On March 25, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral cancer immunotherapies, reported it will sponsor a key opinion leader (KOL) webinar to be held by LifeSci Advisors discussing the anti-PD-1 checkpoint refractory metastatic melanoma landscape and the impact of the results from ILLUMINATE-301 on Wednesday, March 31, 2021 at 12:00 p.m. ET (Press release, OncoSec Medical, MAR 25, 2021, View Source [SID1234577167]).

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The webinar features presentations by KOLs Gregory Daniels, M.D., Ph.D., UC San Diego Health, Paolo Ascierto, M.D., National Tumor Institute Fondazione G. Pascale, John M. Kirkwood, M.D., University of Pittsburgh, and Matteo Carlino, M.D., Westmead and Blacktown Hospitals.

A Fireside Chat moderated by Neil Canavan, author of "The Cure Within," will follow the formal presentations and the KOLs will be available to answer questions afterward.

To register for the event, please click here.

The KOLs will discuss the anti-PD-1 checkpoint refractory metastatic melanoma landscape and commercial outlook:

Gregory Daniels, M.D., Ph.D., UC San Diego Health, will lead the discussion on tumor-infiltrating lymphocytes (TILs). Dr. Daniels, a board-certified oncologist, coordinates care for patients with melanoma, skin cancers and head and neck cancers. Dr. Daniels treats certain skin cancers with highly effective immunotherapy approaches. He is part of the Precision Immunotherapy Clinic, which offers the most promising investigational immunotherapies for many types of cancer. As a professor in the Department of Medicine, Dr. Daniels is involved in training medical students, residents and fellows at UC San Diego School of Medicine. Active in research, much of his work has focused on understanding the link between autoimmunity and tumor immunity in developing more effective and less toxic immune-stimulatory approaches for patients with melanoma. Dr. Daniels completed his fellowship and residency at Mayo Clinic in Rochester, Minn. and earned his medical degree from University of Southern California Keck School of Medicine.

Paolo Ascierto, M.D., National Tumor Institute Fondazione G. Pascale, will co-lead the discussion on intratumoral (IT) toll-like receptor (TLR) 9. Dr. Ascierto is the Director of the Dept. of Melanoma, Cancer Immunotherapy and Development Therapeutics at the National Tumor Institute IRCCS Fondazione G. Pascale in Naples, Italy. He previously served as a postdoctoral fellow and then as vice-director of the Department of Clinical Immunology. His research interest has focused on diagnosis and treatment of melanoma, including assessment of new molecular markers for tumor progression, targeted therapies, immunotherapy and vaccination treatments. He has served as principal investigator in numerous clinical trials and has published numerous peer-reviewed articles on these topics. He earned his M.D. and received board-certification in oncology from the University of Naples.

John M. Kirkwood, M.D., University of Pittsburgh, will co-lead the discussion on intratumoral (IT) toll-like receptor (TLR) 9. Dr. Kirkwood, M.D. is board-certified in internal medicine and medical oncology and is Professor of Medicine at the University of Pittsburgh. He received his medical degree from Yale University School of Medicine, where he was also an intern and resident in internal medicine. His subspecialty is in medical oncology and he completed his fellowship in this field at the Dana Farber Cancer Institute and Harvard Medical School. Dr. Kirkwood’s early research in tumor immunology was done at Memorial Sloan Kettering and his postdoctoral fellowship work in tumor immunology at Harvard University. He is a member of the New York Academy of Sciences, the American Society for Clinical Oncology, the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the American Medical Association, the Eastern Cooperative Oncology Group, the National Cancer Foundation, the International Society for Interferon and Cytokine Research, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), the Society for Melanoma Research, the Clinical Immunology Society and the Society of Natural Immunity.

Matteo Carlino, M.D., Westmead and Blacktown Hospitals, will lead the discussion on IT DNA plasmid-based Interleukin-12 (IL-12). Dr. Carlino is a Medical Oncologist at Westmead and Blacktown Hospitals, where he leads melanoma clinical trials program, a Clinical associate professor at The University of Sydney and a Faculty Member at MIA. He undertook a Ph.D. examining predictors of response and mechanisms of resistance to BRAF and MEK inhibitor treated melanoma. Dr. Carlino continues to be involved in the translational research program based at MIA and the Westmead Institute for Cancer Research. He is an investigator on multiple Phase I, II and III clinical trials in melanoma targeted and immunotherapy.

On March 25, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that initial patient enrollment in the second dose cohort in the Phase 1 portion of the Actimab-A venetoclax Phase 1/2 combination trial in fit and unfit patients with relapsed or refractory Acute Myeloid Leukemia (r/r AML) has been completed (Press release, Actinium Pharmaceuticals, MAR 25, 2021, View Source [SID1234577166]). The Phase 1 portion of the trial is a 3 + 3 dose escalation study to determine the maximum tolerable dose of Actimab-A that is to be studied in the Phase 2 portion of the study. Based on the progress of enrollment, Actinium expects to complete the Phase 1 portion and present further proof-of-concept data in the second half of 2021.

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First-in-human data from the first dose cohort of 0.5 μCi/kg of Actimab-A and Venetoclax were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. Patients enrolled in the first dose cohort had a median of 2 prior therapies (range 2-3) and a median bone marrow blast percentage of 30% (range 20 – >60). All 3 patients had poor risk disease with adverse cytogenetics, and each patient had an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation). One patient who had multiple genetic mutations including IDH2, RUNX1, TP53 and others, achieved a complete remission with incomplete blood count recovery (CRi) after the first cycle of Actimab-A and venetoclax. Next generation sequencing at the end of the first cycle showed that the patient was negative for the known IDH2 and RUNX1 mutations. In addition, another patient achieved a partial response after one cycle of Actimab-A and venetoclax. There were no Actimab-A related dose limiting toxicities or nonhematologic Grade 3 or greater related AEs reported in the first cohort.

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "We are encouraged by the strong progress we are making in this novel combination trial and excited to be studying Actimab-A with venetoclax. Venetoclax has emerged as a standard of care and backbone therapy for patients with AML who are both fit and unfit, however, patients with relapsed or refractory disease have poor outcomes and therefore need better treatment options. Based on the synergistic mechanism of action and preliminary clinical evidence from the first cohort, we are optimistic that Actimab-A in combination with venetoclax can improve outcomes for patients with relapsed or refractory disease using the unique targeted radiation mechanism of Actimab-A. We look forward to presenting data from this cohort of patients as well additional clinical data from the Phase 1 portion of the trial and working to advance this novel combination in the clinic."

In a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Actimab-A was shown to be synergistic with venetoclax in venetoclax resistant cell lines, by depleting Mcl-1, a protein shown to mediate resistance to venetoclax. Further, the induction of direct AML cell death via double-stranded DNA breaks via the radioisotope Actinium-225 in Actimab-A provides a second mechanism for enhancing synergistic potency with venetoclax. Venetoclax is a B-Cell Lymphoma 2 (Bcl-2) inhibitor that is jointly developed and marketed by AbbVie and Genentech and is approved for patients with AML, Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Leukemia (SLL). Despite its approval in AML, venetoclax has produced low response rates of 19% as a single agent in R/R AML.1 A Phase 2 trial studying Actimab-A as a single agent produced a 69% overall response rate in older unfit patients with newly diagnosed AML.

Sandesh Seth, Actinium’s Chairman and CEO, added, "This trial is an exciting evolution of our Actimab-A program and application of the isotope Actinium-225. Actinium-225 is a potent medical isotope that can kill a cancer cell with a single alpha particle hit, emits four alpha particles in its decay and can cause double strand DNA breaks for which cancer cells have no known repair or resistance mechanism. Its energy is also emitted over a very short path length equal to a few cells in diameter enabling precise cell killing while sparing normal cells to limit systemic toxicities. With clinical experience in nearly 150 patients, robust IP and a clinically validated supply chain, we are leaders in the rapidly growing field of targeted alpha radiotherapy and specifically Actinium-225. Through continued clinical progress and innovation driven by our R&D efforts, we are committed to advancing our leadership position in the field of Actinium-225 based therapies and applying them with the goal of improving patient outcomes."

1 Aldoss et al. Efficacy of the combination of venetoclax and hypomethylating agents in relapsed/refractory acute myeloid leukemia. Haematologica2018.1888094.

About Actinium’s CD33 Program

Actinium’s CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant. Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

On March 25, 2021 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported it will present a trial-in-progress poster on KD033-101, the Company’s ongoing dose-escalation, dose-expansion trial of KD033 in patients with metastatic and locally advanced solid tumors, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place virtually April 10 – 15, 2021 (Press release, Kadmon, MAR 25, 2021, View Source [SID1234577165]).

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KD033 is currently being evaluated in an ongoing Phase 1 study in patients with metastatic or locally advanced solid tumors. Initial safety data from the trial are anticipated in Q2 2021. Additional clinical data from the trial are anticipated in Q4 2021.

Details of the AACR (Free AACR Whitepaper) trial-in-progress poster are outlined below:

KD033-101 Poster Presentation

Title: A Phase 1 Multiple Ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors

Category: Session PO.CT08.01 – Phase I Clinical Trials in Progress

Date/Time: April 10, 2021, 8:30 AM – 11:59 p.m. ET

Abstract ID: CT227

About the KD033-101 Clinical Trial

KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.

About KD033

KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability. KD033 was well tolerated in GLP toxicology studies at clinically relevant doses. KD033 process development and manufacturing was completed through a successful collaboration with Wuxi Biologics and exhibited desired manufacturability and stability criteria.

KD033 is the most advanced candidate from Kadmon’s IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.

On March 25, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported fourth quarter and full-year 2020 financial results and recent business updates (Press release, Monopar Therapeutics, MAR 25, 2021, View Source [SID1234577164]).

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Recent Business Updates

Lead Product Candidate Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
The U.S. Patent and Trademark Office (USPTO) allowed patent claims for Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential use of Validive in cancer patients beyond earlier allowed claims specifically for the prevention of oral mucositis in patients receiving CRT.
Camsirubicin

The Phase 2 clinical trial of camsirubicin is anticipated to commence enrollment in the second quarter of 2021. Monopar’s clinical development collaborator, Grupo Español de Investigación en Sarcomas (GEIS), will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).
The trial will begin with an open-label dose escalation "run-in" prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events.
The USPTO allowed patent claims covering compositions of matter (2-pyrrilino camsirubicin) for a novel family of camsirubicin analogs. This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar’s camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells which may enable use in cancer types beyond those treatable with camsirubicin.
MNPR-101 and Related Compounds

Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (i) IsoTherapeutics Group, LLC to develop and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (ii) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (iii) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the clinical development of uPRITs.
The European Journal of Cancer published a peer-reviewed preclinical study which shows the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection.
Results for the Fourth Quarter and Year Ended December 31, 2020 Compared to the Fourth Quarter and Year Ended December 31, 2019

Cash and Net Loss

Cash and cash equivalents as of December 31, 2020 were $16.7 million. Monopar anticipates that its current cash and cash equivalents, which includes an additional $10.9 million of net proceeds raised in the first quarter of 2021 under the Company’s Capital on Demand Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company’s planned operations at least through March 2022. Planned operations include funding and completing the Phase 2b portion of the Validive "VOICE" clinical trial and commencing of the Phase 3 portion; the funding of the run-in portion of the GEIS Phase 2 camsirubicin clinical trial; and continuation of the development of the COVID-19 uPRIT program along with other MNPR-101 related compounds. The Company plans to raise additional funds or engage a partner in the next 12 months to complete the VOICE clinical program and continue the GEIS camsirubicin clinical trial beyond the run-in phase.

Net loss for the fourth quarter of 2020 was $2.1 million or $0.19 per share compared to net loss of $1.2 million or $0.13 per share for the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $6.3 million or $0.58 per share compared to net loss of $4.2 million or $0.45 per share for the year ended December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2020 were $1.6 million compared to $0.6 million for the fourth quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses of $0.5 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.2 million for the VOICE clinical trial planning and manufacturing costs, and $0.3 million for R&D personnel salary and benefits.

R&D expenses for the year ended December 31, 2020 were $4.1 million compared to $2.0 million for the year ended December 31, 2019. This represents an increase of approximately $2.1 million primarily attributed to increases in expenses of $1.1 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.1 million for the VOICE clinical trial planning and manufacturing costs, and $0.9 million for R&D personnel salary and benefits.

General and Administrative (G&A) Expenses

G&A expenses for the fourth quarter of 2020 were $0.6 million, equal to $0.6 million for the fourth quarter of 2019.

G&A expenses for the year ended December 31, 2020 were $2.4 million, equal to $2.4 million for the year ended December 31, 2019.

On March 25, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, reported financial results for its fourth quarter and year ended December 31, 2020 (Press release, Knight Therapeutics, MAR 25, 2021, View Source [SID1234577163]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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2020 Highlights

Financials

Revenues were $199,519, an increase of $152,058 or 320% over prior year.
Gross margin was $81,690 or 41% compared to $26,918 or 57% in prior year.
Adjusted EBITDA1 was $16,837 compared to $2,827 in prior year.
Interest income generated of $14,322 a decrease of $9,220 or 39% over prior year.
Gain from strategic fund investments of $46,733, of which $16,644 was realized.
Adjusted earnings1 of $28,713, an increase of $2,714 or 10% over prior year.
Net income was $31,760 compared to net income of $18,033 in prior year.
Corporate Developments

Promoted Arvind Utchanah from VP Finance to CFO.
Appointed Janice Murray and Nicolás Sujoy on the Board of Directors.
Disposed of the shares of Medison Biotech (1995) Ltd. for a cash consideration of $77,000 and recorded a gain of $2,948.
Purchased 5,748,716 common shares at an average price of $6.40 per share through a Normal Course Issuer Bid ("NCIB").
Completed the tender offer process for an aggregate purchase price of $170,855 and achieved 99.9% ownership of Biotoscana Investments S.A. ("GBT").
Products

Launched Cresemba, indicated for the treatment of invasive aspergillosis and invasive mucormycosis, in Brazil.
Launched Karfib, indicated for relapsed or refractory multiple myeloma, in Argentina.
Received regulatory approval from Health Canada for Ibsrela for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").
Obtained the exclusive Canadian commercial rights of Trelstar, approved for the treatment of advanced prostate cancer.
Obtained regulatory approval for Lenvima and Halaven in Ecuador.
Received regulatory approval from Health Canada for Imvexxy and Bijuva.
Submitted a supplement to a New Drug Submission ("NDS") of Nerlynx for HER2-positive metastatic breast cancer.
Signed a new exclusive distribution agreement with Gilead for the continued commercialization of AmBisome in Brazil, effective January 1, 2021.
Strategic Investments

Disposed of 111,355 common shares of Profound Medical Inc. for total proceeds of $1,825.
Received US$5,000 for the full repayment of the strategic loan issued to Triumvira Immunologics Inc.
Amended strategic loan issued to Synergy CHC Corp. and loaned an additional US$2,500.
Received distributions of $29,128 from strategic fund investments and realized a gain of $16,644.
Key Subsequent Event

Purchased an additional 2,895,456 common shares at an average price of $5.25 per share through the NCIB.
Disposed of 315,600 common shares of Medexus Pharmaceuticals Inc. for total proceeds of $2,624.
Announced the Canadian commercial launch of Ibsrela for the treatment of IBS-C.
"The past year was a transformative year for Knight with the completion of the acquisition of GBT. Despite the challenges due to COVID-19, we continue to progress on integration, while advancing on our product portfolio in both Canada and Latin America. We have received regulatory approvals from Health Canada for Ibsrela, Imvexxy and Bijuva and received regulatory approvals for Lenvima and Halaven in Ecuador. We continue to focus on our mission to acquire, in-license, develop and commercialize innovative medicines and high-quality treatments to improve the health of patients in Latin America and Canada," said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc.