On January 13, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it will present an update from its Phase II study of bemcentinib in combination with anti-PD-1 therapy pembrolizumab (BGBC008) in refractory non-small cell lung cancer (NSCLC) patients at an oral presentation at the 2020 World Conference on Lung Cancer Singapore (WCLC) (Press release, BerGenBio, JAN 13, 2021, View Source [SID1234574334]).

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BGBC008 is a Phase II single-arm, two stage study with bemcentinib and
pembrolizumab for previously treated Stage IV NSCLC patients, comprising three cohorts; chemotherapy failed patients not treated with immunotherapies (post-chemo), patients progressing on prior checkpoint inhibitor therapy (post-CPI monotherapy) and platinum-doublet chemotherapy in combination with immunotherapy (post-chemo-CPI).

The primary endpoint of the study was Overall Response Rate with pre-defined criteria to proceed from the first to second stage in each cohort. Secondary endpoints included Disease Control Rate, Progression Free Survival, Overall Survival and safety.

The interim data shows that bemcentinib in combination with pembrolizumab was well-tolerated and shows promising clinical activity in refractory lung cancer. The presentation will provide updated data from Cohort B of the study, assessing the safety and efficacy of bemcentinib in combination with anti-PD-1 therapy pembrolizumab, in refractory NSCLC patients previously treated with a PD-L1 or PD-1 checkpoint inhibitor (CPI) as a monotherapy.

The full abstract can be found on the WCLC website.

Title: A phase II study of the oral selective AXL inhibitor bemcentinib with
pembrolizumab in refractory patients with advanced NSCLC

Presenting Author: Dr. Matthew G. Krebs PhD.

Session/Abstract ID: Immunotherapy (Phase II/III Trials) / # 3647

Date/Time: Friday 29[th] January 2021 at 09.50 Singapore Time / 02.50 CET

The presentation will be available on BerGenBio’s website from 29 January
2021.

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On January 13, 2021 Sana Biotechnology reported that it has filed with the U.S. Securities and Exchange Commission to raise up to $150 million in an initial public offering (IPO) to help support the company’s cell-based therapy discovery and development operations (Press release, Sana Biotechnology, JAN 13, 2021, View Source [SID1234573994]).

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Seattle, Wash.-based Sana relies on in vivo and ex vivo cell engineering platforms for the development of therapies for oncology, diabetes, cardiovascular disease and genetic diseases as well as central nervous system (CNS) disorders.

Currently, Sana’s therapeutic candidates are undergoing preclinical investigation and development. The company expects IND submission in 2022 and 2023.

Sana, which was founded in 2018, plans to list itself on the Nasdaq under SANA. Joint bookrunners on the initial funding deal for the company included Morgan Stanley, Goldman Sachs, J.P. Morgan and Bank of America Securities. At the time of the IPO announcement, no financial details were disclosed.

Sana’s licensed technology from Harvard University is marketed as featuring the potential to enhance the efficacy of cell-based therapies. Ultimately, this technology may help researchers produce hypoimmunogenic stem cells that are capable of differentiation into any cell type. In turn, these may be transplanted into a patient and sidestep any rejection from the immune system. The company says they plan to leverage this technological platform to create hypoimmunogenic pluripotent stem cells for starting material to produce novel cell therapies.

"We are excited to have placed this important technology with Sana, a startup which has assembled a world-class team to advance the development of allogeneic (off-the-shelf) cell therapies," according to a statement made by Harvard OTD’s Vivian Berlin, Managing Director, Strategic Partnerships. "The company’s leadership, vision, and focus on scaled solutions give us confidence that this groundbreaking technology can be developed and deployed to the fullest extent possible for patients."

The biotech company has been busy appointing new clinical and financial leaders to its Board of Directors, including Josh Bilenker, M.D., Alise Reicin, M.D. and Michelle Seitz, CFA. Dr. Bilenker, CEO of Loxo Oncology at Lilly, will assist in the medical strategy and decision making, while Dr. Reicin, CEO and President of Tectonic Therapeutic, will also assist in clinical development. Seits, Chairman and CEO of Russell Investments, was appointed by Sana to assist in financial planning and decision-making at the company.

BioSpace’s NextGen Bio "Class of 2021" recently listed Sana as its top new life sciences companies to watch in 2021. The company’s programs include gene delivery, immunology, stem cell biology as well as gene modification and control. Sana was supported by financing from Flagship Pioneering, ARCH Venture Partners and F-Prime Capital in 2019 and has continued into 2021.

In June of last year, Sana raised $700 million in initial financing to advance the company’s discovery and development programs. In addition to its initial investors, the summer 2020 financing round was supported by funding from Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds, Altitude Life Science Ventures and several other unnamed institutional actors.

According to the company, the initial $700 million funding was to be used to support IND-enabling as well as initial clinical studies for several treatment candidates, further expand manufacturing capabilities, and buildout of its portfolio of enabling technologies.

In addition, Sana acquired Oscine in October 2020. Oscine focused on the development of curative and disease-modifying cell therapies for brain and CNS disorders. While terms of the acquisition deal were not initially disclosed, the statement made by Sana noted the acquisition "will integrate Oscine’s glial progenitor cell program and underlying technologies together with Sana’s broader platform and programs."

On January 13, 2021 Netcapital Inc. (OTC: NCPL) reported it will partner with C-Reveal Therapeutics to advance the company’s patent pending approach to exposing tumors to immune responses and therapies (Press release, C-Reveal Therapeutics, JAN 13, 2021, View Source [SID1234573991]). As an indication of its high conviction in the company, Netcapital Inc. has taken an equity ownership stake in C-Reveal, adding the innovative immuno-oncology drug development company to its portfolio. C-Reveal Therapeutics is currently engaged in a round of equity fundraising via Netcapital. Additionally, C-Reveal will be attending the upcoming BIO Partnering at JPM Virtual conference and meeting with a number of major pharmaceutical firms to facilitate potential strategic partnerships.

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"In 2019, new cancer cases impacted 1.8 million people in the US alone, and that number is growing. C-Reveal’s mission is to leverage a proprietary novel mechanism of action to enable the body’s immune system to attack and kill cancer," said Thomas Haag, Ph.D, J.D., C-Reveal Co-founder. "Our ground-breaking technology originated in Mark Cobbold’s lab at the Harvard Medical School and we are excited to be partnering with veteran precision oncology drug developer Keith Flaherty to bring new treatment options to patients in need."

"Netcapital Advisors immediately recognized the potential of our important work. Their incredible team of former investment professionals and digital marketing specialists provided unique expertise and spent countless hours readying us for our capital raise; their entire team was truly dedicated to our success."

"C-Reveal’s leadership affords extensive experience in oncology research and development as well as a successful track record in building valuable bio-pharma companies," commented Cecilia Lenk, Netcapital Inc.’s CEO. "We’re thrilled to be able to partner with such a high caliber team to help advance C-Reveal’s innovative approach to increasing the efficacy of immune therapies in the treatment of cancer."

On January 13, 2021 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported plans to begin enrolling the Sentinel Trial in the first half of 2021 (Press release, Strata Oncology, JAN 13, 2021, View Source [SID1234573985]). Sentinel is a prospective, observational study designed to enroll approximately 100,000 patients diagnosed with stage 1-3 solid tumors and indicated for surgery or definitive therapy. The study will evaluate the ability of Strata’s investigational liquid biopsy assay to detect disease recurrence and to monitor treatment effectiveness in patients across solid tumors.

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"The Sentinel Trial will support the validation of our personalized recurrence monitoring assay for patients with solid tumors in a diverse population," said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. "The study will also evaluate the utility of our approach for guiding treatment decisions in patients with early-stage solid tumors. To date, most advances in precision oncology have been in late-stage cancer. The clinical and molecular information generated in this study has the potential to advance precision cancer care to the early-stage."

The Sentinel Trial will pair simultaneous DNA and RNA tissue-based molecular profiling with liquid biopsy-based recurrence monitoring. Study participants will receive the StrataNGS comprehensive genomic profiling test upfront to identify a personalized mutation profile and a treatment selection profile. Results will inform custom design of a personalized liquid biopsy test to detect tumor-specific genomic alterations with high clinical sensitivity and specificity.

Strata Oncology recently made StrataNGSTM broadly available in the U.S. based on its experience processing more than 40,000 tissue specimens from patients with advanced cancer through the Strata Trial. Recent data showed that the StrataNGS test’s performance on small tumor tissue samples may provide treatment selection results for 50% more patients than other leading tumor profiling tests.

About StrataNGS

StrataNGS is a comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements in the industry (>2mm2 surface area). The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.

On January 13, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China’s National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China (Press release, Gracell Biotechnologies, JAN 13, 2021, View Source;an-allogeneic-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-b-all-301206086.html [SID1234573984]).

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GC007g is an allogeneic CAR-T therapy under development for the treatment of a subset of B-ALL patients who relapsed after receiving an allogeneic transplant. The allogeneic therapy is derived from human leukocyte antigen (HLA)-matched donor T cells. This allogeneic approach has the potential to resolve the T cell fitness issue associated with autologous CAR-T cell therapies. The donor-derived CAR-T cell therapy, GC007g, is designed for relaspsed/refractory B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other conditions.

"The approval of the pivotal study for GC007g is an exciting milestone for the program, and more importanty, the approval of the new study design by the Chinese regulatory agency expedites the process of delivering a potential new treatment option to eligible patients in need," Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, commented. "As we continue to explore the potential of GC007g, Gracell remains focused on developing innovative cell therapies for patients with high unmet medical needs."

About GC007g

GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA-matched donors’ T cells were employed to be redirected to eradicate CD19 positive leukemia cells.

About B-ALL

B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.