On October 7, 2019 Vaccibody AS reported that preliminary safety, efficacy and immunogenicity data will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019 which will be held from November 6-10, 2019 in National Harbor, Maryland (Press release, Vaccibody, OCT 7, 2019, View Source [SID1234540088]).

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"We are excited that our abstract presenting Vaccibody’s preliminary VB10.NEO clinical read-outs has been accepted for poster presentation at this year’s SITC (Free SITC Whitepaper) Meeting," said Michael Engsig, CEO of Vaccibody. The poster will be the first presentation to report clinical data from our VB10.NEO cancer neoantigen study and is an important milestone for the company.

Details of the poster presentation:

Title: Preliminary safety, efficacy and immunogenicity results from a phase 1/2a study (DIRECT-01) of cancer neoantigen DNA vaccine VB10.NEO in patients with locally advanced or metastatic solid tumors

Abstract ID: P424

Session Date and Time: Saturday, November 9 th 2019, 7:00 am-8:30 pm local time

About VB10.NEO
VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the patient’s own neoantigens for the personalized treatment of cancer patients. A phase I/IIa neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck.

On October 7, 2019 Verastem, Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that its partner Yakult Honsha Co., Ltd. (Yakult) has dosed the first patient in a Phase 1b Japanese bridging study evaluating COPIKTRA (duvelisib) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following at least one prior therapy (Press release, Verastem, OCT 7, 2019, View Source [SID1234540089]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma in the United States.

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"The start of patient dosing in Yakult’s first clinical study of COPIKTRA in Japan is another important step forward in Verastem Oncology’s strategy to expand the global potential of COPIKTRA for hematological malignancies across the globe," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The results of this study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan, where therapies are extremely limited. We look forward to supporting Yakult through the clinical development of COPIKTRA in Japan to help rapidly advance this oral, novel therapy for patients living with CLL/SLL."

Verastem and Yakult entered into an exclusive licensing agreement in June 2018 for Yakult to develop and commercialize COPIKTRA for the treatment, prevention or diagnosis of all oncology indications in Japan. Yakult’s Phase 1b, multicenter, open-label study is expected to enroll approximately 10 patients with relapsed or refractory CLL/SLL after at least one prior therapy. The primary endpoint of the study is objective response rate. Secondary endpoints of the study include overall survival, progression free survival and safety. This Phase 1b study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 3 DUO study. The results of the Phase 1b bridging study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan.

COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.

Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.

Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.

Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.

INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.

Neutropenia: Monitor blood counts.

Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.

CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.

CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

On October 7, 2019 SHINE Medical Technologies LLC reported the closing of a $50-million financing with funds managed by Oaktree Capital Management L.P. ("Oaktree"), a leading global investment firm with more than $120 billion under management as of June 30, 2019 (Press release, Shine Medical Technologies, OCT 7, 2019, View Source;pk_kwd=shine-closes-50-million-financing [SID1234540975]). The financing supports the ongoing construction of SHINE’s medical isotope production facility and its commercialization of diagnostic and therapeutic isotopes, including molybdenum-99 (Mo-99) and lutetium-177 (Lu-177).

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"We are excited to welcome Oaktree to SHINE’s growing list of top-tier institutional investors," said Greg Piefer, founder and CEO of SHINE. "Oaktree has broad expertise in complex infrastructure projects like our medical isotope facility. It joins Deerfield Management, a leading health care investment firm, as one of our key partners.

"Oaktree and Deerfield will help us deliver on SHINE’s value proposition, including the completion of our isotope production facility and the development of our therapeutics business. Their participation validates the strength of our business case, team and vision for bringing our lifesaving products to market."

Construction of SHINE’s production facility is expected to be completed in 2021 and commercial-scale isotope production should begin in 2022. The facility will be the first of its kind, utilizing the company’s patented technology to produce Mo-99, which is used in more than 40 million procedures every year.

Chronic global shortages of medical isotopes routinely and significantly affect the diagnosis and treatment of patients around the world. SHINE’s production facility will be capable of supplying more than one-third of the global demand for Mo-99.

"SHINE is an outstanding company with a strong management team, exceptional technology and compelling story," said Milwood Hobbs Jr., managing director of Oaktree. "The need for SHINE’s medical isotope production facility is profound, as millions of patients are affected each year by the ongoing shortage of Mo-99. Oaktree is confident SHINE will play a major role in ending that shortage and we are pleased to support SHINE’s production facility construction."

SHINE also will commercialize Lu-177, a therapeutic isotope currently used to treat neuroendocrine cancers and showing promise for the treatment of metastatic prostate and other cancers. In May, the company entered into an agreement with the Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague) that provides SHINE with a global, exclusive license to a novel separation technology that it will use to produce Lu-177. The technology enables SHINE to produce non-carrier-added Lu-177, which should provide the highest therapeutic efficacy.

"Oaktree is pleased to be a partner with SHINE as it executes a growth strategy that includes commercializing therapeutic isotopes and constructing a production facility in Europe," said Aman Kumar, senior vice president of Oaktree. "The global market for therapeutic isotopes, including Lu-177, continues to grow rapidly and SHINE is well positioned to capture significant value in that market. We are equally as excited by SHINE’s commitment to Europe, where the current isotope producers are expected to stop production during the next several years."

About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo‑99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

On October 7, 2019 Gilead Sciences, Inc. (NASDAQ: GILD) reported that Merdad Parsey, MD, PhD, will join the company as Chief Medical Officer, effective November 1 (Press release, Gilead Sciences, OCT 7, 2019, View Source [SID1234540090]). Dr. Parsey will be responsible for the company’s global clinical development and medical affairs organizations. He will join the company’s senior leadership team and will report directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. Under a new structure, William Lee, PhD, Gilead’s Executive Vice President, Research will separately report to Mr. O’Day.

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Dr. Parsey joins Gilead from Genentech, Inc., a member of the Roche Group, where he currently holds the position of Senior Vice President, Early Clinical Development in the Genentech Research and Early Development (gRED) group. In this role, he leads clinical development, quality, compliance, informatics and clinical operations functions. He brings to Gilead significant clinical expertise across a broad array of therapeutic areas, including inflammation, oncology and infectious diseases.

"I am delighted to welcome Merdad, a seasoned and highly respected scientist, clinician and leader, to Gilead," said Mr. O’Day. "Throughout his career, he has built a reputation as an outstanding leader among academic, industry and medical communities alike. I know Merdad’s exceptional skills and expertise will be of great benefit to Gilead as we focus on rapidly expanding our pipeline and clinical development portfolio through internal efforts and external partnerships."

Prior to his most recent tenure with Genentech, Dr. Parsey served as President and CEO of 3-V Biosciences. He has also held development roles at Sepracor, Regeneron and Merck, Inc. and has served as Assistant Professor of Medicine and Director of Critical Care Medicine at New York University School of Medicine. Dr. Parsey completed his MD and PhD at the University of Maryland, Baltimore, his residency in Internal Medicine at Stanford University and his fellowship in Pulmonary and Critical Care Medicine at the University of Colorado.

"I have had many opportunities over the course of my career to help shape clinical development strategies and programs, and I am profoundly excited to bring those experiences to Gilead, an organization I have long admired," said Dr. Parsey. "I am looking forward to working with the company’s talented teams to advance clinical development programs and build a robust pipeline that has the opportunity to change the trajectory of disease and transform the care of many more people in need around the world."

On October 7, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported that ITM´s subsidiary, ITG Isotope Technologies Garching GmbH (ITG) and Nordic Nanovector ASA (OSE: NANO) have signed long-term global supply agreements for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) EndolucinBeta to support R&D, clinical and commercial supply of Betalutin (177Lu-Lilotomab-Satetraxetan) (Press release, ITM Isotopen Technologien Munchen, OCT 7, 2019, View Source [SID1234540091]).

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Under the terms of the agreement for the study phase, ITM has partnered with Nordic Nanovector to support its clinical development. At the same time, both parties signed a commercial agreement for the supply of EndolucinBeta post Marketing Approval of Betalutin. Additional terms of the agreement are not disclosed.

EndolucinBeta, radiolabeled to anti-CD37 murine antibody lilotomab, is an active component of Betalutin, a next generation radioimmuno conjugate (RIC) currently under clinical development in patients who suffer from Non-Hodgkin Lymphoma (NHL). Betalutin is a drug candidate with an excellent profile. As well as leveraging an alternative therapeutic target (anti-CD37 antigen) in recurrent lymphoma patients who have relapsed following anti-CD20-based therapy, it has shown durable responses in heavily pre-treated NHL patients after a one-time administration, combined with a predictable and manageable toxicity, an important feature for elderly NHL patients who may not be suited to chemotherapy.

EndolucinBeta, a radiopharmaceutical precursor, is used in Targeted Radionuclide Therapy in the field of Precision Oncology and has marketing authorization in the EU. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumor tissue is precisely destroyed by cytotoxic doses of ionizing radiation. ITM has developed a unique methodology to produce a particularly highly pure form of Lutetium-177. No-carrier-added Lutetium-177 contains no metastable Lutetium-177m, therefore there is no need for cost intensive clinical waste management. This is especially important in countries with a release limit of Lutetium-177m into public sewage systems.

Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: "We are pleased to extend our collaboration with a long-standing and reliable partner such as ITM. This global supply agreement is a key milestone in the implementation of our CMC (Chemistry, Manufacturing and Controls) strategy for gaining regulatory approval for Betalutin and its subsequent commercial rollout, as it provides certainty of continued supply of n.c.a. Lutetium-177 throughout clinical development as well as after launch. The agreement with ITM, alongside other manufacturing supply and development agreements in place with specialist manufacturers at all stages of the manufacturing and supply chain for Betalutin strengthens our confidence in the ability to deliver a reliable and sustainable supply chain in support of the launch of our lead asset."

Steffen Schuster, CEO of ITM, added: "Nordic Nanovector is one of our longstanding partners, as ITM has been supplying n.c.a. Lutetium-177 to Nordic Nanovector since 2010. We are delighted that Nordic Nanovector has reaffirmed their confidence through this long term supply agreement for EndolucinBeta. In addition to the development of our own pipeline, we have once again been able to gain a strategic partner for the development of targeted radiopharmaceuticals in Precision Oncology, thereby making a significant contribution to advancing a promising treatment option for difficult-to-treat cancers. With our manufacturing facilities around the world and our unrivaled logistics network, we feel well equipped to reliably meet our partners’ needs and to enter into further strategic relationships."