On October 2, 2019 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported a definitive agreement for Lantheus to acquire Progenics in an all-stock transaction. The transaction has been unanimously approved by the Boards of Directors of both companies.

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Under the terms of the agreement, Lantheus Holdings will acquire all of the issued and outstanding common shares of Progenics stock at a fixed exchange ratio. Progenics shareholders will receive 0.2502 shares of Lantheus Holdings stock for each share of Progenics stock, representing approximately a 35% aggregate ownership stake in the combined company. The exchange ratio implies a 21.5% premium to Progenics’ 30-day volume weighted average closing stock price ("VWAP").1

Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer. Progenics takes a leading role in developing diagnostics that help guide physicians and therapeutics that treat patients. The company’s oncology-focused portfolio currently includes three FDA approved products as well as a rich product pipeline. AZEDRA, approved in July 2018, is the first and only FDA approved product used to treat adult and pediatric patients 12 years and older for the ultra-orphan indications of pheochromocytoma and paraganglioma. Progenics’ other approved products are oral and subcutaneous formulations of RELISTOR, which are licensed to Bausch Health Companies Inc.

The combination of Lantheus and Progenics forms an innovative company with a diversified diagnostic and therapeutics portfolio. The transaction leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities. Anchored by Lantheus’ leading microbubble franchise, the resulting company’s robust portfolio includes additional radiopharmaceutical products for precision diagnostics and therapeutics in the field of oncology as well as a related artificial intelligence platform with a 510(k) approved application in oncology. The two companies had pro forma combined revenue of $370.1 million for the 12 months ended June 30, 2019.

"A long-term pioneer in medical diagnostics, Lantheus remains an industry leader in radiopharmaceuticals as well as the world-wide leader of ultrasound contrast agents. With this combination, we broaden our reach in emerging uses of radioisotopes for precision diagnostics and the exciting and expanding field of radiopharmaceuticals in oncology treatment," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Lantheus will be a leader in radiopharmaceutical innovation, providing medical professionals with essential tools and therapies to diagnose and treat neuroendocrine tumors and prostate cancer patients. Our complementary strengths, radiopharmaceutical manufacturing and supply chain expertise, and focus on commercial execution will deliver sustainable and diversified revenue streams and increase our gross margin potential. We have assessed the strategic fit with Progenics for a number of years and I am pleased that we are finally able to make this combination come to fruition; I believe that the combined company will be well positioned for long-term value creation for all of our stockholders."

"Today marks the beginning of an exciting new chapter for Progenics. This combination unlocks additional value for stakeholders and stockholders alike through Lantheus’ enhanced resources and R&D capabilities, proven commercial expertise and complementary portfolio of products. The transaction also creates value for Progenics stockholders through a significant premium and the opportunity to participate in the future growth of Lantheus," said Mark Baker, Chief Executive Officer of Progenics. "Lantheus shares our confidence in the potential of our promising pipeline, and we believe that Lantheus will provide additional commercialization expertise and resources to further advance AZEDRA’s launch and deliver substantial revenue growth. This compelling opportunity would not have been possible without the hard work and dedication of our talented employees. We have gotten to know Lantheus’ Board and management team extremely well as we have discussed this combination over the past nine months and we look forward to working together to continue developing innovative products to target diseases and improve treatment for patients around the world."

Upon completion of the acquisition, which is intended to be tax-free to Progenics’ stockholders for U.S. federal income tax purposes, the combined company will continue to be headquartered in North Billerica, Massachusetts and will trade on the NASDAQ under the ticker symbol: LNTH.

The combined company will be led by Lantheus Chief Executive Officer Mary Anne Heino, who brings 30 years of diverse life sciences industry experience with deep pharmaceutical and operational expertise, including commercializations across complex market channels that will help maximize the success of Progenics’ development pipeline and commercial assets. Ms. Heino will be supported by Chief Financial Officer Robert J. Marshall Jr., CFA, who brings over three decades of finance experience, including in healthcare M&A, capital markets, investor relations and corporate financial planning and analysis, and Chief Operations Officer John Bolla, who has over 22 years of diverse supply chain, global operations and manufacturing experience from pilot to full-scale manufacturing of complex pharmaceutical products. Following the closing, Bradley Campbell, currently a member of Progenics’ Board of Directors, will be added as a member of the Board of Directors of Lantheus Holdings.

Compelling Strategic and Financial Rationale

Robust portfolio of precision diagnostic and therapeutic products: With complementary strengths and products, the resulting company will serve patients and healthcare professionals across the continuum of critical diagnosis and care. Progenics enhances Lantheus’ R&D platform, combining to form an innovative development portfolio of precision diagnostics and oncology therapeutics.

Sustainable and diversified revenue growth: This transaction bolsters and diversifies Lantheus’ revenue growth, which is anchored by DEFINITY’s continued strong performance and the expansion of its microbubble franchise. The combined company will focus on advancing the successful commercialization of AZEDRA to drive revenue growth and on maximizing the value of its development pipeline, which we believe has significant market potential. Supported by Lantheus’ proven manufacturing, supply chain and clinical development expertise in the field of radiopharmaceuticals, the combination is expected to drive enhanced revenue growth over the long term.

Attractive returns and enhanced cash flow generation potential: Through enhanced revenue growth and significant realizable cost savings opportunities through the elimination of redundant costs and process and scale efficiencies, Lantheus is expected to improve its gross margin profile into the future. The company expects to generate approximately $15 to $20 million in run-rate cost savings by 2022. These savings are related primarily to public company costs and G&A expenses. With improved top line growth, operational execution and synergy opportunities, the transaction is expected to enhance the company’s cash flow generation and be accretive to adjusted and reported EPS by 2022 and 2023, respectively.

Experienced executive management team: The combined company will be led by a management team with deep experience in the development, manufacturing and commercialization of precision diagnostics and radiopharmaceuticals, and will continue to deploy a team of highly specialized field personnel. The Lantheus Board of Directors is committed to overseeing and incentivizing management to ensure alignment with stockholders’ interests.

Additional Transaction Details

The transaction is expected to close in the first quarter of 2020, subject to approval by Lantheus and Progenics stockholders, regulatory approvals, and customary closing conditions.

Advisors

SVB Leerink LLC is acting as financial advisor and White & Case LLP is acting as legal counsel to Lantheus. Jefferies LLC is acting as financial advisor to Progenics and O’Melveny & Myers LLP is acting as its legal counsel.

Conference Call and Webcast Details

Lantheus and Progenics will hold a conference call on Wednesday, October 2, at 8:00 Eastern Time. To access the live conference via telephone, please dial 1 (866) 498-8390 (U.S. callers) or 1 (678) 509-7599 (international callers) and provide passcode 5441618. A live audio webcast of the call also will be available at https://lantheusprogenics.transactionannouncement.com/, and replay of the audio webcast will be available approximately two hours after completion of the call and will be archived for 30 days.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

(Press release, Progenics Pharmaceuticals, OCT 2, 2019, View Source [SID1234670312])

On October 2, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting, which is being held from 6-10 November 2019 in Maryland (Press release, BerGenBio, OCT 2, 2019, View Source [SID1234540031]).

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The presentation will provide updates on its phase II study of bemcentinib (BGB324) in combination with pembrolizumab in patients with advanced NSCLC.

Abstract titles have been announced online at View Source (abstracts # O26). Details of the presentation are below.

Title: A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis.

Date: Friday 8th November 2019

Time: 5:10 pm – 5:25 pm (during High Impact Clinical Trials session)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On October 2, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including breast, prostate, colorectal and leukemia, reported the presentation of preclinical data demonstrating significant tumor regression with the combination of onvansertib and paclitaxel, versus either agent alone, in models of triple-negative breast cancer (TNBC) (Press release, Trovagene, OCT 2, 2019, View Source [SID1234540030]).

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The data was featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on Sunday, September 29th, 2019.

"The development of new options to treat TNBC that is resistant to standard-of-care chemotherapy can address a critical unmet clinical need," said Antonio Giordano, MD, PhD, medical oncologist at Medical University of South Carolina (MUSC). "We value our collaboration with Trovagene, and we believe that our preclinical data confirms the potential therapeutic benefit of onvansertib and warrants further evaluation. Planning for the initiation of a clinical trial targeting TNBC patients with the highly-aggressive p53 mutation is currently underway at MUSC."

TNBC is an aggressive form of the disease accounting for 12 to 18% of breast cancers. Although chemotherapy can be effective as standard-of-care, many patients become resistant to treatment. The TP53 gene is mutated in approximately 80% of TNBC and the mutation is considered a target marker. TNBC is defined by the absence of estrogen and progesterone receptors and the absence of HER2 overexpression. These cancers represent a heterogeneous breast cancer subtype with a poor prognosis. Few systemic treatment options exist besides the use of chemotherapy. Currently, there are no approved targeted therapies to treat TNBC.

Presentation Highlights

Background:

Somatic mutation in TP53 gene (mutp53) is a strong prognostic marker in breast cancer
Triple negative breast cancer (TNBC) is characterized by up to 80% mutp53 and the greatest overall genomic instability among subtypes
Polo-like kinase 1 (PLK1) regulates progression of cells through the G2 phase of the cell cycle
Hypothesis that mutp53 in the context of breast cancer can predict synergy to paclitaxel plus onvansertib, an orally available highly selective PLK1 inhibitor
Significant Clinical Need for New Targeted Treatment Option (Onvansertib + Paclitaxel):

Cell lines undergo G2/M cell-cycle arrest following PLK1 (onvansertib) inhibition
Paclitaxel synergizes with onvansertib (the activity of the two drugs together is greater than that of each drug alone) and induces apoptosis (death) of cancer cells
Currently, treatment options are limited to chemotherapy and there is a significant medical need to develop a targeted therapeutic option for the treatment of breast cancer patients with TP53 mutation
A clinical study to assess the safety and preliminary efficacy of the combination of onvansertib and paclitaxel as a potential new targeted treatment option in TNBC is warranted
About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML (NCT03303339). Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On October 2, 2019 Q BioMed Inc. (OTCQB: QBIO), reported that it has entered into a settlement agreement with BioNucleonics Inc. to complete the outright acquisition of the non-opioid cancer bone pain drug Strontium-89 Chloride USP (Press release, Q BioMed, OCT 2, 2019, View Source [SID1234540029]). Q BioMed will assume immediate ownership of the drug, including the aNDA (abbreviated new drug application), under a mutually favorable global royalty agreement.

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Strontium-89 is an important therapeutic option for the treatment of metastatic bone cancer pain. The drug has a long history of providing well-documented pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. The drug is administered by a single injection and has been shown to reduce or even eliminate the need for opioid therapies. It is effective in reducing pain in the majority of patients and lasts 3 or more months with one dose.

Q BioMed has been gearing up its commercial efforts in anticipation of the successful outcome of this action as well as the pending FDA approval of the contract facility that will manufacture the drug in the US.

The Company believes that this is the ideal time to be launching the product given the current climate surrounding the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide improved quality of life to this group is substantial.

QBioMed CEO Denis Corin said, "We have never been more confident in the merits of this program. It has taken longer than anticipated to get here, but we are soon going to be able to serve the needs of patients suffering from metastatic bone pain and provide them the chance to minimize their pain and improve their quality of life during a meaningful moment in their lives. With millions of potential patients, this is a major market opportunity for us and our shareholders. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."

While we cannot comment on the FDA review of our contract facility, we are proactively preparing for launch late this year. We have on-boarded our commercial team and will make further announcements regarding national and international distribution in the very near future. In addition, our commercial infrastructure is prepared, including pharmacovigilance, medical information, government contracting and marketing.

We look forward to updating our shareholders and those awaiting drug availability in the very near term.

On October 2, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported the acceptance of five clinical and preclinical data abstracts for its immuno-oncology portfolio at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, OCT 2, 2019, View Source [SID1234540028]). The presentations include an oral session with a presentation of updated data from the PIVOT-02 study of bempegaldesleukin (NKTR-214, bempeg) with nivolumab in patients with first-line metastatic melanoma. The 2019 SITC (Free SITC Whitepaper) Annual Meeting is being held from November 6 to November 10, 2019, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the oral presentation are as follows:

Abstract Title: "Clinical activity, including deepening of response, of BEMPEG plus NIVO in previously untreated patients with metastatic 1L Melanoma: results from the Phase 1/2 PIVOT-02 Study"
Abstract: O35
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
Session Title: Concurrent Session 310: Combination Phase 1-2 Clinical Trials
Date: Saturday, November 9, 2019, 5:15 p.m. – 5:30 p.m. Eastern Standard Time

Details of the poster presentations are as follows:

Abstract P619: "NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models", Kivimäe, S., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P623: "Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity", Pieper, A., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P622: "Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist", Miyazaki, T., et al.
Session Date and Time: Saturday, November 9th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Details of the Trials in Progress poster presentation are as follows:

Abstract P387: "A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients with Metastatic Castration-resistant Prostate Cancer (PORTER)", Nissola, L., et al.
Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3

About NKTR-255
NKTR-255 is an IL-15 receptor agonist designed to engage the IL-15 pathway to stimulate and expand natural killer (NK) cells and promote the survival and expansion of central memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rγ receptor complex, NKTR-255 enhances formation of long-term immunological memory which may lead to sustained anti-tumor immune response. Native rhIL-15 is rapidly cleared from the body and must be administered frequently and in high doses limiting its utility due to toxicity. NKTR-255 is designed with IL-15 receptor alpha specificity to optimize biological activity and is uniquely engineered to provide optimal exposure and an improved safety profile.