Lantern Pharma and Actuate Therapeutics Announce Research & Development Collaboration Leveraging Lantern’s Artificial Intelligence Platform

On May 3, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it has entered into a research and development collaboration with Actuate Therapeutics (Press release, Lantern Pharma, MAY 3, 2021, View Source [SID1234579015]). The collaboration will focus on leveraging the RADR machine learning technology, large-scale oncology datasets, and the A.I. platform to accelerate key aspects of Actuate’s 9-ING-41 drug candidate, a best-in-class GSK-3β inhibitor in active development in multiple Phase 2 clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately and will potentially generate novel intellectual property that will be jointly owned by the companies.

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Daniel Schmitt, President and Chief Executive Officer of Actuate Therapeutics, commented, "Accelerating the development of 9-ING-41 by leveraging the latest techniques in machine learning and genomics has the potential to aid in bringing our life altering therapies to patients faster and with a greater degree of precision. We are committed to leveraging the latest advances in biomarker driven medicine and technology to advance our drug candidates in the most promising sub-types of cancer and in patients who may have the highest likelihood to benefit from our therapy." In a study published on February 23, 2021 in the journal Cancer Medicine, Dr. Jayson Parker from the University of Toronto and his co-authors provided systematic statistical evidence that biomarkers when used in patient stratification and monitoring in oncology clinical trials improve the likelihood of drug regulatory approvals by a factor of five.

Lantern Pharma recently announced that the RADR platform had surpassed 4.6 billion datapoints and had advanced certain aspects of automation and machine learning as a result of the latest development campaign. The latest development campaign was aimed at improving the predictive power of the biomarker signatures created by RADR and the ability to potentially impact drug development in a broader range of solid tumor subtypes. Lantern expects that RADR will surpass 10 billion curated and tagged oncology datapoints over the next 12 months, which has the potential to make the platform even more useful across a broader range of cancer development and drug development or rescue programs.

Panna Sharma, CEO and President of Lantern Pharma, stated, "Companies like Actuate that are adopting methods that are at the forefront of this new era of data and A.I. guided drug development have the potential to conduct future clinical trials with biomarker signatures that have been generated at a fraction of the cost of traditional techniques. Using highly scalable machine-learning methods to guide drug development can potentially yield new biological insights, while also increasing response rates and improving outcomes in clinical trials."

Under the terms of the collaboration, Lantern Pharma will receive upfront equity in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts. No further financial details were disclosed.

Merus Announces First Patient Treated in Phase 1/2 Clinical Trial of MCLA-129 in Advanced Lung Cancer and Other Solid Tumors

On May 3, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that the first patient has been treated in its phase 1/2 dose escalation and expansion trial evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET (Press release, Merus, MAY 3, 2021, View Source [SID1234579118]). EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

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"The initiation of our phase 1/2 trial of MCLA-129 is an important step in our goal to provide meaningful treatments to patients with cancer, including NSCLC," said Dr. Andrew Joe, Chief Medical Officer of Merus. "Despite the successes with targeted therapies, patients will often develop resistance to currently approved treatments. Based on our preclinical data and other data, we are excited to investigate MCLA-129 as a potential new treatment option for patients with lung and other cancers, especially those that do not respond to EGFR inhibitors."

The phase 1/2, open-label clinical trial of MCLA-129 consists of dose escalation followed by dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity of the recommended phase 2 dose in patients with advanced solid tumors.

More details of the trial can be found at clinicaltrials.gov.

MCLA-129 is the subject of a collaboration agreement between Merus and Betta Pharmaceuticals Co. Ltd. (Betta). In January 2019, Merus and Betta announced this strategic collaboration to develop MCLA-129, where Merus granted Betta an exclusive license to develop and potentially commercialize MCLA-129 in China, with Merus retaining all rights outside of China. In January 2021, Betta announced that the Chinese National Medical Product Administration accepted its Investigational New Drug application of MCLA-129 injection.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

Transactions in connection with share buy-back program

On May 3, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 3, 2021, View Source [SID1234578959]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from April 26, 2021 to April 30, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 231,877 shares as treasury shares, corresponding to 0.35% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

Biofrontera AG: First quarter conference call to be held on May 12, 2021

On May 3, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it will be releasing its financial results for the first quarter 2021 on Tuesday, May 11, 2021 (Press release, Biofrontera, MAY 3, 2021, View Source [SID1234579000]).

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Conference calls for shareholders and interested investors will be held on Wednesday, May 12, 2021, at the following times

FibroGen to Report First Quarter 2021 Financial Results

On May 3, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its first quarter 2021 financial results on Monday, May 10 after the market close (Press release, FibroGen, MAY 3, 2021, View Source [SID1234579016]). FibroGen will also conduct a conference call on that day at 5:00 p.m. ET (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the FibroGen website at View Source It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

A replay of the webcast and investor presentation will be available shortly after the call for a period of 30 days. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and use passcode 2036817.