Dr. Reddy’s Laboratories enters into definitive agreement with Citius Pharmaceuticals, Inc. to sell its rights to anti-cancer agent E7777 (denileukin diftitox)

On September 4, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s"), reported that it has entered into a definitive agreement with Citius Pharmaceuticals, Inc. ("Citius") pursuant to which it sold all of its rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets (Press release, Dr Reddy’s, SEP 4, 2021, View Source [SID1234587243]).

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Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

In March 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: "Addressing unmet patient needs in oncology remains a prime focus area for us. E7777 has significant potential as an important component of systemic therapy for CTCL and other cancers. Post acquiring from Eisai, significant progress was made on the CTCL development front. We are confident of Citius’ ability to realize the full potential of E7777 in the treatment of CTCL as well as in their ability to develop this promising drug for additional oncology and immuno-oncology indications."

G1 Therapeutics to Participate in Two Upcoming September Conferences

On September 3, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming virtual investor conferences in September (Press release, G1 Therapeutics, SEP 3, 2021, View Source [SID1234587578]).

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On September 10, 2021, G1 will participate in the Citi 16th Annual BioPharma Virtual Conference. There is no webcast associated with this conference.

On September 13, 2021, G1’s Chief Executive Officer Jack Bailey will present at the H.C. Wainwright 23rd Annual Global Investment Conference. This will be available on demand beginning the morning of September 13, 2021. The webcast will be accessible on the Events & Presentations page of View Source

Molecular Partners to Present at Upcoming Healthcare Investor Conferences

On September 3, 2021 Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that its Chief Executive Officer, Patrick Amstutz, Ph.D., will present at two upcoming virtual healthcare investor events in September 2021 (Press release, Molecular Partners, SEP 3, 2021, View Source [SID1234587260]).

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Conference Presentation Details:

Event: Morgan Stanley 19th Annual Global Healthcare Conference
Date/Time: Friday, September 10, 11:00 AM – 11:45 AM ET (5:00 PM – 5:45 PM CET)
Event: H.C. Wainwright 23rd Annual Global Investment Conference
Date/Time: September 13-15, 2021; Presentation available on demand from Sept. 13, 7:00 AM ET (1:00 PM CET)
All webcasted presentations will be made available on the Molecular Partners website.

QIAGEN to enter the DAX – Germany’s leading stock market index

On September 3, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported it has been chosen to be included in the DAX (Deutscher Aktienindex), the leading German stock market index in Germany (Press release, Qiagen, SEP 3, 2021, View Source;Germanys-Leading-Stock-Market-Index/default.aspx [SID1234587258]).

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"Joining the ranks of Germany’s top publicly listed companies is a great milestone and achievement for QIAGEN," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "The relevance of molecular testing to fight disease, develop medicines and conquer scientific frontiers has never been stronger. Our employees are the reason for this achievement and have never been more committed to achieving our vision at QIAGEN of making improvements in life possible."

Roland Sackers, Chief Financial Officer of QIAGEN added: "Our inclusion in the DAX 40 is a recognition of the progress QIAGEN has made to deliver long-term profitable growth and create value for shareholders and other stakeholders. Even more important has been the contribution of QIAGEN’s solutions to increasing our knowledge about the biology of life and improving outcomes for patients. This goes to the heart of what our employees do every day and making a significant impact on daily life around the world."

QIAGEN was built on a revolutionary way to extract DNA – composed of the building blocks of life – from a wide range of biological samples. As a spinout of the University of Duesseldorf, QIAGEN has become a global company on track to achieve more than $2 billion in sales in 2021. With about 6,000 employees worldwide, QIAGEN’s corporate headquarter is in Venlo, the Netherlands, while the operational headquarters site is in Hilden, Germany.

QIAGEN is implementing a successful growth strategy that aims to create significant value for its stakeholders, including shareholders. The company’s portfolio of Sample to Insight portfolio address the growing molecular testing needs of customers across the continuum from research and pharmaceutical R&D in the life sciences to clinical molecular diagnostics.

The changes in the DAX, which is being expanded to include the 40 largest companies based on market capitalization, is set to take place on Monday, September 20, 2021. This is also the date when QIAGEN will no longer be included in Germany’s MDAX, which will now be the index for the next 50 companies based on market capitalization after the DAX.

QIAGEN also continues as a member of Germany’s TecDAX, which is comprised of the 30 largest German companies from the technology sector. Additionally, QIAGEN’s Global Shares are listed on the New York Stock Exchange (NYSE), making it one of only a few companies listed on exchanges in both countries.

PharmAbcine Receives HREC Clearance for Phase II Trial of Olinvacimab and Pembrolizumab in mTNBC

On September 3, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has received Human Research Ethics Committee (HREC) clearance to commence the Phase II combination trial of olinvacimab, PharmAbcine’s anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in Australia (Press release, PharmAbcine, SEP 3, 2021, View Source [SID1234587247]).

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The Phase II clinical trial is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study will evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after the administration of 16mg/kg of olinvacimab, and 200mg of pembrolizumab. PharmAbcine will sponsor the clinical trial that will take place in Australia, and MSD will supply pembrolizumab.

PharmAbcine and MSD decided to enter this collaboration based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and certain encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in Partial Response (PR) showed Complete Response (CR) in the target lesion and another PR patient showed CR in a non-target lesion.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"This is a significant milestone for the company, as we strongly believe that olinvacimab could be a new therapeutic option for mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are excited to initiate this study and expect the first patient enrollment to take place in October 2021.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab is an anti-VEGFR2 neutralizing fully human IgG. It is currently in a Phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the ongoing Phase Ib olinvacimab and pembrolizumab combo trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.