On August 17, 2021 Akili Interactive ("Akili"), a leading prescription digital therapeutics company and maker of EndeavorRx, the first and only prescription video game treatment, and Australian Securities Exchange listed digital health company TALi (ASX:TD1), ("TALi"), reported they have completed an agreement for Akili to license TALi’s technology designed to address early childhood attention impairments (Press release, PureTech Health, AUG 17, 2021, View Source [SID1234586707]).

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TALi’s patented technology utilizes new mechanisms specifically engineered to assess, target, and improve attention in early childhood (ages 3-8) and is delivered through an engaging video game experience. Combining over 25 years of research in developmental psychology and cognitive neuroscience, TALi’s training program has demonstrated improved attention in both neurodiverse and neurotypical children, specifically showing improvements in numeracy skills, gains in selective attention skills, and behavioral improvements in a classroom setting. Study data have been published in multiple peer-reviewed papers. The technology is currently available in Australia, India, Singapore and Hong Kong, marketed as TALi DETECT (screening) and TALi TRAIN (attention training).

The terms of the deal, estimated at $37.5M in future contingent milestone payments plus royalties on potential revenues, are structured to leverage each organization’s expertise. Building on their collective clinical development experience and Akili’s success in bringing EndeavorRx through the U.S. regulatory process and to market, the companies will work together to execute clinical trials of the TALi technology in pediatric ADHD and pursue U.S. Food and Drug Administration (FDA) regulatory clearance. Under the terms of the agreement, Akili will lead U.S. commercialization and roll-out.

Through this agreement, Akili is expanding its leadership in prescription digital therapeutics (PDTs) for cognitive impairments and charting a path for a new patient demographic to benefit from innovative technologies proven to improve attention. TALi’s technology builds on Akili’s product portfolio and complements its flagship product EndeavorRx, which is FDA-cleared to improve attention function in children ages 8-12 with ADHD (full indication below).

"Akili is continuously seeking opportunities to expand our suite of targeted treatments for cognitive impairments, including through strategic collaborations with companies that share our commitment to delivering high-quality patient experiences built on scientific rigor," stated Eddie Martucci, PhD, Akili’s co-founder and CEO. "Focused on early childhood intervention targeting attention, TALi’s impressive technology is an ideal addition to Akili’s portfolio. We are committed to changing the way people think about medicine, and strategic agreements like this will allow us to expand our vision to treat cognitive impairments in entirely new ways and usher in the next generation of digital therapeutics."

"Akili is leading the digital therapeutics industry with its ability to dramatically scale into mainstream medicine while maximizing value to patients and to the business, making it an ideal partner for expanding the reach and impact of our technology," said Glenn Smith, Managing Director of TALi. "We’re looking forward to working with the Akili team to provide solutions that deliver digital-first support to the millions of children living with attention issues."

Understanding Prescription Digital Therapeutics

Prescription Digital Therapeutics (PDTs) are clinically validated software-based interventions that prevent, manage, or treat a medical disease or disorder. PDTs are approved by regulators and available by prescription for use alone or alongside other medications or medical devices. Akili is creating PDTs informed by decades of neuroscience and cognitive research and delivered through high-quality video game experiences to treat cognitive impairments across multiple diseases and disorders.

On August 17, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, reported the dosing of the first patient in a Phase 3 study of zandelisib known as COASTAL (Press release, MEI Pharma, AUG 17, 2021, View Source [SID1234586704]). COASTAL is evaluating zandelisib, a selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor, in combination with rituximab in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or marginal zone lymphoma (MZL) who have received at least one prior line of therapy.

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"Zandelisib has the potential to provide a best-in-class therapeutic profile that delivers a meaningful and improved clinical benefit to patients with relapsed or refractory follicular or marginal zone lymphomas," said Professor Wojciech Jurczak, M.D., Ph.D., COASTAL principal investigator, Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology in Kraków, Poland. "Because most patients diagnosed with follicular and marginal zone lymphomas will experience disease relapse or some may not respond well to initial treatments, additional chemotherapy-free therapeutic options are invaluable after first line chemoimmunotherapy."

About the Phase 3 COASTAL Study
The global, randomized, two-arm Phase 3 COASTAL study will compare zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with r/r FL or MZL who received ≥ 1 prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is expected to enroll 534 patients. Zandelisib will be administered once daily for two 28-day cycles followed by an intermittent schedule of once daily dosing for 7 days of each subsequent 28-day cycle for a total of 24 months, in combination with rituximab (R) in the first 6 months only. The control arm will consist of 6 cycles of the standard chemoimmunotherapy regimens R-CHOP or R-bendamustine. The primary efficacy endpoint is progression-free survival; secondary endpoints include overall response rate, overall survival, patient reported outcomes assessments, and safety and tolerability.

COASTAL is intended to support marketing applications in the U.S. and globally in r/r FL and MZL patients who have received at least one prior line of treatment. COASTAL is also intended to act as the required confirmatory study for the potential U.S. accelerated approval of zandelisib based on the ongoing Phase 2 TIDAL study evaluating patients with r/r FL and MZL patients who have received two or more prior lines of treatment.

"Phase 1b zandelisib data reported at the ASCO (Free ASCO Whitepaper) annual meeting earlier this year, including the 95% overall response rate achieved in combination with rituximab in relapsed or refractory follicular lymphoma patients and a low incidence of Grade 3 adverse events, are encouraging and supports our expanding clinical development efforts as we initiate the Phase 3 COASTAL study," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In close collaboration with our global partner Kyowa Kirin, we are excited to advance the zandelisib development program into patients with follicular or marginal zone lymphomas that have received at least one prior line of treatment, building on our efforts to realize zandelisib’s potential as a novel treatment for patients with B-cell malignancies."

"The Phase 3 COASTAL study occupies an important position in evaluating the potential efficacy of zandelisib in patients with relapsed or refractory follicular or marginal zone lymphomas," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "Together with MEI Pharma, we hope to deliver zandelisib as a new treatment option to patients as soon as possible, and we commit to working with medical professionals and the patient community as an R&D-driven pharmaceutical company pursuing advances in life sciences and technologies."

About Zandelisib
Zandelisib (formerly called ME-401), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Differentiated by its molecular structure and pharmacologic properties, zandelisib is administered on an optimized dosing schedule consisting of daily therapy for induction/remission followed by intermittent dosing therapy intended to mitigate immune-related adverse events while providing continued therapeutic benefit.

In March 2020 the U.S. FDA granted zandelisib Fast Track designation for treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

In April 2020, MEI Pharma and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI Pharma and Kyowa Kirin are co-developing and co-promoting zandelisib in the U.S., with MEI Pharma booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Ongoing clinical studies of zandelisib include TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a global Phase 2 study evaluating zandelisib as a monotherapy across two study arms: the first study arm for the treatment of adults with relapsed and refractory follicular lymphoma and the second study arm for marginal zone lymphomas, in both cases after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The primary endpoint of the study is the objective response rate. Subject to the results and discussions with FDA, data from each study arm are intended to be submitted to FDA to support separate accelerated approval marketing applications under 21 CFR Part 314.500, Subpart H.

COASTAL is the Phase 3 study evaluating zandelisib in combination with rituximab in patients with r/r indolent non-Hodgkin’s lymphoma (iNHL). COASTAL is intended to support FDA approval for additional indications and regulatory marketing applications globally. COASTAL is also intended to act as the required confirmatory study for a potential U.S. accelerated approval of zandelisib in patients with r/r FL or MZL being evaluated in the Phase 2 TIDAL study who have received two or more prior lines of treatment.

Another Phase 2 pivotal study in Japan is evaluating zandelisib in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin. This study is intended to support a Japanese filing with PMDA.

About PI3K Delta
Phosphatidylinositol 3-kinase delta ("PI3Kδ") is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancers. Zandelisib displays high selectivity for the PI3Kδ isoform and has distinct pharmaceutical properties from other PI3Kδ inhibitors.

About Follicular and Marginal Zone Lymphomas*
Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20% of all non-Hodgkin’s lymphomas (NHL), which is one of the most common cancers in the U.S., accounting for about 4% of all cancers. FL derives from a type of white blood cell called a B-lymphocyte, and tends to progress slowly in most cases. The average age of people with FL is about 60 years of age. Sometimes follicular lymphomas can change into diffuse large B-cell lymphoma, a fast-growing (aggressive) type of NHL.

Marginal zone lymphoma (MZL) is another group of indolent, or slow growing, lymphomas. The disease also forms on B-cells. MZL accounts for approximately 5% to 10% of all non-Hodgkin’s lymphoma cases in the U.S. The average age of people with the most common form of marginal zone lymphoma is 60 years of age.

*American Cancer Society: View Source, and View Source Accessed June 16, 2021

On August 17, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported it will provide business and corporate updates and report financial results for the six months ended June 30, 2021, before the market opens on Tuesday, August 31, 2021 (Press release, I-Mab Biopharma, AUG 17, 2021, View Source [SID1234586703]). The Company’s management will host conference calls to discuss the results and updates.

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On August 31, 2021, a Mandarin session conference call will be held at 7:00 a.m. ET, and an English session conference call will be held at 8:00 a.m. ET. The conference calls can be accessed by the following Zoom links:

On August 17, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported that the Company will participate in Biotechgate Digital Partnering taking place virtually from August 30 – September 3, 2021 (Press release, PharmAbcine, AUG 17, 2021, View Source [SID1234586702]).

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Biotechgate Digital Partnering is an event that provides a platform for business development in the field of licensing and collaboration. 14 out of the top 20 big pharma companies and more than 2,700 companies from over 60 countries have participated in the past events.

During the event, PharmAbcine’s business development team will hold one-on-one virtual meetings with global pharmas, biotechs, and healthcare companies to discuss potential licensing deals or collaborations for the Company’s main pipelines such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. Currently, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is taking place at multiple sites in both US and Australia. Also, two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM are still ongoing in Australia.

PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy) which are common abnormal vascular-related eye diseases. The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022.

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in development for the treatment of various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways activates T cells’ immune responses and leads to better anti-tumor effects. PMC-309 is expected to enter a global clinical trial in 2022.

Companies can request a business development meeting by registering for the partnering event here.

On August 17, 2021 Partner Therapeutics, Inc. (PTx) reported that Frontiers in Immunology published a systematic review of LEUKINE titled, "Sargramostim (rhu GM-CSF) as Cancer Therapy (Systematic Review) and An Immunomodulator (Press release, Partner Therapeutics, AUG 17, 2021, View Source [SID1234586701]). A Drug Before Its Time?" This manuscript chronicles Leukine’s 30-year history in oncology research, including 27 studies that each enrolled 50 or more patients. Importantly, this clinical research spans multiple therapeutic areas, providing insight into how endogenous GM-CSF orchestrates innate and adaptive immune responses.

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Lead author Hillard Lazarus, MD, FACP, Professor of Medicine at Case Western Reserve University and advisor to Partner Therapeutics, stated, "We can no longer view GM-CSF as a hematopoietic growth factor alone. These data suggest an emerging role for sargramostim immune suppressed sepsis, refractory bacterial and fungal infections, viral respiratory infections, autoimmune pulmonary alveolar proteinosis (aPAP), neurodegenerative diseases, and in combination with immune checkpoint inhibitors." GM-CSF has wide-ranging effects on diverse myeloid cells, including monocytes, macrophages and dendritic cells. It stimulates innate immune responses by activating macrophages and dendritic cells that prompt development of antigen-specific T cells and regulatory T cells, thereby linking innate and adaptive immune systems.

"This review article highlights Leukine’s potential to generate benefit for patients in numerous diseases that feature GM-CSF deficiency," said Edwin Rock, MD, PhD, Partner Therapeutics Chief Medical Officer. "We are committed to engaging in partnerships and supporting research that illuminates how Leukine works in these varied settings and demonstrates Leukine’s potential in both oncologic and non-oncologic diseases."

ABOUT LEUKINE
LEUKINE (sargramostim) is a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) Leukine is approved by the U.S. Food and Drug Administration (FDA) and is also held by the U.S. government in the Strategic National Stockpile. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data should not be extrapolated.

Leukine is indicated:

To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.
For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients two years of age and older.
For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older.
For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older.
To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Important Safety Information for Leukine (sargramostim)
Contraindications

LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.
Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If absolute neutrophil count (ANC) is greater than 20,000 cells/mm3 or if white blood cell (WBC) counts are greater than 50,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
LEUKINE therapy should be discontinued if disease progression is detected during treatment.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9 percent benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.
Adverse Reactions
Adverse events occurring in greater than 10 percent of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, gastro intestinal (GI) hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema