On September 30, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a company whose mission is to deliver innovative therapies that improve the lives of people with cancer, reported that effective January 1, 2021, Mark Velleca, M.D. Ph.D., will transition to the role of senior advisor and continue to serve as a member of the G1 Board of Directors. John ("Jack") Bailey, a member of the company’s board, has been named as G1’s next Chief Executive Officer (Press release, G1 Therapeutics, SEP 30, 2020, View Source [SID1234567815]).

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Mr. Bailey has nearly thirty years of commercial pharmaceutical experience and an in-depth understanding of healthcare market dynamics and the evolution of value-based healthcare systems in the U.S. He has extensive experience successfully guiding the launch and growth of multiple pharmaceutical products. Most recently, Mr. Bailey served as President of GlaxoSmithKline’s pharmaceuticals and vaccines business in the U.S., with responsibility for commercialization efforts across the company’s oncology, immunology/rare disease, respiratory and vaccines portfolios. Earlier in his career, he held various senior leadership positions at Eli Lilly and Company. Mr. Bailey was appointed to the G1 Board of Directors in March 2020. He also serves on the board of Emergo Therapeutics and is a past member of the Board of Directors of PhRMA, the pharmaceutical industry trade association, and the North Carolina Biotechnology Center.

Dr. Velleca has served as G1’s chief executive officer since 2014, joining after its Series A round of venture financing. During this time, he has overseen the successful growth and evolution of G1 from a discovery organization to a fully integrated biopharmaceutical company anticipating the commercialization of its lead investigational therapy, trilaciclib, in early 2021.

"Since moving trilaciclib from the lab into clinical trials in 2014, up through FDA’s granting of Breakthrough Therapy Designation in 2019 and Priority Review of our NDA in 2020, G1 has demonstrated the ability to successfully advance innovative products that benefit patients with cancer. The board and I believe this moment is the right time to institute a leadership transition. Having worked closely with Jack on the board, I am confident he is the right person to lead this remarkable organization into and through its next chapter," said Dr. Velleca. "It has been incredibly rewarding to work alongside this highly talented group of committed professionals for the past six years, and I look forward to continuing my engagement with the company as a board member and senior advisor. I am certain that Jack, together with the leadership team and entire company, will deliver on our vision of improving cancer care and building a successful commercial enterprise."

Garry Nicholson, chairman of the G1 Board of Directors, said, "Jack has a deep understanding of the business through his tenure on the G1 board, and his appointment as CEO is the result of a thorough succession planning process. He brings extensive global leadership experience, a proven track record and tremendous knowledge of our industry. I am confident that under Jack’s stewardship, the company will continue to thrive and become a profitable commercial entity. On behalf of the entire board, I want to thank Mark for his extraordinary leadership and his unwavering commitment to patients. G1 will continue to benefit from Mark’s scientific and clinical expertise as an advisor and director."

"G1 is well positioned to make meaningful contributions to advancing the standard of care in oncology, and I am honored to succeed Mark as CEO," said Mr. Bailey. "Mark and the G1 team have built a patient-focused culture that emphasizes collaboration, respect and integrity. Together with the leadership team and all G1 employees, I look forward to building on this strong foundation to bring trilaciclib to patients battling a range of cancers. Most importantly, I share my new colleagues’ passion for delivering better treatment options to these patients."

On September 30, 2020 Thrive Earlier Detection Corp., a company dedicated to incorporating earlier cancer detection into routine medical care, reported it has strengthened its leadership team with key appointments (Press release, Thrive Earlier Detection, SEP 30, 2020, View Source [SID1234567814]). Sam Asgarian, M.D., has been appointed to chief medical officer and Frank Diehl, Ph.D., as executive vice president of product solutions . Dina Ciarimboli, former general counsel at Third Rock Ventures, has joined Thrive full time as chief legal officer following her interim role as general counsel since the company’s launch.

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Thrive is leading a new era in earlier detection of multiple types of cancer to empower longer, healthier lives. In April, the company published the results from its DETECT-A study, the first and only prospective, interventional study of a blood test used to detect multiple cancers in an asymptomatic population. DETECT-A advances the entire field of blood-based multi-cancer screening, as it doubled the number of cancers found by screening methods in a real world setting, the majority of which were earlier stage disease. Most recently, Thrive announced a $257 million Series B financing which, among other strategic initiatives, will enable the company to develop additional real-world evidence and seek approval of its blood test, CancerSEEK, through a registrational trial. The appointments of these key executives strengthen Thrive’s leadership team, bringing product development, medical and legal expertise to advance the company’s bold mission.

"Since our founding in 2019, Thrive has made significant progress on our mission to save lives by making earlier detection of cancer a routine part of medical care. We published the first-ever prospective study of a multi-cancer blood test in the journal Science, completed our second financing, and now we have further strengthened our leadership team to advance our mission," said David J. Daly, chief executive officer of Thrive. "As our first chief medical officer, Sam brings deep experience from Aetna and CVS Health, where he introduced new innovations into the healthcare system. Frank is a foundational pioneer in blood-based cancer detection and a proven R&D business leader. Dina has been integral since the launch of Thrive, and her strategic counsel will continue to be instrumental to our success."

Each of these executive leaders bring significant experience to Thrive:

Dr. Sam Asgarian, chief medical officer, will lead medical strategy, including the integration of CancerSEEK into routine medical care. Prior to Thrive, Dr. Asgarian was vice president of CVS Health’s Transformation Health Product organization, where he was responsible for the modernization of clinical products and implementation of new solutions to improve consumer convenience and personalize health and wellness. Dr. Asgarian joined CVS as part of the Aetna acquisition, where he served as the chief medical officer of the clinical services organization, overseeing medical management and clinical policy operations across Aetna’s commercial and Medicare businesses. Dr. Asgarian holds a B.A. in molecular and cell biology from the University of California at Berkeley, an M.A. in medical sciences from Loyola University Chicago, an M.D. from Tulane University and an MBA from Cornell University.
Dr. Frank Diehl, executive vice president of product solutions, is a globally recognized leader in cancer biology and detection who has pioneered the use of circulating tumor DNA (ctDNA) to detect and track the progression of cancer. He will lead product development and innovation at Thrive. In 2008, he co-founded one of the world’s first liquid biopsy companies, Inostics, where he served as chief scientific officer through its acquisition by Sysmex and ultimately became CEO of Sysmex Inostics. Dr. Diehl completed a postdoctoral fellowship at the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University and worked in the laboratory of Thrive co-founders Drs. Bert Vogelstein and Kenneth Kinzler, where he developed the first quantitative DNA blood test for colorectal cancer screening. Dr. Diehl holds a Ph.D. in molecular pathology from Ruprecht-Karls University in Heidelberg, Germany.
Ms. Dina Ciarimboli, chief legal officer, will continue to advise on corporate and legal initiatives, company strategy and implementation. Prior to joining Thrive full time, Ms. Ciarimboli was general counsel at Third Rock Ventures, where she was responsible for advising the firm on all legal matters related to fund and firm management and provided legal support to its company creation platform. Prior to joining Third Rock, Ms. Ciarimboli served as general counsel to several venture capital firms focused on early stage investing in various industries including biotech, diagnostics, medical devices and healthcare services. Earlier, she served as an associate at Testa, Hurwitz & Thibeault, LLP and as a senior associate at PricewaterhouseCoopers. Ms. Ciarimboli holds a B.A. in accounting and philosophy from Boston College and completed a J.D. at Boston College School of Law.

On September 30, 2020 DiscoveryBioMed, Inc. (DBM) reported that and excited to be involved in the BIO Alabama Annual Conference to be held virtually from October 5-8 (Press release, DiscoveryBioMed, SEP 30, 2020, View Source [SID1234567813]). There are some great keynote speakers and sessions as well as a one-on-one partnering vehicle that DBM is co-sponsoring for the event. "At the BIO International Convention, DBM takes full advantage of the One on One Partnering vehicle to connect to future potential partners and clients," explained Dr. Erik Schwiebert, CEO and CSO of DBM. "We encouraged a similar vehicle, given the virtual format for the meeting, where connections can be made and/or deepened across the BIO Alabama network and ecosystem."

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In addition, Erik is joining Rachel Lane that leads a scientific writing enterprise called The Written Science for a fireside chat on small business grant programs at the NIH and NSF for life sciences and biotechnology companies. Erik is also going to connect virtually to the Auburn Engineering Club one evening that week to discuss the life sciences and biotechnology career path, DBM, and other topics of interest to Auburn undergraduates. He is also a part of the BIO Alabama Executive Committee and the Planning Committee for this conference.

"Sonia Robinson in particular and the BIO Alabama leadership in general has brought significant new and important energy for our State affiliate and has started many important conversations, including the potential for SBIR-STTR award supplements, to new awardees in the State of Alabama. We need to continue this important momentum for the rest of 2020 and carry it into 2021."

On September 30, 2020 The Mark Foundation for Cancer Research (MFCR) reported that the launch of a new funding program that supports the development of novel cancer therapeutics in areas with high unmet needs (Press release, The Mark Foundation For Cancer Research, SEP 30, 2020, View Source [SID1234567812]). These Drug Discovery Partnership awards are structured to support high-risk, high-reward research and bridge the substantial gap in advancing promising academic discoveries to novel therapies.

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Two projects have been initially selected for funding:

A team at the Dana-Farber Cancer Institute led by Sara Buhrlage, PhD is developing a best-in-class inhibitor of the USP7 enzyme for the treatment of Ewing sarcoma, a rare cancer of the bone and soft tissue that affects children and young adults. USP7 is a deubiquitinating enzyme or "DUB" a class of proteins that regulate cellular protein homeostasis and play an important role in diseases including cancer. Over the past decade there has been much interest targeting DUBs with small molecule therapeutics, however progress has been slow to due to issues with specificity and selectivity. Buhrlage’s lab has discovered a new series of potent and selective USP7 inhibitors that will be optimized preclinically and hopefully bring new therapeutic treatments to the clinic to help treat this devastating childhood cancer. More information on the USP7 project can be found on the MFCR website.
A team at The University of Texas MD Anderson Cancer Center’s Institute for Applied Cancer Science (IACS), part of the institution’s Therapeutics Discovery division, led by Philip Jones, PhD is developing what could be the first inhibitor of the transcriptional co-activator CBP/p300 to be tested clinically in genetically defined leukemias. CBP and p300 proteins are both epigenetic regulators that can read and write certain epigenetic marks on histone proteins and have been linked to the development of cancer and other diseases. The IACS team at MD Anderson has discovered a highly selective series of CBP/p300 bromodomain inhibitors and will now focus on preclinical development. More information on the CBP/p300 project can be found on the MFCR website.
MFCR Drug Discovery Partnerships are focused on key milestones along the continuum from target identification to preclinical development and initial regulatory filings. Projects will typically be supported for 1–3 years with budgets aligned to detailed research plans and award payments made based on milestone achievements. For these initial two projects, up to $4.6M total is expected to be awarded over the next two years.

"From our years of combined pharmaceutical industry experience, my Mark Foundation colleagues and I know that the steps needed to develop a new drug from an early academic concept are fraught with challenges," said Ryan Schoenfeld, PhD, Vice President, Scientific Research. "It’s an area of tremendous unmet need with which we are uniquely capable to help. We’re ecstatic to have the opportunity to provide scientific and technical guidance to brilliant scientists so that we can accelerate their ideas into the clinic."

The scientists at MFCR will also take advantage of their experience working with contract research organizations and other industry partners to provide grantees access to state-of-the-art drug discovery and development capabilities.

Since 2017, MFCR has awarded over $95 million in grants to enable innovative basic, translational, and clinical cancer research, including early-stage drug discovery. MFCR also has a growing investment portfolio that includes drug discovery companies Accent Therapeutics (focused on RNA-modifying proteins implicated in cancer) and Verseau Therapeutics (developing macrophage-targeting immunotherapies), as well as liquid biopsy diagnostics companies C2i Genomics and GRAIL.

On September 30, 2020 ImmuPharma PLC (LSE:IMM), (Euronext Growth Brussels: ALIMM) ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its interim results for the six months ended 30 June 2020 (the "Period") (Press release, ImmuPharma, SEP 30, 2020, View Source [SID1234567811]).

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Key Highlights (including post Period review)

Financials

Stable financial performance over the Period
– Cash balance of £2.7m as at 30 June 2020 (31 December 2019: £1.4m)
– Derivative financial asset of £2.5m as at 30 June 2020 (31 December 2019: £2.3m)
– Incanthera financial asset of £1.2 million (£0.7 million at 31 December 2019) and warrants financial asset of £0.5 million (£Nil at 31 December 2019)
– Convertible loan notes of £2.4 million (face value) (£Nil at 31 December 2019)
– Loss for the period of £3m (30 June 2019: £3.9m)
– Share based expense of £1m (30 June 2019: £1m)
– Research and development expenses of £0.9m (30 June 2019: £1.4m)
– Administrative expenses of £1m (30 June 2019: £0.9m)
– Basic and diluted loss per share of 1.69p (30 June 2019: 2.80p)
– £1.5m subscription agreement through the issue of 15,000,000 new ordinary shares – March 2020
– Agreements with 2 specialist US healthcare investors for a total investment of up to $6.3m (£4.94m) – June 2020
– Placing of new ordinary shares of £6.5m (gross) – September 2020
‘Autoimmunity’: LupuzorTM

License and development agreement with Avion Pharmaceuticals progress
– Avion strengthened advisory team for Lupuzor Phase III trial, including collaboration with leading Lupus patient group and formation of Key Opinion Leaders ("KOLs")
– Submission to the Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) for forthcoming international Phase III trial of Lupuzor

Other program developments

Elro and Ureka combined to form Ureka Pharma SAS
Three therapy areas: Cancer, Metabolism and (new) Anti-Infectives (Anti-Viral, Anti-Bacterial, Anti-Fungal) – these programs include:
– Anti-Infective: BioAMP-B (Anti-Fungal) product for lung infections
– Metabolism: BioGlucagon product – rescue therapy for low sugar events in diabetes
– All programs provide future partnering opportunities
Incanthera plc oncology specialist where ImmuPharma held 11.9% shareholding at 30 June 2020, listed on Aquis Stock Exchange ("AQSE", formerly NEX Exchange) in February 2020 – 2 recent progress updates:
– Successful study results for its skin cancer technology, Sol
– Positive data from Sensitisation study
Commenting on the statement and outlook Tim McCarthy, Chairman, said: "Despite the disruptions of Covid -19 pandemic, we have been focused, in collaboration with our partner Avion, on expediting Lupuzor into a new optimised, international Phase III study in Lupus patients. With the SPA now submitted to the FDA, we await final guidance on the protocol of the trial from the FDA, prior to commencing patient recruitment. "We continue to progress our other R&D programs which includes our anti-fungal Bio-AMP-B therapy, which has the potential of progressing quickly through initial bio-equivalence trials. Discussions for potential partnering opportunities continue. These initiatives create further opportunities in the medium to long term.

"In response to strong investor interest this year, we are delighted to welcome new and returning institutional and private investors as part of three successful capital raisings. This has created a robust financial position with an anticipated cash runway until the end of 2023.

"As we move our key asset, Lupuzor into a new international optimised Phase III trial and continue to progress our development pipeline, the investment thesis of ImmuPharma continues to strengthen and we look forward to providing further value enhancing progress updates over the next period to create long term shareholder value for our shareholders.

"In closing, the Board would like to take this opportunity to thank its shareholders, new and longstanding, for their continued support as well as its staff, corporate and scientific advisers and our partners including, CNRS and Avion."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")