On June 8, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported its acquisition of Frame Cancer Therapeutics, a private company focused on advanced genomics and bioinformatics to identify both unique and shared neoantigens across different cancer types (Press release, CureVac, JUN 8, 2022, View Source [SID1234615757]).

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"The addition of Frame’s technology and talent to CureVac’s oncology research complements our ability to identify and validate promising neoantigens for our mRNA cancer vaccine programs," said Franz-Werner Haas, Chief Executive Officer of CureVac. "The bioinformatics platform developed by Frame’s researchers has the potential to identify a broad panel of neoantigens that go beyond conventional neoantigens and could strongly increase the likelihood of developing highly effective cancer vaccines. We are excited to join forces with the innovative Frame Cancer Therapeutics team and combine their bioinformatics capabilities with our own mRNA expertise to potentially deliver a new class of cancer vaccines."

Frame’s FramePro platform identifies structural changes within the cancer genome that give rise to new open reading frames. These new open reading frames result in novel proteins that are absent in healthy tissues and can thereby be recognized as foreign by the immune system. Although these genetic changes are highly specific to individuals, the resulting neoantigenic proteins may be shared among many patients, potentially enabling development of more broadly applicable cancer vaccines.

An additional application of Frame’s technology is the development of personalized cancer vaccines, thereby leveraging the full antigenic potential of a tumor. In December 2021, regulators in the Netherlands approved Frame’s clinical trial protocol to evaluate this approach based on a peptide vaccine in 15 patients with non-small cell lung cancer. CureVac will refocus development of personalized cancer vaccines on an mRNA modality.

"We are very enthusiastic about the great synergies between our content-driven approach in antigen discovery and validation and CureVac’s extensive experience with mRNA vaccine development," said Ronald Plasterk, Founder and CEO of Frame Cancer Therapeutics. "The resulting vaccines could greatly enhance our ability to activate the human immune system against cancer, both in a personalized and off-the-shelf manner."

The total consideration for the acquisition of Frame Therapeutics is valued at €32 million. It will be paid in CureVac shares. Following a 50 percent upfront payment, the residual amount will be split across two project milestone driven steps. CureVac will expand the antigen discovery and validation activities at the Amsterdam Science Park.

On June 8, 2022 Biogen Inc. (Nasdaq: BIIB) reported that it is unable to participate in the Jefferies Healthcare Conference on Thursday, June 9, 2022, due to considerations related to COVID (Press release, Biogen, JUN 8, 2022, View Source [SID1234615773]).

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On June 8, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that Sigmund Hsu, MD, member of the Company’s Scientific Advisory Board, presented an overview of its ongoing clinical trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, CNS Pharmaceuticals, JUN 8, 2022, View Source [SID1234615789]).

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The abstract titled "Design and initiation of an adaptive, randomized, controlled study of berubicin, a topoisomerase 2 poison that crosses the blood brain barrier (BBB), for the treatment of recurrent glioblastoma multiforme (GBM) after first-line therapy," was presented in the Central Nervous System Tumors poster session by Dr. Hsu.

Berubicin is a novel anthracycline and the first that appears to cross the blood-brain barrier (BBB) with central nervous system (CNS) uptake. The induction of apoptosis and DNA damage by Berubicin was significantly higher than that of doxorubicin (Dox) in all tested cancer cells, demonstrating Berubicin’s greater potential potency and consistently higher cytotoxicity in GBM cell lines than Dox. In models of intracranial orthotopic gliomas, Berubicin prolongs survival when compared to temozolomide (TMZ), currently the standard of care in GBM for first line therapy in combination with radiation. Further evaluation of the orthotopic glioma models demonstrated that Berubicin had greater infiltration into intracranial glioblastoma cells compared to normal tissue, supporting the potential for improved efficacy. TMZ has been shown to be less effective in approximately 50% of patients due to changes (methylation) to a DNA repair enzyme, MGMT, that when unmethylated proves to be a prognostic indicator of a poorer prognosis. These differences have been proven to not be a factor in the activity of Berubicin.

Based on this data, a Phase 1 dose escalation study was conducted by a prior developer in patients with recurrent primary brain tumors. Berubicin was well tolerated, with myelosuppression (neutropenia and thrombocytopenia) as dose-limiting toxicities. Of 25 patients evaluable for efficacy, there was 1 complete response (14+ years), 1 partial response durable for 12 weeks, and 9 patients with stable disease over 6 weeks for a clinical benefit rate of 44%.

"We are fully dedicated to advancing the development of Berubicin toward potentially providing an innovative and much-needed option for treatment in GBM, an area of significant unmet medical need. With this goal in mind, we consider that our global study, which has been thoughtfully designed based on prior data as well as input from key opinion leaders and feedback from the FDA, could potentially be pivotal. We also believe that valuable interactions with our investigators on this study, as well as our heartfelt consideration of the needs of patients has positioned us for a successful outcome," added Dr. Sandra L. Silberman, M.D., Ph.D., Chief Medical Officer of CNS Pharmaceuticals. "Moreover, the positive feedback we’ve received from the regulatory authorities across Europe for this trial bolsters confidence in our state-of-the-art trial design and will significantly expand our ability to reach these patients."

The Company’s ongoing global study is an adaptive, multicenter, open-label, randomized, controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy evaluating efficacy and safety of Berubicin. The primary endpoint of this study, being conducted in the United States and Europe, is overall survival (OS), with a projected 243 patients enrolled in a 2:1 randomization design (Berubicin:Lomustine). This study has pharmacokinetic (PK) evaluations of all patients enrolled, with 15 patients undergoing complete PK assessments throughout the dosing period. Patients will be stratified on the basis of MGMT methylation, documentation of IDH mutational status that now defines Grade IV GBM. No prior administration of bevacizumab will be allowed. An interim analysis will evaluate the comparative effectiveness of these treatments, an adaptive design intended to demonstrate that Berubicin’s efficacy is at least equal to that of Lomustine such that continuation of the study is in patients’ best interests (futility analysis). The overall survival endpoint and sample size have been calculated to be able to show a statistical difference between the two therapies as second line treatment for GBM. Additional studies in malignant diseases of the CNS (e.g., pediatric brain tumors, primary CNS lymphoma, metastatic tumors) are also being explored based on the potential for anthracycline activity in these indications.

For more information about this Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

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.

On June 8, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric, will participate in three upcoming conferences (Press release, Enveric Biosciences, JUN 8, 2022, View Source [SID1234615758]):

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A.G.P.’s Summer Healthcare Conference

Gravitas’ 3rd Los Angeles Summit

H.C. Wainwright 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and Beyond

For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representatives, or send an email to A.G.P. at [email protected], Gravitas at [email protected], H.C. Wainwright at [email protected] or KCSA Strategic Communications at [email protected].