On September 5, 2023 Alkermes plc (Nasdaq: ALKS) reported that management will participate in fireside chat presentations at two upcoming investor conferences (Press release, Alkermes, SEP 5, 2023, View Source [SID1234634873]).

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Morgan Stanley 21st Annual Global Healthcare Conference

Date/Time: Monday, September 11, 2023 at 11:20 a.m. EDT (4:20 p.m. BST)

Cantor Fitzgerald Global Healthcare Conference

Date/Time: Wednesday, September 27, 2023 at 11:30 a.m. EDT (4:30 p.m. BST)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

On September 5, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that Thomas K. Equels, Chief Executive Officer of AIM, will present at the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York, NY and virtually (Press release, AIM ImmunoTech, SEP 5, 2023, https://aimimmuno.com/aim-immunotech-to-present-at-the-h-c-wainwright-25th-annual-global-investment-conference/ [SID1234634872]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 11 at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (aimimmuno.com). The webcast replay will be archived for 90 days following the event.

On September 4, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported promising interim safety and efficacy data from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima in advanced hepatocellular carcinoma (HCC) patients for whom current first- or second-line treatment has proven ineffective or is not tolerable (Press release, Medivir, SEP 4, 2023, https://www.prnewswire.com/news-releases/medivir-reports-promising-interim-data-including-a-first-complete-response-in-phase-1b2a-hcc-study-with-fostrox-in-combination-with-lenvima-301916719.html [SID1234634866]).

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The interim results confirmed the previously announced favorable safety and tolerability profile. No new or unexpected safety events and the combination continues to be tolerable.

The phase 2a dose expansion part of the study is ongoing and is now fully recruited. Data from phase 1b/2a is planned to be presented at an upcoming scientific congress.

– "We are excited about the interim data from the phase 1b dose escalation part. HCC patients, for whom current first- or second-line treatment has proven ineffective, is a difficult-to-treat patient group and expectation regarding clinical benefit and tumor shrinkage is low. This is why it is so encouraging to see that overall response is shown in 3 out of 6 patients and even more so that a complete response was recorded in one patient. Considering that the medical need for a new, effective treatment for HCC is large, these are very encouraging data for the future development of fostrox," says Dr. Pia Baumann, CMO at Medivir.

As a reminder, Medivir will be hosting an Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC later this week on Friday September 8th at 13:00 CET/07:00 EST. Dr Pia Baumann, CMO at Medivir, will also participate in the webcast and provide additional comments regarding the development of fostrox and data.

The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations

The presentation will be available on Medivir’s website after the webcast.

About fostrox

Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On September 4, 2023 Oncorena reported first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis (Press release, Oncorena, SEP 4, 2023, View Source [SID1234634865]). The first treatment was conducted on August 8 without any complication at the Center for Clinical Cancer studies at Karolinska University Hospital, Stockholm, Sweden. The study examines safety, tolerability, pharmacokinetics and anti-tumor effect when treated with ONC175.

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"I am happy to announce first patient, first treatment in our clinical phase I/II trial, Oncorella-1, with ONC175 (orellanine). This is a milestone for Oncorena accelerating our development plan since these patients are in need of more effective therapies," said Börje Haraldsson, CEO and CSO at Oncorena AB.

The clinical study, Oncorella-1, is conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Stockholm, Sweden. Hemodialysis is given at the same hospital, since patients eligible to the study are dialysis-dependent. Now, the first patient was given an infusion of ONC175 for 30 minutes. Additional patients are ready for treatment in the autumn. Each patient is followed up four weeks after the infusion by an independent Data Review Committee recommending potential dose escalations.

The drug candidate ONC175 has a unique mode of action and is being developed as a potential cure in patients with metastatic renal cancer and dialysis-dependent renal failure. Preclinical studies have shown that ONC175 is highly selective organ-targeted chemotherapy with potent anti-tumor effects metastatic renal cancer.

"It concerns a very different and unique medicine that is being tested here on patients with disseminated kidney cancer. We are very happy that the study is underway and we look forward to the results," says Jeffrey Yachnin, M.D. responsible for the study at the Center for Clinical Cancer Studies, Karolinska University Hospital.

This Press Release concerns a drug candidate under development. It does not attempt to communicate any conclusions regarding effect or safety. It is the purpose of clinical trials to objectively assess safety, tolerability and effects of drug candidates. There is no guarantee that the drug candidate’s development program will be completed or that it will gain approval by relevant authorities.

About ONC175

ONC175 with its new and unique mode of action, is being developed for organ-specific chemotherapy with curative potential for patients with metastatic renal cancer. ONC175 is the synthetically produced drug product, which active component is orellanine. Orellanine is found in mushrooms of the Cortinarius family. These can accidentally be picked and eaten as they are mistaken for funnel chanterelles. The clinical effects of orellanine are well documented and highly specific for kidneys. ONC175 is expected to have effects on the two most common forms of renal cancer, i.e., the clear cell och papillary types, representing approximately 90 percent of cases.

About the Phase I/II clinical trial

The Phase I/II clinical trial of ONC175 (orellanine), Oncorella-1, enrolls patients with metastatic renal cancer on dialysis due to renal failure. The study is conducted at the Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden, and studies safety, tolerability, pharmacokinetics and signs of anti-tumour effects in treatment with ONC175. The Phase I/II trial will include up to 40 patients and may include patients from other countries.

About kidney cancer

Approximately 400,000 patients are affected by kidney cancer globally according to the WHO. The disease can often be cured by surgery if detected early, but the prognosis is less favourable if there are metastases. Today, the disease is treated with various types of targeted and immuno-active drugs, that seldom are curative. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.

On September 4, 2023 QIAGEN reported that it will host the Global Oncohematology Summit 2023, held on September 13 and 14, under the theme "I Can: Improving Patients’ Lives Through Oncohematology Testing and Research" (Press release, Qiagen, SEP 4, 2023, View Source;Improving-patients-lives-through-testing-and-research-/default.aspx [SID1234634863]). The virtual event unites experts and patients from around the globe to discuss the latest advances and challenges in oncohematology testing, blood cancer clinical care, and research, focusing on improving patient outcomes. Emphasizing the utmost importance of patients’ perspectives, the summit will feature their testimonies, bringing their voices and considerations to the forefront of the discussion.

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Blood cancer continues to pose a significant global threat, with more than 470,000 new cases of leukemia in 2020 alone and nearly 312,000 deaths . With an overall 5-year relative survival rate in the US of 66.4% for all types of leukemia , early diagnosis and treatment are more crucial than ever. The Global Oncohematology Summit 2023 will be a vital platform for blood cancer clinical researchers, oncohematologists, data specialists, and survivors to exchange innovative ideas and insights in testing, clinical care and research.

"The QIAGEN Global Oncohematology Summit underscores our dedication to improving patient outcomes through collaboration, innovation, and education," said Jonathan Arnold, Vice President, Head of Translational Science and Precision Diagnostics at QIAGEN. "By bringing together experts from around the world, we aim to address the challenges that impact diagnosis, monitoring, and patient care, and ultimately, make a difference in the lives of those affected by blood cancers."

The event’s keynote speaker, Prof. Elias Jabbour, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, USA, said: "It is important to discuss and share the most innovative therapies in hematology from leukemia to myeloma, including assessing and managing measurable residual disease. There will be plenty of time for questions and answers and panel discussions where experts from around the globe will exchange their experiences."

The QIAGEN Global Oncohematology Summit 2023, which is expected to gather over 500 participants from across the world, is a free, educational virtual event that is CME and CPD-accredited. Event highlights include a diverse range of topics such as the latest blood cancer patient therapies management, expert views on CAR-T cell therapy and other breakthroughs, advocate and patient perspectives, new insights into testing and monitoring blood cancer and a European diagnostic laboratory’s perspective on their IVDR strategy.

To join the QIAGEN Global Oncohematology Summit on September 13 and 14, please register here.

QIAGEN: Advancing cancer diagnostics and research

Due to the vast biological and genetic diversity of hematological malignancies, identifying crucial molecular markers is essential for advancing blood cancer precision medicine and research. QIAGEN provides an extensive portfolio, encompassing sample collection to data interpretation. For example, the ipsogen assays provide diagnostic solutions, focusing on the detection of specific genetic and molecular biomarkers. These tests enable personalized care, early detection, treatment selection, response and monitoring, leading to more informed decisions and better patient care. QIAGEN ipsogen tests allow healthcare professionals to tailor treatment plans, assess measurable residual disease, and provide enhanced prognostic capabilities.

QIAGEN is also collaborating with more than 30 global pharmaceutical and biotechnology companies to develop and market companion diagnostics, which detect clinically relevant genetic abnormalities and provide insights that guide clinical decision-making in diseases like blood cancers. QIAGEN has an unmatched depth and breadth of technologies, from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR) for companion diagnostic development.

You can find out more about QIAGEN’s blood cancer portfolio here.