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On May 11, 2021 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the completion of a $135 million Series B financing (Press release, Nuvalent, MAY 11, 2021, https://www.nuvalent.com/nuvalent-completes-135-million-series-b-financing-to-advance-portfolio-of-novel-precisely-targeted-kinase-inhibitors-for-treatment-resistant-cancers/ [SID1234580619]). The round was led by Bain Capital Life Sciences with participation from sole founding investor, Deerfield Management, and additional new investors Fidelity Management and Research Company LLC, Wellington Management Company, Viking Global Investors, Janus Henderson Investors, Avoro Capital Advisors, Boxer Capital of Tavistock Group, Venrock Healthcare Capital Partners, Fairmount Funds Management LLC, Driehaus Capital Management LLC, and Logos Capital. Andrew Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, will join the Nuvalent Board of Directors.

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"We are encouraged by the support of this exceptional group of investors and their shared belief in our mission to develop precisely targeted therapies for patients with cancer," said Alex Balcom, Chief Financial Officer at Nuvalent. "With this financing, we are well positioned to efficiently advance our parallel lead programs into clinical development and to accelerate the discovery of additional novel, selective compounds to meet medical needs in treatment-resistant cancers."

Proceeds from the Series B financing will support the clinical advancement of Nuvalent’s parallel lead programs, NVL-520 (previously NUV-520), a potential best-in-class ROS1-selective kinase inhibitor, and NVL-655 (previously NUV-655), a potential best-in-class ALK-selective kinase inhibitor. The financing is also expected to support further expansion and accelerated development of Nuvalent’s discovery research pipeline of novel, selective small molecule kinase inhibitors.

New preclinical data leading to the selection of NVL-520 and NVL-655 for clinical advancement were recently presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting. These parallel lead compounds have been designed to address the identified clinical needs of kinase selectivity, brain penetrance, and activity against drug-resistance mutations in ROS1- and ALK-driven tumors, respectively. The preclinical data support the potential for NVL-520 and NVL-655 to remain active in tumors that have developed resistance mutations and to minimize off-target adverse events, including TRK-related adverse events affecting the central nervous system (CNS), in order to drive more durable responses for patients.

"Nuvalent’s focused approach to drug development has led to a promising pipeline of novel drug candidates with specific, rational designs and opportunity for meaningful clinical impact," said Dr. Hack. "I am pleased to join the company’s Board of Directors and look forward to working with this talented team as they continue to apply their internal expertise in chemistry and structure-based drug design towards addressing real-world medical needs identified in close collaboration with leading clinical advisors."

Nuvalent also recently announced several additions to its leadership and advisory team, including precision oncology expert Christopher Turner, M.D., as Chief Medical Officer, and leading scientific advisors with deep expertise in targeted therapies for oncology.

"We welcome Andrew to our Board of Directors, who draws from a breadth of experience across early- to late-stage companies in the biotechnology and life sciences sectors to bring a valuable, multi-faceted perspective to our growing team of distinguished leaders and advisors," said James Porter, Ph.D., Nuvalent Chief Executive Officer. "The milestones that we announced today support our significant achievements since our public launch in January 2021, and the tremendous potential that we believe Nuvalent has. With the support of this investor syndicate, we confidently move forward to develop therapies that drive deep, durable responses for patients with cancer."

On May 11, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported Jesse Ledger, Miravo’s President & Chief Executive Officer and Mary-Jane Burkett, Miravo’s Vice President & Chief Financial Officer will be presenting at the Q2 Virtual Investor Summit (Press release, Nuvo Pharmaceuticals, MAY 11, 2021, View Source [SID1234580418]).

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DATE: Tuesday, May 18,, 2021

TIME: 2:00 p.m. ET

COMPLIMENTARY
REGISTRATION: View Source

About The Investor Summit

The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. The Q2 Investor Summit will take place virtually, featuring 80+ companies and over 300 institutional and retail investors.
Please visit the website at www.investorsummitgroup.com

On May 11, 2021 (ASX:PTX) reported a new research program with the Peter MacCallum Cancer Centre (Peter Mac) in Melbourne to advance its CAR-T programs utilising the OmniCAR platform (Press release, Prescient Therapeutics, MAY 11, 2021, View Source;utm_medium=rss&utm_campaign=prescient-signs-car-t-agreement-with-peter-mac-cancer-centre [SID1234580141]).

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The new program builds on the company’s existing research agreement with Peter Mac focusing on cell therapy enhancement programs.

The new agreement expands this relationship to include the development of the OmniCAR platform.

The company said it is developing three OmniCAR programs internally, including next-generation CAR-T therapies for acute myeloid leukaemia (AML), Her2+ solid tumours and glioblastoma multiforme (GBM).

Prescient said it is developing OmniCAR as a CAR-T platform, capable of being deployed by other CAR-T and oncology companies under licence to advance their own programs.

Under the terms of the new agreement, Prescient will have access to the expertise and facilities of Peter Mac, led by international CAR-T expert, Professor Phil Darcy, to undertake part of the OmniCAR preclinical development programs.

Prescient will own any resulting intellectual property from the work.

The company’s partnership with Peter Mac also now includes two post-doctoral scientists and two research assistants who are dedicated full time to Prescient work. Prescient has also secured grant funding of $100,000 from the federal government’s Innovation Connections scheme towards this research.

On May 11, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, MAY 11, 2021, View Source [SID1234580140])

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Overall Japan: In February 2020, Sawai Pharmaceutical assembled a Crisis Management team and implemented thorough measures to prevent infection.
US: In March 2020, USL assembled a cross-functional Crisis Response Team to gather and review information and to develop and implement applicable policies and processes. USL transitioned to a remote working model, with the exception of critical workers who needed to remain on-site, and also shifted to a digitally based sales and marketing. Japan: Under the state of emergency declared by the government, due to medical institutions restricting inperson visits by Medical Representatives, the provision of medical information has shifted to delivery by online meetings, etc.

Sales of respiratory organ agents and antibiotics declined due to the decrease in the number of visits patients made to medical institutions. US: Shifted to digitally based sales and marketing due to restriction of in-person physician sales activities. Restriction of sales activities adversely impacted sales, including Tosymra, which was acquired in 2019. Japan: No significant impact on development schedule.

US: Several R&D projects have seen delays due to the shutdowns in US and OUS. Supply Chain Maintained stable supply function by thoroughly implementing infection prevention and control in Japan and the U.S. There has been no disruption in the importation of raw materials or logistics.Sawai’s Response to the Serious GMP Violation in the Japanese Generics Industry

2 Sawai’s internal action related to this matter Sawai’s action toward quality
・Our Quality Assurance Dept. internally disseminates all the product recall information of other companies and also shares Sawai products’ relevant information on the products related to the recall. (As needed.)
・In addition to information sharing, reconfirmed at all the factories a supervision system of accepting, weighing and adding APIs; a training system for factory workers; and a prevention system of mix-ups of APIs. (Implemented in Dec. 2020.
・Provided briefings on these cases to employees at all the factories and instruct to engage in operations strictly following procedures. (Implemented in Jan. 2021.
） To minimize quality-related risks, the following measures are taken;
・Ensure the quality of APIs in compliance with Good Manufacturing Practices (GMP).
・Implement a quality control system through constant confirmation of GMP compliance at manufacturing facilities. ・Adopt manufacturing and quality control measures based on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S-GMP). Slight increase in net sales and the same level as the previous year in core operating income, despite the severe business environment in both Japan and the US.
 Operating income decreased due to impairment loss on intangible assets in the US.