On February 23, 2023 Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, reported that the first patient has been dosed in the global Phase 2 FORTE clinical trial evaluating FORE8394 with cobicistat in patients with solid or central nervous system (CNS) tumors with BRAF gene fusions and recurrent primary CNS tumors with BRAFV600E mutations refractory to standard therapies (Press release, Fore Biotherapeutics, FEB 23, 2023, View Source [SID1234627609]). The FORTE master protocol trial builds upon the design and interim data of the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with BRAF alterations.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"We are thrilled to have initiated our global Phase 2 trial of FORE8394 in patients with BRAF-mutated tumors who have previously received available treatments and are now in need of alternative therapies," said Stacie Shepherd, MD, PhD., Chief Medical Officer of Fore Biotherapeutics. "FORE8394, our next-generation BRAF paradox breaker, provides the potential for single agent clinical activity for both BRAF V600 mutations and BRAF fusions without MAPK pathway activation, avoiding the resistance and toxicities observed with the earlier-generation BRAF inhibitors. Advancing this novel therapy to address patients’ needs is the driving force behind our team’s mission to advance FORE8394 through the clinic. The dosing of the first patient is a significant milestone for the entire FORE team. With the FDA’s Fast Track Designation of FORE8394 in the third quarter of this past year, we look forward to continuing to develop FORE8394, working with the FDA and other global regulatory agencies to address the high unmet need for patients suffering from these difficult to treat cancers."

The FORTE trial is a global, multi-center, single-arm, open-label, Phase 2 master protocol evaluating the safety and efficacy of FORE8394 with cobicistat, a pharmacokinetic booster commonly used with HIV medications, in patients 10 years of age and older with cancer harboring BRAF alterations. The trial will enroll approximately 130 participants in two subprotocols: A) participants with recurrent primary CNS tumors harboring BRAFV600Emutations (N=50) and B) participants with locally advanced or metastatic solid tumors or recurrent or progressive primary CNS tumors harboring BRAF fusions, excluding colorectal or pancreatic ductal adenocarcinoma (N=80). FORE8394 will be co-administered orally at a dose of 900 mg with cobicistat 150 mg once daily. The primary endpoint of each subprotocol is overall response rate, with duration of response.

The company previously announced interim data from the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with activating BRAF alterations, providing evidence of durable anti-tumor activity in patients with BRAF-mutated (V600+) cancers. The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) in September 2022. Mature data from the Phase 1/2a clinical trial are expected in mid-2023.

About FORE8394

FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore yield improved safety and more durable efficacy than currently approved RAF inhibitors, without the need for combination with a MEK inhibitor. Co-administration with cobicistat helps slow the metabolism, or breakdown, of FORE8394 in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the cancer. FORE8394 was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies.

On February 23, 2023 Xspray Pharma AB, (NASDAQ Stockholm: XSPRAY) reported that it has signed an agreement with EVERSANA to support the U.S. launch and commercialization of the company’s first innovative cancer therapy Dasynoc for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL) (Press release, EVERSANA, FEB 23, 2023, View Source [SID1234627608]). While maintaining financial and strategic control, Xspray Pharma will grant EVERSANA exclusive commercialization access to support its Dasynoc launch, aimed at the second half of 2023. Dasynoc, pending FDA-approval and legal conditions, will be a new and differentiated treatment option for CML and ALL patients, entering the $3.5 billion commercial market for Tyrosine Kinase Inhibitors in the United States – a market that has grown by nearly 5% in the last year alone.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Under the agreement, EVERSANA will provide Xspray with a dedicated commercialization team with deep experience in the successful commercialization of cancer drugs including TKI-products. This agreement provides Xspray with access to EVERSANA’s seasoned commercial leaders and allows for a short launch period while optimizing its launch budget. EVERSANA will additionally support Xspray in the areas of market access, agency services, clinical and commercial field teams, medical science liaisons, patient services and compliance.

"As we explored commercialization options to navigate the complexity of bringing new oncology therapies to the U.S., we wanted to find a full-service commercialization partner with vast experience in oncology," said Per Andersson, CEO of Xspray Pharma. "After a comprehensive evaluation process, EVERSANA met all our selection criteria, and we look forward to their support in bringing Dasynoc to patients in need across the U.S. with chronic myeloid leukemia and acute lymphatic leukemia."

"The commercialization of every oncology treatment is complex and requires a customized approach led by those with expertise in the space. We are proud to partner with Xspray to bring this much needed therapy to market," said Jim Lang, CEO, EVERSANA. "Patients deserve easy access to the best options as they fight this dreadful condition, and novel new therapies like Dasynoc may improve the outcome for thousands of patients. As a team, we truly believe in this product and are highly motivated to do everything possible to successfully bring this therapy to the U.S. as quickly as possible."

Dasynoc brings an important improvement for patients with CML. Retrospective registry data presented at ASH (Free ASH Whitepaper) 2022 show inferior 5-year overall survival for patients on concomitant tyrosine kinase inhibitor (TKI) and proton pump inhibitor (PPI) treatment (e.g. omeprazole) of 79% vs. 94% for patients on TKI only. Nearly 50% of the patients in the study used prescribed PPIs during the first 5-year period, many times despite warnings for low TKI absorption when used together. Dasynoc uptake is not affected by PPIs, hence bringing an important benefit to CML patients. Dasynoc is bioequivalent to Sprycel at a 30% lower dose with significantly better variability allowing for better precision and predictability of dosing. Dasynoc is granted ODD by FDA for the treatment of CML and ALL.

The U.S. launch of the product is planned for the second half of 2023, at which time the company expects to have obtained approval from the FDA. The launch is also conditional on an ongoing litigation process pertaining to patents for crystalline dasatinib forms that Xspray is confident are not present in its product.

For additional information, please contact:
Kerstin Hasselgren, CFO Xspray Pharma AB
Tel: +46 (0) 70 311 16 83
E-mail: [email protected]

Matt Braun, Director, Corporate Communications, EVERSANA
Tel: +1 414-434-4830
E-mail: [email protected]

On February 23, 2023 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported the appointment of Lynn Gallant to the position of Vice President, Clinical Operations (Press release, Enveric Biosciences, FEB 23, 2023, View Source [SID1234627607]). Ms. Gallant brings more than 25 years of clinical operations and trial management experience to Enveric and will work alongside Bob Dagher, M.D., Chief Medical Officer, to oversee the ongoing development of the company’s EVM201 Series and EVM301 Series clinical programs.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"Lynn possesses more than 25 years of experience in the pharmaceutical industry, including leadership positions at both large and emerging pharmaceutical companies. As our newly appointed Vice President, Clinical Operations, she will be responsible for driving the clinical development of our EVM201 and EVM301 product platforms," said Joseph Tucker, Ph.D., Director and CEO of Enveric Bioscience. "During her impressive career, Lynn has led numerous clinical programs from ‘first-in-human’ to Phase 3, managing performance targets to meet company goals, maintain resources, and coordinate process development to ensure optimal trial outcomes. We are delighted that Lynn is joining Enveric’s senior team as we prepare to initiate a clinical trial investigating EB-373, the first product from the EVM201 Series, for the treatment of anxiety disorders."

Ms. Gallant was most recently Vice President, Clinical Operations at BlueRock Therapeutics, a subsidiary of Bayer, where she led multiple clinical programs investigating the company’s cell and gene therapy platform across several disease indications. Additionally, Ms. Gallant worked with BlueRock’s regulatory team to prepare and secure Investigation New Drug (IND) applications, fast track submissions, and breakthrough and orphan drug designations. Prior to BlueRock, Ms. Gallant served as Executive Director, Clinical Operations at Bioverativ, a Sanofi Genzyme company. During her tenure at Bioverativ, Ms. Gallant was responsible for leading the company’s clinical operations and providing strategic direction for its rare blood disease portfolios across multiple indications from development to commercialization to post market access. Earlier in her career, she held clinical operations and trial manager positions at EMD Serono, the healthcare business of Merck KGaA, Sunovion Pharmaceuticals, Genzyme Corporation, and Stryker Biotech. Ms. Gallant holds a B.S. in Medical Biology from the University of New England.

Ms. Gallant stated: "I am excited to join Enveric at a pivotal time for the company as we plan to soon advance EB-373 into the clinic for the treatment of anxiety disorders. I look forward to working with Enveric’s leadership and R&D teams as we seek to transform the lives of patients living with mental illness by developing novel treatments that open new pathways to target impaired neural circuitry, with the overarching goal of improving brain health."

The Company granted restricted stock units ("RSUs") convertible into an aggregate of 10,000 shares to Ms. Gallant, to become employed by the Company as Vice President, effective as of February 22, 2023, as an inducement award outside of the Company’s 2020 Long-Term Incentive Plan. Subject to certain exceptions including change in control or termination of employment, the awarded RSUs shall vest in four equal installments on each of the first four anniversaries of the date of grant. The grant was approved by the board of directors of the Company and made as an inducement material to Ms. Gallant entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

About EB-373

Enveric’s lead drug candidate, EB-373, is next generation synthetic psilocybin analogue developed leveraging its Psybrary drug discovery platform. Enveric selected EB-373 from its EVM200 Series targeting novel and innovative treatments for anxiety disorders. In preclinical studies, EB-373 show positive serotonin 5-HT2A receptor stimulation in vivo, based on induction of the characteristic Head Twitch Response (HTR) behavioral marker in healthy mice. And in an animal behavioral model of anxiety, the Marble Burying Test, the compound exhibited anxiolytic benefit in chronically stressed mice.

On February 23, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that it will regain global commercialization and development rights to GAVRETO (pralsetinib), excluding Greater China, following a decision by Roche to discontinue the collaboration agreement between the companies for GAVRETO for strategic reasons (Press release, Blueprint Medicines, FEB 23, 2023, View Source [SID1234627606]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, the termination will be effective 12 months from the notification date of February 22, 2023. During the transition period, Blueprint Medicines and Roche are mutually committed to ensuring a smooth transition process with no anticipated interruptions or changes to patient access. In addition, the company will explore options to advance and simplify the continued global commercialization and development of GAVRETO.

"At Blueprint Medicines, we are dedicated to driving innovation and changing outcomes for patients with lung cancer. GAVRETO is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers, and we are committed to ensuring that patients being treated with GAVRETO in the commercial and clinical trial settings continue to have access," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "Over the next year, we will work alongside Roche to transition the GAVRETO program. In parallel, Blueprint will determine the optimal path forward to bring GAVRETO to patients in a way that maximizes its impact and value. As we do this, we will remain focused on our 2023 goals, with our highest priorities being the anticipated U.S. launch of AYVAKIT (avapritinib) in indolent systemic mastocytosis and the ongoing advancement of our pipeline of investigational medicines."

Since the initiation of the collaboration with Roche in July 2020, Blueprint Medicines has benefited from approximately $1 billion between upfront and milestone payments and from cost-sharing the commercialization and development of GAVRETO. The company anticipates no impact to its 2023 revenue guidance, which includes $40 million to $50 million in collaboration revenues from existing collaborations, or its anticipated operating expenses in 2023. In addition, the company continues to expect that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.

About GAVRETO (pralsetinib)

GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of three indications: adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In addition, GAVRETO has conditional marketing authorization from the European Commission as a monotherapy for the treatment of adults with RET fusion-positive advanced NSCLC not previously treated with a RET inhibitor. GAVRETO is also approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine treatment is appropriate).

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. For more information, visit GAVRETO.com.

On February 23, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies (Press release, Enlivex Therapeutics, FEB 23, 2023, View Source [SID1234627605]). The clearance of the Phase I/II by the AEMPS follows recent announcements by the Company that (i) the study received IND clearance from the U.S. Food And Drug Administration for recruitment of patients in the U.S., (ii) the independent Data Safety Monitoring Board has completed its prespecified data review for the first cohort of patients in the Phase I/II trial and (iii) the Israeli Ministry of Health had reviewed the data and provided regulatory clearance to continue the study and open the subsequent high dose monotherapy and combination cohorts.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The Phase I/II multi-center clinical trial (clinicaltrials.gov Identifier: NCT05581719) has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

The Phase I/II trial was initiated following encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra was combined with a PD1 or CTLA-4 checkpoint inhibitors in a murine model of peritoneal mesothelioma.

Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024."

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.