneOncology network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from the University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh.
Alberto Chiappori, M.D.
Dr. Chiappori is board certified in medical oncology. He serves as senior member of oncology and medicine for the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and Florida. Dr. Chiappori is an active member of the American Society of Clinical Oncology, the European Society of Medical Oncology, the American Association for Cancer Research, and the International Association for the Study of Lung Cancer (IASLC). Dr. Chiappori received his M.D. from the Universidad Peruana Cayetano Heredia in Lima, Peru, completed his residency at Southern Illinois University School of Medicine in Springfield, Illinois, and finished his fellowship and senior fellowship in medical oncology-hematology at Vanderbilt University School of Medicine in Nashville, Tennessee.
Steven Lin, M.D., Ph.D.
Dr. Lin is a Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers. Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after cancer therapy. Dr. Lin acquired his M.D. and Ph.D. in the Medical Scientist Training Program at the University of California Irvine Medical School. He went on for residency training in Radiation Oncology at The Johns Hopkins Hospital.
About BeyondSpring
BeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary TPD drug discovery platform and has an initial R&D collaboration with Eli Lilly. Learn more by visiting https://beyondspringpharma.com.
About SEED Therapeutics
SEED Therapeutics is an innovative biotech company focusing on harnessing and engineering “molecular glues” and targeted protein degradation (TPD) to attack previously undruggable targets. Backed by a comprehensive intellectual property portfolio, SEED Therapeutics' mission is to positively impact human health by creating novel protein degradation therapeutics to treat various severe diseases that currently have limited treatment options for patients and their families. Through ongoing collaborations with world-leading academic experts in the field, SEED Therapeutics is developing a growing pipeline of novel drug candidates on a path to potential clinical and commercial success. SEED has an initial R&D collaboration and investment from Eli Lilly and Company. Learn more by visiting https://seedtherapeutics.com/.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, our ability to continue as a going concern, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq's continued listing requirements, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
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