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Radius Health Initiates Phase 1 Clinical Trial of RAD140 for the Treatment of Hormone Receptor Positive Breast Cancer

September 29, 2017 Radius Health, Inc. (Nasdaq:RDUS) reported that the first patient has been enrolled in the company’s Phase 1 study of RAD140, a nonsteroidal selective androgen receptor modulator (SARM) undergoing clinical evaluation for the treatment of hormone receptor positive breast cancer (Press release, Radius, SEP 29, 2017, View Source [SID1234520703]). The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients.

“The RAD140 mechanism of action is differentiated from both selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs). We expect RAD140 to play a broad role in endocrine resistance, including a genetically defined population, in patients with tumors that are resistant to treatment with the current standard of care,” said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health.

“RAD140 has significant potential to complement future applications of elacestrant (RAD1901) by targeting distinct mechanisms of endocrine resistance,” commented Jesper Høiland, President and CEO of Radius. “We will provide additional details in peer-reviewed publications and plan to report results from the trial at upcoming scientific conferences.”

The Phase 1 clinical trial is a safety and dose-ranging study in approximately 40 patients with progressive metastatic or locally advanced or metastatic breast cancer. In Part A of the trial, postmenopausal women with metastatic hormone receptor positive breast cancer will receive escalating doses of RAD140 by oral administration over a period of 28 days. Primary safety outcomes include rate of dose-limiting toxicities, adverse events related to treatment, and tolerability as measured by dose interruptions or adjustments. In addition, pharmacokinetics, pharmacodynamics and tumor response will also be evaluated.

About RAD140
RAD140 is an internally discovered nonsteroidal selective androgen receptor modulator, or SARM, which is under investigation for potential use in hormone receptor positive breast cancer. The androgen receptor, or AR, is highly expressed in hormone receptor positive breast cancers. An investigational new drug application, or IND, submitted to the FDA for RAD140 has been accepted.

Emerging clinical data suggest that androgen receptor positivity is associated with favorable clinical outcome in breast cancer. RAD140 selectively targets the AR receptor and has shown significant preclinical activity in endocrine resistant models as a single agent and in combination with standard of care.

Cellectar Biosciences to Present at The MicroCap Conference

On September 29, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused biotechnology company (the “company”), reported that president and CEO Jim Caruso will present and meet with investors at The MicroCap Conference on Thursday, October 5th at 12:30 PM ET at The Essex House in New York City (Filing, 8-K, Cellectar Biosciences, SEP 29, 2017, View Source [SID1234520702]).

The live presentation will be webcast at View Source, and archived on the company’s website following the conference.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, Propanc, 2017, SEP 28, 2017, View Source [SID1234520831])

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TX05 Press Release

On September 28, 2017 Tanvex BioPharma, Inc. reported its plans for an international Phase 3 trial of its biosimilar drug candidate, TX05, its investigational trastuzumab biosimilar (a proposed biosimilar to Herceptin) in patients with early stage breast cancer (Press release, Tanvex BioPharma, SEP 28, 2017, View Source [SID1234524596]). In accordance with advice from the US Food and Drug Administration, the global Phase 3 trial, "A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer", has been designed to compare the therapeutic equivalence of biosimilar candidate TX05 to Herceptin in HER2-positive, early-stage breast cancer patients based on the pathological complete response rate following neoadjuvant therapy. Approximately 800 patients are anticipated to be enrolled from about 209 study centers in 19 countries. The primary efficacy endpoint, pCR, will be assessed through specimens obtained during surgery and analyzed by a central review of local histopathology reports. Equivalence will be considered to be demonstrated if the 95% confidence interval of the risk ratio of the pCR rates (TX05/Herceptin) is within a predefined interval agreed between Tanvex and FDA.

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. Approximately 20% to 30% of primary breast cancers are HER2-positive.

"This represents another major milestone for our company. TX05 will be our second biosimilar product to enter Phase 3 trials and reinforces our commitment to expand access to affordable, high quality products to patients with serious illness," said Allen Chao, PhD, CEO of Tanvex.

US sales of Herceptin were US$2.7 billion in 2016.

Why would Novartis buy a $2.6B radiotherapy maker? Its neuroendocrine franchise, analyst says

Megamerger deal speculation has swirled around Novartis as the Swiss drugmaker eyes its operations—particularly Alcon—for cash-generating sales or spinoffs (Press release, FiercePharma, SEP 28, 2017, View Source;utm_medium=rss [SID1234520701]). But all along, CEO Joe Jimenez has been pledging bolt-on deals instead, and the latest buzz says he has one on tap.

That would be Advanced Accelerator Applications, a maker of radioactive tracers used in diagnostic scans, Bloomberg reports. But the target’s real attraction might be its pipeline. Its lead candidate is an actual cancer therapeutic in a field Novartis already knows: neuroendocrine tumors (NETs).

The in-development med, Lutathera, is at the regulatory filing stage, and it would come with two marketed NET diagnostic agents, NetSpot and Somakit. It’s a radiotherapy based on the rare earth metal leutetium, which is now used primarily as a catalyst for cracking hydrocarbons in oil refineries, according to the Royal Society of Chemistry.

"We believe a Novartis acquisition of AAAP for Lutathera in neuroendocrine tumors would be highly synergistic with [its] existing franchise, including Sandostatin and Afinitor, making a potential deal very logical," Canaccord Genuity analyst John Newman said in a Thursday morning note to investors.

With its $16 billion deal for GlaxoSmithKline’s oncology assets in 2015, Novartis beefed up its cancer portfolio, and the recent approval of its CAR-T drug Kymriah gave it another boost. It moved into the CDK 4/6 cancer therapy market with Kisqali earlier this year, and it’s also been racking up new indications for Afinitor, including nods in gastrointestinal and lung NETs last February.

RELATED: New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph

Right now, AAA’s products are marketed mostly in Europe, with NetSpot its only U.S.-approved agent. Presumably, Novartis would use its expertise at advancing products through the FDA to bring AAA’s meds to the U.S., all while reaping sales in AAA’s established markets. The Big Pharma is adept at winning initial approvals in small patient populations and then expanding into follow-up indications that add significantly to sales prospects.

AAA, which went public in 2015, saw its American depositary receipts surge on the M&A reports, hitting a valuation of $2.6 billion on Thursday morning, Bloomberg says.

Whether Novartis moves forward with a deal remains to be seen; the company has been actively scouting for deals for some time, and various potential buys have been buzzed about over the past couple of years. One of those was Amneal, a generics maker said to be a Novartis target late last year; it’s now reportedly in the sights of Impax Laboratories, the generics maker that recently brought in Actavis/Allergan vet Paul Bisaro as CEO.

But AAA does look like the sort of deal that Big Pharmas have been shopping lately: companies with current revenue streams and late-stage pipeline meds. And if Newman is correct, AAA’s top med could be a boost for Novartis sales for years. "We see very long-duration revenues for Lutathera due to the extremely high barrier for generics, limited supply of leutetium and very high efficacy benefit over current therapies," he wrote.

Just what Novartis plans to do going forward is up in the air, however; Jimenez recently announced his departure, planning to hand the reins to current R&D chief Vas Narasimhan in February.