On June 24, 2021 Personal Genome Diagnostics Inc. (PGDx) reported a strategic collaboration with Massachusetts General Hospital (MGH) (Press release, Personal Genome Diagnostics, JUN 24, 2021, View Source [SID1234584334]). The two organizations will work closely on the development of innovative solutions aimed at enabling seamless introduction of next-generation sequencing and genomic-based tumor profiling capabilities across a diverse set of clinical operations and laboratory settings.

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"PGDx is thrilled to collaborate with MGH, one of the nation’s most highly regarded research hospitals and a leader in advancing the field of genomic testing into clinical cancer care for the benefit of patients," said Megan Bailey, Chief Executive Officer of PGDx. "Our elio tissue complete platform enables comprehensive tumor profiling and assessment of tumor mutation burden, which can be used to inform treatment strategies that employ targeted immunotherapies and other advanced precision medicines. This collaboration will aid in our goal of ensuring this powerful technology is broadly accessible to patients across all types of healthcare settings."

Cancer care in the 21st century requires comprehensive genetic information. The field of oncology has firmly embraced genetic tumor testing into patient care. One of the biggest challenges, however, is having access to all diagnostic information at the right time to make the best treatment decisions possible. The increased demand for testing has resulted in increased pressures on laboratories to implement high-throughput sequencing services.

"Despite dramatic advances in the number of targeted therapies and biomarkers identified in non-small cell lung cancer, several studies have shown that fewer than 50% of patients diagnosed with this disease receive comprehensive genomic profiling," said Lauren Ritterhouse, MD, PhD, Associate Director of MGH’s Center for Integrated Diagnostics. "Many of these instances are associated with a lack of access to multigene next-generation sequencing panels."

The collaboration between PGDx and the MGH recognizes the critical importance of empowering local laboratories. The groups will initially focus on a Precision Diagnostics solution that comes with a playbook and enables seamless introduction of next-generation sequencing testing across many laboratories. The groups are also committed to creating an on-site training program with a special emphasis on laboratory and clinical operations to accomplish broad-scale patient access.

"Next-generation sequencing is complex, and overcoming the various constraints puts many laboratories in a tough position," said Ritterhouse. "MGH is known for bringing discoveries to patients. And we believe it is important to focus our attention on facilitating a solution that will enable broader patient access to precision diagnostics."

On June 24, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported the closing of its previously announced registered direct offering to Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering (Press release, Anavex Life Sciences, JUN 24, 2021, View Source [SID1234584350]).

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The gross proceeds from the offering were approximately $50 million before deducting placement agent fees and other offering expenses. Anavex intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above were offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock have been offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On June 24, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported ahead of this morning’s Virtual Investor and Analyst Day that it anticipates exceeding its previously announced financial guidance for the second quarter ending July 4, 2021, driven by broad-based momentum across both COVID and non-COVID businesses (Press release, PerkinElmer, JUN 24, 2021, View Source [SID1234584319]).

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Presentations from company executives for this morning’s Investor and Analyst Day will begin at 8:30 a.m. ET and conclude at approximately to 11:30 a.m. ET. All participants are requested to register prior to the start of the event. The link can be accessed on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the webcast will be available on the PerkinElmer website following the presentation.

Additionally, PerkinElmer will release its second quarter 2021 financial results after market close on Wednesday, July 28, 2021. The Company will host a conference call the same day at 5:00 p.m. ET to discuss these results. Prahlad Singh, president and chief executive officer, and Jamey Mock, senior vice president and chief financial officer, will host the conference call.

To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 6596884. A live audio webcast of the call will also be available on the Investors section of the Company’s website.

A replay of the webcast will be available beginning at 7:00 p.m. ET, Wednesday, July 28, 2021 through the Investors section of the Company’s website.

On June 24, 2021 Nucleai (www.nucleaimd.com), a precision medicine company using AI-powered image analysis technology to support novel pathology-based biomarker development, and Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported that they have entered into a long-term collaboration to leverage Nucleai’s image analysis and biomarker discovery platform for several Merck KGaA, Darmstadt, Germany clinical stage oncology assets (Press release, Nucleai, JUN 24, 2021, View Source [SID1234584335]).

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As part of the collaboration, Merck KGaA, Darmstadt, Germany will leverage Nucleai’s platform for exploratory research, with the potential to further develop identified pathology-based biomarkers as companion diagnostics. The collaboration will further utilize Nucleai’s technology to expand onto Merck KGaA, Darmstadt, Germany’s analysis capabilities, enabling faster turnaround time and scale for future studies.

Nucleai’s platform analyzes tissue images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may help predict patient response. These biomarkers hold the potential to provide better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. To develop its platform, Nucleai leverages proprietary datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel.

"We are thrilled to announce another major collaboration with a leading pharmaceutical company like Merck KGaA, Darmstadt, Germany to identify and develop novel biomarkers for their oncology assets. By combining real world and clinical trial datasets, with an integrated and scalable technology platform, we are harnessing the power of AI and big data and setting the standard for future precision medicine collaborations, adds Avi Veidman, CEO and Co-Founder of Nucleai."

On June 24, 2021 Scandion Oncology A/S reported that positive results from the dose-finding part 1 of the CORIST Phase II study (Press release, Scandion Oncology, JUN 24, 2021, View Source,c3373635 [SID1234584302]). A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI has been determined and the SCO-101 treatment in the optimized combination resulted in notable potentiation of the biological activity of FOLFIRI. Furthermore, the CORIST study has identified the oncogene RAS as a predictive biomarker, which will be used to optimize the inclusion of patients in part 2. These positive data, have significantly de-risked the further development of SCO-101 and the company is now ready to advance to the proof-of-concept study (part 2) of CORIST.

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Part 1 of the CORIST study demonstrates the potential of SCO-101

"The interim CORIST data support our development plans for SCO-101 and at the same time pioneer the important perspectives around the platform potential of SCO-101, where we revert cancer drug resistance in various cancer diseases. We are looking forward to utilizing these learnings in our overall aim of building value for the patients, society and shareholders. We will communicate more about our plans and strategy at our Capital Market Day in September," says Bo Rode Hansen, President & CEO at Scandion Oncology.

Scandion Oncology, The Cancer Drug Resistance Company, is pleased to announce that the Company has obtained positive interim results from the CORIST trial, which substantiates the path for the further development of SCO-101. The CORIST Phase II study is aimed at combating cancer drug resistance in patients with metastatic colorectal cancer (mCRC) with acquired resistance to the chemotherapy regimen FOLIFRI. The patients enrolled in the trial have all failed prior standard chemotherapy due to resistance and have entered a terminal stage of their disease. Several positive take-home messages can be extracted from the data:

Well tolerated dose of SCO-101 in combination with FOLFIRI established
SCO-101 potentiates the biological effect of FOLFIRI in patients
Treatment benefit appears higher in patients without mutation in the RAS gene (RAS wild-type)
RAS biomarker enables de-risking of part 2 proof-of-concept study with SCO-101 in combination with FOLFIRI, in RAS wild-type patients with mCRC resistant to FOLFIRI
To exploit the new knowledge of the biomarker, the clinical protocol for part 2 of CORIST will be amended. Part 2 will commence as soon as the amendment is approved by the regulatory authorities. Timelines for read-out of CORIST part 2 may extend into Q3, 2022 due to this optimization.

All together, the results from the part 1 of the CORIST study have added significantly to our understanding of the effects of SCO-101 and consequently, de-risked the CORIST program.

We are ready to advance to the proof-of-concept part of the CORIST study

"We are satisfied finding a safe dose of SCO-101 in combination with FOLFIRI which displays biological activity in the patients and also favorably changes the adverse effects of the chemotherapy. We are further excited to have identified RAS as a predictive biomarker in the study. This enables us to tailor the treatment to patients who tolerate the treatment best and thereby have a higher likelihood to benefit from the treatment. We thank the patients and investigators who are participating in the trial," says Peter Michael Vestlev, CMO at Scandion Oncology.

Important data collected and predictive biomarker identified

The objective of CORIST part 1 was to study safety, tolerability and early effect measures of SCO-101 in combination with FOLFIRI in patients with metastatic colorectal cancer (mCRC) with acquired resistance to the chemotherapy regimen FOLIFRI. Part 1 of the CORIST study included 12 patients in the first cohort and 6 patients in the second cohort. The patients continue on treatment with SCO-101 and FOLFIRI until progression. Patients from both cohorts are still on treatment in the study, and the preliminary assessment of data show that:

Dose determination: Well tolerated dose of SCO-101 in combination with FOLFIRI has been determined (MTD), and the recommended dose for part 2 of the study has been identified. Repeated daily doses of SCO-101 in combination with a reduced FOLFIRI dose was well tolerated at exposure levels expected to be clinically relevant in this very fragile patient population.

Good safety profile: No treatment related grade 3 or 4 events were observed at the MTD dosis which is very encouraging. Only mild gastrointestinal adverse reactions were observed related to treatment, which is otherwise a common dose limiting adverse reaction to FOLFIRI. The most commonly observed grade 3 or 4 adverse reaction in the first cohort was neutropenia (reduced levels of white blood cells).
SCO-101 potentiates the effect of FOLFIRI: The combination with SCO-101 resulted in a notable potentiation of the biological effect of FOLFIRI on cells targeted by the chemotherapy (e.g. white blood cells and hair follicles).
Predictive biomarker identified: The RAS mutation status of the cancer at diagnosis was identified as a biomarker for segmentation of patients for the treatment with SCO-101 and FOLFIRI. Patients without mutation in the RAS gene (RAS wild-type) tolerated higher doses of SCO-101 and FOLFIRI. Patients with RAS wild-type also stayed longer on treatment than RAS mutated patients. The identified RAS biomarker is present in 50% of all mCRC patients and is already available from the initial diagnosis of the patients before inclusion in the CORIST study. The biomarker will be used for patient inclusion in part 2 of the study.
Preliminary effect measure: Eight of the included patients in CORIST part 1, were identified as RAS wild-type. Five of these eight patients have shown stable disease for more than eight weeks. Two of the five patients experienced a reduction in tumor volume (<30%). One patient has been on trial for more than 24 weeks and is still on therapy as part of the study. All patients in the RAS mutated group have experienced progressive disease after the first status scan.
Following conclusion of part 1, the study will advance to part 2 which will continue the focus on safety, tolerability and efficacy parameters, to establish proof-of-concept for SCO-101 in combination with FOLFIRI.

Timelines adjusted due to required amendment and reduction in eligible patient population

The de-risking of part 2 of the study by only including patients positive for the recently identified predictive biomarker, requires approval of an amendment from the regulatory authorities before part 2 can be initiated. The amendment will be submitted in July and approval is expected within 1-2 months following submission.

Due to the required amendment and the reduction in the eligible patient population for part 2 (RAS wild-type patients), timelines for reporting of results from part 2 may extend into Q3, 2022. The previous plan was to present results in Q1-Q2, 2022.

Additional trial sites in Denmark and abroad are currently being opened to increase recruitment rate and minimize the anticipated change in reporting timelines.

Design of CORIST part 2

The design for part 2 of the study is a standard single arm phase II study with the aim of further assessing safety, tolerability and preliminary effect of SCO-101 in combination with FOLFIRI. The primary efficacy objective is assessment of response (tumor reduction) and secondary efficacy objectives include assessment of Clinical benefit (Stable Disease, Progression Free Survival (PFS), Overall Survival (OS)) as well as biomarker assessment and correlation to treatment tolerability and outcome. Part 2 of the CORIST phase II study will include 25 patients.

Audiocast today, June 24 at 10:00 am CEST

Scandion Oncology A/S will be hosting an audiocast on June 24 at 10:00 am CEST to present the results from the read-out of the CORIST part 1 study, followed by a Q&A session. Representing the company will be President & CEO, Bo Rode Hansen and CMO, Peter Michael Vestlev. Please login to the audiocast via View Source

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on June 24, 2021 at 8:00 am CEST.