Istari Oncology Announces FDA Clearance of IND to Initiate LUMINOS-103

On April 19, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for PVSRIPO in patients with solid tumors (Press release, Istari Oncology, APR 19, 2021, View Source [SID1234578191]). LUMINOS-103 (NCT04690699) is a Phase 1/2 open-label, multi-center, single-arm basket trial evaluating the administration of PVSRIPO with or without PD-1/L1 inhibitors in adult subjects with solid tumor cancers. The trial will begin with two bladder cancer cohorts and is expected to initiate enrollment mid-2021.

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PVSRIPO is a novel intratumoral viral immunotherapy that activates a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. PVSRIPO enters solid tumor cells and antigen presenting cells (APCs) in the tumor microenvironment via CD155 (the poliovirus receptor). Because CD155 is expressed on virtually all solid tumors, PVSRIPO has the potential to treat many different cancers.

"This will be an important test of PVSRIPO’s versatility – and we’re optimistic," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "If the tumor can be biopsied, it can be injected, so there are a wide range of solid tumors we can investigate with PVSRIPO."

This is the third IND clearance for PVSRIPO. This IND clearance follows other recent clinical trial progress including the initiation of LUMINOS-101 (NCT04479241) in recurrent glioblastoma and LUMINOS-102 (NCT04577807) in anti-PD-1/L1 refractory melanoma.

"LUMINOS-103 enables us to accelerate the clinical development program for PVSRIPO through the basket trial design, providing flexibility to evaluate multiple solid tumor types simultaneously," said Matt Stober, Chief Executive Officer at Istari. "Even with the approval of anti-PD-1/L1 therapies in certain solid tumor cancers, we believe there is still room for improvement. PVSRIPO’s mechanism is synergistic with these therapies and as an intratumorally administered agent, we expect little additive toxicity."

For more information about Istari Oncology and their ongoing clinical trials and research on PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct point of entry (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Upon entry into the cell, PVSRIPO targets tumors via two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) generating innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

Novo Nordisk A/S – Share repurchase programme

On April 19, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, APR 19, 2021, View Source [SID1234578190]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

Since the announcement as of 12 April 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 44,549,889 B shares of DKK 0.20 as treasury shares, corresponding to 1.9% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 16 April 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 5,647,277 B shares at an average share price of DKK 441.86 per B share equal to a transaction value of DKK 2,495,309,191.

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Amgen Launches Biomarker Assist™, a Program To Help More Patients With Non-Small Cell Lung Cancer Gain Access To Biomarker Testing

On April 19, 2021 Amgen (NASDAQ: AMGN) reported the launch of Biomarker Assist, a program to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing (Press release, Amgen, APR 19, 2021, View Source [SID1234578189]). Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment. Through Biomarker Assist, eligible patients may save on biomarker testing.

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Professional clinical guidelines, including the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), the Association for Molecular Pathology (AMP) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) recommend comprehensive biomarker testing of multiple genes simultaneously—for both actionable and emerging biomarkers—for patients diagnosed with advanced NSCLC regardless of clinical characteristics such as age, race or smoking status.1

"Approximately half of all patients with non-small cell lung cancer have oncogene biomarkers, yet despite the integral role that biomarkers play in lung cancer to identify patients who may benefit from targeted therapies, many patients are not tested," said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen.2,3 "Amgen is excited to launch Biomarker Assist, a patient support program that demonstrates our commitment to closing the gap in testing rates. Based on a patient’s biomarker status, clinicians and patients can make informed decisions on personalized treatment plans and targeted therapies which have significantly improved the prognosis for many patients."

NSCLC is a heterogeneous disease associated with different driver mutations that are responsible for cancer development and growth.1 There are currently seven different actionable driver mutations in NSCLC with a number of emerging therapies under investigation for other molecular mutational drivers, including KRAS.

"The advancement of personalized medicine has transformed the treatment of lung cancer leading to the development of innovative targeted immunotherapies and personalized treatment plans for patients," said Jennifer C. King, Ph.D., chief scientific officer of GO2 Foundation for Lung Cancer. "Over the last decade, the cancer community has learned a great deal about precision medicine, particularly for non-small cell lung cancer, but if patients aren’t getting comprehensive biomarker testing, then they are less likely to benefit from all of the therapeutic advancements. We welcome programs like Amgen’s Biomarker Assist because we need support from all stakeholders, including industry, so that comprehensive biomarker testing becomes universal for everyone who is diagnosed with lung cancer."

About Amgen Biomarker Assist
Biomarker Assist is comprised of two programs: the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test (SGT) Program. The NGS Affordability Program offers assistance to eligible patients with out-of-pocket costs for a comprehensive biomarker panel for patients who have advanced or metastatic (stage IV) NSCLC. This panel must include the KRAS gene. The program is for commercially or privately insured patients. The KRAS Single Gene Test Program will provide a KRAS Mutation Analysis at no cost to any eligible patient, regardless of a patient’s results and insurance. Patients will receive results from participating NeoGenomics Laboratories. Both programs are valid for testing performed through Dec. 31, 2021. To learn more about eligibility for these programs and read the full Terms and Conditions, visit www.BiomarkerAssist.com or contact 1-888-4ASSIST with questions.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

Protara Therapeutics Announces Appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer

On April 19, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported the appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer, effective immediately (Press release, Protara Therapeutics, APR 19, 2021, View Source [SID1234578188]). Dr. Olivo brings to Protara more than 15 years of experience in oncology translational and clinical research and global drug development, most recently serving as Vice President, Breast Cancer Clinical Development Lead at Gilead Sciences, Inc. (formerly Immunomedics, Inc.).

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"We are very excited to welcome Dr. Olivo to our leadership team," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "The depth of his experience supporting the development and approval of oncology drug candidates is expected to be particularly instrumental as we continue to advance our lead product candidate, TARA-002, for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations."

"TARA-002 has strong potential to play a meaningful role in the treatment of NMIBC and potentially other cancers," said Dr. Olivo. "I look forward to working with this dynamic leadership team to advance transformative therapies for people with cancer and rare diseases of high unmet need."

Prior to joining Protara, Dr. Olivo served as Vice President, Breast Cancer Clinical Development Lead, at Gilead Sciences, Inc. (formerly Immunomedics, Inc.), a public biopharmaceutical company, from August 2018 to April 2021, where he led clinical development of a treatment for metastatic triple-negative breast cancer. Prior to joining Immunomedics, he served as Global Clinical Lead at Daiichi Sankyo Cancer Enterprise, a global pharmaceutical company, from July 2017 to July 2018, where he established a comprehensive clinical development plan for an early-stage oncology product candidate with applications in lung and breast cancer. From January 2011 to July 2017, Dr. Olivo served in several roles of increasing responsibility in the oncology business group at Eisai Inc., a pharmaceutical company, most recently serving as an International Project Team Leader.

Dr. Olivo received his M.D. from the University of Buenos Aires and his M.S. in Clinical and Pharmacological Research from Austral University in Buenos Aires. He completed his degree as a Clinical Oncologist at the University of Salvador. He has held various academic and clinical positions at the School of Medicine at the University of Buenos Aires, Hospital "Dr. Enrique Tornú" and the National Cancer Institute of Canada Clinical Trials Group.

Zai Lab Announces Proposed Public Offering of American Depositary Shares

On April 19, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $750,000,000 of American depositary shares ("ADSs"), each representing one ordinary share of the Company (Press release, Zai Laboratory, APR 19, 2021, View Source [SID1234578187]). All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase additional ADSs. Investors have an option to receive ordinary shares of the Company ("Shares") in lieu of ADSs in this offering only, and such option will not be available to purchasers of the additional ADSs.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The offering will be made pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021. A preliminary prospectus supplement related to the proposed ADS offering is being filed with the SEC.

Copies of the registration statement on Form S-3ASR, the preliminary prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, Shares or any other securities, nor shall there be any sale of ADSs or Shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.