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Thrive Earlier Detection Strengthens Leadership Team

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.

DiscoveryBioMed, Inc. Involved Actively in BIO Alabama Annual Conference, October 5-8

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."

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."

The Mark Foundation for Cancer Research Launches Drug Discovery Partnerships

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.

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.

INTERIM RESULTS ANNOUNCEMENT for the six months ended 30 June 2020

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]).

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")

IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-8444 for the Treatment of Solid Cancers and Non-Hodgkin’s Lymphoma

On September 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, in patients with solid cancers and non-Hodgkin’s lymphoma (Press release, IGM Biosciences, SEP 30, 2020, View Source [SID1234567810]).

The multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers and non-Hodgkin’s lymphoma. The key objectives of this trial are to provide an initial assessment of the pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy. IGM expects to report initial data from this Phase 1 trial in 2021.

"The initiation of this clinical trial is another significant milestone in IGM’s development, as it marks the second program from our proprietary IgM antibody platform to begin clinical development," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe that IgM antibodies have the potential to overcome some of the limitations of current IgG-based medicines and deliver new therapeutic options to patients with cancer and other serious diseases, and we hope to pursue a broad clinical development strategy for IGM-8444, including in combination with other targeted oncology drugs."

"DR5 IgM antibodies have the capacity for multivalent binding of DR5 and are designed to more efficiently send an apoptotic signal to the cancer cell and enhance in vitro potency in killing cancer cells compared to IgG antibodies with the same binding units," said Johanna Bendell, M.D., Chief Development Officer, Director, Drug Development Program, Sarah Cannon Research Institute at Tennessee Oncology. "I look forward to working with the IGM team in their pursuit to fully elucidate the potential of this novel therapy."