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.

On June 24, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, for the treatment of HER2-high and HER2-low expressing gastric cancers (Press release, Pieris Pharmaceuticals, JUN 24, 2021, View Source [SID1234584320]).

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"The granting of orphan drug designation to cinrebafusp alfa underscores the high unmet medical need that persists in the treatment of gastric cancer and reinforces our conviction in the importance of developing this program while setting a high bar for success to help patients with limited therapeutic options," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We look forward to beginning the phase 2 trial of cinrebafusp alfa later this summer."

FDA grants orphan drug designation to promote the development of a drug that targets a condition affecting 200,000 or fewer U.S. patients annually. Orphan drug designation provides qualifying therapies with development and commercial incentives, including FDA assistance in clinical trial design, tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years following FDA approval, in addition to other available regulatory exclusivities.

About Cinrebafusp Alfa:
Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. Based on encouraging phase 1 study results, which demonstrated clinical benefit as single agent and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel for the treatment of HER2-high expressing gastric cancer and in combination with tucatinib for the treatment of HER2-low expressing gastric cancer.

On June 24, 2021 City of Hope, a world-renowned cancer research and treatment center, reported that it has identified how cancer cells in patients with early-stage breast cancer change and become resistant to hormone or combination therapies, according to a new study published in Nature Cancer (Press release, City of Hope, JUN 24, 2021, View Source [SID1234584336]).

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About 80% of breast cancer cases are hormone receptor positive, meaning that these cancer cells need estrogen or progesterone to grow, according to the American Cancer Society. Doctors currently treat people with estrogen receptor positive (ER+) breast cancer using therapy that inhibits both estrogen levels and cell cycle activity. While these therapies often initially shrink tumors, about 90% of metastatic patients and 50% of Stage 2 and 3 breast cancer patients develop resistance.

A research team led by Andrea Bild, Ph.D., a professor in City of Hope’s Department of Medical Oncology & Therapeutics Research, used single-cell RNA sequencing to identify resistant traits cancer cells acquire; these cancer cells are able to persist despite therapy. The team also identified when these resistant traits are acquired and found them as early as two weeks after the start of a treatment regimen, which is months faster than current methods used to measure treatment response.

"If health care providers are able to identify the development of tumor resistance earlier, then they can quickly switch gears and offer a different treatment regimen that could eventually bring the breast cancer patient into remission rather than continuing on a path that may fail to achieve a positive outcome," Bild said. "With the current available set of precision medicine tools, medical professionals could measure patient response to treatment earlier to offer treatment options that are more likely to work for each individual patient."

Bild and her colleagues studied the evolution of the DNA and RNA in breast tumor cells of postmenopausal women with ER+ breast cancer who were enrolled in the FELINE trial. These patients were treated with endocrine therapy (letrozole) alone and in combination with cyclin-dependent kinase (CDK) inhibitor therapy (ribociclib), a treatment that restrains tumor cells from growing. Patients were treated with targeted therapy in a neoadjuvant setting, meaning prior to surgery to remove the tumor, to assess response. Biopsies from over 40 patients’ tumors were processed and analyzed from cells taken prior to, two weeks after and six months from the start of endocrine and combination treatments.

City of Hope researchers found that resistant cells that persist even after endocrine and cell cycle (CDK4/6) inhibition therapy tend to shift their growth engine from using estrogen signaling to using alternative growth factor receptors and to rewiring cell cycle pathways. For example, resistant cells bypass the blocked pathways by turning on alternative signaling pathways such as growth receptors and MAPK signaling; this rewiring enables cancer cells to continue growing despite the estrogen and cell cycle drug inhibitors. Targeting these acquired resistance pathways with appropriate therapies may help doctors in the future treat patients with resistant ER+ early-stage breast cancer.

"The study is impressive in its scope, presenting comprehensive genomic profiling of the longitudinal samples from multiple patients," said Suwon Kim, Ph.D., who was not involved in the research and is an associate professor at Translational Genomics Research Institute (TGen), an affiliate of City of Hope, and a faculty member of the University of Arizona College of Medicine. "The results are significant, revealing the emergence of the alternate specific pathways in single tumor cells as they become resistant to CDK inhibitors and endocrine therapy. The study findings offer opportunities for evidence-guided therapeutic intervention for therapy-resistant breast cancer."

Understanding how tumor cells quickly change and rewire signaling pathways so that they can persist after combination neoadjuvant cancer treatment will enable scientists to design novel treatment regimens that target tumor resistance. Bild and colleagues are now identifying drugs that block the traits found specifically in resistant cancer cells.

"Early-stage ER+ and PR+ (progesterone receptor positive) breast cancer is often curable, and we need to continue down this line of research to design therapy strategies that provide a positive patient outcome that lasts," Bild said. "I recommend that, when possible, clinicians continue to collect tumor biopsies so we can measure cancer cell responses during treatment to understand how the patient’s tumors are responding. In addition, we need to look at RNA changes and not just DNA modifications, as these changes may more broadly capture resistance mechanisms."

She added, "I am grateful to patients who participate in clinical trials so that scientists can continue to find better ways to treat this disease."

The study was supported by a Cancer Prevention Research Institute of Texas Core Facility Support Award (RP170668) and by the National Cancer Institute of the National Institutes of Health (U54CA209978).