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Humanigen Appoints Dr. Adrian Kilcoyne to the role of Chief Medical Officer

On April 21, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported the appointment of Adrian Kilcoyne, MD, MBA, MPH, to the newly-created role of Chief Medical Officer, effective immediately, reporting to Dr. Cameron Durrant, CEO of Humanigen (Press release, Humanigen, APR 21, 2021, View Source [SID1234578312]).

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Dr. Kilcoyne brings to Humanigen strong leadership experience from multinational pharmaceutical and biotechnology companies and a strong clinical background in both Internal Medicine and Public Health Medicine. His most recent leadership role was in AstraZeneca, where he served as Vice President of Oncology Global Medical Affairs, Head of Evidence Generation and External Alliances, and previously as Vice President and Head of US Medical Affairs and Health Economics and Outcomes Research. Dr. Kilcoyne oversaw the development and delivery of the fully integrated global evidence strategy across the company’s complete oncology portfolio, including managing development of real-world evidence, epidemiology, biostatistics and data sciences, health economics and outcomes research, payer evidence, medical affairs sponsored research, and investigator research. He also led Global Oncology External Alliances, building strong scientific partnerships to advance patient care.

"Humanigen is delighted to welcome Dr. Kilcoyne," said Dr. Durrant. "His experience and knowledge in multiple areas, including COVID-19, CAR-T and other oncology clinical development areas, medical affairs, regulatory affairs, evidence generation, health economics, and partnering gives him a unique insight that can be leveraged towards Humanigen’s COVID-19, acute GvHD, CAR-T and other oncology programs with lenzilumab and ifabotuzumab. In addition, Adrian’s leadership in the external alliances arena will be instrumental in helping guide the progress of Humanigen’s pipeline and potential commercialization."

During his tenure at AstraZeneca, Dr. Kilcoyne oversaw multiple launches of innovative therapies in oncology, including acalabrutinib, a Bruton’s tyrosine kinase inhibitor, in the US (marketed as CALQUENCE) which has also been investigated in two Phase 2 studies in COVID-19 patients. Previously, Dr. Kilcoyne held several leadership positions at Celgene Corporation, a subsidiary of Bristol Myers Squibb, including Executive Medical Director, Global Lymphoma Program Lead, Clinical Research and Development overseeing the development of lenalidomide in Diffuse Large B-Cell Lymphoma (DLBCL). He was also the US lymphoma CAR-T lead supporting the clinical development and launch preparation of lisocabtagene maraleucel (or liso-cel, marketed as Breyanzi) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy. Prior to this, Dr Kilcoyne held Medical Affairs and Clinical Development leadership roles in Sanofi Pasteur MSD, Roche and Eli Lilly.

Dr. Kilcoyne’s responsibilities as Humanigen Chief Medical Officer include the clinical development and regulatory strategy for lenzilumab across its varied potential therapeutic indications including CAR-T, acute GvHD, CMML and COVID-19. Additionally, Dr. Kilcoyne will be responsible for the clinical development and regulatory strategy for ifabotuzumab in solid tumors. Dr. Kilcoyne will also be responsible for medical affairs, real-world evidence generation, health economics and outcomes and participate in external alliance evaluation.

"I am excited to join the Humanigen team at this time and look forward to the opportunity to contribute to the company’s strategic long-term growth. I am honored to have the opportunity to deliver on the promise that Humanigen’s innovative portfolio offers to patients with significant unmet medical need," said Dr. Kilcoyne.

Dr. Kilcoyne graduated from Trinity College, Dublin and holds a MSc in Public Health from the London School of Hygiene and Tropical Medicine, along with a MSc in Business Administration from the Warwick Business School. He is the co-author of Pharmaceutical Medicine, a textbook published by Oxford Specialist Handbooks in 2013, edition 2 now being finalized.

EdiGene Raises Approximately USD 62 Million in Series B Plus Financing and Expands Operation Locations to Advance and Scale Up Clinical Translation of Gene Editing Technologies

On April 21, 2021 EdiGene, Inc. ("Company", or "EdiGene"), reported the successful completion of an RMB 400 million (approximately USD 62 million) Series B Plus financing (Press release, EdiGene, APR 21, 2021, View Source [SID1234578311]). Loyal Valley Capital led the round and other new investors included BioTrack Capital and Sherpa Healthcare Partners, along with continued support by existing investors including IDG Capital, Lilly Asia Venture, 3H Health Investment, Huagai Capital, Sequoia Capital China, Alwin Capital and Kunlun Capital. EdiGene is a biotech company develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases. Previously the company completed a Series B Financing of an RMB 450 million (approximately USD 67 million) in October 2020. Proceeds from the financing will be used to advance the company’s pipeline into clinics and to scale up the business operation.

Andy Lin, Founding Partner of Loyal Valley Capital commented: "Gene-editing, as one of the most exciting technologies in life science, has showcased huge potential in treating or curing various diseases in recent years and may fundamentally transform the current ways of disease treatment in the future. As the leading company in China in translating gene-editing technologies into innovative therapies, EdiGene has assembled a team of world-class researchers and experienced drug developers to develop and commercialize such assets, with full scientific rigor and quality. With their lead product receiving the first gene-editing therapy IND application approval in China, their pipeline addresses serious unmet medical needs with innovative and creative approaches. Investing in EdiGene fits very well with our value of ‘investing in and fostering leaders that make the world a better place’. We are honored to lead the round and join force with EdiGene and other investors to bring effective and accessible innovative therapies to patients in China and globally. We look forward to supporting the company in financing, scaling up development capabilities, linking up key resources upstream and downstream and collaborating with global partners, helping the company to become a global player in research and translation of gene editing technologies."

"We are delighted to add these top tier investors and are grateful for the continuous support from the current investors," said Dong Wei, Ph.D.，CEO of EdiGene, "The company is speeding up portfolio advancement and scaling up business footprints. Adding to our existing Beijing R&D center and Guangzhou Clinical Application Center, we have opened our Clinical Development Office in Beijing, Business Development Office in Shanghai and launched a R&D center in Cambridge, Massachusetts, USA. The round enables us to continue our efforts in translating gene-editing technologies into therapeutics and further grow the company in terms of scale, global competitiveness and business development. With these efforts, we strive to bring innovative therapies to patients in need sooner."

"We are grateful for the investors’ support, which enables us to move forward in R&D, company scale and globalization and propel the company to a brand new stage," said Wensheng Wei, Ph.D., Scientific Founder of EdiGene, "We will continue to translate genome editing technologies into transformative therapies, bringing new hope and new options to patients in China and around the world."

In January 2021, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved EdiGene’s Investigational New Drug (IND) application for ET-01, an investigational CRISPR/Cas 9 gene-editing therapy for patients with transfusion dependent β-thalassemia. It marks the first gene-editing therapy and the first hematopoietic stem cell therapy IND application approval in China. The Company is preparing to initiate ET-01’s Phase I clinical trial, and furthermore, is advancing other assets including allogeneic CAR-T therapy, in vivo therapies based on RNA base editing technology LEAPER, as well as novel targeted therapies discovered through high-throughput genome-editing screening.

Mustang Bio to Participate in Chardan’s 5th Annual Genetic Medicines Manufacturing Summit

On April 21, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, and Knut Niss, Ph.D., Chief Technology Officer, will participate in Chardan’s 5th Annual Genetic Medicines Manufacturing Summit, taking place virtually on April 26 and 27, 2021 (Press release, Mustang Bio, APR 21, 2021, View Source [SID1234578310]). The company will participate in a fireside chat on Monday, April 26, 2021, at 3:15 p.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s fireside chat will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.

Pacira to Report First Quarter 2021 Financial Results on Tuesday May 4, 2021

On April 21, 2021 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its first quarter financial results before the open of the U.S. markets on Tuesday, May 4, 2021 (Press release, Pacira Pharmaceuticals, APR 21, 2021, View Source [SID1234578309]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8238109. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8238109. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Cassava Sciences Reports First Quarter 2021 Financial Results and Announces Guidance on Clinical Data Release

On April 21, 2021 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the first quarter ended March 31, 2021 and guidance regarding the release of new clinical data with simufilam (Press release, Pain Therapeutics, APR 21, 2021, View Source [SID1234578308]). Simufilam is the Company’s lead drug candidate to treat Alzheimer’s disease.

"Alzheimer’s is a progressive disease, so a patient’s cognition is expected to worsen over time," said Remi Barbier, President & CEO. "Patients’ cognition scores actually improved following 6 months of open-label treatment with simufilam. Showing similar drug effects following 9 months of open-label treatment would be remarkable, yet consistent with simufilam’s mechanism of action. Eventually, we’d like this drug candidate to benefit cognition for a year or longer."

In July 2021, Cassava Sciences plans to announce results of a pre-specified interim analysis that summarizes safety and cognition data on approximately the first 50 subjects to complete at least 9 months of open-label drug treatment. The Company will present these data July 26 – 29th at the 2021 Alzheimer’s Association International Conference (AAIC). AAIC’s scientific committee has invited the Company’s scientists to present the dataset as an oral presentation.

About the Open-label Study with Simufilam
In March 2020, Cassava Sciences initiated a long-term, open-label study to evaluate simufilam in patients with Alzheimer’s disease. This study is funded by a research grant award from the National Institutes of Health (NIH). The open-label study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice-daily for 12 months or longer in patients with Alzheimer’s disease. Another study objective is to measure changes in cognition on ADAS-Cog, a standard test of cognition in Alzheimer’s disease. The study’s clinical protocol has pre-specified cognition measurements at 6, 9 and 12 months.

The study’s target enrollment is approximately 150 subjects with mild-to-moderate Alzheimer’s disease (recently increased by 50 subjects). One-hundred subjects have enrolled in this study across multiple clinical sites in the U.S. and Canada.

On February 2, 2021, Cassava Sciences announced positive results of a first interim analysis that summarizes clinical data on the first 50 subjects to complete 6 months of open-label treatment. Patients’ cognition scores improved from baseline following 6 months of simufilam treatment, with no safety issues. Six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6.

In September 2021, Cassava Sciences plans to announce results of an interim analysis that summarizes safety and cognition data on approximately the first 50 subjects to complete at least 12 months of open-label drug treatment.

About the Cognition Maintenance Study (CMS)
In June 2021, Cassava Sciences plans to initiate a double-blind, randomized, placebo-controlled study in patients with Alzheimer’s disease. Patients who have completed at least one year of open-label treatment with simufilam qualify to enroll in the Cognition Maintenance Study (CMS). Study subjects in the CMS will be randomized (1:1) to simufilam or placebo for six months. The CMS is designed to compare simufilam’s effects on cognition in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment.

About the Phase 3 Clinical Program
Cassava Sciences plans to initiate a Phase 3 program of simufilam in Alzheimer’s disease in the second half of 2021. The Phase 3 program consists of two large, double-blind, randomized, placebo-controlled studies in patients with mild-to-moderate Alzheimer’s disease dementia.

Cassava Sciences’ first Phase 3 study is designed to evaluate disease-modifying effects of simufilam in Alzheimer’s disease. The goal is to demonstrate a slower rate of decline in cognition and health function in subjects treated with simufilam compared to placebo. Approximately 1,000 subjects to be enrolled, randomized (1:1:1) to simufilam 100 mg, 50 mg or placebo BID, and treated for 18 months. The co-primary efficacy endpoints are ADAS-Cog, a cognitive scale, and ADCS-ADL, a functional scale, both widely used clinical tools in trials of Alzheimer’s disease.

Cassava Sciences’ second Phase 3 study is designed to evaluate symptomatic improvement in Alzheimer’s disease. The goal is to demonstrate improved cognition and health function in subjects treated with simufilam compared to placebo. Approximately 600 subjects to be enrolled, randomized (1:1) to simufilam 100 mg or placebo BID, and treated for 12 months. The co-primary efficacy endpoints are ADAS-Cog, a cognitive scale, and ADCS-ADL, a functional scale.

Slide Deck
Cassava Sciences’ latest corporate presentation is available on its website under the Investors/Presentations page: View Source

Financial Results for First Quarter 2021
Net loss was $3.5 million, or $0.09 per share, compared to a net loss of $1.2 million, or $0.05 per share, for the same period in 2020. Net cash used in operations was $2.3 million during the first quarter of 2021.

Net cash use for operations for full-year 2021 is expected to be approximately $20 to $25 million. Cash and cash equivalents were $282.2 million as of March 31, 2021, with no debt.

Financial Highlights for First Quarter 2021

At March 31, 2021, cash and cash equivalents were $282.2 million, compared to $93.5 million at December 31, 2020, with no debt. Cash balance included net proceeds of approximately $189.8 million from the sale of 4.1 million shares of common stock completed February 2021. Cash balance also included $0.7 million from exercise of common stock warrants in the quarter. There were no remaining common stock warrants outstanding as of March 31, 2021.

Net cash used in operations during the quarter ended March 31, 2021 was $2.3 million, net of reimbursements received from NIH grant awards.

Research grant funding reimbursements of $0.6 million were received from NIH and recorded as a reduction in research and development (R&D) expenses. This compared to $1.3 million of NIH grant receipts received for the same period in 2020.

Net cash use for operations for full year 2021 is expected to be approximately $20 to $25 million, consistent with previous financial guidance. Net cash use in 2021 is expected to be driven by higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, professional services expenses related to clinical programs, and operating costs such as insurance, office space and IT related expenses.

R&D expenses were $2.5 million. This compared to $0.5 million for the same period in 2020, representing a 365% increase. This increase was due primarily to costs related to manufacture of clinical trial supplies in anticipation of launching a Phase 3 clinical program in simufilam, increased personnel expenses, as well as a decrease in grant funding received from NIH compared to the prior year.

General and administrative (G&A) expenses were $1.0 million. This compared to $0.8 million for the same period in 2020, representing a 29% increase. This increase was due primarily to higher insurance costs and professional fees compared to the prior year.
About Simufilam
Simufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. Cassava Sciences is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test.

Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. As of 2020, there were approximately 50 million people worldwide living with dementia, a figure expected to increase to 150 million by 2050.1 The annual global cost of dementia is now above $1 trillion, according to Alzheimer’s Disease International, a charitable organization.