On February 3, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, FEB 3, 2022, View Source [SID1234607718]):

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SVB Leerink Annual Global Healthcare Conference on Wednesday, February 16 at 2:20pm ET

Raymond James Annual Institutional Investors Conference on Tuesday, March 8 at 1:05pm ET

Cowen Annual Health Care Conference on Wednesday, March 9 at 10:30am ET

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On February 3, 2022 Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported that it has appointed Ma’an Muhsin, M.D., as President and Chief Medical Officer of Kriya Oncology, the company’s oncology therapeutic area division (Press release, Kriya Therapeutics, FEB 3, 2022, View Source [SID1234607717]). Dr. Muhsin will lead overall strategic, development, and partnership activities to accelerate and expand Kriya’s portfolio of transformative gene therapies for cancers of high unmet need.

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"Ma’an brings a wealth of experience in the development of novel oncology therapies across a number of modalities," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "He is uniquely positioned to accelerate the expansion and clinical translation of our growing pipeline of gene therapies that can be combined with existing and emerging standards of care in oncology. We are keen to bring forward in vivo gene therapy as a new modality to treat cancer, and Ma’an is a leader with an exceptional track record that will help us achieve this goal."

Dr. Muhsin previously served as Chief Medical Officer at Medicenna Therapeutics where he designed and executed clinical trials of the company’s solid tumor programs. Prior to joining Medicenna, he served as Medical Lead, Oncology Clinical Development for Nektar Therapeutics where he oversaw the progression of the PIVOT-12 and REVEAL clinical studies for metastatic melanoma and advanced and local solid tumors, respectively. Dr. Muhsin has held roles of increasing responsibility at HUYA Bioscience International where he served as the Senior Vice President, Oncology Clinical Development, and at Halozyme Therapeutics where he served as Senior Medical Director, Oncology Clinical Development. He also worked in the U.S. Army Combat Support Hospitals (CSH) and held other positions within the Medical Brigade and the Medical Command under the United States Department of Defense (DoD). Dr. Muhsin completed his medical education at the Baghdad University School of Medicine and completed postgraduate education in oncology drug development at Tufts University Center for the Study of Drug Development (CSDD).

"I am excited to join Kriya and look forward to advancing its promising portfolio of gene therapies in oncology," said Dr. Muhsin. "While the management of cancer has come a long way in the last decade, I believe in the potential to further enhance the treatment of patients with the incorporation of rationally engineered gene therapies that can transform treatment paradigms for a wide array of cancers. I look forward to leveraging Kriya’s fully-integrated gene therapy engine to deliver a pipeline of novel medicines with the potential to significantly impact the lives of cancer patients."

On February 3, 2022 Synthekine Inc., an engineered cytokine therapeutics company, reported the dosing of the first patient in a Phase 1a/1b clinical trial of its IL-2 partial agonist, STK-012, for the treatment of solid tumors. STK-012 is designed as an alpha/beta-biased IL-2 partial agonist to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid stimulation of toxicity causing immune cells, such as natural killer cells (Press release, Synthekine, FEB 3, 2022, View Source [SID1234607716]).

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"We are proud to begin this year with the important milestone of dosing the first patient in our Phase 1 trial of STK-012," said Debanjan Ray, chief executive officer of Synthekine. "STK-012 is a highly differentiated IL-2 partial agonist tuned to expand the therapeutic index of IL-2 by biasing towards efficacy driving antigen-activated T cells and away from toxicity causing lymphocytes, such as natural killer (NK) cells. STK-012 is the first program from our broad portfolio of biased cytokines to enter the clinic, and its rapid progress into clinical investigation further highlights our team’s tremendous ability to execute efficiently and move our pipeline forward."

Aldesleukin (recombinant IL-2) has shown to be active in certain cancers, but its use is limited due to life threatening toxicities such as capillary leak syndrome (CLS). Synthekine presented preclinical data at AACR (Free AACR Whitepaper) 2021 demonstrating a mouse surrogate of STK-012 achieved superior tumor regression compared to both wild-type mouse IL-2 and a non-alpha-IL-2 agent, representing a different approach to biasing IL-2. In toxicity models, the mouse surrogate of STK-012, unlike these same comparators, was well tolerated and did not induce CLS. In non-human primate studies, STK-012 avoided lymphopenia, NK cell activation and CLS induction, which was observed with both aldesleukin and a non-alpha-IL-2 agent.

The Phase 1a/1b clinical trial is an open-label, multi-center study enrolling patients with advanced solid tumors. The dose escalation portion of the study will evaluate STK-012 both as a monotherapy and in combination with pembrolizumab. Following completion of the dose escalation, Synthekine will initiate expansion cohorts with STK-012. For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

On February 3, 2022 Sprinter Health, an on-demand mobile health service bringing personalized and affordable healthcare services to the home, reported a collaboration with Naveris, a molecular diagnostics company dedicated to improving patient care through early detection of virus-related cancers (Press release, Naveris, FEB 3, 2022, View Source [SID1234607715]).

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The partnership will improve the detection, treatment, and clinical management of HPV-driven cancers, such as head and neck cancers, by augmenting the convenience of Naveris’ lead product, NavDx, which requires regular blood draws. Patients living in Sprinter Health service areas will be able to easily schedule a visit from a Sprinter Health nurse or phlebotomist (also known as "Sprinters") to collect blood specimens for the test in the comfort of their homes.

The NavDx blood test uses proprietary technology to detect circulating tumor tissue modified HPV (TTMV) DNA. NavDx helps healthcare providers optimize the clinical management of HPV-driven cancer by accurately assessing treatment response, identifying the presence of post-treatment molecular residual disease, and conveniently monitoring for recurrence. The test has been shown to accurately detect cancer recurrence a median of four months earlier than it would present clinically via PET or CT scan, which can facilitate earlier intervention of salvage therapy.1

"Patients being monitored with NavDx need regular blood draws, so we want to make sure they have a consistent, positive experience and don’t have to navigate a complex system just to get their blood specimens collected," said Piyush Gupta, CEO of Naveris. "Sprinter Health’s tech platform makes booking appointments easy for our patients and customer support reps, and they have become a partner we can count on to deliver high quality, reliable care that our patients love."

"Barriers to access can hold back progress toward better care. Lowering these barriers starts with using technology to improve the patient experience," said Max Cohen, CEO of Sprinter Health. "My father is an oncologist, and I’ve seen firsthand the difficult journeys of patients and families experiencing cancer. We’re proud to play a small part in helping patients access Naveris’ innovative test, and look forward to expanding our partnership throughout 2022."

Both companies have been working together in California for several months and plan to expand the partnership to new states in the first half of 2022.

On February 3, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported a collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases (Press release, Castle Biosciences, FEB 3, 2022, View Source [SID1234607713]).

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CM cases in the SEER registries that were diagnosed between 2013-2018 were linked with DecisionDx-Melanoma results and additional clinicopathologic information from patients tested between 2013-2018. The Company expects to continue collaborating with the NCI to link the SEER registries’ CM cases diagnosed post-2018 with DecisionDx-Melanoma test results. The initial linked dataset is expected to be broadly available to interested researchers through the standard data request process for SEER Specialized Datasets in 2022.

Data analysis from the first subset of patients was shared in a poster presentation at the 2022 Winter Clinical Dermatology Conference, held Jan. 14-19 in Koloa, Hawaii.

"We are excited to collaborate with the NCI to link DecisionDx-Melanoma test results with the SEER registries’ data," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle is committed to providing clinically actionable tests to improve patient outcomes. Analysis from the first subset of patients (65 years or older at time of diagnosis and diagnosed in 2016 or later) provides real-world evidence of the capability of our test to do just that. Specifically, when controlling for demographic and clinicopathological variables, patients tested with DecisionDx-Melanoma had better overall survival rates over 2.5 years than patients not tested."

The poster, titled "31-gene expression profile testing survival benefit in a population-based analysis of cutaneous melanoma patients ≥65 years of age," highlighted the first analysis of Castle’s DecisionDx-Melanoma testing data in the NCI’s SEER Program registry. The poster can be viewed here.

Study methods and findings:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. Among other outputs of the test, DecisionDx-Melanoma classifies a patient’s tumor as lowest risk of recurrence/metastasis (Class 1A), increased risk of recurrence/metastasis (Class 1B/2A) or highest risk of recurrence/metastasis (Class 2B).
All incident CM cases diagnosed between 2013-2018 in the NCI’s SEER Program registry were included in the study. The SEER registries linked CM cases in the registry to DecisionDx-Melanoma testing data provided by Castle Biosciences.
While all CM diagnoses between 2013-2018 were included in the linkage, this analysis was limited to a subset of 2,048 patients with Stage I-III melanoma who were ≥65 years or older at the time of diagnosis and were diagnosed between 2016-2018 to account for access to adjuvant therapy.
Patients tested with DecisionDx-Melanoma were successfully matched to those not tested with DecisionDx-Melanoma based on clinical, pathological and demographic data.
After matching, patients tested with DecisionDx-Melanoma had better overall survival rates than patients who had not been tested, demonstrating a direct effect of DecisionDx-Melanoma testing on patient survival (hazard ratio=0.66 compared to untested patients, p=0.002).
The results also confirmed DecisionDx-Melanoma’s ability to stratify patient risk in an unselected, prospectively tested population of CM patients into low (Class 1A) and high-risk (Class 2B) mortality groups.
Patients who received a DecisionDx-Melanoma high-risk result had a ten-fold increase in death rate compared to patients who received a low-risk result (12.3% death rate for a Class 2B result compared to 1.5% for a Class 1A result), demonstrating the independent prognostic value of the test.
In sum, the study data provide direct evidence that CM patients tested with DecisionDx-Melanoma have better survival rates than untested patients, suggesting that the test can aid in risk-aligned treatment plans for improved patient outcomes and survival rates.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About the SEER Program

The Surveillance, Epidemiology and End Results (SEER) Program (View Source) is an authoritative source for cancer statistics in the United States. The SEER Program provides information on cancer statistics in an effort to reduce the cancer burden among the U.S. population and is supported by the Surveillance Research Program (SRP) in the NCI’s Division of Cancer Control and Population Sciences (DCCPS). The SEER Program registries collect data on cancer cases diagnosed in their catchment area from various locations and sources throughout the United States. Data collection began in 1973 with a limited number of registries and continues to expand to include even more areas and demographics today covering 48% of US population. The SEER Program registries link to data provided by a variety of federal and commercial partners to support the research community in conducting cancer surveillance and epidemiological research. The data are available to qualified researchers.