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.

On April 21, 2021 Hamlet Pharma reported that the report of the phase I/II bladder cancer trial has been accepted for publication in Nature Communications; a leading international journal (Press release, HAMLET Pharma, APR 21, 2021, View Source;utm_medium=rss&utm_campaign=bladder-cancer-study-results-accepted-for-publication-in-nature-communications [SID1234578330]).

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The paper is entitled "Bladder cancer therapy using a conformationally fluid tumoricidal peptide complex" and has been accepted for publication in Nature Communications. The Nature journals are extremely competitive and only accept innovative science of highest quality and with significant interest for a discerning audience. The journals are widely read, with a high impact.

The paper analyses the structure of the Alpha1H complex, characterizes its tumor killing effects and describes the successful clinical trial of Alpha1H in patients with bladder cancer. A detailed analysis of primary and secondary end points is provided and differences between the Alpha1H treated patients and the placebo group are described for several crucial efficacy variables. Alpha1H triggered significant shedding of tumor cells in patients, who received the treatment (p< 0.0001 compared to the placebo group) and reduced the tumor size (p<0.04), illustrating its potent effects.

The treatment is also shown to be safe, as no drug-related side effects were observed. The publication offers interested readers a detailed understanding of the molecular properties and promising clinical effects, inspiring further development of Alpha 1H as a new potential drug for patients with bladder cancer.

"Publishing in Nature journals is an important quality stamp and an excellent way to spread the news of our clinical advances" says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.

"This is a very important milestone, inspriring us to continue the clinical development of Alpha1H with full speed" says Mats Persson, CEO of Hamlet Pharma Ltd.

On April 21, 2021 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 in relapsed/refractory multiple myeloma (Press release, Allogene, APR 21, 2021, View Source [SID1234631116]). The FDA granted RMAT designation based on the potential of ALLO-715 to address the growing unmet need for patients who have failed other multiple myeloma therapies.

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"RMAT designation was granted based on our encouraging initial clinical experience in heavily pretreated patients. ALLO-715 demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR T manufacturing," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to completing the UNIVERSAL study and working closely with the FDA as we seek to rapidly advance this important therapeutic alternative to patients with advanced multiple myeloma."

Initial results from the UNIVERSAL study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. As part of the Company’s anti-BCMA strategy, the Phase 1 UNIVERSAL study continues to optimize the dosing regimen of ALLO-715 and ALLO-647. The UNIVERSAL study is also enrolling patients to receive ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

On April 21, 2021 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan reported its first quarter sales 2021 (January 1 – March 31, 2021) (Press release, Chugai, APR 21, 2021, View Source [SID1234578294]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.16% of the total number of shares issued excluding treasury stock) as of the end of March 2021.

Its press release and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to March 31, 2021 is included in the announced Roche Group’s results.

On April 21, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the full commercial launch of CNSide, its cerebrospinal fluid (CSF) assay designed to better detect and manage treatment of metastatic cancers involving the central nervous system (CNS) (Press release, Biocept, APR 21, 2021, View Source [SID1234578313]). The assay, initially introduced in January 2020, has the ability to offer a timely and accurate method to diagnose disease, identify actionable biomarkers, and assess response to therapy, potentially impacting life expectancy and quality of life.

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CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method paired with assays to identify actionable molecular treatment targets. The assay answers three key questions: Is there involvement by tumor? Is there a target for treatment? Is there a trend with respect to treatment response?

The CNSide assay addresses a high unmet clinical need, as the current standard of care, CSF cytology, has limited sensitivity for detecting brain metastasis and assessing therapy response, and does not provide quantitative results. Between 10% and 30% of patients with cancer, depending on cancer type, will develop brain or spinal cord metastasis. Overall survival expectancy is low, and many patients are not diagnosed early enough for therapeutic intervention. However, the use of newer targeted therapies for lung and breast cancer with intracranial metastasis can often extend survival for a year or more, resolving symptoms and substantially improving quality of life.

"Simply stated, patients diagnosed with advanced cancer and their physicians need better tools to diagnose brain metastasis earlier, more accurately, and to assess response to therapy in a timely, quantitative fashion so that patients can benefit from the remarkable advances in cancer therapies available today," said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "These patients do not have time to waste on inaccurate or uncertain diagnostic tests."

"CNSide, with Target Selector technology, provides information well beyond what we can obtain from current diagnostics—specifically, it provides insights to help us select the right treatment for our patients, as well as insights on duration of therapy," said Priya Kumthekar, MD, Associate Professor of Neurology and Oncology, Northwestern University Feinberg School of Medicine, during a recent key opinion leader webinar. "I see CNSide as a way to improve diagnosis and monitoring of CNS involvement in a patient population that represents a very high unmet need, and a population that appears to be growing."

"The full sales force launch of our CSF assay, along with new branding, is an exciting next step toward our goal of establishing CNSide as a new standard-of-care diagnostic test for cerebrospinal fluid," said Michael Nall, Biocept’s President and CEO. "Initial acceptance by neuro-oncology early-adopters has been highly encouraging as physicians from nearly two dozen leading academic institutions have ordered CNSide—with many becoming repeat users. This represents a significant market opportunity that we estimate at more than $1 billion annually in the United States for breast and lung cancers that have metastasized to the central nervous system."

In 2020, Biocept presented highly favorable results from pilot studies with the assay at three major scientific meetings.1-3 The studies showed that in approximately 80% of the cases of suspected CNS involvement, tumor cells were detected using the CNSide assay, compared with about 50% of cases examined by CSF cytology. The assay is currently validated to identify metastatic cancers originating in the lung and breast. Biocept plans to expand its CSF testing menu for additional tumor types and biomarkers in the future.

A recent webinar hosted by Biocept featured leading neuro-oncologists discussing the use of the CNSide assay for diagnosing and managing tumors that have metastasized to the CNS. The webinar can be viewed here.