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BUSINESS INSIGHTS, PHARMA TECH

Xtalpi Partners with Singapore's Drug Discovery Platform to Find Better Cancer Treatments

XtalPi Inc. | December 29, 2022 | Read time : 02:00 min

Xtalpi Partners
One of the pioneering pharmaceutical technology companies - XtalPi, powered by artificial intelligence (AI) and automation, has recently announced a strategic collaboration with Singapore's national platform for drug discovery and development, the Experimental Drug Development Centre (EDDC), which is hosted by the Agency for Science, Technology, and Research of Singapore (A*STAR). The goal of this partnership is to find novel treatment candidates for non-small cell lung cancer (NSCLC).

“According to Research and Markets, the size of the global market for NSCLC treatments will surpass USD 20 billion by 2027”


Lung cancer is the second-most prevalent cancer worldwide and the leading cause of cancer-related mortality. NSCLC accounts for more than 80% of all lung cancer occurrences, while its incidence continues to rise worldwide. Despite growing interest and investment in drug research, there is a substantial unmet demand for effective targeted therapeutic alternatives for NSCLC patients to improve outcomes.

In this partnership, EDDC and XtalPi will work together to find promising candidates against an NSCLC target chosen by EDDC. XtalPi will use its AI technology, automation platform, and expert domain knowledge. It will also use quantum physics and an AI-driven platform to create and test millions of molecules for the De-novo drug design. Iterations will be used in its robotics-powered synthesis and testing lab to confirm and improve the predicted top-performing molecules with desirable drug properties. EDDC will give helpful information and data about the new NSCLC target, which will speed up the process of finding new drugs and carry the program forward.

XtalPi said in a statement that it is delighted to work with EDDC. It intends to help people all over the world by using AI and automation to improve the speed, size, variety, and success rate of drug research and development. In line with this, EDDC stated that it is excited to collaborate with XtalPi to translate science and research into practical and targeted cancer therapies. Furthermore, EDDC is confident that this collaboration will accelerate the development of much-needed targeted therapies for NSCLC patients due to XtalPi's experience in AI and automation technologies.

About XtalPi


XtalPi is a quantum physics-based, AI-powered drug R&D firm aiming to improve the speed, scale, novelty, and success rate of drug discovery. To meet the needs of its clients and partners, the company has offices in China and the United States. Frost & Sullivan cites the company as one of the world's first AI-powered drug R&D companies, with an iterative feedback loop between dry and wet lab capabilities.

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Spotlight

Do you know how industrial automatic tabletop gummy candy depositor machine works?

Aipak gummy depositor can be also called semi-automatic gummy making machine or small gummy making machine,it is suitable for industrial large scale requirement of various gummy candies.The gummy depositor can produce various gummy candy with various materials in various shape&size.It is compact in appearance and structure , easy to operate.

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RESEARCH, PHARMA TECH

Ionis Pharma's Eplontersen for ATTRv-PN Gets FDA's NDA Acceptance

Ionis Pharmaceuticals, Inc. | March 10, 2023

Ionis Pharmaceuticals, a leading RNA-targeted therapy firm, recently announced that the USFDA has accepted for review a new drug application (NDA) for eplontersen. Eplontersen is an investigational antisense medicine designed to reduce the production of transthyretin (TTR) protein and treat hereditary and non-hereditary forms of ATTR amyloidosis (ATTR). The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of December 22, 2023. The FDA has declared that no review concerns were detected and made no new data requests. The FDA also stated that it does not intend to conduct a meeting of the advisory committee to discuss the application. ATTR amyloidosis is a systemic disease caused by the accumulation of TTR protein in organs, leading to progressive organ damage and eventually death. Patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) experience ongoing debilitating nerve damage throughout their bodies, resulting in the progressive loss of motor function. The NDA for eplontersen is based on results from the global Phase 3 NEURO-TTRansform study showcased at the International Symposium on Amyloidosis (ISA). In the study, eplontersen showcased a statistically significant and clinically meaningful change relative to the baseline for its co-primary and critical secondary endpoints compared to the external placebo group. In addition, Eplontersen also demonstrated a favorable safety and tolerability profile. Ionis and AstraZeneca announced a strategic partnership to develop and commercialize eplontersen in December 2021. Eplontersen is being developed and commercialized jointly by both businesses in the United States and will be created and commercialized by AstraZeneca throughout the rest of the globe, except Latin America. The FDA granted eplontersen Orphan Drug Designation in the United States in January 2022. Eplontersen is also being studied in the worldwide Phase 3 CARDIO-TTRansform trial for transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic, progressive, and deadly disorder leading to progressive heart failure and death within 3 to 5 years after disease start. About Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company headquartered in Carlsbad, California. Its unique antisense technology platform allows them to develop RNA-targeted therapies that modify the production of disease-causing proteins, leading to the development of treatments for rare genetic disorders, cardiovascular diseases, and neurodegenerative diseases. The company's most significant achievement is developing and commercializing Spinraza, the first approved treatment for spinal muscular atrophy. Ionis Pharmaceuticals has also developed drugs for other rare diseases, including transthyretin amyloidosis, Huntington's disease, and myotonic dystrophy type 1.

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BUSINESS INSIGHTS, PHARMACY MARKET

EyePoint Pharmaceuticals Completes Enrollment in Oversubscribed Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for Maintenance Treatment of Wet AMD

Globenewswire | March 28, 2023

EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control. “We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.” “We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. “Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.” About EYP-1901 EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

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PHARMACY MARKET, PHARMA TECH

Capsida Biotherapeutics and AbbVie Announce Expansion of Collaboration

Capsida Biotherapeutics | February 27, 2023

Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration. The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021. As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales. Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development. Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases." (Source- PR Newswire) About Capsida Biotherapeutics Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.

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Ionis Pharma's Eplontersen for ATTRv-PN Gets FDA's NDA Acceptance

Ionis Pharmaceuticals, Inc. | March 10, 2023

Ionis Pharmaceuticals, a leading RNA-targeted therapy firm, recently announced that the USFDA has accepted for review a new drug application (NDA) for eplontersen. Eplontersen is an investigational antisense medicine designed to reduce the production of transthyretin (TTR) protein and treat hereditary and non-hereditary forms of ATTR amyloidosis (ATTR). The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of December 22, 2023. The FDA has declared that no review concerns were detected and made no new data requests. The FDA also stated that it does not intend to conduct a meeting of the advisory committee to discuss the application. ATTR amyloidosis is a systemic disease caused by the accumulation of TTR protein in organs, leading to progressive organ damage and eventually death. Patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) experience ongoing debilitating nerve damage throughout their bodies, resulting in the progressive loss of motor function. The NDA for eplontersen is based on results from the global Phase 3 NEURO-TTRansform study showcased at the International Symposium on Amyloidosis (ISA). In the study, eplontersen showcased a statistically significant and clinically meaningful change relative to the baseline for its co-primary and critical secondary endpoints compared to the external placebo group. In addition, Eplontersen also demonstrated a favorable safety and tolerability profile. Ionis and AstraZeneca announced a strategic partnership to develop and commercialize eplontersen in December 2021. Eplontersen is being developed and commercialized jointly by both businesses in the United States and will be created and commercialized by AstraZeneca throughout the rest of the globe, except Latin America. The FDA granted eplontersen Orphan Drug Designation in the United States in January 2022. Eplontersen is also being studied in the worldwide Phase 3 CARDIO-TTRansform trial for transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic, progressive, and deadly disorder leading to progressive heart failure and death within 3 to 5 years after disease start. About Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company headquartered in Carlsbad, California. Its unique antisense technology platform allows them to develop RNA-targeted therapies that modify the production of disease-causing proteins, leading to the development of treatments for rare genetic disorders, cardiovascular diseases, and neurodegenerative diseases. The company's most significant achievement is developing and commercializing Spinraza, the first approved treatment for spinal muscular atrophy. Ionis Pharmaceuticals has also developed drugs for other rare diseases, including transthyretin amyloidosis, Huntington's disease, and myotonic dystrophy type 1.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

EyePoint Pharmaceuticals Completes Enrollment in Oversubscribed Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for Maintenance Treatment of Wet AMD

Globenewswire | March 28, 2023

EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control. “We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.” “We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. “Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.” About EYP-1901 EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

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PHARMACY MARKET, PHARMA TECH

Capsida Biotherapeutics and AbbVie Announce Expansion of Collaboration

Capsida Biotherapeutics | February 27, 2023

Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration. The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021. As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales. Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development. Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases." (Source- PR Newswire) About Capsida Biotherapeutics Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.

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