On September 21, 2020 Novellus, Ltd., a clinical-stage biotechnology company focused on precision oncology reported that it has raised $57 million in a Series C financing round (Press release, Novellus, SEP 21, 2020, View Source [SID1234565451]). The round was led by Pontifax, and joined by OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Asset Management, Novartis Venture Fund (NVF), SR One, as well as existing investors.

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Proceeds from the financing will be used to fund the continued clinical development of the company’s lead program, PLX-8394, a BRAF inhibitor with a differentiated mechanistic profile licensed from Plexxikon, a Daiichi Sankyo company, earlier this year. PLX-8394’s development will focus on clinical settings for which there are currently no FDA-approved BRAF inhibitors, including BRAF fusions and certain BRAF-mutated gliomas. The proceeds will also be used to fund the expansion of Novellus’ pipeline based on the company’s functional genomics platform.

"We believe PLX-8394 has the potential to address a major unmet need by targeting patient populations that are bereft of effective treatment options." said Michael Vidne, Chief Executive Officer of Novellus. "The financing from this group of leading life science investors will enable us to realize the potential of PLX-8394 as a unique BRAF inhibitor."

Novellus’ industry-leading FACT platform recapitulates naturally occurring mutations in vitro and tests their effect on signaling pathway activity and their response to different compounds. By doing so, it identifies unique, molecularly defined subpopulations of patients, that are predicted to respond to given drugs. "PLX-8394 was the first drug we identified using our platform as having an effect across a wide range of unique BRAF mutations. With this investment, we will extend this work to other genes and other compounds to create a unique pipeline," said Gabi Tarcic Chief Technology Officer of Novellus.

"We are pleased to partner with Novellus and support their important work in advancing groundbreaking drugs for hard-to-treat cancers. The company’s platform has the potential to support additional precision medicines for genetically defined subsets of cancer," commented Ran Nussbaum, Managing Partner at Pontifax.

On September 21, 2020 Bristol Myers Squibb (NYSE: BMY) reported that it has successfully completed its transaction to acquire Forbius for their TGF-beta program, including its lead investigational asset AVID200, currently in Phase 1 for oncology and fibrosis (Press release, Bristol-Myers Squibb, SEP 21, 2020, View Source [SID1234565450]).

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"We are pleased to complete the transaction with Forbius and add their TGF-beta program to our growing pipeline of innovative assets," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President and President, Research & Early Development, Bristol Myers Squibb. "We look forward to progressing the program through our exceptional research and development capabilities with the goal of helping more patients."

Pursuant to the terms of the transaction, Forbius’ non-TGF-beta assets were transferred to a newly formed private company which is being retained by Forbius’ existing shareholders.

Davis Polk & Wardwell LLP and Osler, Hoskin & Harcourt LLP served as legal advisors to Bristol Myers Squibb.

About selective inhibition of TGF-beta

TGF-beta isoforms 1 & 3 are believed to be central mediators of tumor microenvironment (TME). Selective inhibition of TGF-beta 1 & 3 is proposed to enhance anti-tumor efficacy by acting synergistically with immunotherapy and has broad potential as an anti-fibrotic therapy across several indications with high unmet need.

About AVID200

AVID200 is a highly potent and isoform-selective TGF-beta inhibitor. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency. These isoforms are known to be drivers of fibrosis and tumor immune resistance. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. The ability of AVID200 to selectively target TGF-beta 1 and -beta 3 positions it to be an effective and well-tolerated therapeutic in fibrotic diseases and immuno-oncology.

On September 21, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, SEP 21, 2020, View Source [SID1234565449]).

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"The completion of our first BLA submission to the FDA is a significant milestone for ADC Therapeutics and takes us one step further in our evolution toward becoming a commercial-stage organization," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We are grateful to the trial participants and investigators and to all our employees for their commitment to this clinical program, and we look forward to working with the FDA to bring Lonca to patients as quickly as possible."

The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following ≥2 lines of prior systemic therapy. In June 2020, the company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). As of the April 6, 2020 data cut-off date, 145 patients were enrolled in the trial and patients had received a median of 3 prior lines of therapy. Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was generally manageable, with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increased (16.6%) and anaemia (10.3%).

"A critical unmet need remains for heavily pretreated patients with relapsed or refractory DLBCL, including those with a poor prognosis, those who never responded to prior therapy and those who received prior stem cell transplant," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "Based on the anti-tumor activity, durability and generally manageable tolerability Lonca has demonstrated in LOTIS 2, we believe Lonca has the potential to fill this need."

The company has also initiated LOTIS 5, a Phase 3 confirmatory clinical trial of Lonca in combination with rituximab, which is intended to support a supplemental BLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca is being evaluated in LOTIS 2, a pivotal Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), LOTIS 3, a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL), and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

On September 21, 2020 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that it has licensed intellectual property relating to its pioneering chlorotoxin chimeric antigen receptor (CLTX-CAR) T cell therapy to Chimeric Therapeutics Limited, an Australian biotechnology company (Press release, City of Hope, SEP 21, 2020, View Source [SID1234565448]).

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The therapy is currently being used in a phase 1 clinical trial at City of Hope to treat glioblastoma (GBM), a type of brain tumor. The first patient in the trial was recently dosed; Behnam Badie, M.D., chief of City of Hope’s Division of Neurosurgery and The Heritage Provider Network Professor in Gene Therapy, is leading this innovative, first-of-its-kind trial.

Chimeric has acquired the exclusive worldwide rights to develop and commercialize certain patents relating to City of Hope’s CLTX-CAR T cells, as well as to further develop the therapy for other cancers.

"City of Hope is excited to enter into this agreement with Chimeric as it supports our innovative research in CAR T cell therapy and our commitment to extend these therapies to more patients, particularly those with GBM and other solid tumors that are difficult to treat," said Christine Brown, Ph.D., The Heritage Provider Network Professor in Immunotherapy and deputy director of City of Hope’s T Cell Therapeutics Research Laboratory. "Chimeric shares our goal of providing effective CAR T cell therapies to more patients with current unmet medical needs."

Led by Brown and Michael Barish, Ph.D., chair of City of Hope’s Department of Developmental and Stem Cell Biology, and Dongrui Wang, Ph.D., a recent graduate of City of Hope’s Irell & Manella Graduate School of Biological Sciences, the team developed and tested the first CAR T cell therapy using CLTX, a component of scorpion venom, to direct T cells to target brain tumor cells. The research was published this past March in Science Translational Medicine.

"Chimeric is excited to join City of Hope in its quest to find more effective cancer therapies. This is an exceedingly rare opportunity to acquire a promising technology in one of the most exciting areas of immuno-oncology today," said Paul Hopper, executive chairman of Chimeric. "Furthermore, the CLTX-CAR T cell therapy has completed years of preclinical research and development, and recently enrolled its first patient in a phase 1 clinical trial for brain cancer."

CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a synthetic 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

In this recent study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets. They found that CLTX bound to a greater proportion of patient tumors, and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells without off-tumor targeting and toxicity in cell-based assays and in animal models.

City of Hope, a recognized leader in CAR T cell therapies for GBM and other cancers, has treated more than 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world — it currently has 30 ongoing CAR T cell clinical trials, including CAR T cell trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13Rα2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent GBM, combining IL13Rα2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"City of Hope is delighted to license this technology to Chimeric," said Sangeeta Bardhan Cook, Ph.D., City of Hope director of the Office of Technology Licensing. "We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. At City of Hope, our mission is to transform the future of health care. We believe Chimeric has the vision to offer innovative therapies to cancer patients."

On September 21, 2020 Bayer reported that a new ad hoc analysis from the Phase III ARAMIS trial showed 97.2% of men with non-metastatic castration-resistant prostate cancer (nmCRPC) taking NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) received the full, planned dose of 600 mg twice daily compared to 98.4% who received ADT alone (Press release, Bayer, SEP 21, 2020, View Source [SID1234565447]).1 The percent of planned dose was calculated as the actual dose received (sum of dose received over total time span) over the planned dose per protocol (sum of planned dose over total time span).1 The study also evaluated dose modifications (interruptions or delays and reductions) and incidence of permanent discontinuation due to adverse events (AEs) in both treatment arms.1 These data were presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020, held from September 19-21, 2020.

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"In clinical practice, ability to maintain planned dose and schedule are important considerations"

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"In clinical practice, ability to maintain planned dose and schedule are important considerations," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. "These data support darolutamide’s value as a treatment option in men with nmCRPC."

Data from the Phase III ARAMIS trial of men receiving NUBEQA plus ADT were analyzed ad hoc to determine tolerability and association of prostate-specific antigen (PSA) decline in response to treatment with NUBEQA plus ADT and metastasis-free survival (MFS).1 ARAMIS was unblinded following positive results from the primary analysis for MFS.1 The ad hoc analyses reported here were performed on data from both the primary and final analyses of the double-blind period.1 The median time on treatment at primary analysis was 14.8 months for NUBEQA plus ADT and 11.0 months for ADT alone; at final analysis, the median time on treatment was 18.5 months for NUBEQA plus ADT and 11.6 months for ADT alone.1

The association between PSA decline from baseline in response to NUBEQA plus ADT treatment and MFS was evaluated using the Cox proportional hazards model.1 97.2% of patients received the full, planned treatment dose of NUBEQA plus ADT after a median follow-up of 14.8 months.1 At baseline, the median [range] PSA for NUBEQA plus ADT was 9.0 [0.3–858.3] ng/mL and 9.7 [1.5–885.2] ng/mL for ADT alone.1 Additionally, 83.6% of patients on NUBEQA plus ADT had a PSA response (≥50% decrease from baseline) versus 7.6% of patients on ADT alone.1 The median PSA decrease from baseline for NUBEQA plus ADT was 91.7% compared to 31.9% for ADT alone.1 Most patients (approximately 95%) with a maximum PSA decrease from baseline of >90% remained metastasis-free after one year.1

Dose modifications (interruptions or delays and reductions) were experienced by 15.2% (145/954) of patients receiving NUBEQA plus ADT compared to 9.7% (54/554) who received ADT alone.1 Notably, most patients in both treatment arms were able to re-escalate to the full, planned dose (91.7% [133/145] versus 88.9% [48/54], respectively).1 Permanent discontinuation due to disease progression was higher in the ADT group than in the NUBEQA plus ADT group at the primary analysis (23.3% [129/554] versus 11.7% [112/954]) and the final analysis (25.8% [143/554] versus 12.6% [120/954]).1 Disease progression was defined as the presence of centrally confirmed metastasis, with the exception of one patient receiving NUBEQA plus ADT and three patients receiving ADT alone, in the final analysis for whom metastasis was confirmed locally at the unblinding visit.1 The safety population excluded one patient in the NUBEQA plus ADT group who did not receive any dose of NUBEQA.1

Data from Primary Analysis of Phase III ARAMIS Trial

At the primary analysis, 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of MFS, with a median of 40.4 months (n=955) with NUBEQA plus ADT, compared to 18.4 months (n=554) for ADT alone (p<0.001); however, overall survival (OS) data were not yet mature at the time of the MFS analysis (57% of the required number of events). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Adverse reactions occurring more frequently in the NUBEQA plus ADT arm (≥2% over ADT alone) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA plus ADT was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

Permanent discontinuation due to adverse reactions occurred in 9% of patients in both arms of the study. The most frequent adverse reactions requiring discontinuation in patients who received NUBEQA plus ADT included cardiac failure (0.4%) and death (0.4%). Dose interruptions due to an adverse reaction occurred in 13% of patients treated with NUBEQA plus ADT. The most frequent adverse reactions requiring dosage interruption in patients who received NUBEQA plus ADT included hypertension (0.6%), diarrhea (0.5%) and pneumonia (0.5%). Dose reductions due to an adverse reaction occurred in 6% of patients treated with NUBEQA plus ADT. The most frequent adverse reactions requiring dosage reduction in patients treated with NUBEQA plus ADT included fatigue (0.7%), hypertension (0.3%) and nausea (0.3%).

About NUBEQA (darolutamide)2

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.2 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

On July 30th, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or ADT alone. The primary efficacy endpoint was MFS.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.2 The approvals of NUBEQA in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.2 Filings in other regions are underway or planned.

INDICATION

NUBEQA is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Clinically significant adverse reactions occurring in ≥ 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA –Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs –NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.3 In 2020, about 192,000 men in the U.S. will be diagnosed with prostate cancer and an estimated 33,000 will die from the disease.4 Prostate cancer is the fifth leading cause of death from cancer in men.3 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.5 It mainly affects men over the age of 50, and the risk increases with age.6

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.7 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.8

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly for CRPC patients who have prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level, which is called non-metastatic castration-resistant prostate cancer, or nmCRPC.9,10 About one-third of men with nmCRPC go on to develop metastases within two years.11 In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.10

About Prostate Cancer at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer.3 The company’s franchise includes two products on the market and several compounds in development, including a unique approach of advancing targeted alpha therapies. Bayer is focused on addressing the unique needs of prostate cancer patients.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. We have the passion and determination to develop innovative medicines to help extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. A key area of focus is prostate cancer, where we have several treatments on the market or in development. Another key focus at Bayer is on shifting oncology treatment, with an approved TRK inhibitor exclusively designed to treat solid tumors that have an NTRK gene fusion, a key oncogenic driver, and another TRK inhibitor advancing through the pipeline. The company’s approach to research prioritizes targets and pathways with the potential to impact the way that cancer is treated.