On August 24, 2021 Atavistik Bio ("Atavistik", "Company"), a pre-clinical biotechnology company pioneering the identification of metabolite-protein interactions that have the potential to lead to the discovery and development of first-in-class drug candidates powered by distinct allosteric control mechanisms, reported that the Company had completed a $60 million Series A financing round (Press release, Atavistik Bio, AUG 24, 2021, View Source [SID1234586854]). The financing was led by The Column Group and joined by Lux Capital, and Nextech Invest, Ltd.

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The new financing will support development of Atavastik’s drug discovery platform, and future identification of select drug candidates based on deep knowledge of disease relevant pathways that have evolved over millions of years by nature to be allosterically regulated by metabolites.

The Company will be helmed by John A. Josey, PhD, Acting CEO of Atavistik Bio, who was formerly CEO at Peloton Therapeutics, which was acquired by Merck in 2019. Dr. Josey is an experienced CEO with a long track record of novel drug discovery. Marion Dorsch, PhD, has been appointed President and CSO. Dr. Dorsch is a highly accomplished scientist and senior executive with more than twenty years of biotech and pharma experience in oncology, inflammation and rare genetic diseases. She is known for her innovative drug discovery that has contributed to several accelerated drug approvals in oncology. Prior to this role, Dr. Dorsch was CSO at Blueprint Medicines.

"Our unique approach marries a validated platform with structure-aided drug design capabilities and cutting-edge insights into the regulation of metabolic systems, which will be applied to genetically validated targets in metabolic disease and cancer," said John A. Josey, PhD, CEO of Atavistik Bio and Venture Partner at The Column Group. "We are delighted to gain the support of such an esteemed collection of venture investors in our quest to find first-in-class drug compounds in metabolic diseases and cancer."

Atavistik was co-founded by prominent scientific investigators and members of the Howard Hughes Medical Institute. Atavistik’s platform is built on technology developed by co-founder Jared Rutter, PhD, Professor of Biochemistry at the University of Utah. Professor Rutter is well-known for his work regarding novel protein metabolite interactions that has resulted in identification of novel allosteric regulatory sites for proteins of interest in disease. Additionally, co-founder Dr. Ralph DeBerardinis, MD, PhD is a professor at the University of Texas Southwestern Medical Center. He is a leading medical geneticist with a deep understanding of human metabolism with a focus on pediatrics. Dr. DeBerardinis still attends to patients and has a unique understanding of the high unmet need in this critical area of human health. The co-founders will stay closely involved with the scientific direction at Atavistik as advisors.

"Atavistik has a differentiated platform that has tremendous potential to identify novel regulatory sites to tackle the underlying cause of many diseases," said Marion Dorsch, PhD, President and Chief Scientific Officer, Atavistik Bio. "Our technology was founded by a leading metabolism expert and validated by the discovery of numerous known and novel metabolite-protein interactions. We look forward to building on this technology and utilizing our drug discovery platform to identify first-in-class drug candidates."

"Atavistik has positioned itself at the forefront of allosteric regulated metabolic drug discovery, a novel and exciting new area of drug discovery and medicine, that has immense potential," said Tim Kutzkey, Managing Partner at The Column Group and Atavistik Bio board member. "The company is built around Marion’s drug-discovery expertise and successful track record of bringing experimental medicines to market quickly. She will be joined by a team of experts in metabolism and a robust investment syndicate that will support Atavistik’s scientific focus."

Atavistik has opened a new office in Cambridge at 38 Sidney St. To learn more, please visit AtavistikBio.com.

On August 24, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it will host its fifth annual virtual R&D Day for analysts and investors at 8:00 a.m. ET on Thursday, September 9 (Press release, Moderna Therapeutics, AUG 24, 2021, View Source [SID1234586853]).

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Moderna’s R&D Day will include presentations from Stéphane Bancel, Chief Executive Officer, Paul Burton, M.D., Ph.D., Chief Medical Officer, Stephen Hoge, M.D., President, clinical team leaders and key opinion leaders with a focus on the Company’s clinical development pipeline.

Register for the virtual event here. The webcast will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

On August 24, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that it has been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration (VHA) for its DecisionDx-Melanoma gene expression profile test (Press release, Castle Biosciences, AUG 24, 2021, View Source [SID1234586852]).

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The VHA is a component of and implements the healthcare program for U.S. veterans through the U.S. Department of Veterans Affairs (VA). The contract became effective on Aug. 15, 2021, and provides greater access to DecisionDx-Melanoma for veterans being treated through the VHA, the largest integrated health care system in the U.S., as well as active-duty service members and their families seeking medical treatment through the Military Health System (MHS).

"At Castle, we are committed to improving the lives of patients with skin cancer," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe that adding the personalized genomic information provided by our DecisionDx-Melanoma test to traditional clinical and pathology factors can help clinicians make improved treatment decisions for their patients. This contract provides veterans and active-duty service members treated in VA and MHS medical centers greater access to our test, allowing them to incorporate DecisionDx-Melanoma into their management plans."

Melanoma is the most frequently diagnosed and most deadly form of skin cancer, according to the American Cancer Society. Additionally, according to a 2017 study in the Journal of the American Academy of Dermatology (JAAD) titled "Skin cancer in the military: A systematic review of melanoma and nonmelanoma skin cancer incidence, prevention, and screening among active duty and veteran personnel," active-duty military personnel and veterans are at increased risk of developing melanoma due to occupational sun exposure.

In early-stage melanoma, reliance upon clinicopathologic staging factors alone has been shown to result in a significant overuse of sentinel lymph node biopsies and miss patients with aggressive tumor biology. DecisionDx-Melanoma uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors, to improve patient outcomes and inform disease management decisions.

About Veterans Health Administration

The Veterans Health Administration (VHA) is the largest integrated health care system in the United States, providing care at 1,293 health care facilities, including 171 VA Medical Centers and 1,112 outpatient sites of care of varying complexity (VA outpatient clinics) to over 9 million Veterans enrolled in the VA health care program. VA Medical Centers provide a wide range of services including traditional hospital-based services such as surgery, critical care, mental health, orthopedics, pharmacy, radiology and physical therapy.

About Military Health System

The Military Health System (MHS) is one of America’s largest and most complex health care institutions, and the world’s preeminent military health care delivery operation. The MHS saves lives on the battlefield, combats infectious disease around the world, and is responsible for providing health services through both direct care through military treatment facilities and private sector care to approximately 9.6 million beneficiaries, composed of uniformed service members, military retirees and family members.

About U.S. Federal Supply Schedule

The U.S. Federal Supply Schedule (FSS), also known as the General Services Administration (GSA) Schedule and the Multiple Award Schedule (MAS), is a long-term government-wide contract with commercial companies that provide access to millions of commercial products and services at fair and reasonable prices to the government. MAS makes buying easy and efficient with the use of modern technology to connect government buyers and industry.

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 sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 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. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. 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. Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma.

On August 24, 2021 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immune-therapeutics based on Seneca Valley Virus (SVV-001), reported the issuance and allowance of several U.S. patents for TEM8 (also known as ANTXR1) licensed from Memorial Sloan Kettering Cancer Center (MSK) (Press release, Seneca Therapeutics, AUG 24, 2021, View Source [SID1234586851]). TEM8 may enable pre-screening of solid tumors to determine if SVV-001 might be effective in that patient. This discovery is based on research from Charles Rudin, MD, PhD., Chief, Thoracic Oncology Service at MSK and his team.

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U.S. Patent No. 11,096,972 B2 for Seneca valley virus (SVV) cellular receptor targeted oncotherapy, was issued today by the U.S. Patent Office. This patent covers combination therapies with Seneca Valley Virus (SVV) in patients who have a normal or an elevated expression level of ANTXR1 and a decreased expression level of IFN-I in a cancerous tissue.

That patent follows U.S. Patent No. 10,537,599 B2 for Seneca valley virus (SVV) cellular receptor targeted oncotherapy which issued on January 21, 2020 and broadly covers methods for treating cancer, comprising: determining an expression level of anthrax toxin receptor 1 (ANTXR1) in a cancerous tissue from a patient, and administering to the patient an effective amount of Seneca Valley Virus (SVV) if a normal expression level or an elevated expression level of ANTXR1 is detected in the cancerous tissue.

Patent applications protecting these inventions are also pending throughout the world in Europe, China, Australia, Canada, Israel and India. This adds to the growing body of issued intellectual property that broadly covers SVV, SVV analogues, and methods of killing cancer cells using SVV and related analogues, to which Seneca Therapeutics owns exclusive rights.

Dr. Paul Hallenbeck, Founder, President, and Chief Scientific Officer at Seneca Therapeutics commented "We are very pleased with the progress of these patents in the U.S. Patent Office. Our exclusive license to these patents, with rights to sublicense, will help to maintain Seneca Therapeutics’ leadership in treating cancers using SVV."

On August 24, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that Rubraca (rucaparib) is now available and reimbursed in Switzerland (Press release, Clovis Oncology, AUG 24, 2021, View Source [SID1234586850]). The Swiss authority responsible for the authorization and supervision of therapeutic products (Swissmedic)i gave a positive recommendation for Rubraca as maintenance treatment for recurrent platinum sensitive ovarian cancer.2 Rubraca is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.2

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"PARP inhibition is the major improvement of the last years in the treatment of ovarian cancer," said Prof. Dr. med. Viola Heinzelmann-Schwarz, Head of the Department of Gynaecology and Gynaecological Oncology at the University Hospital Basel.

Approximately 600 women are diagnosed with ovarian cancer in Switzerland every year, which equates to 1 to 2 new diagnoses every day.3 It is the third most frequent gynecological cancer in Switzerland.4 In addition, up to approximately 25 percent of patients harbor a germline BRCA1/2 mutation correlating to responsiveness to therapy, while the majority of women who are diagnosed are BRCA wild-type will have a worse prognosis and limited therapeutic options.5,6 Despite advancements in treatment and care, on average 500 women in Switzerland still die each year.7

The Swissmedic authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial, which found that Rubraca significantly improved PFS in all ovarian cancer patient populations studied.1 ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).1,2 In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).2 The overall safety profile of Rubraca is based on data from 937 patients with ovarian cancer treated with Rubraca monotherapy in clinical trials.2

"We are pleased to make Rubraca available in Switzerland and offer a new maintenance treatment option for eligible women with relapsed ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "There has been a significant need for additional treatment options for women with relapsed ovarian cancer, and we are proud that women who may benefit will have access to rucaparib. We remain committed to making rucaparib available to eligible patients in the US and Europe."

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Click here and search for Rubraca to access the Swiss PI.

Healthcare professionals should report any suspected adverse reactions via their national reporting systems. Click here to access the Swiss national reporting system.

Rubraca (Rucaparib) 200mg, 250mg and 300mg film-coated tablets:

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected new or serious adverse reactions. Active substance: rucaparib. Composition: film-coated tablet containing 200 mg, 250 mg or 300 mg rucaparib as rucaparib camsylate. Excipients: Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133), indigo carmine aluminium lake (E132). Indications/Uses: Rubraca is indicated for the maintenance therapy of adult patients with advanced, platinum-sensitive, relapsed, high-grade serous ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial remission following a platinum-based chemotherapy. Contraindications: hypersensitivity to the active substance or any of the excipients listed under Composition. Breastfeed during treatment with Rubraca and for 2 weeks following the last dose. Undesirable effects: Very common: anaemia, thrombocytopenia, neutropenia, decreased appetite, blood creatinine increased, dysgeusia, dizziness, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, photosensitivity reaction, fatigue, pyrexia. Common: myelodysplastic syndrome / acute myeloid leukaemia, leukopenia, lymphopenia, febrile neutropenia, dehydration, hypercholesterolaemia, dyspnoea, transaminases increased, rash maculo-papular, palmar-plantar erythrodysaesthesia syndrome, erythema. Prescription status: prescription. Other information: see product information. Marketing authorisation holder: Clovis Oncology Switzerland GmbH, Seefeldstrasse 69, 8008 Zurich. Medical information: Email: [email protected]. Toll-free phone line: +41 (0)800677526. Date of revision: November 2020.