PharmaEssentia Announces Appointment of Meredith Manning to President of the Americas

On 16, 2022 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the appointment of Meredith Manning to President of the Americas, effective immediately (Press release, PharmaEssentia, MAY 16, 2022, View Source [SID1234614674]).

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"PharmaEssentia has continued to build momentum with our strong pipeline and partnerships around the world. Now, with a world-class foundation built in the U.S. and launch underway, we are expanding our growth ambition across the American continents to address the clear gaps today in therapeutic options for the treatment of myeloproliferative neoplasms (MPNs)," said Ko-Chung Lin, PhD, co-founder and chief executive officer. "Meredith has built an incredible team of expert leaders and has established a strong infrastructure already in Boston, so they are well poised to build our presence with communities in both North and South America."

In this new scope, Ms. Manning will be supported by her U.S. leadership team to evaluate potential commercial strategies and partnerships to reach MPN patient communities throughout the American continents, with a near-term focus on Canada and Latin America. The company’s ongoing clinical trial SURPASS-ET, evaluating a potential therapy in the treatment of essential thrombocythemia (ET) has recently expanded into sites in Canada.

"The progress we’ve made in the last two years has been transformative for our mission and has established the right foundation to enable strong and sustainable growth as we expand into new markets," said Ms. Manning. "Together with our seasoned leadership team here in the U.S., I am optimistic that we can introduce our portfolio in areas that remain underserved today to help advance care of people with MPNs around the world."

Ms. Manning has served as General Manager for the U.S. subsidiary of PharmaEssentia since February 2020, expanding the team nearly three-fold since her arrival and leading the organization through the U.S. regulatory approval and commercial launch of the Company’s first product, BESREMi. With a sharp focus on data-driven market insights and commercial strategy, Ms. Manning’s career has been focused on introducing transformative therapies into underserved communities. She was previously Chief Commercial Officer at resTORbio, and prior to that served as a vice president of marketing for a seven-brand hemophilia portfolio at Baxter BioScience (now Takeda). Earlier in her career, Meredith built and managed successful commercial teams for Vertex and Pfizer.

ITM to Host Scientific Precision Oncology Symposium in Parallel to the ASCO Annual Meeting on Friday, June 03, 2022

On May 16, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will host a scientific symposium on precision oncology titled "Targeted Radionuclide Therapy – present and future prospects" held as an ancillary event in parallel to the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, ITM Isotopen Technologien Munchen, MAY 16, 2022, View Source [SID1234614673]). The symposium will feature key opinion leaders in the field and will be held in a hybrid format on June 03, 2022 from 11:00 am – 12:30 pm CST in the Hyatt Regency McCormick Place, in Chicago, USA and online.

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Targeted Radionuclide Therapy is an approach to treating a variety of cancer types. As new areas of interest and advancing approaches to implementing this uniquely selective therapeutic modality continue to be highlighted, the session will offer an overview of the key topics. The panel will focus on the clinical application of Targeted Radionuclide Therapy in the treatment of neuroendocrine tumors, prostate cancer and potential future prospects. They will also spotlight the benefits and risks of this therapeutic approach, address any challenges that may be encountered, and provide valuable insights to their patient management experiences. Participants will be able to interact with the speakers in a Q&A session at the end of the event.

Scientific Program and Speakers:

Welcome and Introduction
Pamela Kunz, MD
Smilow Cancer Hospital and Yale Cancer Center

Clinical Application of Targeted Radionuclide Therapy in Neuroendocrine Tumors
Pamela Kunz, MD (20min)
Smilow Cancer Hospital and Yale Cancer Center, New Haven

Clinical Application of Targeted Radionuclide Therapy in Prostate Cancer
Michael Morris, MD (20 min)
Memorial Sloan Kettering Cancer Center, New York

Personalizing the Targeted Radionuclide Therapy, Advancements and Challenges
Thomas Hope, MD (20min)
University of California, San Francisco

The Future of Targeted Radionuclide Therapy
Wolfgang Weber, MD, PhD (20min)
Klinikum rechts der Isar (the University Hospital of the Technical University of Munich)

Discussion & Closing Remarks
Pamela Kunz, MD

For the full scientific program and registration form please click here:
View Source

The symposium will be recorded, and available on demand for 6 months after the event.

The event is not sponsored, endorsed, or accredited by ASCO (Free ASCO Whitepaper), CancerLinQ, or Conquer Cancer the ASCO (Free ASCO Whitepaper) Foundation.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

POINT Biopharma Unveils FRONTIER: A Pan-Cancer FAP-α Targeted Clinical Program

On May 16, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported details of the initial clinical trial in the Company’s pan-cancer Fibroblast Activation Protein-α (FAP-α) targeted program PNT2004, FRONTIER (Press release, Point Biopharma, MAY 16, 2022, View Source [SID1234614672]).

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FRONTIER stands for "FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors".

The Phase 1 clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (68Ga)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent. The Phase 1 clinical protocol will evaluate PNT6555 in ~30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

Dosing will start at 4 GBq with each subsequent dose level increasing by 4 GBq and 2 GBq dose de-escalations. Each 177Lu PNT6555 dose will be followed by a 6-week interval. 68Ga-PNT6555 PET/CT imaging will be conducted approximately 90 minutes post injection, and dosimetry will be completed at the time of first 177Lu-PNT6555 dose and each subsequent cycle. The primary objective of the study is to determine the maximum tolerated dose (MTD), and the Recommended Phase II Dose (RP2D). The company expects to present initial imaging and dosimetry data in early 2023.

"We believe radiopharmaceuticals are on the verge of a revolution," said Dr. Joe McCann, CEO of POINT Biopharma. "For most of their existence, therapeutic radio-pharmaceuticals have been limited to small, orphan indications. Drug candidates like PNT6555 could exponentially increase the number of patients which could benefit from this treatment modality. FAP-α is an extremely exciting target for therapeutics. It is present in greater than 90% of epithelial tumors, which include many of the highest prevalence forms of cancer. Not only would better imaging to detect metastatic dis-ease enable more cancers to be treated earlier, but the capability of delivering radiation directly to a wide variety of cancers could also revolutionize treatment paradigms."

FRONTIER will be the first in-human trial of PNT6555, while additional preclinical studies are in development and include other therapeutic isotopes such as actinium-225 (225Ac). A summary of the pre-clinical data for the program can be found in a poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting last month, titled "Pre-clinical characterization of the novel Fibroblast Activation Protein (FAP) targeting ligand PNT6555 for the imaging and therapy of cancer" (Abstract ID: 3554, Session: Preclinical Radiotherapeutics). The presented data conclude:

• In pre-clinical xenograft models: 68Ga-PNT6555 is an effective imaging agent, with strong tumor targeting, low background in normal tissues and rapid clearance via urinary excretion, and 177Lu-PNT6555 shows prolonged tumor retention out to 168 hours post-injection.

• Efficacy studies with 177Lu-PNT6555 or 225Ac-PNT6555 demonstrate compelling and dose-responsive inhibition of HEK-mFAP tumor growth.

A link to the poster can be found on the Investor Presentations section of the Company’s website: View Source

ChemoCentryx to Present at the H.C. Wainwright Global Investment Conference

On May 16, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference on Tuesday, May 24, 2022 at 12:30 p.m. ET (Press release, ChemoCentryx, MAY 16, 2022, https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-present-hc-wainwright-global-investment-conference [SID1234614671]). The conference will be held at the Fontainebleau Miami Beach Hotel in Miami, FL.

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A live audio webcast of the presentations can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company’s website for two weeks following the live presentation.

VYANT BIO REPORTS FIRST QUARTER 2022 RESULTS AND PROVIDES STRATEGIC AND BUSINESS HIGHLIGHTS

On May 16, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT) is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, MAY 16, 2022, View Source [SID1234614670]). The Company’s central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Today, Vyant Bio expects to file its Form 10-Q for the First Quarter 2022 with the Securities and Exchange Commission and will report its First Quarter 2022 highlights and business updates this afternoon in a conference call and webcast scheduled for 4:30 pm ET.

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"During the first quarter of 2022, we progressed our scientific work by using our proprietary drug discovery platform centered on human iPSC-derived neurospheroids to unveil novel targets and potentially disease-modifying therapeutics to treat patients suffering from severe neurodevelopmental and neurodegenerative diseases. We are validating important data that we believe will demonstrate our ability to de-risk the selection of therapeutics that can rescue a disease phenotype. We believe current preclinical models are not sufficiently predictive, and many current therapies for CNS disorders only address the symptoms and do not reverse the effects of neurological diseases. Our focus during the first 90 days of 2022 was to progress our platform validation efforts to advance our CNS programs that are designed to identify disease-modifying therapeutics, consistent with our plans and prior disclosures to our shareholders," stated Jay Roberts, the Company’s Chief Executive Officer.

"As we highlighted in our last earnings conference call, we believe our focus on complex neurodevelopmental and neurodegenerative disorders addresses significant unmet medical needs, and will lead to the identification of important, disease modifying therapies for major causes of death and disability worldwide. Our Rett patient-derived neural spheroids show a robust and reproducible disease-specific phenotype that can be quantified in an unbiased manner across dozens of endpoints. By phenotypic screening of our Rett neural spheroids, we identified VYNT-0126 which has consistently shown a dose-dependent unique rescue of the RTT functional phenotype with a differentiated mechanism of action from other Rett syndrome clinical candidates. Our ongoing work on CDKL5 and familial Parkinson’s disease has further established that our discovery platforms represent a new, unique robust model for human-first CNS drug discovery" stated Dr. Robert Fremeau, Chief Scientific Officer of Vyant Bio.

FIRST QUARTER 2022 FINANCIAL RESULTS

Cash and cash equivalents totaled $16.4 million as of March 31, 2022. The Company implemented two new vehicles to facilitate the raising of additional equity capital at the Company’s option with the finalization of the Lincoln Park Equity line of credit allowing access to raise up to $15 million, as well as signing a $14.5 million ATM with Canaccord Genuity. The Company’s current cash balances, future proceeds from the sale of vivoPharm and future proceeds from the equity line of credit and ATM are expected to fund operations well into 2023.

During the first quarter of 2022, the Company continued the process of divesting the vivoPharm business which is expected to complete in 2022. Therefore, the vivoPharm business is classified as a "held-for-sale" asset, and its financial information as "discontinuing operations".

The Company’s loss from continuing operations aggregated $4.4 million in the first quarter of 2022 and included non-cash depreciation and amortization as well as stock-based compensation expenses of $98 thousand and $278 thousand, respectively, and one-time severance charges of $437 thousand. Discontinuing operations net loss for the March 31, 2022 quarter aggregated $4.8 million and included a non-cash impairment charge of $4.3 million resulting from changed market conditions for contract research organizations from December 31, 2021 to March 31, 2022.

Total revenue from continuing operations increased 49.3%, or $100 thousand, to $303 thousand for the three months ended March 31, 2022, as compared with $222 thousand for the three months ended March 31, 2021.

Cost of goods sold – service from continuing operations totaled $38 thousand and $64 thousand, respectively, for the three months ended March 31, 2022 and 2021, resulting in a cost of goods sold of 40% and 66%, respectively, of service revenue.

Cost of goods sold – product costs decreased by 12%, or $48 thousand to $348 thousand for the three months ended March 31, 2022, as compared with $396 thousand for the three months ended March 31, 2021.

Research and development expenses increased by 89%, or $731 thousand, to $1.6 million for the three months ended March 31, 2022 from $820 thousand for the three months ended March 31, 2021. This increase is principally due a $336 thousand increase in payroll-related and consulting expenses, a $315 thousand increase in research and development activities at our Maple Grove facility, and $48 thousand related to moving to a new facility in California.

Selling, general and administrative expenses increased by 128%, or $1.5 million, to $2.8 million for the three months ended March 31, 2022, as compared with $1.2 million for the three months ended March 31, 2021. The 2021 period reflects the Company as a privately-held company whereas the 2022 period reflect the Company as a publicly-held company. The quarter ended March 31, 2022 includes incremental $564 thousand of payroll-related expenses, including one-time contractual severance benefits for two former employees of $437 thousand. The Company incurred incremental professional services fees of $472 thousand in the first quarter of 2022 as compared with the same prior-year period related to accounting, audit and other professional services and incurred $418 thousand of additional insurance expense.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Monday, May 16, 2022 at 4:30pm ET to discuss the first quarter 2022 results and provide strategic business updates as well as answer questions. Event information is below:

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.