ALX Oncology to Present ALX148 Clinical Biomarker Data at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

On October 2, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that it will be presenting clinical biomarker data from its ongoing ALX148 phase 1 clinical program at the SITC (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland (Press release, ALX Oncology, OCT 2, 2019, View Source [SID1234540025]).

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Poster Presentation Information
Title: Pharmacodynamic biomarker characterization of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy (Abstract P449)
Date: Friday, November 8, 2019
Time: 7:00 am – 8:00 pm

Lantheus to Acquire Progenics to Form a Leading Precision Diagnostics Imaging and Therapeutics Company

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])

Alpine Immune Sciences Announces Upcoming Scientific Presentations at SITC and ACR/ARHP 2019 Annual Meetings

On October 2, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported planned poster presentations at upcoming scientific meetings highlighting new preclinical data on the Company’s lead programs: ALPN-101, a first-in-class dual CD28/ICOS inhibitor for the treatment of autoimmune diseases, and ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of cancers (Press release, Alpine Immune Sciences, OCT 2, 2019, View Source [SID1234540010]).

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2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting – National Harbor, MD

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit Potent Anti-Tumor Immunity Superior to Checkpoint Blockade Alone
Poster #: P793
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Enhances the Activity of Multiple Standard of Care Modalities
Poster #: P467
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

American College of Rheumatology 2019 ACR/ARHP Annual Meeting – Atlanta, GA

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis
Session Title: Spondyloarthritis Including PsA–Clinical Poster II: Treatment of Axial Spondyloarthritis and Psoriatic Arthritis
Date: Monday, November 11, 2019
Time: 9:00 a.m. – 11:00 a.m. ET

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Associated with Sjögren’s Syndrome
Session Title: Sjögrenʼs Syndrome–Basic & Clinical Science Poster I
Date: Tuesday, November 12, 2019
Time: 9:00 a.m. – 11:00 a.m. ET

NMPA Approves IND Application for CT103A, a Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by IASO BIO and Innovent Biologics

On October 2, 2019 IASO Biotherapeutics (IASO BIO), a clinical stage biotechnology company advancing the development of innovative therapies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that IASO BIO has received National Medical Products Administration (NMPA) approval for an Investigational New Drug Application (IND) for CT103A—an innovative therapy for the treatment of relapsed refractory multiple myeloma (rr/mm) patients (Press release, IASO BioMed, OCT 2, 2019, View Source [SID1234540026]). IASO Bio and Innovent will start a Phase Ib/II study to confirm the R2PD and move to phase II shortly after, with approval anticipated in 2021.

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Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems and bone fractures. With a global annual incidence rate of 2/100,000 persons, it is one of the most commonly diagnosed blood cancers, second only to non-Hodgkin lymphoma.

Hu Guang, Ph.D., Director of R&D at IASO BIO, commented that: "This is an important milestone that allows us to continue with CT103A’s clinical development for the treatment of rr/mm. We’re a young company, and this is a big step forward in achieving our objectives to develop and bring to market the most advanced therapies for treating patients more effectively."

News of the IND approval coincided with the latest presentation of CT103A clinical results at the 17th Annual International Myeloma Workshop, Boston, September 12-15 (Abstract #440).

This annual event is devoted to fostering scientific and clinical exchange on the latest breakthroughs in multiple myeloma and related plasma cell disorders.

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, researchers presented compelling results for efficacy and persistence of a therapy that may provide patients, having relapsed from a prior CAR-T, an option for CAR-T retreatment.

In general, the treatment was well tolerated, with dosage levels ranging from 1X106, 3X106 and 6X106 CAR-T/kg.

CRS occurred in 17/18 patients (Grade 1&2- 66.6% (12), Grade 3- 22.2% (4), Grade 4- 5.6% (1)), but was generally manageable with no neurotoxicity.

At even the lowest dosage level (1 x106 cells/kg), CT103A remains effective with an improved safety profile. For response, 7/8 evaluable patients achieved VGPR or better. With respect to safety, only 1/8 evaluable patients experienced CRS at > grade 2.

About CT103A:

CT103A is an innovative therapy co-developed by IASO BIO and Innovent Biologics, Inc. Previous studies indicated patients with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.

About Nanjing IASO Biotherapeutics:

Founded in March 2017, IASO BIO is a clinical stage biotechnology company advancing the development of innovative cell therapies for cancer. IASO BIO is dedicated to curing cancer using engineered autologous/allogenic T cell therapies designed to enhance the immune system’s ability to recognize and eradicate cancer cells.

Currently, IASO BIO is developing over 10 high-potential, high-end biopharmaceutical products, utilizing a fully-human scFv sequence targeting hematological, solid and virus associated tumors. Additional development efforts include unique TCR-like CAR-T cell therapy products for indications such as gastric cancer, nasopharyngeal carcinoma and viral infection related solid tumors.

IASO BIO has developed broad capability including; a proprietary phage library(>1×1011)supporting the development of CAR-T products, antibody drugs and intracellular targets, a screening system using high-throughput CAR-T analysis techniques and large scale data mining to obtain Best-in-class CAR-T drug candidates, in-house plasmid, lentivirus and CAR-T production technology platforms meeting the requirements for IND submissions and clinical research. For more information, please visit: www.iasobio.com

Novocure to Report Third Quarter 2019 Financial Results

On October 1, 2019 Novocure (NASDAQ: NVCR) reported that it will report financial results for the third quarter 2019 on Thursday, October 31, 2019, before the U.S. financial markets open (Press release, NovoCure, OCT 1, 2019, View Source [SID1234539994]). Novocure management will host a conference call and webcast to discuss its financial results for the three and nine months ended September 30, 2019, at 8 a.m. EDT on Thursday, October 31, 2019.

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Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1178711. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website (www.novocure.com/investor-relations), as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.