On April 30, 2021 Immunicom, Inc., a clinical-stage biotechnology company pioneering "subtractive" advanced cancer therapies, reported that promising preliminary data from trials investigating ImmunopheresisTM therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy (Press release, Immunicom, APR 30, 2021, View Source [SID1234578906]). The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the 2021 ISFA/E-ISFA virtual joint conference established that Immunopheresis administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.

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Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.

"Standard drug treatments are additive therapies that introduce substances into the body to treat cancers. We are developing high-affinity subtractive therapies specifically for these difficult metastatic cancers," said Immunicom’s CEO, Amir Jafri. "Our mission is to define a new era of cancer treatment that is safe and effective."

Dr. Segal’s presentation focused on results from over 600 Immunopheresis procedures conducted in 34 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

Subtractive Therapy – ImmunopheresisTM and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy," in contrast to drugs that are "additive." Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

On April 30, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has received exercise notices from Kreos Capital along with other historical investors who have converted warrants to shares (Press release, Noxxon, APR 30, 2021, View Source [SID1234578905]).

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A total of 3,768,449 new shares in NOXXON shall be issued consequently to the transaction, and NOXXON shall receive €1.2 million. This brings the total number of outstanding shares in NOXXON to 65,223,981. Following this warrant exercise, Kreos Capital holds 7.38% of outstanding shares in NOXXON.

The warrants were issued in connection with NOXXON’s €1 million private placement, Kreos Capital’s partial conversion of debt into equity and €10 million convertible notes with warrants on May 2, 2017. Details of the transaction can be found in the associated press release.

"We are pleased to exercise these warrants and increase our investment in NOXXON. We have been involved in NOXXON since 2014 and are confident the company has exciting long-term prospects, based on its differentiated technology, strong oncology-focused pipeline and the development strategy being implemented by management," said Aris Constantinides, General Partner at Kreos Capital.

"I would like to thank Kreos Capital for their ongoing long-term support of NOXXON. We look forward to working closely together as we continue to focus on improving cancer treatments by targeting the tumor microenvironment, including our lead candidate NOX-A12, which is progressing well in a Phase 1/2 brain cancer trial, with data read-outs expected in May and November 2021," said Aram Mangasarian, CEO of NOXXON.

On April 30, 2021 KIYATEC, Inc reported that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures (Press release, KIYATEC, APR 30, 2021, View Source [SID1234578904]). The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.

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Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.

"We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers," said Matthew Gevaert, CEO and co-founder of KIYATEC.

The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.

Robart said, "KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors."

On April 30, 2021 Guardant Health reported that For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients (Press release, Guardant Health, APR 30, 2021, View Source [SID1234578903]). Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue.1,2

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The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

"The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue," said AmirAli Talasaz, Guardant Health president. "We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making."

"By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have comparable sensitivity and specificity as tumor informed approaches, but without the need for tumor tissue."

Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw.1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%)2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, "Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients" can be found here.

On April 30, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported its national sponsorship of the American Academy of Dermatology’s (AAD) "Skin Cancer, Take a Hike!" steps challenge for Skin Cancer Awareness Month (Press release, Castle Biosciences, APR 30, 2021, View Source [SID1234578902]).

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"Skin Cancer, Take a Hike!" is a participant-driven fundraising event that has raised $1.5 million since its inaugural 2014 hike. By educating the public about skin cancer prevention and early detection, the AAD and its partners like Castle aim to drive sun-safety behaviors that can reduce skin cancer and ultimately save lives. "Skin Cancer, Take a Hike!" proceeds are dedicated to reducing the incidence of skin cancer through public education and access to life-saving programs and services, including free skin cancer screenings, permanent shade structures where children learn and play, and sunscreen dispensers in public areas, such as parks and pools.

At this year’s virtual event, held throughout May for Skin Cancer Awareness Month, hundreds of participants across the country will complete 9,500 miles in honor of the approximately 9,500 people diagnosed with skin cancer every day.

"We greatly appreciate the support of Castle Biosciences in our efforts to help the public prevent skin cancer and detect it early, when it’s most treatable," says dermatologist Kenneth J. Tomecki, M.D., FAAD, president of the AAD. "Skin cancer is the most common cancer in the U.S., and nearly 20 Americans die from melanoma, the deadliest form of skin cancer, every day. By working together to raise awareness through ‘Skin Cancer, Take a Hike!’, we want to remind the public that they can protect their skin from the sun and reduce their risk of skin cancer by seeking shade, wearing protective clothing — including a wide-brimmed hat and sunglasses with UV protection — and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all skin not covered by clothing."

"Skin Cancer, Take a Hike!" is part of the AAD’s SPOT Skin Cancer initiative to reduce skin cancer mortality and incidence through public awareness, community outreach programs and services, and advocacy that promotes the prevention, detection and treatment of skin cancer. Thanks to the campaign’s dedicated volunteers and donors, SPOT Skin Cancer has provided more than 2.8 million free skin cancer screenings and awarded 432 shade structure grants, which provide shade for nearly 3.5 million individuals daily.

"Among the viable techniques to mitigate harm caused by skin cancer, the importance of prevention and early detection cannot be overstated," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle’s primary focus is to improve the lives of patients with skin cancer. In addition to our suite of prognostic and diagnostic tests, we recognize that reducing sun exposure, wearing sunscreen and UV-blocking clothing and getting screened for cancer are critical for improving health outcomes. Often, the largest barriers to wide uptake of those measures include insufficient awareness and insufficient financial allocation to their distribution—two barriers that we are proud to confront alongside the AAD."

About the AAD

Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 20,000 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow the AAD on Facebook (American Academy of Dermatology), Twitter (@AADskin), Instagram (@AADskin1), or YouTube (AcademyofDermatology).