On June 9 2022 Race Oncology Limited ("Race") reported the Board has approved an on-market share buyback for up to 4 million Race Oncology ordinary shares over the next 12 months (Press release, Race Oncology, JUN 9, 2022, View Source [SID1234615803]).

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Race Oncology’s Board believes an on-market buyback is an efficient capital management option available to maximize shareholder value. All committed clinical and preclinical programs as outlined in the November 2021 Share Purchase Plan remain fully funded.

The structure of an on-market buyback allows Race Oncology to take advantage of share price volatility through opportunistic share purchases during periods in which the share price does not reflect the robust outlook for the company.

The on-market buyback does not require shareholder approval and will be executed at Race Oncology’s discretion. The buyback will remain in place for a period of up to 12 months or until completed. Race may vary, suspend or terminate the buyback based on its view of market conditions and other factors. The shares that are bought will be purchased at a price of not more than 5% above the 5-day volume weighted average price of Race’s shares.

On June 9, 2022 ORPHELIA Pharma and Gustave Roussy reported the publication in the scientific journal Pharmaceuticals of the work related to the development of the first temozolomide oral suspension for the treatment of young children and adults with cancer and presenting difficulties to swallow temozolomide capsules (Annereau M. et al., Pharmaceuticals, 2022) (Press release, ORPHELIA Pharma, JUN 9, 2022, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-and-gustave-roussy-announce-the-publication-in-pharmaceuticals-of-the-scientific-work-related-to-the-development-of-the-first-temozolomide-oral-suspension-for-children [SID1234615800]).

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"Since 2015, we have been manufacturing a liquid temozolomide hospital compounded formulation to address the needs of young patients treated in our hospital and a few partner centers," explains Maxime Annereau, pharmacist at Gustave Roussy and the originator of this project. "In collaboration with ORPHELIA Pharma, we carried out the necessary research work to optimize the physico-chemical properties and the stability of the suspension. Then we conducted a palatability study in order to select the aroma capable of covering the bitterness of temozolomide in the most efficient way. The development of this concentrated suspension has made it possible to obtain a form adapted to the needs of patients and caregivers", he adds.

"The work done in collaboration with our partner Gustave Roussy led to a prototype of KIMOZO, an industrialized and patented version of this drinkable and highly concentrated suspension. KIMOZO is currently in an advanced phase of clinical development," says Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma. "Temozolomide is an essential drug in the management of many pediatric cancers, including relapsed or refractory neuroblastoma which unfortunately affects very young children. Thanks to the results of this collaboration, we intend to make this pediatric formulation available to patients soon," he concludes.

About KIMOZO 40 mg/ml

KIMOZO 40 mg/ml is a liquid, taste-masked and ready-to-use oral formulation of temozolomide developed in collaboration between the pharmacists and clinicians of Gustave Roussy and the development team of ORPHELIA Pharma. The formulation of KIMOZO has been covered by a patent application in Europe and in the US.

On June 9, 2022 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric clinical trial enrollment for oncology, and AdhereTech, a pioneer and leading provider of smart devices that connect patients to care with real-time interventions, reported their partnership to provide advanced, data-driven digital health technology solutions, focusing in oral oncolytic agents providing real-time integrated access to care for cancer patients to precision oncology drugs and leading-edge clinical trials (Press release, Massive Bio, JUN 9, 2022, View Source [SID1234615799]). Both companies were recognized in the 2022 NYC Digital Health 100, which showcases the most exciting digital health companies in the New York region.

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Massive Bio and AdhereTech have committed to combining their products and services to offer global, comprehensive solutions to measure, analyze and monitor precision oncology medication adherence for patients participating in clinical trials and those prescribed commercially available treatments. Both companies currently are contracted with leading pharmaceutical companies and major specialty pharmacies. Their work with payers, pharmacies, and pharmaceutical companies to develop adherence programs utilizing device-generated data to optimize processes and improve cost-effective measures for specialty drug and clinical trial programs that may save the industry hundreds of billions of dollars per year.

"While the conversation around digital health and pharma has expanded well beyond adherence, in oncology it provides the link between cost-effective treatments, and an opportunity to prioritize clinical trials when most appropriate," mentioned Selin Kurnaz, CEO and Co-Founder of Massive Bio. "Even modest improvements can lead to huge cost savings for payers and the pharmaceutical research industry while allowing streamlined access in real-time to effective on-label precision oncology treatments. It is a win-win situation for all stakeholders, from patients to specialty pharmacies, payers, and the commercial and cancer research ecosystem. AdhereTech is one of the few companies successfully achieving those goals, and we are excited about this collaboration."

With over 13,000 active cancer clinical trials in the US at any given time, and dozens of biomarkers and precision oncology molecules under study, Massive Bio aims to use AI and patient-centric concierge services at scale to reach cancer patients globally and accelerate the oncology research and development infrastructure. Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, and also the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its Massive Bio’s AI-based technology, website and apps across iOS and Android platforms, expanding their presence as a global company with country-level success in 12 markets.

AdhereTech is a leader in medication programs, providing commercialized digital solutions to measure and manage medication adherence in a variety of settings, including academics, clinical trials, and commercially prescribed treatments. It develops and produces treatment management solutions utilizing smart devices with integrated cellular technology that seamlessly connects patients in real-time to confirm when patients take their medication and provides two-way communications to ensure dosing regimens are followed and reports and escalate the reasons for and missed doses.

"The Aidia System creates personalized patient support with specialty pharmacies and healthcare teams, enabling timely health interventions when necessary, and clinical trials can benefit from those key interventions," said Chris O’Brien, Chief Executive Officer of AdhereTech. "Upon learning of Massive Bio’s traction in the oncology space and the opportunities of using our Aidia System, expansive network, and real-world data to help patients, physicians and the cancer research industry at a technology-enabled scale, it made absolute sense to explore and operationalize this partnership."

"Our AI-enabled clinical trial and precision oncology therapy-finding technology works at its best when paired up with real-time patient-reported insights" said Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "By leveraging real-time data from AdhereTech’s Smart Adherence System in combination with our SYNERGY-AI cancer trial matching platform, we can identify key opportunities for clinical trial enrollment while also optimizing medication adherence and access in both precision oncology care and cancer research."

"At AdhereTech, we strive to bring data, analytics, and new technologies to market to serve patients and life science companies with better resources in the vital clinical research and treatment realms," said Gregory Gallo, Chief Revenue Officer of AdhereTech. "We’re excited to partner with a cutting-edge solutions provider in the critical oncology therapeutic category. Integrating technology and resources will streamline patient journeys and achieve more consistent engagement, enhance care, and ultimately improve outcomes and scientific advances," added Gallo.

On June 8, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory LBCL (Press release, Allogene, JUN 8, 2022, View Source [SID1234616278]). The RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies.

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"The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Patients who are eligible for autologous CAR T therapy are often faced with treatment delays and manufacturing failures, placing them at risk for disease progression and disease-related complications. We look forward to initiating our pivotal trial on ALLO-501A and making this innovative product candidate readily available to patients."

Results from the ALPHA2 study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021. Data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients.

ALLO-501A was associated with consistent and manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS).
There were no relapses observed in LBCL CAR T naïve patients who were in a complete response (CR) at six months with the longest ongoing CRs with ALLO-501A at 15+ months.
Nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days in ALPHA2.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

On June 8, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has granted conditional marketing authorisation for the CD20xCD3 Tcell engaging bispecific antibody Lunsumio (mosunetuzumab), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies (Press release, Hoffmann-La Roche, JUN 8, 2022, View Source [SID1234616239]). Lunsumio is an off-the-shelf therapy that is readily available, so people do not have to wait to start treatment.

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Each year, more than 28,000 people in Europe are diagnosed with FL, which accounts for approximately one in five non-Hodgkin lymphoma cases.1,2 Despite treatment advances, FL is considered an incurable disease and relapse is common, with outcomes worsening on each consecutive treatment.1

"We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated."

"Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes," said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor at City of Hope. "It is exciting to have a new class of immunotherapy like Lunsumio, offering a readily available, chemotherapy-free and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously."

The approval is based on positive results from the phase I/II GO29781 study where Lunsumio demonstrated high complete response rates, with the majority of complete responders maintaining responses for at least 18 months, and favourable tolerability in people with heavily pre-treated FL. After a median follow-up of 18.3 months, the median duration of response among responders was 22.8 months (95% CI: 9.7-not estimable), the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90). The most common adverse event was cytokine release syndrome (39%), which was generally low grade (grade 2: 14%), and resolved by the end of treatment. Other common (≥20%) AEs were neutropenia, pyrexia, hypophosphatemia and headache. The initial dose was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition.3

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

A robust development programme for Lunsumio is ongoing including two phase III studies: CELESTIMO, investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL).

This is Roche’s second EU approval in lymphoma in 2022, following the approval of Polivy in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL.4 With a broad portfolio and pipeline, Roche is committed to providing treatment solutions for different stages of blood disorders, that are tailored to the disease, patient, physician, and healthcare system, as monotherapies or in combination with established and/or novel agents.

About Lunsumio (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers.

About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio (mosunetuzumab) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).

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.1 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 28,000 people in Europe.1,2

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 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 (rituximab), Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and Lunsumio (mosunetuzumab), targeting both CD20 and CD3, and cevostamab, targeting both 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.