On April 26, 2022 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 Amgen, its collaboration partner for MP0310 (AMG 506), has informed the Company of their decision to return global rights of MP0310 to Molecular Partners following a strategic pipeline review (Press release, Molecular Partners, APR 26, 2022, View Source [SID1234612959]). Molecular Partners is presently conducting a phase 1 study of MP0310 and will look to present full phase 1 data at a scientific conference when available.

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"We would like to thank Amgen for a very fruitful collaboration which has led us to the initial clinical findings that an immunostimulatory receptor, such as 4-1BB, can be activated in a localized fashion," said Patrick Amstutz, Molecular Partners’ CEO. "This collaboration has enabled us to broaden our immuno-oncology expertise, DARPin platform knowledge, and clinical development capabilities which are now being applied across our portfolio. We continue to anticipate the full phase 1 dataset later this year, following which we can begin to explore potential collaborations for the program with new partners."

MP0310 is a dual-targeted compound, targeting both FAP and 4-1BB, that has the potential to activate T-cells and other immune cells, specifically in the tumor microenvironment, aiming to avoid systemic side effects associated with 4-1BB activation. Given this mode of action, future development will call for combination therapy trials. No additional clinical studies of MP0310 have been planned at this time. Following completion of the ongoing Phase 1 study, the Company will look to initiate discussions with potential collaborators.

The collaboration with Amgen was initiated in December 2018, providing an upfront payment of $50 million to Molecular Partners. Per the terms of the agreement, Molecular Partners is conducting the phase 1 clinical trial of MP310. Under the agreement with Amgen, following Phase 1 data, Amgen would have had the right to progress the program into later stage development, including into combination trials. The phase 1 clinical study was initiated in October 2019 in patients with solid tumors. Initial preliminary data from patient biopsies has demonstrated the potential of MP0310 to colocalize with FAP (fibroblast activation protein) and activate 4-1BB in the tumor microenvironment, after a first dose. A second part of the phase 1 clinical trial was initiated to optimize dosing and to demonstrate sustained activity at later time points. Data from the second part of the trial is pending. The remaining patient cohorts will be treated and followed, per the trial protocol, which is expected to be completed in the second half of 2022.

On April 26, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that its first quarter 2022 financial results will be released on Tuesday, May 10, 2022 after the markets close (Press release, Exelixis, APR 26, 2022, View Source [SID1234612958]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6282616 to join by phone.

A telephone replay will be available until 8:00 p.m. ET on May 12, 2022. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6282616. A webcast replay will also be archived on www.exelixis.com for one year.

On April 26, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that results for the first quarter of 2022 and increased the outlook for full-year 2022 (Press release, Qiagen, APR 26, 2022, View Source [SID1234612957]).

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Net sales for Q1 2022 rose 11% (+15% CER) from Q1 2021 to $628.4 million, ahead of the outlook for at least 7% CER growth. Sales were driven by 14% CER growth in the non-COVID-19 product portfolio and an 18% CER rise in sales of products used for COVID-19 testing and surveillance. Adjusted diluted earnings per share (EPS) rose to $0.80 ($0.83 CER) from $0.66 in Q1 2021, and above the outlook for at least $0.72 CER.

Based on the strong start to the year, QIAGEN has increased its full-year 2022 net sales outlook to at least $2.12 billion CER and for adjusted diluted EPS of at least $2.14 CER.

The updated outlook reflects a reaffirmation of the previous goal for double-digit CER sales growth from the non-COVID product groups, but for a significant year-on-year decline in COVID-19 product group sales based on the expected volatile pandemic trends in 2022. Also taken into consideration was an updated assessment of current inflation and macro-economic trends. This included the adverse impact of anticipated lost sales in 2022 from Russia, Ukraine and Belarus as a result of the war in Ukraine. These countries represented approximately 1% of total QIAGEN sales in 2021. QIAGEN continues to make ongoing investments into its portfolio, in particular the five pillars of growth, for new products, test menu and applications. This outlook does not take into consideration any future acquisitions.

"QIAGEN is off to a strong start in 2022, led by the solid performance of our non-COVID product portfolio in the first quarter driven by a focus on execution against our goals. These results have also reaffirmed our confidence in double-digit CER sales growth for 2022 from these products, which form the basis for our mid-term growth ambitions," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "This performance in the first quarter has set a solid stage for continued execution in an increasingly volatile environment while our proactive initiatives have helped to build resilience into our business."

"Our teams of empowered QIAGENers are focused on delivering on our promises for future growth. We continue to execute, quarter after quarter, from sales goals to project development. We continue to develop a well-balanced portfolio between Life Science and Molecular Diagnostics customers, across our different regions, and also between our five pillars of growth and our core business." Bernard said.

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "Our results for the first quarter of 2022 show the power of QIAGEN with strong sales growth, improved profitability and operating cash flow over the same period in 2021. We are confident that investments into our portfolio are creating value and positioning QIAGEN toward new growth waves in the coming years. We continue to review opportunities for capital deployment, including bolt-on acquisitions, that are aligned with our strategy and set to create greater value for shareholders and our other stakeholders."

Please find the full press release here.

Investor presentation and conference call

A conference call is planned for Thursday, April 28, 2022, at 16:00 Frankfurt Time / 15:00 London Time / 10:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation is planned to be available shortly before the conference call at View Source

On April 26, 2022 Tiziana Life Sciences Ltd (NASDAQ: TLSA) ("Tiziana" or the "Company"), a clinical-stage biopharmaceutical company developing alternative routes of immunotherapy with a focus on innovative drugs for neurodegenerative diseases, including treatment with intranasal foralumab for Secondary Progressive Multiple Sclerosis, reported its Chief Executive Officer and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will participate in a fireside chat at the B.Riley Securities 2022 Virtual Neuro & Ophthalmology Conference on Wednesday, April 27, 2022 at 2:30 p.m. ET (U.S. and Canada) to provide Company updates (Press release, Tiziana Life Sciences, APR 26, 2022, View Source [SID1234612956]).

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Date: Wednesday, April 27, 2022
Time: 2:30 p.m. Eastern Time (U.S. and Canada)
Webcast: Click this link to access: View Source

On April 26, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has opened patient enrollment in the Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma (Press release, Phio Pharmaceuticals, APR 26, 2022, View Source [SID1234612955]).

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"We are excited to advance our first-in-human clinical trial for our lead program, PH-762, to treat patients with melanoma. The start of this clinical study marks a significant milestone for Phio and our INTASYL therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This is an important study for patients with advanced melanoma as well, since currently, there are no neoadjuvant treatment options approved for these patients. In addition, the clinical program for PH-762 to treat melanoma is supported by a robust set of preclinical data generated over the past several years. These data show that local treatment of PH-762 inhibits not only local tumor growth, but also elicits an abscopal effect or systemic immune response in distal, untreated tumors."

The Phase 1b study, which is being conducted at the Gustave Roussy Institute, one of the largest cancer centers in Europe, will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will feature a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose. This is the first clinical trial with PH-762.

PH-762, activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.