On March 10, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that scheduled in-person presentation at the Barclays Global Healthcare Conference in Miami Beach was changed by conference organizers to a webcast only, as the conference has been reconfigured (Press release, Ligand, MAR 10, 2020, View Source [SID1234555367]). The webcast will take place as previously scheduled at 2:35 p.m. ET and is available here. Conference one-on-one investor meetings have been moved to telephone calls, and the new slides Ligand will be using during those meetings have been posted to www.ligand.com.

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The new slides contain recent pipeline and business updates, including:

Palvella Therapeutics completed enrollment in the Phase 2/3 pivotal study of PTX-022 for treatment of pachyonychia congenita, with topline data expected in Q4. PTX-022 is a Fast Track-designated program.
Gloria Pharmaceuticals, Ligand’s partner for the OmniAb-derived anti-PD-1 antibody zimberelimab in China, announced they are filing for marketing authorization in China based on positive Phase 2 data in classical Hodgkin’s lymphoma. This program joins C-Stone’s CS1001 as another OmniAb antibody that may be approved in 2020. OmniAb-derived zimberelimab is also in development in the U.S. by partner Arcus Biosciences.
In addition to zimberelimab, Ligand’s portfolio of partnered programs includes six new products that could launch by the end of 2022 including Takeda’s pevonedistat, Retrophin’s sparsentan, Eisai’s parempanel-IV, Palvella’s PTX-022, Xi’an Xintong’s Pradefovir and C-Stone’s CS-1001. Additional partnered programs could launch in this timeframe as well.
Retrophin announced enrollment of the first 190 patients in its pivotal Phase 3 DUPLEX study of Sparsentan in Focal Segmental Glomerulosclerosis. Topline efficacy data from the 36-week proteinuria endpoint analysis of the trial are expected in the first quarter of 2021.
Nucorion Pharmaceuticals completed filing of an IND for its novel liver-targeted hepatitis B program NC0-1010, obtained FDA acceptance of the IND and is on track for initiation of a Phase 1 clinical trial in the U.S in March. This is the first clinical-stage program to leverage Ligand’s novel, internally developed LTP Technology Platform.
Ligand continues to support Captisol orders from partners related to remdesivir, an investigational product candidate being actively assessed in Phase 2 and Phase 3 clinical studies to treat COVID-19, with the first studies expected to be completed in April.
"2020 is off to an excellent start, with a good flow of news and updates from our partnered portfolio. We are facing the most substantial calendar of partner events in our history and see the potential for several major new product launches over the next couple of years," said John Higgins, Chief Executive Officer of Ligand. "Our OmniAb business is doing very well, with two antibody-based drugs filed or expected to be filed for potential approval."

"We have also been very active working with partners to meet their Captisol needs to formulate clinical supplies of the antiviral drug remdesivir, which is being studied as a potential treatment for COVID-19," he added. "Our team has made substantial progress over the past few weeks working with partners to provide supply-chain support that was not anticipated at the start of the year."

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.

On March 10, 2020 Proteostasis Therapeutics, Inc. (Nasdaq: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) through theratyping, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update (Press release, Proteostasis Therapeutics, MAR 10, 2020, View Source [SID1234555383]).

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"Proteostasis made important progress throughout 2019 in delivering on our goal of bringing more treatment choices to patients with CF," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. "With our Phase 2 trials complete, we are moving forward with a Phase 3 clinical development plan that embraces the pursuit of personalized medicine in CF through theratyping. Our mission is to deliver combinations of our investigational agents to preselected patients identified as responders to our therapies through the ex vivo testing of their own organoids. We believe that the theratyping path, or the process of matching CFTR modulators to individual CF patients based on a laboratory assay regardless of CFTR genotype, has the potential to become a patient-friendly and cost-effective approach to treatment for patients with CF, thereby increasing access to treatment options and optimizing risk-benefit and cost-effectiveness of CFTR modulators."

Ms. Chhabra continued, "Through our next set of clinical trials that may be registrational trials, we will continue to explore the potential of our proprietary CFTR modulators – posenacaftor, dirocaftor and nesolicaftor – in rare and common CF mutations using both traditional and novel study approaches. We look forward to initiating these trials later this year and to providing updates, beginning with the CHOICES trial, soon thereafter."

Fourth Quarter and Recent Highlights

Last month, Proteostasis announced the completion of enrollment of 502 patients with CF in the HIT-CF Europe project, a research project which aims to provide better treatment and improve lives for people with CF and rare mutations. HIT-CF is leading a European-based initiative that is conducting confirmatory trials to assess the predictability of the organoid assay for clinical benefit, such as the CHOICES study (Crossover trial based on Human Organoid Individual response in CF – Efficacy Study). Proteostasis’ drug combinations will be tested first in an ex vivo study expected to be completed in the first half of 2020. Then, responders and non-responders will be selected for the CHOICES study. Dosing in CHOICES is expected to begin in the second half of 2020, with preliminary clinical data anticipated to be reported in early 2021.

In January of this year, Proteostasis announced a regulatory update following the completion of a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (MHRA) that outlined a path forward for the initiation and execution of our Phase 3 program and the potential filing of a Marketing Authorization Application for posenacaftor, dirocaftor and nesolicaftor. The Company announced that it will continue to seek additional advice from other major regulatory agencies throughout 2020.

In December 2019, Proteostasis announced results from a Phase 2, 28-day clinical trial designed to assess the safety, tolerability and efficacy, of the Company’s once-daily proprietary combinations, 600 mg of posenacaftor (PTI-801) and 300 mg of dirocaftor (PTI-808), with or without 10 mg of nesolicaftor (PTI-428), or placebo. The results demonstrated that the combination was generally well-tolerated in the trial, with the majority of reported adverse events mild to moderate in severity. Homozygous subjects receiving the triple combination experienced a mean absolute improvement in ppFEV1 of 8 percentage points (p ≤ 0.01) and a reduction in sweat chloride concentration of -29 mmol/L (p < 0.0005) at day 28 compared to pooled placebo. In a population with high disease burden, the combination demonstrated compelling improvements in lung function and sweat chloride, including improved outcomes in the most challenging settings, including subjects with at least two pulmonary exacerbations within 12 months prior to study entry.

During the fourth quarter of 2019 through the date of this release, Proteostasis announced several peer-reviewed publications and medical meetings presentations, as well as a Company-hosted event:

In February 2020, the Company co-authored an article, titled "Amplifiers co-translationally enhance CFTR biosynthesis via PCBP1-mediated regulation of CFTR mRNA," which was published in the Journal of Cystic Fibrosis. The publication highlights nonclinical data on the mechanism of action of nesolicaftor (PTI-428).
In January 2020, the Company presented a poster, entitled "Intestinal Organoid Models as a Path for Personalized Therapy Development in Cystic Fibrosis," at the Keystone Symposia on Tissue Organoids. The poster highlighted the results from an ex vivo study of the Company’s proprietary CFTR modulators in organoids from individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype, a population of approximately 2,300 adults in Europe alone.
In October 2019, the Company was noted in a presentation highlighting data from the Company’s CF clinical development programs at the North American Cystic Fibrosis Conference that was delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.
In October 2019, the Company hosted a CF patient summit featuring members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.
Year End 2019 Financial Results

Proteostasis reported a net loss of approximately $59.1 million for the year ended December 31, 2019, as compared to a net loss of $61.8 million for the year ended December 31, 2018.

The Company recorded $5.0 million of revenue for the year ended December 31, 2019, as compared to $2.8 million for the same period in the prior year. Revenue for the year ended December 31, 2019 was related to the Company’s agreement with Genentech, Inc., while revenue for the year ended December 31, 2018 was related to the Company’s agreement with Astellas Pharma Inc., which was terminated in the fourth quarter of 2018.

Research and development expenses for the year ended December 31, 2019 were $52.3 million, as compared to $50.3 million for the same period in the prior year. The increase was primarily due to an increase in clinical-related activities.

General and administrative expenses for 2019 were $13.8 million, as compared to $15.7 million for the same period in the prior year. The decrease in general and administrative expenses was due primarily to a decrease in professional fees and facilities-related expenses.

Cash, cash equivalents and short-term investments totaled $69.5 million as of December 31, 2019, compared to $118.4 million as of December 31, 2018. The Company believes that its existing cash, cash equivalents and short-term investments are sufficient to fund operations into the second half of 2021. However, additional funding will be necessary to advance the Company’s proprietary combination therapy candidates through regulatory approval and into commercialization, if approved.

Fourth Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $11.9 million for the three months ended December 31, 2019, as compared to a net loss of $16.9 million for the same period in the prior year.

There was no revenue in either the three months ended December 31, 2019, or in the same period in the prior year.

Research and development expenses for the three months ended December 31, 2019 were $9.1 million, as compared to $13.7 million for the same period in the prior year. The decrease in research and development expenses for the three months ended December 31, 2019 was primarily due to a decrease in clinical-related activities.

General and administrative expenses for the three months ended December 31, 2019 were $3.1 million, as compared to $3.8 million for the same period in the prior year. The decrease in general and administrative expenses for three months ended December 31, 2019 was due primarily to a decrease in professional fees.

On March 10, 2020 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the fourth quarter and full year ended December 31, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, MAR 10, 2020, View Source [SID1234555346]).

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"Last year was transformational for Bicycle as the completion of our initial public offering and the strengthening of corporate leadership enabled successful execution against our pipeline development strategy," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This year is already off to a strong start, with two new immuno-oncology collaborations designed to expand upon our wholly owned portfolio of systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs). We look forward to the momentum continuing as we progress multiple Bicycle Toxin Conjugates through the clinic this year and prepare to begin clinical development of our first TICA. We believe our anticipated near-term milestones will further demonstrate the role Bicycles could play in creating a much-needed new treatment paradigm for people living with cancer and other serious diseases."

Fourth Quarter 2019 and Recent Highlights

Entered into Strategic Collaboration with Genentech to Discover, Develop and Commercialize Novel Bicycle-based Immuno-oncology Therapies. In February 2020, Bicycle entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Bicycle will be responsible for discovery research and early preclinical development up to candidate selection. Bicycle will receive a $30 million upfront payment. The upfront payment and potential milestone payments could total up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties. None of Bicycle’s wholly owned oncology assets, including its immuno-oncology candidates, are included in the collaboration.
Announced Collaboration with Cancer Research UK to Develop New Bicycle Immuno-oncology Candidate, BT7401. In January 2020, Bicycle announced a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research. Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase I/IIa clinical study.
Dosed First Patient in Phase I/II Trial of BT5528, a Second-generation Bicycle Toxin Conjugate (BTC) Targeting EphA2, in Patients with Advanced Solid Tumors. In November 2019, Bicycle announced that the first patient had been dosed in the Phase I dose escalation portion of its Phase I/II trial of BT5528 in patients with advanced solid tumors associated with EphA2 expression. BT5528 is the first second-generation BTC to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies.
Presented New Preclinical Data for Novel, Fully Synthetic TICAs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. In an oral presentation at SITC (Free SITC Whitepaper), Bicycle presented new data showing that its lead immuno-oncology candidate, BT7480, a TICA targeting Nectin-4 and agonizing CD137, rapidly penetrates tumors and effects powerful anti-tumor activity in preclinical models.
Anticipated Key Events in 2020

Initiation of Phase IIa trial of BT1718, a BTC targeting MT1-MMP, in patients with solid tumors expressing MT1 (trial sponsored by Cancer Research UK)
Interim BT5528 Phase I data readout from the ongoing Phase I/II trial
Initiation of nivolumab arm in BT5528 Phase I portion of the ongoing Phase I/II trial
Initiation of a Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, a tumor antigen shown to be overexpressed in tumor cells, in patients with solid tumors
Financial Results

Cash was $92.1 million as of December 31, 2019, compared with $63.4 million as of December 31, 2018. Cash at December 31, 2019 does not include the $30 million upfront payment from Genentech.
Research and development expenses were $6.6 million for the three months ended December 31, 2019 and $25.5 million for the year ended December 31, 2019, compared to $6.5 million for the three months ended December 31, 2018 and $20.8 million for the year ended December 31, 2018. The increase of $0.1 million for the three months ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $0.4 million of incremental non-cash share-based compensation expense, offset by a decrease of $0.9 million in direct program spending. The increase of $4.8 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase of $2.1 million in direct program spending as well as an increase in personnel-related expenses, including $0.8 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $3.4 million for of the three months ended December 31, 2019 and $14.6 million for the year ended December 31, 2019, compared to $2.1 million for of the three months ended December 31, 2018 and $8.1 million for the year ended December 31, 2018. The increase of $1.3 million for the three months ended December 31, 2019 as compared to the same period in the prior year is primarily due $0.9 million in personnel-related costs, including $0.4 million of incremental non-cash share-based compensation expense, as well as $1.6 million in professional fees and costs related to operations as a public company, offset by a $1.2 million favorable effect of foreign exchange rates. The increase of $6.4 million for the year ended December 31, 2019 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $1.2 million of incremental non-cash share-based compensation expense, as well as an increase in professional fees and costs related to operations as a public company, offset by a $0.6 million favorable effect of foreign exchange rates.
Net loss was $4.4 million, or $(0.25) basic and diluted net loss per share, for the three months ended December 31, 2019 and net loss was $30.6 million, or $(2.77) basic and diluted net loss per share for the year ended December 31, 2019, compared to net loss of $6.6 million, or $(13.19) basic and diluted net loss per share for the three months ended December 31, 2018, and net loss of $21.8 million, or $(49.78) basic and diluted net loss per share for the year ended December 31, 2018.

On March 10, 2020 NuCana plc (NASDAQ: NCNA) reported preliminary results from part one of the Phase II study of single-agent Acelarin in patients with platinum-resistant ovarian cancer (PRO-105) (Press release, Nucana BioPharmaceuticals, MAR 10, 2020, View Source [SID1234555368]). This part of the study compared a 500mg/m2 dose of Acelarin versus a 750mg/m2 dose of Acelarin in patients who were heavily pre-treated (at least 3 prior lines of chemotherapy). This study is now closed to recruitment and data analysis from part one of the study is ongoing.

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Forty-five patients with platinum-resistant ovarian cancer were evaluable for response and all responses had confirmatory scans. Based on an assessment by blinded independent central review, one patient achieved a complete response and two patients achieved partial responses. In addition, 16 patients achieved stable disease.

Patients who entered PRO-105 were heavily pre-treated, having received a median of five prior lines of treatment, and 72% had at least one comorbidity at study entry. Highlighting the fragility of this difficult-to-treat patient population, 45% of patients did not complete the first cycle of treatment with Acelarin despite not having any disease progression or any serious Grade 3 or 4 adverse events. However, for 23 patients in the study who received two or more cycles of Acelarin, the confirmed response rate was 13% and the disease control rate was 83%. These data are still being analyzed and the findings remain preliminary and subject to change.

NuCana’s CEO, Hugh S. Griffith, remarked: "We are pleased with this favorable disease control rate and Acelarin’s ability to achieve confirmed complete and partial responses in this very heavily pre-treated patient population. We are further encouraged by these results in light of the recent CLIO study in less heavily pre-treated patients with platinum-resistant ovarian cancer, where no patients in the chemotherapy group achieved a complete response and only one patient achieved a confirmed partial response which resulted in a confirmed overall response rate of 3%."

The CLIO study reported on the efficacy of the current chemotherapy standards of care, namely paclitaxel, pegylated liposomal doxorubicin, topotecan and gemcitabine. Thirty-three patients received chemotherapy in the CLIO trial and were significantly less heavily pre-treated than those in the PRO-105 trial, with a median of 3 prior lines of treatment. However, given differences in trial design and statistical analyses, comparisons across studies should be interpreted with caution.

Part two of the PRO-105 study was designed to then investigate the optimal dose identified in part one in an expansion cohort. In December 2019, consistent with NuCana’s previous announcement that it is prioritizing resources on its key programs of Acelarin in biliary tract cancer and NUC-3373 in colorectal cancer, the company determined not to proceed with part two of the PRO-105 study.

Mr. Griffith concluded: "The advent of PARP inhibitors has changed the ovarian cancer treatment landscape markedly in recent years resulting in a more complex regulatory pathway for single-agent therapy. In addition, we have been very encouraged by the synergy we have observed with Acelarin in combination with platinum agents, both in patients with biliary tract cancer and ovarian cancer. As such, any further development of Acelarin in patients with ovarian cancer would likely involve combining it with a platinum agent."

On March 10, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, MAR 10, 2020, View Source;jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html [SID1234555384]). JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.1 Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations.2

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Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to EGFR tyrosine kinase inhibitor (TKI) treatments and carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).3 The current standard of care for this patient population is conventional cytotoxic chemotherapy.4

"JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer."

The Breakthrough Therapy Designation is supported by data from a Phase 1, first-in-human, open-label, multicenter study (NCT02609776).5 The study evaluates the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy and in combination with lazertinibi, a novel third-generation EGFR TKI, in adult patients with advanced NSCLC.5 The study seeks to determine the recommended Phase 2 dose in patients with advanced NSCLC.5 Enrollment into the Part 2 dose expansion cohorts is ongoing, as the study evaluates JNJ-6372 monotherapy activity in multiple NSCLC sub-populations with genomic alterations such as those with C797S resistance mutation or MET amplification.5

A U.S. FDA Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.6 The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.6

i In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About JNJ-61186372 (JNJ-6372)
JNJ-6372 is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications.5,7 The production and development of the antibody followed Janssen’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Non-Small Cell Lung Cancer (NSCLC)
In the U.S., lung cancer is the second most common cancer in both men and women, after skin cancer; NSCLC makes up 80-85 percent of all lung cancers.8,9 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.10 The most common driver mutation for NSCLC is the EGFR genetic alteration, which is a receptor tyrosine kinase that helps cells grow and divide.10 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.11,12,13 EGFR exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for at least nine percent of all EGFR mutations.14 The five-year survival rate for patients with metastatic NSCLC is currently six percent.15