On October 14, 2021 Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported the appointment of Theresa Heah, M.D., MBA as Chief Medical Officer and President of Kriya’s newly launched ophthalmology division, Kriya Ophthalmology (Press release, Kriya Therapeutics, OCT 14, 2021, View Source [SID1234591217]). Dr Heah will be responsible for advancing Kriya’s current pipeline of ophthalmology gene therapies and continuing to expand Kriya’s ophthalmology portfolio through its in-house R&D and business development engines.

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Kriya Ophthalmology is focused on the discovery and development of transformative gene therapies for ocular diseases with high unmet need. By leveraging Kriya’s computationally enabled vector design, data analytic and manufacturing technologies, Kriya Ophthalmology is uniquely positioned to accelerate the development of best-in-class gene therapies for rare and prevalent ocular diseases. Kriya Ophthalmology is currently advancing therapeutic programs in uveitis, geographic atrophy and additional undisclosed disease areas.

"Gene therapy has the potential to deliver transformative clinical benefits to address severe ocular diseases for which there are currently few effective treatment options," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya Therapeutics. "The launch of Kriya Ophthalmology, and the appointment of Theresa to lead our specialized division focused exclusively on diseases of the eye, reflects our commitment to delivering better products to patients suffering from a range of rare and prevalent ocular diseases. We believe that Kriya’s advanced technology platforms, combined with Theresa’s leadership and track record in ophthalmology, uniquely position this division to become one of the industry leaders in the development of gene therapies for ocular diseases."

"We are thrilled to welcome Theresa to lead Kriya Ophthalmology," said Ilise Lombardo, M.D., Chief Medical Officer of Kriya Therapeutics. "Her success in developing and launching treatments for ocular diseases will help Kriya play a pivotal role in the advancement of novel gene therapies that address a range of severe ocular conditions."

Dr. Heah is an accomplished executive with more than 20 years of R&D, regulatory strategy and clinical development experience. She previously served as Chief Medical Officer and Executive Vice President of Operations for AsclepiX Therapeutics where she led the company’s Series A financing and advancement of its pipeline products into the clinic. Prior to joining AsclepiX Therapeutics, Dr. Heah served as Chief Medical Officer at Applied Genetic Technologies Corporation (AGTC), where she worked to develop gene therapies in ophthalmology and rare diseases. She has also held several leadership positions with increasing responsibility in early-stage private companies (Fovea Pharmaceuticals), publicly traded companies (Aerie Pharmaceuticals, Allergan) and big pharmaceutical companies (Bayer Healthcare, Sanofi).

Dr. Heah has led multiple successful global regulatory submissions and commercialization of products including Ozurdex, EYLEA, Rhopressa and Rocklatan. While at Bayer, she launched EYLEA successfully into its eventual status as a blockbuster drug. She earned her M.D. from Guy’s, King’s and St. Thomas’ School of Medicine, King’s College, University of London, and her Executive Master’s in Business Administration from the European School of Management & Technology (ESMT), Berlin.

"My career has been dedicated to patients and the development of transformative and meaningful therapies aimed at improving their quality of life," said Dr. Heah. "Many still suffer from serious eye diseases for which there are no viable treatments. There is immense untapped potential in gene therapy, and it will be our mission to uncover and advance novel medicines for the betterment of underserved patient communities."

On October 14, 2021 OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, reported the appointment of Jennifer R. Diamond, M.D., as Chief Medical Officer (Press release, OnKure, OCT 14, 2021, View Source [SID1234591216]). Dr. Diamond, a trained oncologist, brings over 10 years of extensive clinical expertise in early phase trials and translational oncology research.

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"We are very pleased to welcome Jennifer to our growing leadership team," said Tony Piscopio, Ph.D., Co-Founder, President and Chief Executive Officer of OnKure. "Her vast knowledge of conducting early-stage trials for novel oncology therapeutics, as well as her experience exploring novel combination strategies, will be vital as we continue to build and advance our broad pipeline of best-in-class precision medicines."

In addition to serving in her role at OnKure, Dr. Diamond works in the Division of Medical Oncology at the University of Colorado Anschutz Medical Campus as a breast cancer medical oncologist and Associate Professor of Medicine. She is also the Clinical Research Director of the Phase 1 and Expansion/Molecular Studies Program (POEMs) and the founding Co-Director of the Women’s Cancer Developmental Therapeutics Program at the CU Cancer Center. Dr. Diamond has been involved in clinical and translational research in the Phase 1 and Breast Cancer research programs at CU since 2007 and currently runs a research laboratory focused on the development of targeted agents in TNBC, including strategies to overcome treatment resistance. She received her B.A. from the University of Arizona and her M.D. from the University of Arizona College of Medicine. Dr. Diamond completed her fellowship in Medical Oncology at CU under Dr. Gail Eckhart.

"I am thrilled to be joining OnKure at such an important time in the Company’s growth," said Dr. Diamond. "OnKure’s proven structure-based drug design approach has the potential to create optimal, tumor-agnostic treatments for cancer patients with high unmet need. I look forward to leveraging my experiences to lead the Company’s clinical development efforts and advance its promising lead candidate, OKI-179, as well as future oncology programs in the clinic."

On October 14, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL) (Press release, Hoffmann-La Roche, OCT 14, 2021, View Source [SID1234591207]). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regular rate of infusion can take approximately three to four hours, so administering over a shorter time period can result in time savings for patients and could also reduce pressure on healthcare systems. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.[1]

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"Gazyvaro has improved outcomes for people with follicular lymphoma, and now has the additional benefit of a shorter infusion time," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems."

The approval is based on the phase IV GAZELLE study and other supportive studies investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion. The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. Following this approval, Gazyvaro’s label update is being implemented immediately and Roche is aiming to launch short duration infusion Gazyvaro for patients in the EU with previously treated and untreated advanced FL as soon as possible. Gazyvaro is already approved for the treatment of FL, and now shorter duration infusion Gazyvaro will offer another more convenient option to enhance FL patients’ treatment experiences.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

About the GAZELLE study
GAZELLE [NCT03817853] is an open-label, international, multicentre, single arm, phase IV study investigating the safety and efficacy of the short duration infusion (SDI; target 90-minute infusion) of Gazyvaro (obinutuzumab) administered in combination with chemotherapy in patients with previously untreated advanced follicular lymphoma (FL). Patients who did not experience Grade 3 or higher infusion-related reactions were eligible to receive short duration infusion Gazyvaro from cycle 2. The primary endpoint of the study was the proportion of patients who experience Grade 3 or higher infusion-related reactions associated with short duration infusion during cycle 2 (the first treatment cycle with short duration infusion).

Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on B-cells, including malignant B-cells, but not on stem cells or plasma cells. Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyvaro is marketed as Gazyva in the US.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

Additional combination studies investigating Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About follicular lymphoma
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[2] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 30,000 people in Europe.[3]

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On October 14, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL) (Press release, Hoffmann-La Roche, OCT 14, 2021, View Source [SID1234591207]). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regular rate of infusion can take approximately three to four hours, so administering over a shorter time period can result in time savings for patients and could also reduce pressure on healthcare systems. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.[1]

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Gazyvaro has improved outcomes for people with follicular lymphoma, and now has the additional benefit of a shorter infusion time," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems."

The approval is based on the phase IV GAZELLE study and other supportive studies investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion. The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. Following this approval, Gazyvaro’s label update is being implemented immediately and Roche is aiming to launch short duration infusion Gazyvaro for patients in the EU with previously treated and untreated advanced FL as soon as possible. Gazyvaro is already approved for the treatment of FL, and now shorter duration infusion Gazyvaro will offer another more convenient option to enhance FL patients’ treatment experiences.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

About the GAZELLE study
GAZELLE [NCT03817853] is an open-label, international, multicentre, single arm, phase IV study investigating the safety and efficacy of the short duration infusion (SDI; target 90-minute infusion) of Gazyvaro (obinutuzumab) administered in combination with chemotherapy in patients with previously untreated advanced follicular lymphoma (FL). Patients who did not experience Grade 3 or higher infusion-related reactions were eligible to receive short duration infusion Gazyvaro from cycle 2. The primary endpoint of the study was the proportion of patients who experience Grade 3 or higher infusion-related reactions associated with short duration infusion during cycle 2 (the first treatment cycle with short duration infusion).

Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on B-cells, including malignant B-cells, but not on stem cells or plasma cells. Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyvaro is marketed as Gazyva in the US.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

Additional combination studies investigating Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About follicular lymphoma
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[2] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 30,000 people in Europe.[3]

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On October 13, 2024 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the Company has obtained results from the bioequivalence studies with the generic product candidate HyNap-Dasa ANDA C (Press release, Xspray, OCT 13, 2021, View Source [SID1234649573]). The results show that the bioequivalence with the reference product Sprycel was achieved in fed but not in fasting subjects due to the high variability of Sprycel. The Company now chooses to focus entirely on the improved version, Dasynoc, which has achieved bioequivalence with a 30 percent lower dose than Sprycel, and decides to end development of the generic version of dasatinib.

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"We have been developing the generic and the improved versions of dasatinib, Dasynoc, in parallel, but now we choose to focus on Dasynoc since the market value is high not only during, but also after the end of the patent window. A shorter time in the patent window decreases the importance of the generic version in our product portfolio. An important consequence of this decision is to free up the capacity to accelerate the development of our current product candidates in the pipeline with longer patent window. The development of Dasynoc has been rapid and we can take advantage of the clinical improvements that amorphous formulations of protein kinase inhibitors (PKIs) provide for patients, doctors and payers", says Per Andersson, CEO of Xspray Pharma.

Submission for the market approval for Dasynoc in the USA is scheduled as planned for the fourth quarter this year, in accordance with the 505(b)(2) procedure.