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BERGENBIO PRESENTS PHASE II BEMCENTINIB COMBINATION STUDY IN NSCLC AT annual SITC meeting

On November 11, 2020 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 updated clinical & translational analysis from its Phase II bemcentinib and pembrolizumab combination study (BGBC008) in advanced non-small cell lung cancer (NSCLC), at an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Annual Meeting (Press release, BerGenBio, NOV 11, 2020, View Source [SID1234570896]).

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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 16 refractory NSCLC patients previously treated with a PD-L1 or PD-1 checkpoint inhibitor (CPI) as a monotherapy.

"AXL is implicated in resistance to immunotherapy and this study is based around the hypothesis that blocking AXL signalling represents a novel approach to prevent cancer survival mechanisms and to improve the efficacy of immuno-oncology drugs," commentedProfessor James Spicer, PhD, who will give the presentation at SITC (Free SITC Whitepaper). "Our findings from this interim analysis suggest that bemcentinib has potential to reverse acquired resistance to checkpoint inhibitors among previously treated NSCLC patients by targeting AXL expressing macrophages and regulatory dendritic cells. These encouraging results support the further development of AXL inhibition as a means to extend the efficacy of immunotherapy in biomarker-selected NSCLC patients."

The combination of bemcentinib and pembrolizumab was overall shown to be well tolerated and clinically active in CPI-refractory composite AXL (cAXL) positive NSCLC. Of the evaluable patients in Cohort B 58% were cAXL-positive, 25% were PD-L1 negative (<1%TPS), and 42% patients were PD-L1 low positive (1-49% TPS). 86% of cAXL-positive patients achieved clinical benefit (one partial response, five stable disease) while none was observed in cAXL negative patients.

The study demonstrated a median progression-free survival among cAXL positive patients in Cohort B patients of 4.73 months, compared with 1.87 months among cAXL-negative patients.

Full details of the presentation are as follows:

Title: A PhII study of bemcentinib, a first-in-class selective AXL kinase inhibitor, in combination with pembrolizumab in pts with previously-treated advanced NSCLC: Updated clinical & translational analysis

Author: Professor James Spicer, Professor of Experimental Cancer Medicine at King’s College London

Session/Abstract ID: Combinatorial Therapies, 362

Date/Time: 11 November 2020, 11.40am EST

The presentation will be made available on BerGenBio’s website, under ‘Presentations’.

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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.

QIAGEN announces start of share repurchase for up to $100 million

On November 11, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has commenced a share repurchase of up to $100 million as authorized in a repurchase program already announced on May 6, 2019 (Press release, Qiagen, NOV 11, 2020, View Source [SID1234570801]).

In the period between today and December 17, 2020, at the latest, up to $100 million of QIAGEN shares (or the equivalent Euro amount thereof, in each case without ancillary purchasing costs) are planned to be repurchased through a financial institution commissioned by the Company exclusively on the electronic trading platform of the Frankfurt Stock Exchange (XETRA). Based on the closing price on Tuesday, November 10, 2020, this represents a repurchase volume of approximately two million shares.

"This share repurchase program reflects our confidence in QIAGEN’s growth prospects and outlook, and is a reaffirmation of our commitment to creating value for shareholders and other stakeholders," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V.

"We have a very healthy balance sheet that enables a disciplined capital deployment policy to support QIAGEN’s business expansion while also increasing returns to shareholders," said Roland Sackers, Chief Financial Officer of QIAGEN N.V.

QIAGEN will provide regular updates on the progress of the repurchase program in the Investor Relations section at www.qiagen.com.

APOLLOMICS, INC. RECEIVES CHINA INVESTIGATIONAL NEW DRUG APPROVAL FOR APL-102 TO INITIATE A PHASE 1 STUDY

On November 11, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of new tumor-targeting agents and immuno-oncology agents and their combination therapies, reported that APL-102 has received China Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study of APL-102 in patients with advanced solid tumors (Press release, Apollomics, NOV 11, 2020, View Source [SID1234570750]).

Dr. Guoliang Yu, the company’s Co-Founder, Chairman and CEO said that: "APL-102 is a small molecule multi-kinase inhibitor developed by us. It has demonstrated broad and potent antitumor activity in patient derived xenograft mouse models of liver cancer, breast cancer, colorectal cancer, gastric cancer, esophageal cancer and non-small cell lung cancer, demonstrated excellent oral bioavailability and relatively low toxicity in pre-clinical studies. APL-102 may not only be used as a single agent to treat patients, but also has a potential of being co-administered with immunotherapy and other treatments as a combination therapy."

About APL-102

APL-102 is an oral, multi kinase inhibitor (mKi) targeting several key oncogenic drivers. APL-102 inhibits both receptor tyrosine kinase (RTKs) and serine/threonine-kinases, including: angiogenesis via vascular endothelial growth factor receptors (VEGFRs) and platelet-derived growth factor receptors (PDGFRs); mitogen-activated protein kinase (MAPK) pathway via B-RAF and C-RAF; RET, CSF1R, DDR1 and c-KIT.

Apollomics owns the global clinical development, production and commercial sales rights of APL-102.

Biofrontera reports third quarter and first nine months 2020 results

On November 11, 2020 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported its results for the third quarter ended September 30, 2020 (Press release, Biofrontera, NOV 11, 2020, View Source [SID1234570737]). In addition, the Company provided an overview of the current business performance.

"The coronavirus pandemic continues to be a tremendous challenge for us all. Following a 30% decline in product sales in the first half of the year when compared to the same period in 2019, the decline for the first nine months of 2020 has narrowed to just 23%. The closing of the revenue gap is mainly due to the crisis in the USA, whose gradual easing is reflected in the sales figures. The overall decrease in US-revenues was compensated by the strong sales performance in Germany and the one-time payment made by Maruho Co., Ltd., so that an overall 9% increase in sales was achieved compared to the same period last year" commented CEO Prof. Dr. Hermann Lübbert. "In the third quarter, we saw sales stabilize to a great extent in line with the usual seasonality. Even against the background of the ongoing pandemic, we are therefore optimistic about the fourth quarter. Due to the implementation of our global cost-saving measures since March, we managed to keep Q3 operating costs during the coronavirus crisis well below the previous year’s level. As a result, our operating result was considerably better than in Q3 2019 despite the 9% drop in quarterly sales."

Business performance

The most significant impact of the coronavirus crisis was felt in the USA. There, product sales of EUR 9,095 thousand generated in the reporting period were down 33% compared to the same period of the previous year (EUR 13,603 thousand). This includes EUR 202 thousand in sales generated with Xepi.

Nine-month sales in Germany, on the other hand, increased by 19% to EUR 3,893 thousand (previous year period: EUR 3,279 thousand). Sales in other European countries decreased by 26% to EUR 1,349 thousand (previous year period: EUR 1,810 thousand).

Expenses and result of operations

As a result of the cost reduction measures introduced throughout the Company in March, operating expenses were significantly lower in Q3 2020 compared to the same period last year. In particular, sales and marketing expenses were significantly lower year-on-year. Additionally, administrative expenses were further reduced due to lower legal costs. 2019 figures also included costs related to the first-time consolidation of Cutanea Life Sciences, Inc.

The loss from operating activities improved by EUR 12,729 thousand to EUR 8,364 thousand compared to a loss of EUR 21,093 thousand in Q3 2019.

Current clinical studies

In October, the clinical phase of the pharmacokinetics study in the US, which has been ongoing since the beginning of the year, was completed. This study evaluated the safety of photodynamic therapy for the treatment of actinic keratoses on large or multiple surfaces using up to three tubes of Ameluz at a time. Despite delays in patient recruitment due to the coronavirus pandemic, the clinical phase of the study was completed in early October with the so-called "last subject last visit". The Company still expects to complete the final study report before the end of the year. The study is another important milestone to increase the competitiveness of Ameluz in the US.

At the same time, the new BF-RhodoLED XL lamp is being completed, which enables the application of Ameluz on larger areas. Due to delays in the supply of parts for the first manufacturing batch caused by the coronavirus crisis, the dossier for marketing approval will now be submitted to the FDA in the first quarter of 2021.

Despite the difficult conditions, Biofrontera is working intensively to maintain all ongoing clinical studies and to meet the communicated timelines as far as possible. The already slow patient recruitment of the Phase III study of Ameluz in the US for the treatment of basal cell carcinoma also continues as planned.

Litigation

Since September, the company has been engaged in a process of mediation with the Deutsche Balaton Group by order of the US District Court for the Southern District of New York. Within the framework of the ongoing process of mediation, an experienced and renowned mediator has been engaged to resolve ongoing (legal) disputes. In order to have sufficient time for the complex negotiations, the parties mutually agreed to extend the original deadline of November 11, 2020 until the end of February 2021.

In its ruling of September 22, 2020, the German Federal Supreme Court overturned a ruling of the Cologne Higher Regional Court of November 15, 2018, which had been directed against the Company. The reversed judgment of the Cologne Higher Regional Court concerned an action for rescission and nullity by the shareholder Deutsche Balaton AG, which is directed against resolutions of the Annual General Meeting on May 24, 2017. The matter has now been referred back to the Cologne Higher Regional Court for retrial and decision. In its reasons for the decision, the Cologne Higher Regional Court assumed that the Management Board had violated the requirement of equal treatment of shareholders in connection with a capital increase carried out in October/November 2016 in a severe and unequivocal manner. The German Federal Supreme Court has now determined that the violation of law assumed by the Cologne Higher Regional Court has not at all occurred. Among other things, the Annual General Meeting on May 24, 2017, had resolved to create new authorized capital.

The Company has again submitted an application to the Cologne Higher Regional Court for approval of the capital increase resolved by the 2020 Annual General Meeting.

In the trial of DUSA Pharmaceuticals, Inc. (DUSA) filed in March 2018 with the District Court of Massachusetts against the Biofrontera Group, in October the further proceedings were referred to the decision by a jury. A trial date has not yet been set. The lawsuit includes the alleged infringement of DUSA Patents No. 9,723,991 and No. 8,216,289 through the sale of BF-RhodoLED in the USA, claims based on unauthorized use of alleged trade secrets as well as tortious interference with contractual relations and deceptive and unfair trade practices. DUSA has asserted considerable claims for damages in these proceedings. However, the Company considers these to be unfounded and unsubstantiated.

Financial position

Cash and cash equivalents amounted to EUR 16.6 million as of September 30, 2020 compared to EUR 11.1 million as of December 31, 2019. This amount includes the proceeds from the mandatory convertible bond 2020/21 issued during the reporting period.

The prior financing requirement of at least EUR 5 million to maintain business operations until the end of April 2021 was covered by the successfully completed capital measure generating gross proceeds of EUR 7.9 million, leaving the Company with sufficient liquidity at present.

Outlook

Biofrontera continues to be affected by the economic and social impact of the coronavirus pandemic. As a result, it remains difficult to accurately predict the company’s business performance. However, as in previous years, the Company expects a significant increase in sales in the fourth quarter.

Conference call

Conference calls for shareholders and interested investors will be held on Thursday, November 12, 2020, at the following time

Salarius Pharmaceuticals Reports Business Highlights and Third Quarter 2020 Financial Results

On November 11, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for children and adults with pediatric cancers, solid tumors and other cancers, reported its corporate and financial results for the third quarter ended September 30, 2020 (Press release, Salarius Pharmaceuticals, NOV 11, 2020, View Source [SID1234570731]).

Recent Business and Corporate Events:

Ewing sarcoma Phase 1/2 clinical trial is completing dose escalation to establish maximum tolerated dose (MTD) and is expected to advance into Phase 2 dose-expansion in Q1 2021
Ewing sarcoma clinical trial expansion phase expanded to include patients with Ewing-related sarcomas such as myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas with similar biology to Ewing sarcoma
º Ewing sarcoma and Ewing-related sarcomas represent rare cancers affecting both children and adults where there is a high unmet need for additional treatment options
Financial Highlights:

Total cash and cash equivalents of $9.6 million as of September 30, 2020 due in part to $6.2 million gross proceeds in an underwritten public offering closed August 3, 2020
Three-month period ended September 30, 2020 net loss per common share – basic and diluted – of $0.10, compared to $0.73 for the same period ended September 30, 2019
"The events of the third quarter of 2020 affirm the company’s growth strategy and demonstrate the potential of seclidemstat as a treatment for cancers with high unmet need," said David Arthur, President and CEO of Salarius. "Our lead clinical program in Ewing sarcoma continues to advance, and we expect to reach the maximum tolerated dose (MTD) in the Phase 1 portion of the clinical trial and, as planned, begin the Phase 2 dose-expansion portion of the trial in Q1 2021. This is an important milestone as it allows us to establish the recommended Phase 2 dosing regimen for the trial and begin treating a broader group of patients with Ewing and Ewing-related sarcomas."

Mr. Arthur continued, "Ewing sarcoma and advanced solid tumors (AST) remain our most advanced development programs, but we believe seclidemstat offers the opportunity to address numerous cancers where additional treatment options are needed. In this regard, we recently expanded the dose-expansion phase of the Ewing sarcoma clinical trial to include several additional sarcomas. This decision was based on preclinical data and early clinical data observations from the ongoing clinical trials that suggest seclidemstat may demonstrate drug activity and have applicability in other sarcomas that have a similar gene arrangement to Ewing sarcoma, known as Ewing-related sarcomas. Among those observations, Salarius previously disclosed that a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions, which generally represent a patient’s largest measurable tumors."

Ewing Sarcoma Clinical Trial Expanded
On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas. Sarcomas of interest include myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma.

These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma. As Salarius previously disclosed, a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions. Target lesions generally represent a patient’s largest measurable tumors. However, at eight weeks, an increase in non-target lesions resulted in an overall patient classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

The amendment to the ongoing clinical trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase.

Additional Clinical Trials to Expand Development Program
Mr. Arthur concluded, "In addition, in the third quarter we continued preparatory work on two additional clinical trials and look forward to announcing the initiation of these trials soon. These additional clinical trials support our growth strategy focused on maximizing the market potential of seclidemstat."

Three-Month Financial Results:
For the three-month period ended September 30, 2020, Salarius’ reported net loss was $1.7 million, or $0.10 per basic and diluted share, compared to a net loss of $2.6 million, or $0.73 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended September 30, 2020 decreased by $2.0 million compared to the same time span last year, primarily due to a $2.2 million decrease in general and administrative expenses which more than offset the increase of $0.7 million in research and development expenses. Increased research and development costs resulted from increased clinical trial expenses and drug manufacturing costs. The decrease in general and administrative costs resulted from the absence of costs related to Salarius’ one-time transformation into a public company during 2019 which did not reoccur in the current period.

As of September 30, 2020, total cash, cash equivalents and restricted cash were $9.6 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offerings of stock in the first quarter and third quarter 2020. The Company expects its cash and cash equivalents to fund its operations into the third quarter of 2021.

$6.2 Million Underwritten Public Offering
On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering and ongoing non-dilutive financial support from the Cancer Prevention Institute of Texas (CPRIT) to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.

Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, November 11, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2020. Interested participants and investors may access the conference call by dialing either:

An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on November 11, 2020.