On September 20, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s anti-tumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported it has begun dosing patients in its Phase 1b expansion study investigating PY159 in patients with prioritized cancer types: ovarian cancer, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), HR+HER2- breast cancer, head and neck squamous cell carcinomas (HNSCC), and colorectal cancer (CRC) (Press release, Pionyr Immunotherapeutics, SEP 20, 2022, View Source [SID1234619695]).

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"We developed PY159 to target TREM1 and reprogram myeloid cells within the tumor microenvironment to promote anti-tumor responses – a novel approach to TREM1 biology for anti-tumor drug development," said Leonard Reyno, M.D., Pionyr Executive Vice President and Chief Medical Officer. "In the Phase 1a dose escalation study, PY159 was well tolerated in doses up to 10 milligrams per kilogram and showed dose-proportional pharmacokinetics. With these conclusions from Phase 1a, we are excited to begin this Phase 1b expansion study with leading clinical sites and investigators."

PY159 is an afucosylated humanized monoclonal antibody (mAb) that specifically binds human Triggering Receptor Expressed on Myeloid Cells 1 (TREM1). In preclinical studies, PY159 effectively induces signaling through the TREM1–DAP12 complex, leading to downstream phosphorylation, and an increase in production of cytokines and chemokines and the upregulation of costimulatory and activation markers. Taken together, Pionyr’s research indicates that PY159 converts suppressive tumor-associated myeloid cell populations into inflammatory cells that promote anti-tumor immune responses.

This Phase 1b portion of the study follows Pionyr’s Phase 1a dose-escalation trial. The multi-centered, US-based Phase 1a study evaluated the safety and tolerability of PY159 alone and in combination with pembrolizumab in multiple solid tumors and determined a recommended Phase 1b dose for expansion.

The Phase 1b study will evaluate PY159 administered alone and in combination with pembrolizumab in predefined tumor types. The first patient has been dosed in the single-agent ovarian cancer cohort. In addition to characterizing the anti-tumor activity of PY159, this study will continue to evaluate the safety, tolerability, and pharmacokinetics of PY159. Additional exploratory biomarkers will be evaluated, including analysis of TREM1-expression in the immune infiltrate of tumor biopsy samples. For more information, please visit www.clinicaltrials.gov (Identifier: NCT04682431).

PY159 is an investigational compound and is not approved by any regulatory authority.

About Myeloid TuningTM

Pionyr has developed a therapeutic platform called Myeloid Tuning, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that play an important role in both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAM), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes called M1-like and M2-like macrophages: M1-like typically exerts anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells; M2-like macrophages can promote the occurrence and metastasis of tumor cells, inhibit T cell-mediated anti-tumor immune response, promote tumor angiogenesis and lead to tumor progression.

Myeloid TuningTM effectively describes the mechanism of introducing agents that shift the balance of inhibitory myeloid cells – including M2-like TAMs – towards more inflammatory M1-like TAMs to promote anti-tumor immune responses in the TME and destroy solid tumors.

On September 20, 2022 Alliance Pharma plc (AIM: APH), the international healthcare group, reported its interim results for the six months ended 30 June 2022 ("the Period") (Press release, Alliance Pharma, SEP 20, 2022, View Source;lang=en-GB&companycode=uk-aph&v= [SID1234619694]). The Group navigated the challenges of H1 well and is on track to accelerate revenues in H2 as supply constraints ease and our marketing and product development initiatives stimulate greater demand. We remain on track to meet market expectations for full year financial performance, noting that the timing of certain orders in Q4 is dependent on the rate of recovery in those markets.

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OPERATING AND FINANCIAL HIGHLIGHTS

· H1 revenue growth impacted by lockdown in Shanghai, and associated temporary disruption to supply chain, therefore, as previously indicated, performance more heavily weighted to H2 due to order phasing

· Consumer Healthcare see-through revenue* up 1% to £57.4m (H1 21: £56.8m) with 15% growth in Other Consumer Healthcare revenues offsetting softer performance in key brands

·Robust Prescription Medicine performance with revenues of £24.1m in line with prior year (H1 21: £24.1m)

· Free cash flow of £5.1m (H1 21: £6.5m). Highly strategic acquisition of ScarAway and US rights to Kelo-cote for $19.4m (£14.8m) led to an increase in net debt and Group leverage of 2.05x at Period end.

DEVELOPING OUR BUSINESS

· Integration of ScarAway and US rights to Kelo-cote completed, with revenues in-line with expectations

·Last remaining Nizoral marketing authorisations transferred from J&J to Alliance in China and Vietnam, new top-tier Chinese distributor appointed and manufacturing supply consolidation progressing well which will result in improvements in efficiencies and COGS

· Several new complementary proprietary products launched, or planned to launch this year, including Kelo-cote Kids and Kelo-cote Scar Sheets in China, and Canker-X in the USA, all of which will contribute to ongoing organic growth

· ERP system successfully rolled out to further territories including North America

· Scope 1 and 2 emissions target set to achieve net zero in 2030, with an interim reduction of 65% by 2025

Commenting on the results, Peter Butterfield, Chief Executive Officer of Alliance, said:

"I am pleased with the performance of the Group in the first half of 2022 against the backdrop of difficult global trading conditions. Our portfolio continues to provide a robust platform from which to grow our consumer healthcare brands. I was also delighted to close a highly strategic US acquisition in the Period which consolidates our position in the scar reduction market. The integration of ScarAway has gone very smoothly and we continue to evaluate opportunities to acquire selective complementary new products to enhance our Consumer Healthcare platform.

"The second half of 2022 has got off to an encouraging start as lockdowns and supply constraints have eased. We anticipate strong sales growth in H2 as our marketing campaigns yield benefits, we integrate our new distribution partners and launch new products to grow our market share. Our FY 22 expectation includes several large distributor orders in Q4 to meet increased demand, with the timing of these orders dependent on the rate of recovery in those markets. Our base business remains strong with further new product launches expected in 2023 to secure future growth."

* The performance of the Group is assessed using Alternative Performance Measures ("APMs"), which are measures that are not defined under IFRS but are used by management to monitor ongoing business performance against both shorter term budgets and forecasts and against the Group’s longer term strategic plans. APMs are defined in note 17.

Specifically, see-through revenue includes all sales from Nizoral as if they had been invoiced by Alliance as principal. For statutory accounting purposes the product margin relating to Nizoral sales made on an agency basis is included within Revenue, in line with IFRS 15.

ANALYST MEETING & WEBCAST

A meeting for analysts will be held at 9.30am this morning, 20 September 2022, at Investec Bank plc, 30 Gresham Street, London EC2V 7QP. For further details, analysts should contact Buchanan at [email protected].

On September 20, 2022 Genome Medical, the leading telehealth provider of genetic services and genomics-based care, and Pierian, the global leader in advanced clinical genomics technology and services, reported a collaboration designed to streamline and optimize onsite genomics programs for health care organizations and provider groups (Press release, PierianDx, SEP 20, 2022, View Source [SID1234619691]). The companies’ services, when combined with genomic testing capabilities, create an end-to-end patient and clinician experience that elevates standards of care and patient outcomes .

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Genome Medical and Pierian are working together to efficiently identify patients who may benefit from genomic testing and an enhanced clinical genomics workflow. The combined solution for clinicians facilitates the ordering of appropriate testing which is then processed in onsite laboratories supported by Pierian.

First, through its RISE Patient Engagement Modules, Genome Medical helps clinicians Reach, Inform, Support and Educate patients. RISE includes a Hereditary Cancer Risk Assessment Module that collects and analyzes family and personal health history to determine if a patient meets genetic testing criteria for hereditary cancer. When criteria is met and testing is ordered, laboratory customers utilize Pierian’s advanced technology platform to ingest, analyze, interpret and report on genomic insights for more precise care.

For physician-owned or -managed service organizations, Pierian and Genome Medical deliver a streamlined path to in-house, high-quality precision medicine programs that provide recommended and appropriate care to all patients who meet national standards for genomic testing. This can also include virtual post-test genetic counseling from Genome Medical’s nationwide team to help explain the test findings and advise on recommended follow-on care, if needed.

"We are excited to partner with a like minded innovator, Genome Medical, to combine our leading edge platforms and expertise to enable the clinicians we are privileged to serve," said Mark McDonough, CEO of Pierian. "At Pierian, we are passionately committed to catalyzing precision medicine at scale through our tools, our team, our customers, and our partners like Genome Medical. We are united in our belief that all patients deserve access to high quality, affordable, genetic testing."

Genome Medical has pioneered a virtual model of tech-enabled care delivery and assembled an unmatched team of genetic specialists, enabling rapid, efficient access to genetic counseling and related services. The company offers flexible genetic services programs to approximately 100 partners, including health systems, diagnostic testing labs, insurers, and other partners. In addition, its services are a covered, in-network benefit for more than 160 million people in the U.S.

"Genome Medical is pleased to be able to partner with Pierian to bring our patient screening and clinical genetic services to provider groups who are looking to improve and expand their genomic testing programs," said Jill Davies, CEO of Genome Medical. "This collaboration represents two industry leaders delivering the services and tools that will make in-house genomic testing programs accessible to a wider array of providers and patients."

Pierian partners with academic centers, health systems, physician-owned laboratories and reference laboratories worldwide to establish high-quality clinical genomics programs and a global sharing network. With advanced interpretation technology connected to the most comprehensive knowledge base, Pierian’s unique, adaptive learning algorithms make intelligent associations between comprehensive datasets and individual patient results. Post analysis and interpretation, clinical reports are easy to generate, which empowers clinicians with genomic insights to fulfill the promise of precision care.

On September 20, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel (LSAM-DTX), has been published in Drug Delivery and Translational Research (DDTR) (Press release, NanOlogy, SEP 20, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-review-article-of-preclinical-and-clinical-research-supporting-lsam-dtx [SID1234619689]).

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The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel (LSAM-PTX), published in DDTR in 2020.

Highlights from the current article:

LSAM-DTX is retained in the tumor as a depot for continuous drug release after intratumoral injection in a range of solid tumor preclinical models.
LSAM‑DTX in combination with an immune checkpoint inhibitor demonstrated synergy in a preclinical metastatic breast cancer model.
Evidence of efficacy is seen in preclinical xenograft models of bladder, prostate, and renal cancer as well as evidence of an abscopal effect in a preclinical syngeneic renal cell adenocarcinoma model.
In the high risk nonmuscle invasive bladder cancer clinical trial arm (n=19) of a dose escalation/expansion trial of intramural and intravesical LSAM-DTX in urothelial carcinoma, 100%/78%/50% of subjects in the high-dose cohort (n=9) achieved a complete response at the 3/6/12 month timepoints respectively. Moreover, evidence suggesting favorable immunomodulation was reported after analysis of suitable tissue samples collected pre/post administration of LSAM-DTX.
In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity.

Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322), Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology.

On September 20, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that its Board of Directors appointed Jay Backstrom, M.D., M.P.H., as Chief Executive Officer-Elect, effective September 20, 2022 (Press release, Scholar Rock, SEP 20, 2022, View Source [SID1234619688]). Dr. Backstrom will work closely with Founding and Interim CEO Nagesh Mahanthappa, Ph.D., M.B.A., before officially assuming the role of President & CEO on October 20, 2022, at which time he will also join the company’s Board of Directors.

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Dr. Backstrom has a unique combination of clinical research and development, regulatory, and leadership experience, which spans 30 years across the biopharmaceutical industry. He has been instrumental in organizing and executing development strategies and has led programs in a broad range of therapeutic areas through regulatory approvals. He most recently served as Executive Vice President, Research and Development at Acceleron Pharma, which was acquired by Merck in 2021. Prior to Acceleron, Dr. Backstrom served as the Chief Medical Officer and Head of Global Regulatory Affairs for Celgene Corporation and spent more than a decade at the company during a time of significant pipeline expansion and revenue growth. Prior to Celgene, he was Vice President, Global Medical and Safety at Pharmion Corporation. Early in his career he held industry roles at Quintiles, Hoechst Marion Roussel, and Marion Merrell Dow.

"Jay is an exceptional executive leader with a track record of success that spans several decades in the biopharmaceutical industry. He is the ideal leader for Scholar Rock, as he has brought transformative therapies targeting the TGFβ signaling pathway through development and into commercialization, including REBLOZYL and sotatercept," said David Hallal, Scholar Rock’s Chairman. "On behalf of the entire Board of Directors, I am thrilled to welcome Jay as Scholar Rock’s next CEO, where his extensive leadership experience and expertise in R&D and regulatory strategy will be critical for the next phase of the company. I would like to thank Nagesh for his remarkable leadership and commitment to Scholar Rock during his 10-year tenure at the company. He has led Scholar Rock from its initial startup phase and built an innovative company with a broad, late-stage pipeline targeting the TGFβ signaling pathway to bring potentially transformative therapies to patients suffering with devastating and life-threatening diseases."

"I am both honored and humbled to have this opportunity to lead Scholar Rock at such a pivotal time, and I am excited about the potential of Scholar Rock’s spinal muscular atrophy and oncology programs, where we have near-term opportunities to develop transformative therapies for patients through a highly differentiated platform targeting growth factors like TGFβ," said Dr. Backstrom. "I look forward to working closely with Nagesh, the Board, the executive team, and Scholar Rock employees to advance our lead clinical assets, build our pipeline, increase our impact on the lives of patients, and grow Scholar Rock for its next phase of success."

During the transition period, Dr. Backstrom will fully engage with the company, working closely with Dr. Mahanthappa, members of the executive team, the R&D team, and other functions to advance the pivotal Phase 3 trial for apitegromab for patients with spinal muscular atrophy, the Phase 1 SRK-181 proof-of-concept study for patients with advanced cancer, and pre-clinical programs from the company’s innovative platform. Dr. Mahanthappa will remain interim CEO until October 20, following which he will step off the Board of Directors and serve as a strategic advisor to Scholar Rock.

Dr. Backstrom holds an M.D. from Temple University School of Medicine, received post-graduate training in Internal Medicine at Temple University Hospital, and holds an M.P.H. from St. Louis University School of Public Health. Dr. Backstrom currently sits on the board of directors of Autolus Therapeutics, Be Biopharma, Disc Medicine, and Lava Therapeutics.