New Metrics Show The US Oncology Network Practices Leading the Way in Value-Based Care

On November 16, 2021 The Centers for Medicare & Medicaid Innovation (CMMI) reported that released results for the 8th Performance Period (PP8) of the Oncology Care Model (OCM), and practices in The US Oncology Network (The Network) participating in the program achieved high marks on quality metrics and provided significant cost savings to Medicare (Press release, US Oncology, NOV 16, 2021, View Source [SID1234595681]).

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All 14 of The Network participating practices improved patient care by achieving top quality measurement scores, resulting in a 100% Performance Multiplier for all 14 practices. Together, the practices saved Medicare approximately $54 million over the six-month performance period — for a total savings of $197 million since the OCM began in 2016.

The OCM is a pilot program designed by CMMI to provide higher quality, more coordinated cancer care at the same or lower cost to Medicare. It is an integral part of Medicare’s ongoing effort to transition healthcare to a more value-based approach.

"We are extremely proud of the exceptional performance of all 14 of the practices in The US Oncology Network participating in the OCM and the cost savings they delivered to Medicare," said Stuart Staggs, senior director of Strategic Programs for The Network. "Practices in The Network are bending the cost curve for oncology while providing enhanced care to patients, as demonstrated by their outstanding quality performance scores."

Since the program’s inception, The Network practices have improved steadily in OCM metrics, culminating in these impressive results for PP8. For example, patient emergency department use was the lowest since the start of the program, as practices cared for patients needing immediate attention through a variety of heightened services, such as nurse navigation, enhanced triage, telehealth or urgent care visits within the clinic. All practices also reported substantial gains on depression screening and pain management.

The 14 OCM practices in The Network represent approximately one-fourth of all providers participating in the program, demonstrating the leadership role The US Oncology Network is playing in the development of value-based oncology care. Since the program launched, more than 110,000 patients have been enrolled in the OCM across The Network, receiving high-quality, value-based care in their local communities.

"Much of the success The Network practices have achieved in the OCM is the result of strong support from The US Oncology Network," said Lalan Wilfong, MD, vice president of Payer Solutions and Practice Transformation for The Network. "The Network is dedicated to ensuring its member practices have access to the tools and expertise they need to thrive in the evolving healthcare landscape."

Comprehensive, proven resources are available, including industry-leading technologies from Ontada that support decision-making at the point of care and advanced analytics for optimal data management and reporting. The Network, supported by McKesson, also gives practices access to thought leaders and key staff who have deep expertise in value-based care. This includes a Value-Based Care Transformation Lead, an expert assigned to each practice to guide them in not only program requirements, but also performance improvement.

"It is reassuring to see how well The Network practices are performing, as the OCM is a bridge to the future and an important first step in creating patient-centered cancer care that focuses on both quality and value," said Judi Payne, director of Value-Based Care Transformation for The Network. "Building on our successes in the OCM, The US Oncology Network will continue working to advance value-based cancer care by finding new and innovative ways to elevate and enhance patient care while controlling costs."

Sermonix Pharmaceuticals Closes $40 Million Series A3 Financing Round Led by Perceptive Xontogeny Ventures Fund II

On November 16, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported that it successfully closed a $40 million Series A3 financing round led by Perceptive Xontogeny Ventures Fund II (PXV Fund) (Press release, Sermonix Pharmaceuticals, NOV 16, 2021, View Source [SID1234595680]). Existing investors also participated in the financing.

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As part of the agreement, Fred Callori and Ben Askew, Ph.D., partners in the PXV Fund, were appointed to the Sermonix Board of Directors.

"We are excited to welcome investors who share our passion as we work to leverage a precision medicine approach to address a significant unmet need in the metastatic breast cancer setting," said David Portman, M.D., Sermonix founder and chief executive officer. "This is a pivotal moment for Sermonix. With a strengthened balance sheet and both our ELAINE Phase 2 studies fully enrolled and progressing, we have set the stage for a catalyst-rich 2022, with initial data from each trial expected in the first half."

The PXV Fund team brings significant scientific, business, operational and investment expertise to the Sermonix team, with a singular goal of shepherding lasofoxifene through compelling and rigorously designed clinical proof-of-concept studies.

"We are pleased to announce our support for Sermonix Pharmaceuticals in their endeavors to develop an effective treatment for the approximately 40% of breast cancer patients who develop ESR1 mutations and progress following endocrine therapy," said Mr. Callori. "We believe lasofoxifene, if approved, may become a treatment of choice for oncologists and many of their patients with this challenging disease. The accomplished team at Sermonix recognizes the acute medical need and will be executing effectively on these strategies."

Sermonix recently announced significant progress in the advancement of its ELAINE (Evaluation of Lasofoxifene in ESR1 Mutations) Phase 2 clinical program for lasofoxifene:

In August, Sermonix announced completion of enrollment in its Phase 2 ELAINE 1 trial (NCT03781063), which is evaluating lasofoxifene versus the current standard of care, fulvestrant, for the treatment of ER+/HER2- breast cancer in patients with an ESR1 mutation. Sermonix expects topline data from the trial, which enrolled a total of 100 patients, in the first half of 2022.
In June, Sermonix announced completion of enrollment in its Phase 2 Elaine 2 trial (NCT04432454), which is evaluating lasofoxifene in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Initial data from the trial is expected in the first half of 2022.
LifeSci Capital acted as placement agent for Sermonix on this transaction.

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Oncotelic Announces Successful Completion of the Safety Evaluation of a TGF-β Inhibitor (OT-101) and IL-2 (Aldesleukin) in Phase 1 Combination Trial in Solid Tumor Cancers

On November 16, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported an update on ongoing OT-101/IL-2 combination trial (the "Trial"), which has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 clinical trials and higher doses (Press release, Mateon Therapeutics, NOV 16, 2021, View Source [SID1234595679]).

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The Trial, Multi-center, Open label, Phase Ib clinical study to evaluate the safety, tolerance, and efficacy of TASO-001 ("OT-101"), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, "IL-2"), in patients with advanced or metastatic solid tumor cancer. ClinicalTrials.gov Identifier: NCT04862767.

OT-101 is a first-in-class anti-TGF-β ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19.

In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in the prior trial targeting pancreatic cancer, melanoma, and colorectal cancer ("P001"). In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.

"We are excited to see this clear demonstration of safety for the OT-101/IL-2 combination," noted Dr. Vuong Trieu, CEO of Oncotelic. "Unlike other common treatments, such as chemotherapy, IL-2 has the potential to bring about long-lasting responses and even cures in about one in 10 patients with metastatic kidney cancer and metastatic melanoma. Our analysis to date suggests that the OT-101/IL-2 combination could further improve the cure rate of these cancers. We look forward to updating shareholders as we gain further insights with additional data."

The Trial is being conducted by Autotelic BIO, a partner of Oncotelic on the OT-101/IL-2 combination, and Clinigen Group, a UK-based global pharmaceutical company.

About OT-101

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 could further demonstrate its utility as adjunct to other immunotherapies. IL-2, immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma. OT-101 has also received orphan drug designation for glioblastoma, melanoma, and pancreatic cancers. Furthermore, the Food and Drug Administration recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is being evaluated for effectiveness against coronaviruses, including COVID-19, and has been deployed against the COVID-19 epidemic in the Company’s C001 trial.

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).

PerkinElmer to Present at Evercore ISI HealthCONx Conference 2021

On November 16, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Evercore ISI 4th Annual HealthCONx Conference 2021 on Wednesday, December 1, 2021 at 10:30 a.m. ET (Press release, PerkinElmer, NOV 16, 2021, https://ir.perkinelmer.com/news-releases/news-release-details/perkinelmer-present-evercore-isi-healthconx-conference-2021 [SID1234595678]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update on the Company and its strategic priorities. To register, click here.

A live audio webcast will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and will be available for 90 days following.

Invitation to Roche’s virtual event on key hematology data presented at ASH 2021

On November 16, 2021 Hoffmann-La Roche reported to invite investors and analysts to participate in our virtual event on Wednesday, 15 December, 2021, highlighting Roche data presented at the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting, from 11-14th December (Press release, Hoffmann-La Roche, NOV 16, 2021, View Source [SID1234595673]).

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