On October 8, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its third-quarter 2019 financial results after the close of the U.S. financial markets on Oct. 29, 2019 (Press release, Exact Sciences, OCT 8, 2019, View Source [SID1234540099]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
Third-Quarter 2019 Webcast & Conference Call Details

Date:

Tuesday, Oct. 29, 2019

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 833-235-7650
International callers, dial +1 647-689-4171
Access code for both domestic and international callers: 4168628

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4168628. The webcast, conference call and replay are open to all interested parties.

On October 7, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it has signed a long-term global supply agreement with a subsidiary of ITM Isotopen Technologien München AG (ITM), Isotope Technologies Garching GmbH (ITG) to ensure the supply of high quality, no-carrier-added (n.c.a.) Lutetium-177, a key component of Betalutin (177Lu-lilotomab-satetraxetan) for R&D, clinical and commercial uses (Press release, Nordic Nanovector, OCT 7, 2019, View Source [SID1234553444]).

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ITM, a biotechnology and radiopharmaceutical group of companies and world-leader in the development and production of radiopharmaceuticals and radionuclides for the targeted treatment of cancers as well as for diagnostics, has been supplying n.c.a. Lutetium-177 (EndolucinBeta)* to Nordic Nanovector since 2010.

Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: "We are pleased to extend our collaboration with a long-time 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 during 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 and 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."

*EndolucinBeta, registered trademark of ITM’s EMA approved pharmaceutical n.c.a. Lutetium-177.

On November 7, 2019 BridgeBio Pharma, Inc. (NASDAQ: BBIO) reported financial results for the third quarter, which ended September 30, 2019, and provided recent highlights across the company’s research and development portfolio (Press release, BridgeBio, NOV 7, 2019, View Source [SID1234552609]).

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"We continue to make progress towards achieving our goals, which ultimately is the delivery of meaningful medicines to patients with genetic diseases," said Neil Kumar, Ph.D., founder and chief executive officer of BridgeBio. "We will present new data from our TTR stabilizer program this month at the American Heart Association (AHA). We are also on track to begin filing this year our rolling new drug application for BBP-870, a treatment for the often-fatal genetic disease molybdenum cofactor deficiency type A. We are growing our pipeline as well, adding BBP-418, a novel treatment for the neuromuscular disorder limb-girdle muscular dystrophy type 2i. We remain on track to put five or more programs into the clinic next year on a risk-adjusted basis."

Recent Highlights:

BBP-831 – FGFR1-3 inhibitor for achondroplasia: Initiated PROPEL, a prospective observational study in children with achondroplasia, the most common genetic form of short stature (NCT04035811). The study will establish annualized growth velocity (AGV) for each child over a minimum period of six months. PROPEL is designed to provide baseline measurements for children who enroll in PROPEL2, a Phase 2 study of low-dose infigratinib in achondroplasia which is on track to start in 2020. Additionally, in October 2019, new preclinical data supporting tolerability and efficacy of infigratinib in the mouse model of achondroplasia were reported at the American Society of Human Genetics conference (link to poster).

BBP-870 – cPMP replacement therapy for MoCD type A: Presented natural history study data at the Society of Inborn Errors of Metabolism Conference (link to poster) in September. These data suggest an urgent need for new therapies in molybdenum cofactor deficiency (MoCD) type A, an often-fatal rare genetic disease, and will be a critical component of the planned new drug application.

BBP-812 – Gene therapy candidate for Canavan disease: Opened a natural history study in Canavan disease (treatcanavan.com). Presented preclinical data (link to poster) demonstrating intravenous (IV) dosing of BridgeBio’s experimental therapy for Canavan disease (BBP-812) achieved broad central nervous system delivery; the IV approach is much less invasive compared to intrathecal or intracerebroventricular alternatives.

BBP-631 Gene therapy candidate for CAH: Presented preclinical update (link to poster) for gene therapy candidate BBP-631 in congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency wherein IV dosing of non-human primates with BBP-631 resulted in durable delivery and expression of the gene product to the adrenal tissue.

BBP-398 – SHP2 inhibitor for treatment-resistant cancer: Presented data (link to poster) highlighting the discovery and preclinical efficacy of BBP-398, a potent and selective SHP2 inhibitor, which is currently being prepared for the submission of an IND in 2020 for evaluation in RTK-driven cancer.

BBP-265 (AG10) – TTR stabilizer for ATTR: Granted Alexion Pharmaceuticals, Inc. an exclusive license to develop and commercialize AG10 in Japan for an upfront payment of $25 million and an equity investment of $25 million.

Pipeline growth: Announced addition of a new asset, BBP-418, to the pipeline. BBP-418 is a substrate supplementation therapy for the treatment of limb-girdle muscular dystrophy type 2i and is in IND-enabling studies. This condition affects an estimated 7,000 patients in the United States and European Union with no currently approved therapies.

Organizational growth: Added two new members to the senior leadership team. Brian Stolz joined as Chief Operating Officer of BridgeBio. Mr. Stolz most recently held the position of Chief People Officer at Activision Blizzard. Yi Ching Yau joined as Chief Accounting Officer of BridgeBio. Prior to joining BridgeBio, Ms. Yau served as the VP of Finance at Nektar Therapeutics.

Upcoming Milestones:

BBP-265 (AG10) – TTR stabilizer for ATTR: Plan to present interim analysis of the ongoing Phase 2 open label extension study (NCT03536767) of AG10 in patients with TTR amyloid cardiomyopathy, an inherited form of heart failure, at the American Heart Association 2019 Scientific Sessions in a Late-Breaking Featured Science Oral Presentation. A Phase 3 study of AG10 in ATTR-PN (ATTRibute-PN) is on track to begin in the first quarter of 2020.

BBP-870 – cPMP replacement therapy for MoCD type A: On track to initiate a rolling new drug application submission for our first-in-class therapy for molybdenum cofactor deficiency (MoCD) type A, BBP-870, by the end of 2019.

BBP-589 – COL7A protein replacement therapy for recessive dystrophic epidermolysis bullosa: Plan to share topline data from the ongoing Phase 1/2 study (NCT03752905) during 2020.

BBP-831 (infigratinib) – FGFR1-3 inhibitor for FGFR2+ cholangiocarcinoma: Plan to complete enrollment of the ongoing pivotal Phase 2 study (NCT02150967) in second line cholangiocarcinoma (bile duct cancer) and present updated results at a major oncology meeting in 2020. Remain on track to submit new drug application for FDA approval in 2020.

Consolidated cash, cash equivalents and marketable securities, excluding restricted cash, totaled $611.9 million as of September 30, 2019. Excluding Eidos, BridgeBio’s cash balance as of September 30, 2019 was $446.1 million compared to $162.4 million as of June 30, 2019. The net change in cash balance of $283.7 million reflects net proceeds received from BridgeBio’s initial public offering of $368.7 million, offset by the repurchase of a non-controlling interest for $26.4 million and approximately $58.6 million primarily for operating expenses.

Operating Expenses

Operating expenses for the three months that ended September 30, 2019 were $81.3 million, as compared to $41.5 million for the same period in the prior year. The increase in operating expenses of approximately $39.8 million was mainly attributable to increased research and development expenses related to the progression of our programs

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 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in global health, reported that the FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Company’s proprietary Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda) (Press release, Aethlon Medical, OCT 7, 2019, View Source [SID1234540098]).

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An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation. In this patient population, pembrolizumab was recently approved for initial first line treatment. Non-clinical studies conducted by Aethlon Medical’s collaborators and other investigators have suggested that a primary mechanism of resistance to pembrolizumab and other immuno-oncology drugs is the secretion by tumor cells of exosomes, which are small, sub-cellular particles that have previously been demonstrated to be cleared by the Hemopurifier. Based on this observation, in November 2018 the FDA granted the Hemopurifier a Breakthrough Designation "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease."

The primary endpoint for the EFS, which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approval is subject to FDA approval of Informed Consent documents from the trial site. More details on the trial will be disclosed in the future.

"This IDE approval is a critical first step in our plans to develop the Hemopurifier for applications in oncology" stated Timothy Rodell, M.D., Aethlon’s CEO. "We believe that the clearance of immunosuppressive tumor-derived exosomes has the potential to improve response rates to these already game-changing immuno-oncology agents. Our Breakthrough Designation has allowed us to move very quickly with rapid, frequent and helpful communication with the FDA and clearly demonstrates the value of the Breakthrough program."