On September 9, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported that Jesse Ledger, Nuvo’s President & Chief Executive Officer will present at the H.C. Wainwright 21st Annual Global Investment Conference to be held September 8-10, 2019 in New York City (Press release, Nuvo Pharmaceuticals, SEP 9, 2019, https://www.prnewswire.com/news-releases/nuvo-pharmaceuticals-update-to-nuvos-presentation-time-at-hc-wainwright-global-investment-conference-300913789.html [SID1234539389]).

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Updated Nuvo Presentation Details

Date:

Tuesday, September 10, 2019

Time:

4:15 p.m. ET (previously announced time 5:00 p.m. ET)

Location:

Lotte New York Palace Hotel

A link to the live audio webcast of the presentation will be available on the Home Page of the Company’s website at www.nuvopharmaceuticals.com. The archived webcast will be available for 30 days.

Mr. Ledger will be available during the conference for one-on-one meetings. Members of the investment community who are interested in meeting with the Company should contact conference coordinators to arrange an appointment or contact Nuvo directly via email at [email protected].

On September 9, 2019 PharmaMar (MSE:PHM) reported new data on lurbinectedin during the World Conference on Lung Cancer (WCLC), which is taking place from 7th to 10th September in Barcelona (Press release, PharmaMar, SEP 9, 2019, View Source [SID1234539374]). The Conference, organized by the International Association for the Study of Lung Cancer (IASLC), brings together the world’s leading experts on this pathology and presents the latest advances in its treatment.

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At this conference, PharmaMar presented two posters on lurbinectedin for the treatment of Small Cell Lung Cancer (SCLC).

The first of them evaluates new combinations with lurbinectedin for the treatment of this type of tumor. The poster entitled "Lurbinectedin (L) Combined with Paclitaxel (P) or Irinotecan (I) in Relapsed SCLC. Results from Two Phase Ib Trials (Abstract 1588)" shows the results of a Phase Ib trial in which combinations of lurbinectedin with paclitaxel or irinotecan were evaluated in patients with relapsed SCLC. Both combinations have shown similar activity and a predictable and manageable safety profile. The combination of lurbinectedin and irinotecan has shown encouraging activity in the third line treatment of patients. Also of interest, the combination of lurbinectedin and paclitaxel has shown higher activity in resistant patients (CTFI<90 days – patients for whom time from the last dose of first-line chemotherapy to the occurrence of progressive disease is less than 90 days).
These results warrant further evaluation of the combinations of lurbinectedin with paclitaxel or irinotecan. The expansion cohort of the irinotecan combination is already ongoing.

The second poster, entitled "Antitumor Activity of Single Agent Lurbinectedin in Patients with Relapsed SCLC Occurring ≥30 Days After Last Platinum Dose (Abstract 1710)" shows data from SCLC cohort of the Phase II Basket trial of lurbinectedin as a single agent, (presented in an oral session at the last ASCO (Free ASCO Whitepaper) Congress). Data are shown for the subset of 84 patients with a CTFI≥30 (time from the last dose of first-line chemotherapy to the occurrence of progressive disease is longer than or equal to 30 days). In this group of patients, the Overall Response Rate (ORR) was 40.5%. For the resistant patients with a CTFI of 30-89 days, the ORR was 29.2%, for whom no currently approved treatment exists. For the 60 patients that were sensitive (CTFI≥90 days; patients for whom time from the last dose of first-line chemotherapy to the occurrence of progressive disease is longer than or equal to 90 days), the ORR was 45%.

As for the safety of the compound in this group of patients, lurbinectedin has shown a safety profile that was acceptable and well tolerated. The most common treatment-related adverse effect has been neutropenia, and no unexpected toxicities have been observed.

During the Congress, Dr. Camilla L. Christensen, from Harvard University, will present in an oral session on transcription as a target in the treatment of SCLC, where, among others, the mechanism of action of lurbinectedin will be discussed. Lurbinectedin is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent.

On September 9, 2019 KAHR Medical, a biopharmaceutical company developing a novel drug platform based on bi-functional, immunotherapeutic fusion proteins known as DSP (Dual Signaling Proteins), reported a new clinical collaboration with Roche (Press release, KAHR Medical, SEP 9, 2019, View Source [SID1234539390]). The collaboration will explore KAHR’s lead program, DSP107, a SIRPα-41BBL DSP, in combination with Roche’s PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced NSCLC who are refractory to checkpoint inhibitors. KAHR expects to file an Investigational New Drug (IND) application with the U.S. Food Drug Administration (FDA) and begin a Phase I/II trial in H1 2020 to evaluate DSP107 as a monotherapy and in combination with atezolizumab.

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"We are extremely pleased to collaborate with Roche to study the potential of atezolizumab in combination with DSP107, our lead drug candidate," said Yaron Pereg, PhD, CEO, KAHR Medical. "The combined approach of DSP107 alongside immune-checkpoint inhibition has already shown promise in preclinical studies. We look forward to examining the potential of DSP107 with atezolizumab in treating NSCLC patients with limited treatment options."

DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific activated T-cells. CD47 is overexpressed on many cancer cells and binds SIRPα on immune phagocytic cells to produce a "don’t eat me" signal. DSP107 binds CD47 on cancer cells, blocking interaction with SIRPα and thus blocking the "don’t eat me signal". Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction. In combination with atezolizumab, DSP107 has the potential to enhance anti-tumor immune response.

The planned Phase I/II study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 in advanced solid tumors. The preliminary efficacy of both DSP107 monotherapy and combination therapy with atezolizumab will be evaluated in patients with advanced NSCLC who are refractory to PD-1/PD-L1 inhibitors. KAHR will be the sponsor of the study and Roche will provide the clinical supply of atezolizumab.

On September 9, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported it has appointed M. Scott Harris, M.D. as Chief Medical Officer (Press release, Altimmune, SEP 9, 2019, View Source [SID1234539375]). Dr. Harris is succeeding Dr. Sybil Tasker, who resigned June 30, 2019 to continue her professional focus on infectious diseases.

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"Dr. Harris is a seasoned medical professional with extensive experience in hepatology and gastroenterology and broad expertise in managing clinical trials from early stage development through successful Phase 3 trials. He has led multidisciplinary forums on drug development and clinical trial design at national and international scientific meetings, and fostered collaborations between professional medical societies and the FDA. We are thrilled that a candidate of Dr. Harris’ caliber is joining the Altimmune team," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "We expect his clinical leadership to be pivotal to our success, and his appointment is timely as we are currently designing our ALT-801, HepTcell, and NasoShield clinical trials."

Dr. Harris added, "I am delighted to be joining Altimmune, and was attracted to the opportunity based on the Company’s pipeline and strong balance sheet. My background in liver and GI drug development especially complements Altimmune’s liver disease portfolio and I look forward to guiding these programs through the clinic. This is an exciting time to join Altimmune."

Dr. Harris is an accomplished drug development scientist who has led numerous global clinical studies and programs in GI and liver diseases. Previously, he was co-founder and Chief Medical Officer of Lyric Pharmaceuticals, helping raise a $21 million Series A round in 2014. He has also served as Chief Medical Officer of Avaxia Biologics, interim Chief Medical Officer of Tranzyme Pharma, and Chief Medical Officer of Ocera Therapeutics. Dr. Harris was also Chief Medical Officer and Vice President of Clinical Affairs at Napo Pharmaceuticals where he authored the pivotal clinical study that led to the approval of crofelemer (Mytesi), the first Phase 2/3 adaptive trial design resulting in a drug approval. Earlier in his career he held senior roles in global clinical development and medical affairs at Otsuka Pharmaceuticals and Abbott. He sits on the faculty of Georgetown University School of Medicine as an Adjunct Professor, where he directs a course on drug development under a grant from the NIH. Dr. Harris has been a consultant on third-world drug development for the Bill and Melinda Gates Foundation and a speaker at national and international forums on drug development. Dr. Harris has an M.D. from Harvard Medical School and an MS in Administrative Medicine and Population Health from the University of Wisconsin Medical School. His post-graduate training includes residencies at John Hopkins Hospital and the University of Pennsylvania, and a Gastroenterology and Hepatology Fellowship at the Yale University School of Medicine.

On September 9, 2019 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported that its Chief Executive Officer, Dr. Phillip Chan, MD, PhD, will present an overview of the company at the 21st Annual Global Investment Conference sponsored by H.C. Wainwright & Co. on Tuesday, September 10, 2019 in New York, NY (Press release, Cytosorbents, SEP 9, 2019, https://www.prnewswire.com/news-releases/cytosorbents-to-present-at-the-hc-wainwright-21st-annual-global-investment-conference-300913899.html [SID1234539391]). Both Dr. Chan and Chief Financial Officer, Kathleen Bloch will meet with investors in 1×1 meetings during the conference on September 9-10, 2019.

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21st Annual Global Investment Conference sponsored by H.C. Wainwright & Co.
Where: Lotte New York Palace, 455 Madison Ave, New York, NY
When: Tuesday, September 10, 2019 from 4:40-5:05PM EDT
Room: Holmes II
Webcast: 21st Annual Global Investment Conference Webcast Link

A live webcast of the presentation will be available at the above webcast link. An archived replay of the webcast will be available for 90 days following the event.