On March 29, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported a charitable commitment totaling $7.5 million to The Leukemia & Lymphoma Society (LLS), a global leader in the fight against blood cancer (Press release, Royalty Pharma , MAR 29, 2022, View Source;lymphoma-society-lls-to-advance-initiatives-that-address-healthcare-disparities-in-blood-cancer-care-and-treatment-301512545.html [SID1234611151]). Through this five-year alliance, Royalty Pharma will support initiatives focused on reducing healthcare disparities in blood cancer care and treatment. Royalty Pharma is a founding donor of the LLS IMPACT grant program (Influential Medicine Providing Access to Clinical Trials) which awards funding to major cancer research and treatment centers to expand access to clinical trials for underserved and minority populations. Royalty Pharma plc will not receive any economic benefit in exchange for any aspect of these donations.

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Royalty Pharma is supporting initiatives focused on reducing healthcare disparities in blood cancer care and treatment.

"Despite many advances in blood cancer care and treatment, barriers exist in many communities to prevent patients from accessing new, more effective therapies and protocols that can lead to better outcomes," said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. "The gift awarded through Royalty Pharma’s alliance with The Leukemia & Lymphoma Society is intended to propel the work LLS is doing in underserved communities through three key initiatives that will help break down these barriers and ensure that everyone has access to the care they need to treat their blood cancer."

Blood cancer does not discriminate, affecting people of every age, gender, race and ethnicity. But not all people have equal access to care and treatments. LLS exists to ensure that all patients get the care they need. Royal Pharma’s annual contribution of $1.5 million over five years will be equally distributed to the following LLS initiatives that address disparities:

Equity in Access Research Program is a grantmaking program designed to generate evidence that will guide changes in healthcare policy and practice to ensure that all blood cancer patients and survivors achieve access to the cancer care and services they need throughout their lives. This new and novel program is based on the concept of health equity as the principle underlying a commitment to reduce—and ultimately, eliminate—disparities in health.
LLS IMPACT* Research Grants initiative has been established to improve access to clinical trials for underrepresented patients, including Black, Indigenous and People of Color (BIPOC) patients and people from rural communities. Through this initiative, LLS has awarded funding to three major cancer centers located in New York, Tennessee, and Minnesota to partner with community-based hospitals and clinics on creating networks of clinical trial sites in their regions. Additional sites will be selected in the coming months. More information, including participating sites, the communities they serve and the need to address disparities in these areas can be found here.
Myeloma Link is carried out by LLS staff and volunteers in 13 Black communities across the country. It is an education and outreach initiative that raises community awareness about myeloma and connects Black patients and caregivers to trusted, free myeloma information and support and enhances access to care and the latest treatments. Black Americans have at least double the incidence of myeloma as any other racial or ethnic group, and recent studies show they experience less optimal care. To learn more, including the cities where Myeloma Link is active, please visit this site.
"The Leukemia & Lymphoma Society has a long-standing commitment to serving all blood cancer patients and reaching underserved communities where there are barriers to access and equitable care," said Louis J. DeGennaro, Ph.D., President and Chief Executive Officer of The Leukemia & Lymphoma Society. "Royalty Pharma’s generous contribution to these three important initiatives will bring us closer to achieving our goal to ensure a future of expanded access and better outcomes for all blood cancer patients and their families."

On March 29, 2022 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage pharmaceutical company focused on research and development for novel cancer therapeutics, reported that the first patient has been dosed in the Phase 1/2 study of DSP-5336, an inhibitor of menin binding to mixed-lineage leukemia (MLL) protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) (Press release, Sumitomo Dainippon Pharma, MAR 29, 2022, View Source [SID1234611150]).

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"Patients with refractory or relapsed AML or ALL have an unfavorable prognosis and respond poorly to available treatments.1 Dosing the first patient in our Phase 1/2 study is an important milestone as we evaluate DSP-5336 and its safety and potential benefits for this patient population," said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, Inc (SDP Oncology). "It is our hope that the data generated by this study furthers our goal of advancing meaningful treatments for patients with blood cancer."

The Phase 1/2 open-label study consists of two parts, dose escalation and dose expansion. The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D). Secondary objectives include assessment of preliminary clinical activity of DSP-5336 in adult patients with relapsed or refractory AML or ALL.

Following the completion of the Phase 1 dose escalation portion of the study, the study will move into the Phase 2 dose expansion. The primary objective of the Phase 2 dose expansion portion of the study is to further evaluate the safety and clinical activity of DSP-5336 in adult patients with relapsed or refractory AML who have MLL rearrangement or nucleophosmin 1 (NPM1) mutation.

Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04988555).

About DSP-5336

DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2, 3 Binding of menin to MLL fusion and wildtype proteins leads to the upregulation of HOXA family and MEIS1 genes that function to stall myeloid cellular differentiation and induce leukemogenic transformation.2,4,5 Preclinical evidence shows that the disruption of fusion and wild-type menin-MLL interactions inhibits leukemic cell proliferation and restores terminal differentiation of MLL-rearranged and nucleophosmin 1 (NPM1)–mutated leukemic cells.1,6 (NCT04988555).

On March 29, 2022 Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, reported that the first patient has been dosed in its Phase 3 registration study AB-205-301 (E-CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT) (Press release, Angiocrine Bioscience, MAR 29, 2022, View Source [SID1234611148]). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.

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E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ vascular stem cell niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. The US Food and Drug Administration has conferred special regulatory status to AB-205 via the Regenerative Medicine Advanced Therapy and Orphan Drug designations for this indication.

More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.

"We expect 2022 to be a transformational year at Angiocrine, and we are excited to initiate this pivotal Phase 3 study," said Paul Finnegan, MD, Angiocrine’s CEO. "We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program."

Series B Financing
Angiocrine Bioscience recently completed a Series B equity financing led by Cobro Ventures along with participation from Angiocrine’s existing stockholders. The newly raised capital will be used to accelerate Angiocrine’s clinical assets and expand its research pipeline. "We are enormously excited about the potential of Angiocrine’s E-CEL platform," said Dennis Klinman, MD, PhD, Chief Scientific Officer at Cobro Ventures. "Angiocrine’s approach is truly innovative and has great potential to regenerate tissues that have been injured or damaged by diseases including degenerative, auto-immune, and ischemic diseases, in addition to high-intensity cancer treatments."

About AB-205
AB-205 is an experimental, genetically engineered cell therapy consisting of allogeneic engineered human endothelial cells (E-CEL cells). AB-205 is being developed for multiple indications and is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the vascular stem cell niches of multiple organs sustained during high-dose chemotherapy.

About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is considered a standard-of-care consolidative treatment to cure patients with aggressive systemic lymphoma who have failed 1st-line chemotherapy and respond to chemotherapy induction. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue, which can lead to severe toxicities and serious, costly complications. Complication rates and severity increase with age and, thus, many older patients are turned away from this potentially curative therapy due to concerns over complication risks.

On March 29, 2022 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2021 (Press release, Ampio, MAR 29, 2022, View Source [SID1234611147]).

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"We have made significant progress on core objectives, including the release of positive Phase 3 data and the submission of a Type C meeting request to the FDA," said Mike Martino, Chairman and CEO of Ampio. "Additionally, we have secured incremental liquidity that improves financial strength and is expected to fund current operations into the second half of 2023. This provides strategic options as we continue discussions with the FDA and potential partners. Further, we have strengthened our corporate governance, compliance, and clinical development expertise through the expansion of our Board of Directors and appointments of key leadership positions."

Ampio is pleased to provide recent operational highlights that are summarized below.

OAK Clinical Development
Phase 3 Study, AP-013: The AP-013 study, a Phase 3 trial designed to evaluate pain and function in patients with the target condition of severe osteoarthritis of the knee (OAK), was designed to confirm the efficacy observed in the first pivotal study, AP-003-A, and support an Ampion Biologics Licensing Application (BLA). The AP-013 study was found to have been impacted by COVID-19 using a blinded sensitivity analysis. To mitigate this impact, a modified-intent-to-treat (mITT) population is proposed to evaluate efficacy in AP-013.

Analysis of AP-013 Data: AP-013 analysis of the three efficacy analysis populations demonstrated:

In the mITT population, Ampion demonstrated a statistically significant reduction in pain (p=0.042) and trended toward improvement in function versus saline control.

In the Per Protocol population of AP-013, Ampion demonstrated statistically significant reduction in pain (p = 0.020) and a statistically significant improvement in function (p = 0.027) versus saline control.

The Intent to Treat population was impacted by a large amount of missing data and mandated imputation due to COVID-19 and did not demonstrate statistically significant reduction in pain or statistically significant improvement in function.

Type C Meeting with FDA: The FDA has agreed to a written response to our Type C Meeting request regarding the AP-013 study. By the end of the first half of this year, the Company expects to have FDA clarity on whether the AP-013 trial together with AP-003-A will support an Ampio BLA for the treatment of pain associated with severe OAK.
COVID-19 Clinical Development
AP-017 Intravenous (IV) Treatment for Severe COVID: Study AP-017 was designed to evaluate IV Ampion treatment in severe COVID-19 patients in up to 200 patients with an interim analysis at 30 patients for sample size re-estimation. The interim enrollment and analysis for sample size re-estimation is complete. The observed safety profile of IV Ampion treatment has been excellent to date and there will be no sample size adjustment in the study. However, enrollment has been slow, and the COVID-19 treatment and regulatory approval landscape has evolved. Therefore, the Company has stopped further enrollment and will analyze the data completely to determine next steps for the use of IV Ampion.

AP-018 Inhaled Treatment for Long-COVID: Study AP-018 was designed to evaluate inhaled Ampion treatment in 30 patients with Long-COVID. Enrollment was completed in December 2021, and the Day 60 post-treatment safety and efficacy measures are currently underway. Once complete, the data will be prepared for analysis, and the Company will determine next steps for the program when the analysis has been completed. Ampio is on track to complete the data analysis by the end of the second quarter of 2022.

AP-019 Inhaled Treatment for Severe COVID: Study AP-019 was designed to evaluate inhaled Ampion treatment in up to 200 severe COVID-19 patients with an interim analysis for sample size re-estimation. The interim enrollment was completed with 129 patients in the first quarter of 2022. Ampio is on track to complete the data analysis by the end of the second quarter of 2022, at which time the Company will determine next steps for the study.
Expansion of Leadership
Expansion of Board of Directors: Ampio announced the appointment of J. Kevin Buchi, Michael Martino, and Elizabeth Varki Jobes, Esq. to the Ampio Pharmaceuticals Board of Directors. These appointments expand the Company’s Board of Directors to eight members and prepares the Company for its next phase.

Strengthening of Management: Ampio announced the appointment of Michael Martino as Chairman of the Board of Directors and Chief Executive Officer. Additionally, Howard Levy, M.B.B.Ch., Ph.D., M.M.M., was appointed as Chief Medical Officer, and Holli Cherevka was promoted to the position of President and Chief Operating Officer.
Fourth Quarter and Full-Year 2021 Financial Results
Net Loss: Net loss was $6.2 million for the fourth quarter compared to net loss of $4.6 million for the fourth quarter of 2020, and $17.1 million for the year compared to a loss of $15.9 million for the year ended December 31, 2020. Further details on these variances are below.

R&D Expenses: Research and development expenses were $4.7 million for the fourth quarter compared to $2.1 million for the fourth quarter of 2020, and $11.9 million for the year compared to $9.2 million for the year ended December 31, 2020. The primary drivers of the year-over-year increase were incremental costs associated with the COVID-19 Phase 1 and 2 studies which were initiated late in 2020 and during the 2021 period. These costs were partially offset by (i) reduction in costs associated with the AP-013 study which was paused in the 2020 period.

G&A Expenses: General and administrative expenses were $4.5 million for the fourth quarter compared to $1.8 million for the fourth quarter of 2020, and $8.7 million for the year compared to $6.7 million for the year ended December 31, 2020. The increase was primarily attributable to (i) increase in share-based compensation and professional fees for legal and other advisory services

Cash position: Cash and cash equivalents on December 31, 2021, totaled $33.9 million, compared to $17.3 million as of December 31, 2020, driven primarily by (i) net proceeds from the closing of a registered direct offering in December totaling $20.7 million, and (ii) net proceeds of $10.0 million from the sale of common stock with the "at-the-market" equity offering program throughout the year; partially offset by cash used in operating activities totaling $14.1 million. Ampio projects its cash position will fund current operations into 2H 2023.

On March March 29, 2022 Photocure ASA (OSE: PHO), The Bladder Cancer Company, reported that President and Chief Executive Officer, Dan Schneider and Chief Financial Officer, Erik Dahl will present corporate overviews and host 1-on-1 meetings with investors at the DNB Small & Medium Enterprises Conference on April 7, 2022, and the 21st Annual Needham Healthcare Conference being held virtually April 11-14, 2022 (Press release, PhotoCure, MAR 29, 2022, View Source;medium-enterprises-and-needham-healthcare-301512912.html [SID1234611146]).

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For the Needham Healthcare Conference, Photocure’s presentation is scheduled to take place April 14th at 8:00am ET (2:00pm CET) and can be accessed via the following link: View Source

About the conferences:

Now in its 18th year, the DNB Small & Medium Enterprises Conference 2022 is a one-day conference that will include company presentations from various sectors. Before the pandemic, more than 500 investors, company representatives and other market participants from the Nordics, UK and Continental Europe attended the conference.
The 21st Annual Needham Virtual Healthcare Conference will feature leading public and private companies in the Biotechnology, Specialty Pharmaceuticals, Medical Technology, and Diagnostics sectors.