On August 19, 2021 NuCana plc (NASDAQ: NCNA) reported its financial results for the second quarter ended June 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 19, 2021, View Source [SID1234586776]).

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As of June 30, 2021, NuCana had cash and cash equivalents of £73.4 million compared to £78.6 million at March 31, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £9.1 million for the quarter ended June 30, 2021, as compared to a net loss of £6.1 million for the quarter ended June 30, 2020. Basic and diluted loss per share was £0.17 for the quarter ended June 30, 2021, as compared to £0.19 per share for quarter ended June 30, 2020.

"It has been a productive first half of 2021 with our release of important non-clinical and clinical data announcements. These include data from the NuTide:302 Phase Ib study of NUC-3373 in patients with advanced colorectal cancer as well as from the NuTide:701 Phase I study of NUC-7738 in patients with advanced solid tumors," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "These data presentations, made at several medical conferences, continue to support the favorable clinical profile we have observed to date and the broad potential of our ProTide technology."

Mr. Griffith continued: "As we look ahead to the second half of the year, we anticipate presenting additional clinical data from NUC-3373 and NUC-7738. Despite the COVID-19 pandemic, we remain on track to recruit sufficient patients in 2021 in the ongoing NuTide:121 Phase III clinical study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer to enable the first interim analysis in 2022. We are hopeful that this could enable us to submit an NDA in the United States under the FDA’s accelerated approval program. We are also on track with other key milestones, including the initiation this year of a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer."

Mr. Griffith also noted that NuCana has established preliminary objectives for the first half of 2022: "We are looking forward to 2022, which will be an important and active year for NuCana. With Acelarin, we anticipate announcing whether the NuTide:121 study has achieved the overall response rate objective at the first interim analysis in the first half of 2022. Additionally, based on the encouraging data seen to date with NUC-3373 and 5-FU’s broad usage in oncology, we anticipate initiating in 2022 a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors to identify further indications to target. We also expect to announce in 2022 data from the Phase II study of NUC-7738, which is anticipated to start later in 2021."

Mr. Griffith concluded: "Lastly, it is my pleasure to welcome Dr. Jeffrey Bloss to NuCana as our new Chief Medical Officer. Jeff brings more than two decades of relevant oncology experience leading clinical development and medical affairs at a number of companies. Over his career, he has been a key member of the teams responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar, Tarceva, Sorafenib, Tykerb and Xtandi. His experience and contributions will be invaluable to NuCana as we continue to advance our pipeline of novel ProTides through the clinic and towards commercialization."

Anticipated Milestones: H2 2021 & H1 2022

•Acelarin (a ProTide transformation of gemcitabine)

ºIn 2021, NuCana expects to reach enrollment of at least 418 evaluable patients to enable the first interim analysis in 2022 of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer; and
ºIn the first half of 2022, NuCana expects to announce whether the overall response rate objective for the first interim data from this Phase III study has been met, which may enable an NDA submission in the United States under the FDA’s accelerated approval program.

•NUC-3373 (a ProTide transformation of 5-FU)

In 2021, NuCana expects to:

ºReport data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer;
ºInitate and report data from the Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer;
ºInitiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer; and
ºReport data from the Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
In the first half of 2022, NuCana expects to:
ºInitiate a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and
ºExpand the Phase Ib / Phase II study to include second-line colorectal cancer patients, as well as evaluate NUC-3373 in combination with monoclonal antibodies such as bevacizumab (Avastin).

•NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2021, NuCana expects to:

ºReport data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors; and
ºInitiate a Phase II study of NUC-7738 in patients with solid tumors.

In the first half of 2022, NuCana expects to:

ºAnnounce data from the Phase II study of NUC-7738 in patients with solid tumors.

On August 19, 2021, Palisade Bio, Inc. (the "Company") and Yuma Regional Medical Center (the "Investor") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") pursuant to which the Investor purchased 1,509,896 shares (the "Shares") of the Company’s common stock, par value $0.01 per share (the "Common Stock") and a warrant to purchase up to 377,474 shares of Common Stock (the "Warrant") for a total purchase price of $5,209,141.20 (Filing, 8-K, Seneca Biopharma, AUG 19, 2021, View Source [SID1234586848]). The Shares were sold at a purchase price of $3.45 per share. The Warrant has an exercise price of $3.45 per share, subject to certain adjustments, and is exercisable for five years.

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Pursuant to the Purchase Agreement, the Company has agreed to file one or more registration statements with the Securities and Exchange Commission (the "SEC") registering the resale of the Shares and the shares of Common Stock issuable upon exercise of the Warrant by the Investor, to have all such registration statements declared effective within the timeframes set forth in the Purchase Agreement, and to keep such registration statements effective for up to five years. The Company will bear all expenses of the registration, excluding fees of legal counsel for Investor.

The Purchase Agreement contains customary representations and warranties of the Company and the Investor. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such Purchase Agreement and are made as of specific dates; are solely for the benefit of the parties (except as specifically set forth therein); may be subject to qualifications and limitations agreed upon by the parties in connection with negotiating the terms of the Purchase Agreement, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties, instead of establishing matters as facts; and may be subject to standards of materiality and knowledge applicable to the contracting parties that differ from those applicable to the investors generally. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company.

The Investor was a stockholder of the Company prior to the investment described above. Robert J. Trenschel, D.O., is a member of the Company’s board of directors and is the president and chief executive officer of the Investor. Dr. Trenschel does not have any pecuniary interest in the Company’s securities that are owned by the Investor.

On August 19, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada) (Press release, Adagene, AUG 19, 2021, View Source [SID1234586744]). The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck’s anti-PD-1 KEYTRUDA (pembrolizumab) in advanced or metastatic solid and/or hematological malignancies (ADG106-P2001/KEYNOTE-D12). This clinical study builds on the promising monotherapy and combination therapy data from a Phase I trial of ADG106. Engineered using Adagene’s proprietary NEObody platform technology, ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 immunoglobulin G4 (IgG4) monoclonal antibody (mAb).

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"We are excited to continue our partnership with Merck in a third clinical collaboration that now combines our anti-CD137 agonist, ADG106, with KEYTRUDA," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "While PD-1 drugs have advanced the cancer treatment paradigm, there are still a substantial number of patients with advanced metastatic solid and hematological malignancies who either relapse or are unresponsive, highlighting the need for new approaches. ADG106 targets a unique and highly conserved epitope with a novel mechanism of action and broad species cross reactivity, which enables testing in immunocompetent hosts. In multiple syngeneic models, we have shown a strong additive effect between ADG106 and anti-PD-1/PD-L1 agents."

"We look forward to working closely with Merck and combining ADG106 with KEYTRUDA", said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. "Together with our novel mechanism of action, extensive preclinical and strong clinical data generated to date, we believe ADG106 is an ideal candidate to combine with an anti-PD-1 antibody to potentially create a new therapeutic option for cancer patients with unmet medical needs."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ADG106

ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb being developed for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T cell proliferation and survival. In preclinical studies, we observed that ADG106 had robust antitumor activity and was well tolerated as a single agent and in combination with the existing standard-of-care and other immuno-oncology therapies. ADG106 activates CD137 in a native ligand-like fashion, blocks reverse CD137 ligand signaling, and induces potent cross-linking by Fc receptors. Because of this novel mechanism of action, ADG106 was observed to favorably balance CD137 agonism over CD137-induced liver toxicity, which we believe has potential to address the limitations of other existing anti-CD137 therapies.

ADG106 Phase I trials have been successfully completed with enrollment of nearly 100 patients with advanced solid tumors and non-Hodgkin’s lymphoma in the United States and China. Based on the promising Phase I data, ADG106 is being evaluated in a Phase Ib/II combination study in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.

On August 19, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company, reported that a successful preclinical study has shown its drug candidate LP-184 is able to inhibit tumor growth and improve survival in animal models of glioblastoma (GBM) (Press release, Lantern Pharma, AUG 19, 2021, View Source [SID1234586759]). This study was conducted in collaboration with the research group of John Laterra, M.D., Ph.D., at Kennedy Krieger Institute, which is affiliated with Johns Hopkins University. Lantern had previously announced the initiation of this GBM focused collaboration with Dr. Laterra in December of 2020.

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Recent in vitro and in vivo data from this collaboration on the efficacy of LP-184 in GBM cell lines, patient-derived neurospheres and mice models validated in-silico predictions generated by RADR on the efficacy of the drug candidate. RADR is Lantern’s proprietary machine learning-based artificial intelligence platform that integrates data analytics, experimental biology and large-scale genomic analysis to transform the cost, pace and timeline of oncology drug discovery and development.

In the research done with Johns Hopkins, LP-184 treatment induced tumor regression evidenced by greater than 106% tumor growth inhibition in two subcutaneous xenograft models of GBM (U87 and M1123). LP-184 also prolonged survival in mice bearing an intracranially implanted tumor model of GBM (U87), as compared with those that did not receive any drug substance. Intravenous administration of LP-184 over two cycles reduced subcutaneous xenograft tumor volume in mice by greater than 85% within the treatment group. In the orthotopic GBM xenograft tumor model in mice, a single cycle of LP-184 resulted in a statistically significant (p < 0.0001) extension of median overall survival in the LP-184-treated group (42 days) versus the control group (33 days). Lantern expects to further refine the dosing regimen and cycle in the next phase of work with the expectation that additional improvements in survival can be translated into human clinical trials.

Results from this ongoing translational research program highlight the promising in vivo anti-tumor effect of LP-184 in multiple GBM xenograft models and are expected to help guide the clinical application and focus of the drug candidate. Data from this study will be used to power future insights and analyses provided by RADR, in addition to further enhancing the signature of response for LP-184 in genomically-defined GBM. Additionally, these findings are expected to support Lantern Pharma’s orphan drug designation application to the FDA for the use of LP-184 in the treatment of glioblastoma. The study’s observations and detailed results are being prepared for peer-reviewed publications and scientific conferences.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. RADR-driven analyses have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair pathways as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy.

"This new data reinforces that LP-184 may have clinical utility for the treatment of primary and metastatic brain cancers," says Panna Sharma, Lantern Pharma’s chief executive officer. "We believe that LP-184’s molecular features and distinct mechanism of action, anti-tumor efficacy and strong correlation with specific biomarkers have the potential to provide a unique and powerful approach aimed at addressing high unmet needs in GBM and other aggressive CNS tumors. With this exciting data, we look forward to continuing our work with Dr. Laterra evaluating the potential of LP-184 as a new, potent treatment option for GBM, especially in areas not adequately addressed today, including MGMT-unmethylated, TMZ-resistant, EGFR-aberrant and recurrent GBMs associated with poor prognosis."

Based on these observations, Lantern recently extended and expanded its collaborative agreement with Kennedy Krieger Institute and Johns Hopkins. The objectives of the expanded agreement include further validation of in-silico and other experimental results that support the observation that LP-184 can be an effective treatment in GBM regardless of MGMT (a DNA repair enzyme) status of the cancer. This has significant potential to provide a much-needed alternative to the standard-of-care drug, temozolomide (TMZ), especially in GBMs that over-express MGMT — which can be up to 50% of GBM cancers. These patients that have GBMs that over-express MGMT are generally unresponsive to TMZ and need new therapy options that can exploit other molecular pathways and mechanisms. Development of an agent with efficacy in GBM, regardless of its MGMT methylation status, would be an important advance towards addressing a critical gap in the current standard of care.

Lantern’s RADR platform has also identified a subset of GBM with a low expression of nucleotide excision repair (NER) genes as being responsive to LP-184. Since NER is a critical mechanism for the repair of DNA damage induced by LP-184, the collaboration will further examine the enhanced sensitivity of this subset of GBM cancers to LP-184. In parallel, Lantern is also engaging in an additional study with Johns Hopkins to determine the pharmacokinetics and pharmacodynamics of LP-184 as it relates to the central nervous system (CNS) which has the potential to help uncover additional CNS cancers where LP-184 can play a key therapeutic role.

This research at the Kennedy Krieger Institute is being conducted in collaboration with Dr. Laterra, a professor in the Departments of Neurology, Neuroscience and Oncology at The Johns Hopkins University School of Medicine and a research scientist at Kennedy Krieger Institute. He is the director of the Division of Neuro-Oncology in the Department of Neurology at Johns Hopkins. Dr. Laterra’s laboratory focuses on the cellular and molecular biology of primary brain tumor malignancy, with the combined goals of defining basic mechanisms and translating these discoveries into experimental therapeutics. He is particularly interested in the molecular mechanisms, as well as the potential therapeutic interventions, to reverse glioma cell growth and survival pathways, and in the functioning of the blood-brain and blood-tumor barriers.

On August 19, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported its financial results for the six months ended June 30, 2021 (Press release, Biofrontera, AUG 19, 2021, View Source [SID1234586745]).

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The Biofrontera Group generated revenues of EUR 13,094 thousand in the first half of 2021, a decrease of 19% compared to EUR 16,117 thousand in the first half of 2020. The decrease was due to a one-time payment of EUR 6,000 thousand received by the Company in April 2020 from Maruho Co., Ltd. as part of a licensing agreement. All revenues in 2021 were derived from product sales, an increase of 35% compared to EUR 9,676 thousand in product revenues in the first half of 2020.

"Sales development in the first half of the year shows that we are gradually recovering from the pandemic. Since mid-March, sales have benefited from the easing of pandemic restrictions compared to the previous year. As a result, we were pleased to achieve product sales at pre-crisis levels in recent months," summarized Prof. Dr. Lübbert, CEO of Biofrontera. "Product sales from all markets in Q2 2021 showed an increase in sales of around 126% compared to Q2 2020 and about 10% compared to Q2 2019, prior to the pandemic. In our largest market, the U.S., product revenues from sales of Ameluz and the red-light lamp BF-RhodoLED increased by approximately 130% and about 7% in Q2 2021 compared to Q2 2020 and Q2 2019, respectively. The continued encouraging trend allows us to remain positive going into the second half of the year. From today’s perspective, we therefore confirm the guidance for the full year 2021, which may, however, change in connection with the planned IPO of Biofrontera Inc."

In the U.S., the Company generated revenues from product sales of EUR 8,657 thousand in the first half of 2021, compared to EUR 6,347 thousand in the same period of the previous year, an increase of 36%. This includes EUR 53 thousand (previous year: EUR 157 thousand) from revenues with the product Xepi. While revenues in the USA in January and February 2021 were significantly below those of the previous year due to the pandemic, Biofrontera Group has recorded a considerable year-on-year revenue recovery starting as early as mid-March 2021.

Sales in Germany increased by 15% to EUR 2,718 thousand compared to EUR 2,364 thousand in the prior-year period. In other European countries, sales improved by 78% to EUR 1,719 thousand compared to EUR 965 thousand in the first six months 2020. In this context, the Company recorded a large increase in sales particularly in the second quarter of this year, partly because June sales included the first batch of Ameluz for reintroduction by Galenica AB in the Scandinavian market. Sales from other regions, which included revenues from licensing fees as well as development projects with Maruho (Japan) in the previous year, were not generated in the reporting period (prior-year period: EUR 6,441 thousand).

Cash and cash equivalents of the Biofrontera Group amounted to EUR 32,632 thousand as of June 30, 2021, compared to 16,546 TEUR as of December 31, 2020.

Outlook
Performance in the first six months of 2021 was in line with the Management Board’s expectations. The Management Board therefore maintains its guidance for fiscal year 2021 published on April 12, 2021 in its entirety. Accordingly, the Management Board expects annual revenues between EUR 25 and 32 million as well as EBITDA loss between EUR 11 and 14 million and EBIT loss between EUR 13 and 16 million. However, changes to the Group’ s structure in connection with the planned IPO of Biofrontera Inc. (ad hoc announcement of July 6, 2021) may affect the full-year 2021 guidance of the Biofrontera Group.

The detailed annual forecast is available in the Company’s Annual Report 2020, which is published on the website of Biofrontera AG at View Source

Conference call
Conference calls for shareholders and interested investors will be held on Friday, August 20,
2021, at the following times:

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Biofrontera AG’s half-year report is available for download on the Company’s homepage at View Source