On November 17, 2020 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the Company met its initial 55 patient enrollment target for its pivotal Phase 2, open-label, multicenter, clinical trial of rivoceranib (apatinib) in patients with recurrent or metastatic adenoid cystic cancer (ACC) one year ahead of schedule (Press release, LSK BioPharma, NOV 17, 2020, View Source [SID1234571233]). The Company also announced increasing the target size of the trial to 72 patients and expects to complete enrollment by the end of the year. The Company plans to establish an Expanded Access Program to provide rivoceranib for "compassionate use" in patients with ACC.

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"Today’s announcement represents an important step forward in our development and registration strategies for rivoceranib and brings us closer to providing a new potential therapeutic option to patients with recurrent or metastatic adenoid cystic cancer (ACC), a devastating disease with no therapeutic treatment options," said Steven Norton, Ph.D., chief drug development officer at Elevar Therapeutics. "The rapid pace of enrollment underscores a strong interest by patients and physicians in the potential clinical benefit of rivoceranib in ACC which speaks to the critical unmet need for new treatment options. We are incredibly grateful to the trial participants, investigators and their staff for their commitment to completing enrollment, despite the current COVID-19 global pandemic."

The Phase 2, open-label, multicenter, single-arm clinical trial of oral rivoceranib is evaluating patients with recurrent or metastatic ACC of all anatomic sites of origin who are not eligible for curative surgery or radiotherapy. Due to an increased level of interest from physicians and patients, Elevar increased enrollment to 72 patients from the originally planned 55 patients. The primary endpoint of the study is the frequency of patients with partial or complete responses to treatment (Objective Response Rate). Secondary objectives include overall survival, progression free survival, duration of response and time to progression.

"The data generated by this clinical program thus far are highly encouraging and also demonstrate the potential rivoceranib holds for recurrent and metastatic patients with adenoid cystic cancer (ACC), who have no current standard treatment options," said Hyunseok Kang, M.D., associate professor of Clinical Medicine at University California, San Francisco. "I would like to thank my co-investigators for the speed of enrollment of this important study, especially during the ongoing pandemic. I look forward to seeing the trial results."

Rivoceranib has been granted Orphan Drug designation in the U.S., Europe and South Korea.Additional information can be found at ClinicalTrials.gov (Identifier: NCT04119453).

Requests for access to rivoceranib can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment. Physicians seeking help on behalf of their patients may contact Elevar at 801-303-7440.

About Adenoid Cystic Carcinoma

Adenoid cystic cancer (ACC) is a rare form of cancer with a reported 1,200 new cases diagnosed each year in the United States. Elevar is preparing to file for orphan drug designation (fewer than 200,000 patients) in the United States. ACC is considered a slow growing but relentless cancer that is characterized by nerve invasion and metastases. ACC typically occurs in salivary glands but can also occur in secretory glands located in other tissues such as the esophagus, breast and lungs. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. Currently, no curative treatments are available for these patients which underscores the need for effective new therapies.

About Rivoceranib (apatinib)

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib potently and selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide. As a best-in-class therapeutic known for its safety and tolerability, Elevar believes rivoceranib has the potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy.

On November 17, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported results for its first quarter ended September 30, 2020 (Press release, Palatin Technologies, NOV 17, 2020, View Source [SID1234571232]).

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First Quarter Ended September 30, 2020 Financial Highlights

Net loss for the quarter was $(3.9) million, or $(0.02) per share, compared to a net loss of $(4.5) million, or $(0.02) per share for the comparable quarter of 2019;
Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. Recognized $(288,560) in Vyleesi product revenue, net of allowances and accruals;
Recognized no contract and license revenue for the quarter, compared to $97,379 for the comparable quarter of 2019;
Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination agreement, compared to $5.0 million for the comparable quarter of 2019;
As of September 30, 2020, the Company had $86.6 million in cash and cash equivalents and $5.0 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.
Business Highlights and Updates

In July 2020, regained exclusive North American rights to market Vyleesi (bremelanotide injection), the first and only on demand treatment for premenopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women;
Vyleesi commercial activities: solidified the distribution network and procedures, improved contact with prescribers and healthcare providers through virtual meetings, increased insurance reimbursement coverage, and initiated a highly-selective digital marketing and telemedicine campaign to rebuild awareness and demand among pre-menopausal women with initial geo-targeting to top prescriber and digital locations;
Completed enrollment of a Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). Data readout expected December 2020;
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021.
"We have made significant progress and improvement on Vyleesi commercial activities, specifically around insurance reimbursement and expanded coverage. This put us in the proper position as we initiated a targeted marketing digital campaign to raise condition and treatment awareness with premenopausal women," stated Carl Spana, Ph.D., President and CEO of Palatin.

"Despite the challenges posed by the ongoing viral pandemic, we are on track for data readout next month on our PL9643 Phase 2 clinical study in subjects with dry eye disease. Most people living with dry eye disease suffer from episodic flare-ups. These flares can be caused by a multitude of triggers and frequently are not sufficiently addressed by current therapies."

Programs Overview

Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi (bremelanotide injection)

In July 2020, Palatin announced the mutual termination of its License Agreement with AMAG Pharmaceutical, Inc, for Vyleesi. Under the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi, including existing inventory. AMAG is providing certain transitional services to Palatin for a period to ensure continued patient access to Vyleesi and regulatory compliance during the transition back to Palatin. Palatin is reimbursing AMAG for the agreed upon costs of the transition services.

Palatin is exploring its options to enhance the commercialization of Vyleesi, including discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories outside the currently licensed territories of China and Korea and anticipates executing multiple agreements through calendar year 2021.

The Company’s strategy implements an informed and highly targeted approach to marketing, focusing on telemedicine, social media, and digital advertising. The Company is committed to working with payers and healthcare professionals to ensure women with HSDD have continued and affordable access to Vyleesi. Vyleesi remains commercially available through specialty pharmacies Avella and BioPlus. Patients also can connect with a healthcare provider through telemedicine. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com.

Vyleesi is the first FDA-approved product for the as-needed treatment for premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. This treatment is available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter.

Anti-Inflammatory / Autoimmune Programs

Enrollment in a Phase 2 clinical study with PL9643 for the treatment of dry eye disease was completed in August 2020. Data readout is targeted for December of 2020. If results from the Phase 2 study support advancing to Phase 3, the Company will initiate a Phase 3 efficacy study as early as mid-calendar year 2021.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021, with data readout potentially in the first half of calendar year 2022.

The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an investigational new drug (IND) filing targeted for mid-calendar year 2021.

The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which the FDA granted orphan drug designation, in the second half of calendar year 2021.

Palatin is advancing its COVID-19 development plan and is conducting all the required activities needed to file an IND and begin clinical studies with PL8177 as a treatment in COVID-19 patients. These activities will be completed in the fourth calendar quarter of 2020, allowing the Company to potentially file an IND with the FDA and initiate a clinical study of PL8177 for the treatment of COVID-19 patients early in the first calendar quarter of 2021.

The landscape for treating and conducting clinical studies in COVID-19 patients is rapidly evolving. This impacts the design, risk, and ability to conduct clinical studies in COVID-19 patients. Considering the risk and uncertainty of conducting COVID-19 clinical studies, the start of a PL8177 clinical study is subject to receiving external funding and operational support. The Company is in the process of applying to government programs that provide such support.

Natriuretic Peptide Receptor (NPR) System Program

PL3994, an NPR-A agonist, will be evaluated in a Phase 2A clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. Patient enrollment in the study has commenced and the first patient was dosed in November 2020.

Genetic Obesity Program

Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 17, 2020 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 3383273. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3383273. The webcast and telephone replay will be available through November 24, 2020.

On November 17, 2020 Perrigo Company plc (NYSE; TASE: PRGO), reported that CEO and President, Murray S. Kessler and CFO, Ray Silcock, will present at the Morgan Stanley Global Consumer & Retail Conference at 1:00 PM EST on Tuesday, December 1, 2020 (Press release, Perrigo Company, NOV 17, 2020, View Source [SID1234571230]). Interested parties can access the presentation webcasts at View Source

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On November 17, 2020 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will host a Virtual Life Science Event for the investment community on Thursday, December 10 at 8:30 a.m. ET (Press release, PerkinElmer, NOV 17, 2020, View Source [SID1234571229]).

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This event is organized to serve as an in-depth breakdown of the Company’s business serving Life Science End Markets, including its portfolio, strategy, latest innovations and scientific advances. Speakers will include Jamey Mock, SVP and chief financial officer of PerkinElmer, Alan Fletcher, VP and GM of PerkinElmer Life Sciences, Kevin Willoe, VP and GM of PerkinElmer Informatics, and Gary Grecsek, VP and GM of PerkinElmer Enterprise Services.

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.

On November 17, 2020 NantHealth, Inc. (NASDAQ: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported the publication of a study that revealed RNA sequencing is not only viable but may also provide significant clinical value in analyzing a cancer patient’s specific disease biology to enable an optimized treatment decision with a higher likelihood of success (Press release, NantHealth, NOV 17, 2020, View Source [SID1234571228]). The study was published in Nature’s Scientific Reports, an open access, peer-reviewed journal dedicated to original research from across all areas of the natural and clinical sciences.

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Prepared in collaboration with NantOmics, LLC and ImmunityBio, Inc., the study was designed to explore the potential use of formalin-fixed paraffin-embedded (FFPE)-derived RNA transcriptome profiling for clinical decision-making. This technique was previously not considered to yield significant clinical value due to the lower quality, degraded samples typically produced by the formalin fixation process. FFPE is the most common method used in clinical settings for storing tumor biopsies.

The study revealed an overall sequencing success rate of 81% with highly consistent coverage in direct FFPE and fresh-frozen (FF) replicates (98% agreement). The results provide strong rationale for the use of FFPE-derived RNA sequencing in clinical decision-making based on the reproducibility, robustness, and consistency of whole transcriptome profiling. This research enables the comparison of clinical samples to research studies, which generally differ in both data collection and sequencing methods, and which may unlock highly valuable insights that would not be possible with DNA sequencing techniques alone.

"This is an important step to advancing towards molecularly informed medicine, both from the perspective of diagnostics to precise therapeutic intervention," said Dr. Patrick Soon-Shiong, CEO of NantHealth, NantOmics and ImmunityBio. "Genomic reporting capabilities could be enhanced through clinical applications resulting from this technology, including identifying cancers of unknown primary (CUP), prevalence of immune cell infiltrates in the tumor microenvironment (immunome), and expression analysis of checkpoint markers including those targeted by commercial and investigational immunotherapies," he continued.

The study also demonstrates that RNA sequencing is not only clinically viable but valuable and can provide a more thorough understanding of what genes are driving each individual patient’s tumor to better inform personalized treatment decisions.

To achieve this, researchers performed ribo-deplete RNA extractions on more than 3,200 FFPE slide samples to measure the expression of clinically significant genes that help identify treatments with the highest likelihood of response. The study included a comprehensive evaluation of RNA extraction methods (Poly-A and ribo-depletion) by comparing transcriptomes from The Cancer Genome Atlas (TCGA) cohort and 3,116 FFPE samples. Findings showed minimal differences between the two approaches within clinically important genes, while establishing a computational framework for comparing the expression of FFPE clinical samples to the growing database of research samples generated by academic studies.

"These are very exciting results from a robust scientific study of a high caliber," said Shahrooz Rabizadeh, Ph.D., Chief Scientific Officer, ImmunityBio. "The implication of using RNA sequencing to molecularly define a patient’s cancer, identify the origin of cancers of unknown primary, and most importantly, optimize treatment plans for the highest chance of success, especially with immunotherapies, is profound."

"Through this research, we demonstrated the robustness of the RNA assay and the informatics techniques that help clinicians understand the transcriptional drivers of disease in their patients, allowing the further advancement of personalized medicine," said Dr. Sandeep "Bobby" Reddy, Chief Medical Officer, NantHealth. "NantHealth knows that high-quality data is the backbone of modern medicine. This study unlocks valuable insights through a method that allows the analysis of both academic research and clinical data for treatment optimization, further strengthening our fight against cancer."

Receiving widespread attention in policy documents and the media, Scientific Reports is the seventh most-cited journal in the world, with more than 350,000 citations. The publication has an extensive network of expert peer reviewers and an editorial team who provide rigorous and objective review. Scientific Reports is guided by the same ethical and editorial guidelines as other Nature Research publications to ensure that all the research is original, scientifically robust and of the highest quality. The journal is published through a number of different channels, including nature.com, where it receives approximately two million monthly visitors.