On July 28, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported the online publication of the manuscript, "Single-cell Spatial Proteomic Revelations on the Multiparametric MRI Heterogeneity of Clinically Significant Prostate Cancer" in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, BostonGene, JUL 28, 2021, View Source [SID1234585314]). The study, led by oncologists at Washington University School of Medicine in St. Louis – in collaboration with BostonGene – identified distinct molecular, cellular, and structural characteristics associated with MRI-visible clinically significant prostate cancer (csPCa).

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Multiparametric MRI (mpMRI) has increased the detection rate and has improved the prediction rate of prostate cancer; however, mpMRI is unable to detect almost 15% of csPCa and often misidentifies healthy patients as csPCa. To uncover the mechanisms underlying MRI visibility in csPCa, the group performed the first integrated multi-omics analysis of clinically matched mpMRI-invisible and -visible PCa. Tumor tissues from clinically matched patients with mpMRI-invisible and mpMRI-visible csPCa who underwent radical prostatectomy were evaluated. In this collaborative study, BostonGene performed integrated analysis of multiplex immunofluorescence single-cell spatial imaging and gene expression profiling with its artificial intelligence-based analytic algorithms to examine the tumor and surrounding microenvironment. Expression profiling identified a stromal enrichment signature in mpMRI-invisible PCa that correlated with better PCa clinical outcomes. Interestingly, mpMRI-invisible tumors displayed molecular, cellular, and structural features more akin to normal prostate tissue, which may render these tumors undetectable by MRI imaging.

"This AI-based analytical approach could distinctly identify the molecular and cellular composition of tumor tissue. Integrated multi-omics analysis in conjunction with mpMRI shows promise for the diagnosis and personalization of treatment options for patients with clinically significant prostate cancer," said Russell K. Pachynski, MD, lead study author and genitourinary medical oncologist at Washington University School of Medicine in St. Louis and its affiliated Siteman Cancer Center.

"The results of our collaboration with Washington University and Siteman Cancer Center validate the use of multiplexed immune-fluorescent microscopy and gene expression profiling coupled with cutting-edge analytics to solve clinical unmet needs," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings created an opportunity to improve PCa patient outcomes."

On July 28, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") reported its entry into an amended collaboration agreement (the "Restated Agreement") with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates (Press release, Protagonist, JUL 28, 2021, View Source [SID1234585331]). The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn’s disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232 and PN-235 are currently in Phase 1 clinical development.

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The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications. As such, certain development milestones have been reconfigured based on multiple drug candidates advancing in parallel. Protagonist remains eligible to potentially receive approximately $900 million in future development and sales milestones, in addition to the $80 million in payments already received under the original agreement. Royalty rates remain unchanged. Janssen will have the right to continue research on IL-23 receptor antagonists developed during the collaboration for three years from the closing of the Restated Agreement.

Under the terms of the Restated Agreement, Janssen will conduct all future studies beyond those that are currently ongoing with PTG-200, PN-232 and PN-235 and will be solely financially responsible for any such studies. Accordingly, Protagonist’s development and expense obligations will be limited to its relative share of the currently ongoing studies with these candidates. With this revised agreement, Janssen will continue to deploy the breadth of its established global capabilities and proven experience toward further clinical development of these assets.

"We are very pleased with this amendment to our agreement, which reflects the successful trajectory of the collaboration to date, giving rise to the parallel development of multiple oral IL-23 receptor antagonists," said Dinesh Patel, PhD, President and Chief Executive Officer of Protagonist. "The progress from de novo discovery to development validates our innovative technology platform and its potential to develop oral peptide drugs for diverse clinical indications. We look forward to supporting our Janssen counterparts in their parallel development efforts for PTG-200, PN-232, and PN-235 in multiple indications, which may ultimately provide significant benefit to patients."

Janssen retains exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from the research collaboration conducted under the Original Agreement, or Janssen’s further research under the Restated Agreement. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis (UC) and CD in the U.S. market.

Further details related to the Restated Agreement are available on the Company’s Form 8-K as submitted to the U.S. Securities and Exchange Commission.

Conference Call and Webcast Information

Protagonist management will host a conference call and webcast today at 5:00 p.m. ET to provide a brief overview of the amended collaboration agreement. To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On July 28, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that it will report second quarter financial results following the close of U.S. financial markets on August 9 (Press release, Turning Point Therapeutics, JUL 28, 2021, View Source [SID1234585420]). The company will host a conference call at 1:30 p.m. PT/4:30 p.m. ET to discuss the results and provide operational updates. President and CEO Athena Countouriotis, M.D., will host the call, which will include a question and answer session.

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The update will be accessible via audio webcast through the "Investors" section of www.tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 4029189. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On July 28, 2021 Almac Clinical Technologies, a member of the contract and development organization, Almac Group, and THREAD, a technology and service provider enabling decentralized clinical trials (DCTs), and reported a strategic partnership (Press release, Almac, JUL 28, 2021, View Source [SID1234585447]). The market leaders will integrate their technologies to enable more efficient clinical trials that generate better outcomes.

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By integrating their proprietary technology platforms, Almac and THREAD will provide sponsors and contract research organizations (CROs) with a full range of tools to reduce the risk of trial delays. Almac’s IXRS solution and industry-leading services for randomization and clinical trial supply management will be available to THREAD customers and THREAD’s DCT solution will be available to Almac customers. The two companies will leverage single sign-on and application program interfaces (APIs) to integrate their technologies and automate DCT workflows across their respective platforms to:

• minimize duplicate data entry, particularly for research sites
• provide sponsors with integrated reports on trial progress
• preserve automation to ensure operational efficiency

Organizations interested in learning more can request more information here.

"We’re thrilled to be working with THREAD, an acknowledged leader in DCT technology," said George Tiger, vice president of Global Business Development, Almac Clinical Technologies. "As part of our growing Partnership and Alliance program, this specific partnership will enable us to offer an additional level of support to Almac clients as they seek to decentralize their clinical trials."

"A common pain point for research sites is the abundance of technologies they have to independently maintain for each clinical trial," said John Reites, chief executive officer of THREAD. "By integrating Almac within our comprehensive platform, sites and study teams will have a single DCT study experience. Almac is a longstanding global leader in clinical research, and we’re excited about this synergistic partnership."

On July 28, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported financial results for the fiscal year ended March 31, 2021 (Press release, Portage Biotech, JUL 28, 2021, View Source [SID1234585260]).

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"Over the past year, we’ve transformed Portage, positioning the Company to capitalize on our promising portfolio of immuno-oncology platforms and assets as well as leverage our innovative drug development engine," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Throughout this transformation, we’ve maintained efficiency in our capital expenditures and operations to maximize value for shareholders thanks to the support of our lean, experienced team. Our efficiency coupled with our recent financing provides us with sufficient cash runway to complete Phase 1 and Phase 2 clinical trials for our lead invariant natural killer T cell (iNKT) agonists and is our first with formal biotech institutional support. We believe iNKTs have the potential to re-sensitize PD-1 tumors and could significantly expand the PD-1 market opportunity. With sufficient resources now in place, we are poised to advance our iNKT agonists and other assets through multiple data milestones and other value-driving catalysts in the coming year."

Financial & Business Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Increased financial resources with over $29 million raised since fiscal year end:
Successful public offering of 1,150,000 ordinary shares with gross proceeds of $26.5 million, securing a 2-year cash runway sufficient to advance programs and enable achievement of numerous milestones.
Generation of an additional $2.6 million through the sale of approximately 91,000 shares via the Company’s At-the-Market offering as of June 7, 2021.
Improved stock liquidity:
Listing of common shares on the NASDAQ exchange and subsequent voluntary delisting from the Canadian Securities Exchange.
Inclusion in the Russell 2000 Index, bringing added visibility to the Company’s robust immuno-oncology pipeline.
Immuno-oncology focused: Divestiture of three legacy businesses (Portage Pharmaceuticals Limited, including subsidiaries Portage Glasgow Ltd. and EyGen Ltd) to Juvenescence Ltd. Through this divestiture, Portage may be entitled to share in revenues upon the achievement of certain milestones based on specified development criteria and may be eligible to receive potential royalties on net sales of products developed utilizing legacy intellectual property.
Clinical Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Acceleration of development programs from the Company’s first-in-class immuno-oncology asset portfolio, including milestones related to lead iNKT agonists PORT-2 and PORT-3 and intratumoral amphiphilic therapy PORT-1. Key milestones included:
Initiation of the PRECIOUS-01 Study of PORT-3 for the treatment of NY-ESO-1 positive solid tumors, the first in a comprehensive clinical development plan to evaluate the Company’s iNKT agonists (PORT-2 and PORT-3) to improve outcomes in a variety of solid tumors.
Initiation of the INVINCIBLE Trial, a Phase 2 early-stage breast cancer study of INT230-6 (PORT-1) conducted by Intensity Therapeutics.
Presentation of interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference from the IT-01 Phase 2 trial conducted by Intensity Therapeutics demonstrating strong safety and survival data for INT230-6 (PORT-1) as both a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors.
Financial Results FY 2021 (April 2020 – March 2021)

The Company generated a net loss of $17.2 million in fiscal year 2021, compared to a net loss of $7.2 million in fiscal year 2020, an increase in net loss of $10.0 million year over year. Operating expenses, which include research and development and general and administrative expenses, were $12.4 million in fiscal year 2021, compared to $6.0 million in fiscal year 2020, an increase of $6.4 million. Operating expenses included $8.8 million of non-cash stock-based compensation expense in fiscal year 2021, compared to $2.1 million in fiscal year 2020.

Research and development ("R&D") costs increased by $3.2 million, or approximately 78%, from $4.1 million in fiscal year 2020, to $7.3 million in fiscal year 2021. The increase was attributable to non-cash stock-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $5.1 million, partially offset by a decrease in iOx related stock-based compensation expense of $0.8 million. Finally, fiscal 2021 development was slowed by the impact of the pandemic.

General and administrative ("G&A") expenses increased by $3.2 million, from $1.9 million in fiscal year 2020, to $5.1 million in fiscal year 2021. The principal reason for the increase was the $2.8 million of non-cash stock-based compensation expense associated with the Company’s 2021 Equity Incentive Plan in fiscal 2021. Additionally, the Company incurred approximately $0.2 million relating to initiatives associated with a corporate restructuring and business development.

Other items of income and expense were substantially non-operating in nature and were $2.5 million net expense in fiscal year 2021, compared to $0.5 million net expense in fiscal year 2020. $2.0 million of the net expense in fiscal year 2021 was non-cash. Other items of income and expense included:

A loss on equity issued at a discount of $1.3 million in fiscal year 2021, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx Notes and warrants;
A loss from our equity investment in Stimunity of $0.5 million, compared to a small gain in fiscal year 2020;
A loss of $0.8 million representing the change in the fair value of the warrants issued with respect to the SalvaRx settlement;
A non-cash gain relating to the settlement of related liabilities on the disposition of PPL of $0.4 million, of which $0.2 million was recorded in operations in fiscal year 2021; and
Interest expense of $0.2 million is fiscal year 2021, compared to $0.6 million in fiscal year 2020 due to the settlement of the SalvaRx Notes. The Company also recorded a loss of $0.2 million on the early extinguishment of the SalvaRx Notes in fiscal year 2021.
Additionally, the Company reflected net deferred income tax provisions of $2.3 million and $0.7 million in the fiscal years 2021 and 2020, respectively.

As of June 30, 2021, the Company had approximately $28.6 million of cash on hand.