On October 18, 2021 Prime Therapeutics, a leading pharmacy benefit manager (PBM) serving more than 33 million members, reported that IntegratedRx – Oncology (Press release, Prime Therapeutics, OCT 18, 2021, View Source;oncology-301402335.html [SID1234591491]). This new clinically integrated program streamlines the treatment pathway for members who are fighting cancer so they can now receive their oral oncolytic and companion medications in the clinical setting directly from their oncologist’s clinic or affiliated hospital pharmacy. This promotes lower drug costs, quicker time-to-medication, better adherence and an improved patient and provider experience for Blue Plans and their members.

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The IntegratedRx – Oncology program represents Prime’s channel independent approach of identifying solutions that drive the best financial and quality outcomes for Blue Plans and members. It makes Prime the only large PBM that doesn’t prioritize a central fill specialty pharmacy as the primary model to receive their oral oncolytic medications.

The nationwide rollout of IntegratedRx – Oncology builds on a successful pilot program with McKesson Health Mart Atlas, the largest pharmacy services administrative organization (PSAO) in the U.S., conducted in Florida, Minnesota and the Pacific Northwest earlier this year. The integrated care pilot indicated benefits to providers as well as patients, including:

Shorter fill times allowing patients to begin treatment up to two days faster.
Significantly better medication adherence.
Reduced drug costs.
"We were delighted to work with Prime to innovate and develop this new program that employs a best-in-care integrated dispensing model for cancer medications," said Mark Alwardt, vice president of Medically Integrated Dispensing at McKesson. "At McKesson, we have a patient-first mentality and saw the opportunity to help deliver superior member outcomes through improved therapy management, a collaborative care model and expanded drug access."

"By connecting the care team to the practice pharmacy, IntegratedRx Oncology removes roadblocks that can complicate the cancer care journey," said Joseph Leach, M.D., chief medical officer for Prime and a practicing oncologist. "This type of channel-agnostic approach is a hallmark of Prime’s focus on improving the member and provider experience. An integrated pharmacy-provider model is proven to improve medication adherence and results in better care management. IntegratedRx is designed to bring the pharmacy, caregiver and physician closer together to the patient."

Prime is also collaborating with other national health care companies to operationalize and ensure success of the program, including AmerisourceBergen and Shields Health Solutions. As a leading distributor of specialty pharmaceuticals, AmerisourceBergen is now offering IntegratedRx to physician practice and health systems customers.

"As a company that helped pioneer medically-integrated dispensing programs within independent oncology and launched the first-ever specialty PSAO, we believe in enabling the necessary access to specialty drugs and oral oncolytics in an integrated care setting," said Lisa Harrison, RPh, President of Specialty Distribution at AmerisourceBergen. "The IntegratedRx program enhances the patient and provider experience, and elevates a new model for how oncology care is delivered. We are excited to be a part of this program."

Prime has also partnered with NCODA to launch a new Center of Excellence Accreditation Program Prime will prefer for its new clinically integrated program.

"Allowing medically integrated pharmacies to go beyond the first fill provides the most optimal outcome for the patient and all stakeholders involved," said Michael Reff, NCODA Executive Director. "Developing a model for MIPs several years ago and now collaborating with Prime and seeing them bring it to scale with a formal MIP Accreditation requirement, is a pinnacle point in this mission that brings sustainability, improved clinical experience and better care to millions of patient lives."

"Prime’s IntegratedRx program allows Blue Plans to lead in market with a differentiated care model that benefits their members and clients," added Leach. "We appreciate the willingness of all our program partners to innovate with us on this new offering."

Beginning with Oncology, the IntegratedRx suite of products will streamline medication delivery for various medical conditions. Available to all Blue Plans, several Prime clients will implement IntegratedRx – Oncology starting in the fall of 2021.

On October 18, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported an agreement with Care Continuity Inc., a leader in network integrity and care navigation across the care continuum (Press release, NantHealth, OCT 18, 2021, View Source [SID1234591490]). The agreement was formed to improve the management of care logistics for complex, high risk and chronic diseases. The care pathways enabled by this collaboration will support clinicians, patients, and their families across health networks, and help to ensure patients receive equal, high-quality access to treatment. The initial focus is the extension of cancer pathways through Eviti Connect, then adding other high risk and chronic care pathways through NantHealth’s NaviNet payer/provider collaboration platform.

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Health systems, payers and Accountable Care Organizations (ACOs) invest significant resources building care delivery networks, yet too often rely on patient/member self-navigation and ad hoc tools to connect the dots across the various access points. This results in poor outcomes, patient attrition, and ultimately, lost market share.

Care Continuity’s cloud-based provider communication and consultation management platform will leverage NantHealth’s Eviti Connect to guide patients through their healthcare plans step by step. Eviti provides data—including evidence-based standards and therapies—that gives payers and providers confidence to prescribe and reimburse high-quality, high-value cancer care. Care Continuity will connect patients/members with information that helps them navigate from one step of the treatment to the next. Navigation offerings include:

Emergency Discharge Program: Designed to ensure members visiting the emergency department receive timely care from a physician in the payers’ high quality provider network. Navigators will reach out to targeted patients to offer assistance in scheduling their post-discharge follow-on care.
Inpatient Discharge Services: Designed to ensure that members have all required post discharge follow-on care scheduled prior to discharge, are supported in the transition to post-acute services (e.g., rehab, home care), and are provided with subsequent scheduling of physician appointments and handling of the associated care logistics.
High Touch Care Management Support: An experienced concierge team provides a high level of support, helping to enroll members in complex care management programs.
Referrals Workflow: Through more coordinated health networks, primary care givers can refer patients to the highest quality provider in the network and reduce network leakage.
"When it comes to cancer care, there are many overwhelming decision points for the patient and provider," said Ron Louks, Chief Operating Officer at NantHealth. "Health care navigation through our agreement with Care Continuity furthers NantHealth’s commitment to providing our customers with better data and insights while also helping to advocate for equal, quality healthcare for every patient."

"Patients, when most vulnerable, should not be expected to navigate care on their own," said Andrew Thorby, Chief Executive Officer at Care Continuity. "We are honored, as a trusted patient advocate, to partner with NantHealth and leverage actionable insights to ensure members get the essential services they need."

On October 18, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that a research team led by Prof. Shaomeng Wang, Ph.D., Co-Founder and Chief Scientific Advisor of Ascentage Pharma, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, University of Michigan, has recently published a paper in the renowned Journal of Medicinal Chemistry demonstrating the highly promising therapeutic potential of the embryonic ectoderm development (EED) inhibitor, EEDi-5273 (APG-5918), and the compound’s ability to achieve complete and persistent tumor regression by modulating the epigenetics and microenvironment of tumors and overcoming drug resistance (Press release, Ascentage Pharma, OCT 18, 2021, View Source [SID1234591479]). Ascentage Pharma has obtained the exclusive global development rights to EEDi-5273 and is currently actively preparing to submit an Investigational New Drug (IND) application for this drug candidate.

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This paper published by Dr. Shaomeng Wang’s research team was titled Discovery of EEDi-5273 as an Exceptionally Potent and Orally Efficacious EED Inhibitor Capable of Achieving Complete and Persistent Tumor Regression. The study found that the oral administration of EEDi-5273 is capable of achieving complete and persistent tumor regression in the KARPAS422 xenograft model in mice. As an exceptionally potent novel EED inhibitor that is capable of epigenetic modulations, EEDi-5273 has broad therapeutic potential in the treatment of multiple hematologic malignancies, solid tumors, and non-oncologic indications.

According to the paper, the polycomb repressive complex 2 (PRC2) is a protein complex that consists core subunits including the enhancer of zeste homolog 2 (EZH2), EED, and suppressor of zeste 12 (SUZ12). Of these components, EED allosterically stimulates the methyltransferase activity of EZH2 through its binding to H3K27me3. Therefore, EED inhibitors can theoretically produce antitumor effects similar to that of EZH2 inhibitors, and deliver even more potent antitumor activity by overcoming resistance to EZH2 inhibitors while simultaneously inhibiting EZH2 and EZH1. In 2017, scientists from Novartis and AbbVie reported their discovery of A-395 and EED226, respectively, as allosteric inhibitors of EED. To date, only two EED inhibitors, MAK683 from Novartis and FTX-6058 from Fulcrum Therapeutics, have progressed into clinical development.

Previous preclinical and clinical studies have shown the broad therapeutic potential of EZH2/EED inhibitors in the treatment of multiple tumor types and non-oncologic indications. EZH2/EED inhibitors also have immunomodulatory functions that can render "cold" tumor "hot" through mechanisms such as antigen presentation, thus enhance tumor response to immune-checkpoint inhibitors, leading to improved antitumor efficacy. Clinical studies investigating the immunomodulatory functions of EZH2/EED inhibitors are currently ongoing. By bolstering the expression of fetal hemoglobin (HbF), EEH inhibitors may also achieve therapeutic effects in the treatment of multiple subtypes of anemia associated with low levels of hemoglobin.

Compared to A-395 and EED226, EEDi-5273 has higher binding affinity to EED and more potent cell growth inhibitory activity in the KARPAS422 cell line carrying a Y641N EZH2 mutation. In the KARPAS422 xenograft model, EEDi-5273 at 50mg/kg achieved complete tumor regression after 5 weeks of treatment and maintained the complete regression until at least day 114, thus demonstrated persistent antitumor activity. Meanwhile, ADME and PK studies of EEDi-5273 have demonstrated excellent drugability. In these studies, EEDi-5273 did not display obvious inhibitory and inducive activity in cytochrome P450 (CYP) enzymes, signaling a low risk of drug-drug interactions. In the plasma of all tested preclinical species and human, EEDi-5273 has demonstrated a half-life of over 2 hours, showing an excellent plasma stability. Collectively, data from this study showed that EEDi-5273 represents a highly promising EED inhibitor.

Dr. Shaomeng Wang said: "ED inhibitors have the promising therapeutic potential for the treatment of human cancers carrying EZH2 mutations and other types of human cancers, as well as other human diseases such as sickle cell anemia. Our data suggest that EEDi-5273 (APG-5918) possess an excellent profile as a development candidate and has the potential to become the best-in-class EED inhibitor."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, commented: "These findings by Dr. Wang’s team are indeed very exciting, as they further validated APG-5918 as a highly promising EED inhibitor with the most potent vitro activity and impressive in vivo efficacy, thus provide solid preclinical data supporting our future clinical development of the compound. EED inhibitors have broad clinical applications and enormous therapeutic potential especially in the treatment of non-oncologic indications. We will press forward with the development of APG-5918 and advance the compound to the clinical-stage as soon as possible in effort to bring a novel therapeutic to patients in need."

On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591478]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information

On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Additional information about the listing

The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors

Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 18, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the IND submission for the initiation of phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) as well as head and neck cancers (Press release, I-Mab Biopharma, OCT 18, 2021, View Source [SID1234591477]).

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Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Treatment with efineptakin alfa has distinct advantages over other cytokines such as human IL-2 that have a narrow therapeutic window and cause serious adverse effects.

Efineptakin alfa has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China. According to the data from the NIT-110 dose-escalation study presented at ASCO (Free ASCO Whitepaper) 2021, the combination of efineptakin alfa and pembrolizumab is safe and well-tolerated in patients with advanced solid tumors. It significantly increased T cell numbers in both the tumor microenviroment and the peripheral blood. At the SITC (Free SITC Whitepaper) 2020, data from the phase 1b/2 Keynote-899 study (NCT03752723) have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC. In addition, interim results from the phase 1 trial (NCT03687957) in high-grade gliomas unresponsive to chemoradiotherapy showed a 1.3 – 4.1 fold increase in the absolute lymphocyte count (ALC) with a one-year survival rate of 83.3%.[1] Further, a China phase 1b trial (NCT04001075) in patients with advanced solid tumors will soon complete to facilitate further development of efineptakin alfa.

"Efineptakin alfa is the first rhIL-7 for cancer treatment and underscores I-Mab’s commitment to innovation. Oriented by patients’ needs, we look forward to initiating this important trial to accelerate the clinical development and deliver a potentially transformative solution to patients," said Dr. Joan Shen, CEO of I-Mab.

Efineptakin alfa is also being studied in another phase 2 clinical trial (NCT04600817) to evaluate its efficacy and safety in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have been treated with standard concurrent chemoradiotherapy. The study is currently advancing rapidly with the first patient dosed in February 2021.

[1] Data can be viewed in NeoImmuneTech’s poster presentation at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting at the following link: View Source;fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.