On March 31, 2021 Notable Labs Inc., a leader in technology-powered life science with a proprietary platform for predicting patient outcomes and accelerating precision drug development, reported the appointment of Thomas A. Bock, MD, MBA, as Chief Executive Officer (Press release, Notable Labs, MAR 31, 2021, View Source [SID1234577435]). Dr. Bock joined Notable’s Board of Directors in August 2020 and now succeeds Laurie Heilmann as the company’s executive leader, with Notable Founder Matt De Silva remaining as Chairman of the Board.

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"Thomas has built four successful life science organizations with tremendous impact for patients and investors, achieving leadership in novel and fast-growing markets including cancer precision medicine and ultra-rare disorders. His dual experience in life science and technology makes him the right leader to champion Notable in its technology-powered advancement of cancer medicine and precision oncology therapies," said De Silva. "Notable’s integration of cutting-edge predictive technology and life science therapeutic programs not only opens strategic commercial opportunities, but also creates a unique workplace blending top talent across tech and life science."

Dr. Bock founded and served as Chief Executive Officer of HeritX Inc., a pioneer in cancer prevention through pre-cancer vaccines, immunoprevention, and gene repair, with the largest cancer prevention pipeline in the industry. Previously, he served as Senior Vice President Medical Affairs on the executive management team of Alexion Pharmaceuticals, building a start-up into a global frontrunner in ultra-rare disorders, a growth leader on NASDAQ, and the world’s second most innovative company, according to Forbes. Before joining Alexion, Thomas built and led the worldwide Medical Departments of Novartis Oncology and Celgene as their Vice President and Global Head of Medical Affairs. Prior to Celgene, Thomas served as the medical head of Amgen Europe for hematology and oncology. He developed and commercialized six lifesaving paradigm-changing blockbuster medicines in cancer, ultra-rare disorders, and inflammation. He is recognized for achieving five of the most successful product launches in life science.

Thomas earned his MD degree at RWTH Aachen University and his MBA at Columbia Business School. He is the Chair of the Healthcare Advisory Board at Columbia Business School, former Chair of the Board of Directors of HeritX Inc., and former Board Chair and President of FORCE, the US patient organization for inherited breast and ovarian cancer.

"I am thrilled to work together with Notable’s outstanding team and seize the tremendous opportunities that our predictive technology platform offers for accelerating the development of personalized cancer treatments," said Bock. "Building on our robust platform, collaborations and insights, we can now focus on the most promising projects and advance them with the sense of urgency that patients deserve."

On March 31, 2021 Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech company, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an Affimed and NKMax America co-sponsored Phase 1/2a dose escalation and expansion study in which the two companies will investigate the combination of AFM24, an EGFR/CD16A innate cell engager (ICE), and SNK-01, an autologous NK-cell product, in patients suffering from tumors known to express EGFR (Press release, NKMax America, MAR 31, 2021, View Source [SID1234577434]). The combination represents a novel approach to exploring innate immunity-based therapeutics to treat patients with solid tumors who failed conventional therapy with the aim to improve outcomes for high-medical need patient populations.

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"This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors. In addition to NK cell-based combinations, we are also developing AFM24 as single agent and in combination with atezolizumab in several tumor indications," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "The mechanism of action of the two compounds could be highly synergistic as AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy."

"The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our Natural Killer cell therapy development program," said Stephen Chen, Chief Operating Officer and Chief Technical Officer of NKMax America. "We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced/metastatic EGFR-expressing cancers."

Further Information About the AFM24/SNK-01 Phase 1/2a study

The Phase 1/2a study is based on preclinical in vitro testing, combining Affimed’s ICE AFM24 with NKMax America autologous NK-cell product SNK-01, which showed enhanced activity of NK cell induced target cell killing. The Phase 1/2a study will be an open-label, non-randomized, multi-center, US only, dose escalation trial to evaluate the combination in adult patients with EGFR-expressing tumors. The primary objective of the phase 1 study part will be to establish the safety and the recommended phase 2 dose of AFM24/SNK-01 combination, as well as to evaluate pharmacokinetics, pharmacodynamics, and preliminary activity in patients with advanced cancers expressing EGFR. The phase 2a portion of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.

On March 31, 2021 BioCanRx researchers Dean Fergusson, Justin Presseau, Natasha Kekre, Harold Atkins, Kednapa Thavorn, Rob Holt, Manoj Lalu, and patient representative Terry Hawrysh reported that they have recently published results in two medical journals from their BioCanRx-funded project, "Getting better Outcomes with Chimeric Antigen Receptor T-cell therapy (GO–CART): A BioCanRx Research Excelerator to Safely and Effectively Translate CAR T-Cell Therapy for Hematological Malignancies" (Press release, BioCanRx, MAR 31, 2021, View Source;utm_medium=rss&utm_campaign=biocanrx-funded-researchers-publish-results-car-t-csei-project [SID1234577433]).

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The study, which began in 2017, aimed to bring together experts from different backgrounds as well as patient representatives to formulate a feasible, safe, effective, and economical trial protocol that addressed the pitfalls some early-phase trials have faced in the past. Its ultimate aim was to help BioCanRx scientists effectively use CAR T cells in Canada.

Read about the results of their research below:

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials

On March 31, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the fiscal year ended December 31, 2020 and provides a business update (Press release, AIM ImmunoTech, MAR 31, 2021, View Source [SID1234577432]).

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2020 Financial Highlights

As of December 31, 2020, AIM had cash, cash equivalents and marketable securities of $54.4 million, compared with $8.8 million as of December 31, 2019.

Research and development expenses for 2020 were $5.7 million, compared with $4.7 million for 2019. General and administrative expenses for 2020 were $8.7 million, compared with $7.0 million for 2019.

The net loss from operations for 2020 was $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019.

Please refer to the full 10-K for complete details.

Update on COVID-19 Pandemic Initiatives

AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for COVID-19. Due to Ampligen’s established record of antiviral activity against closely related coronaviruses, AIM believes there is a reasonable probability that its antiviral effects against SARS-CoV-1 will extend to SARS-CoV-2. In animal studies, Ampligen demonstrated complete protection (100% survival) against SARS-CoV-1. This created a compelling case for pre-clinical and clinical testing of Ampligen against SARS-CoV-2 to evaluate Ampligen as a potential prophylactic and early-onset treatment for COVID-19, and, as discussed below, such human clinical trials are now underway.

AIM reached several significant COVID-19 milestones in 2020 and early 2021:

AIM announced that it had identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, with the results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
AIM reported that Roswell Park Comprehensive Cancer Center’s Phase 1/2a study evaluating the two-drug combination of AIM’s Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study. Based upon that, in March 2020, the company also announced an Institutional Review Board amendment to add a single-agent Ampligen arm to the study.
AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with Ampligen.
Dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod). Additional patients are in the process of being enrolled.
Entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, for the AMP-COV-100 (CHDR2049) clinical study in the Netherlands on the safety of AIM’s drug Ampligen as an intranasal therapy.
Received approval from the Ethics Committee in the Netherlands to commence its Phase 1 clinical study.
Dosed the first healthy subjects in its Phase 1 clinical study.
Ampligen has shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the only drug approved for severe CFS in the world. As witnessed in the prior SARS epidemic of 2002-03, 27% of hospitalized survivors met the U.S. CDC criteria for chronic fatigue syndrome. More than 30 million people in the United States have been infected with SARS-CoV-2, representing a considerable number of people facing potential COVID-induced ME/CFS-like illness in their future. All these facts support our optimism and hopes for the development of a therapy for COVID-induced chronic fatigue.

Update on Cancer Clinical Trials/Programs

Ampligen demonstrated the potential for standalone efficacy in the clinical setting in a number of solid tumors. Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

AIM reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program treating 27 subjects with advanced pancreatic adenocarcinoma conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM’s drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was 7.0 months higher in the Ampligen arm as compared to the historical controls. A manuscript for publication is being prepared by the Erasmus MC team.

Towards this end, AIM intends to seek FDA authorization for a follow-up pancreatic cancer Phase 2/3 clinical trial and cancer centers have already expressed interest in serving as clinical sites.

Additionally, Ampligen was awarded an FDA Orphan Drug Designation for the treatment of pancreatic cancer, and a European Medicines Agency orphan medicinal product designation for pancreatic cancer. AIM intends to seek FDA fast-track status for pancreatic cancer. The company will promptly update stockholders and the market as more information on these studies becomes available.

"We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts. We are conducting important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs within large addressable markets. We are in a solid financial position that enables us to continue to execute on our corporate strategy without relying on third-party grants or assistance. Our strong balance sheet also allows us to accelerate our clinical trials without the need to wait for grants. We look forward to updating stockholders and the market as developments unfold," commented Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.

On March 31, 2021 AbbVie (NYSE: ABBV) reported that it will announce its first-quarter 2021 financial results on Friday, April 30, 2021, before the market opens (Press release, AbbVie, MAR 31, 2021, View Source [SID1234577431]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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