On August 5, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the Company will host a conference call reviewing the financial results for the second quarter of 2022, at 8:00 A.M. EST on Friday, August 12th, 2022 (Press release, CASI Pharmaceuticals, AUG 5, 2022, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-second-quarter-2022-financial-results-and-host-conference-call-august-12-2022-301600771.html [SID1234617712]).

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On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing 1-866-218-2402 (U.S.) or 1-412-902-6605 (International) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call. Confirmation #10169302.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (International) and enter 9173539 to access the replay.

On August 5, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Immunome, AUG 5, 2022, View Source [SID1234617667]).

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"The second quarter marked our transition into a clinical stage company, as we continue to dose patients in our Phase 1b study of our COVID-19 antibody cocktail, IMM-BCP-01," stated Purnanand Sarma, Ph.D., President and CEO of Immunome. "We also presented data in the second quarter that demonstrated the retention of neutralizing activity against the BA.4/.5, and BA.2.12.1 subvariants of SARS CoV-2. We look forward to reporting topline results from our Phase 1b study of IMM-BCP-01 in the second half of this year."

Dr. Sarma continued, "Additionally, we continue to make strides with our lead oncology candidate, IMM-ONC-01. Through an extensive profiling assessment of IL-38 mRNA using a database1 of over 60 cancer subtypes, we concluded that IL-38 is overexpressed in multiple cancers of high clinical unmet need. We are excited to continue advancing IMM-ONC-01 towards IND submission, as we believe IL-38 represents a promising target in multiple tumor types."

Highlights

IMM-BCP-01 Retains Neutralizing Activity Against Prevalent Omicron Subvariants, BA.4/.5 and BA.2.12.1. In July 2022, Immunome announced that its antibody cocktail retained activity against the BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing. Data recently published in the peer-reviewed journal Science Immunology provides a mechanistic basis for how IMM20253 binding, which is conserved across all variants to date including Omicron and its sub-lineages, neutralized SARS-CoV-2.
Initiation of Phase 1b Study of IMM-BCP-01 for the Treatment of COVID-19. In June 2022, Immunome announced the first patient had been enrolled in a clinical trial of IMM-BCP-01, a three-antibody cocktail for the treatment of SARS-CoV-2. Immunome currently expects to announce topline data in the second half of this year.
Research & Development Update on Lead Oncology Candidate Targeting IL-38. In May of 2022, Immunome announced updates to the ongoing development of its lead oncology program, IMM-ONC-01, specifically on mRNA expression profiling and collaboration with Fox Chase Cancer Center.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2022 were $5.7 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2022 were $3.2 million.
Net loss: Net loss for the three months ended 2022 was $8.9 million.
Cash and cash equivalents: As of June 30, 2022, cash and cash equivalents totaled $34.6 million.
The investigational work related to IMM-BCP-01 was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

[1] Tempus RealWorld Data

On August 5, 2022 IMV Inc. ("IMV" or the "Company") (Nasdaq: IMV; TSX: IMV) a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that it plans to maintain its existing at-the-market facility initially announced on October 16, 2020 under its recently renewed base shelf prospectus, which is effective for a period of 25 months from July 25, 2022 (Press release, IMV, AUG 5, 2022, View Source [SID1234617696]). IMV has entered into an equity distribution agreement (the "EDA") dated August 4, 2022 with Piper Sandler & Co. ("Piper Sandler") pursuant to which the Company may from time to time sell through "at-the-market" offerings (the "ATM Offering"), with Piper Sandler acting as sales agent, on the Nasdaq Capital Market (the "Nasdaq") such number of common shares that have an aggregate offering price of up to US$50 million under the ATM Prospectus Supplement (as defined below).

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The ATM Offering will be made by way of a prospectus supplement (the "ATM Prospectus Supplement") to the Company’s Canadian final base shelf prospectus dated July 22, 2022, and the Company’s United States final base shelf prospectus which is contained in the Company’s U.S. registration statement on Form F-10 dated July 25, 2022, as amended (File No. 333-266082) (the "Registration Statement"). The Registration Statement was effective on filing with the United States Securities and Exchange Commission (the "SEC") on July 25, 2022. The ATM Prospectus Supplement has been filed with the Nova Scotia Securities Commission, as principal regulator in Canada, and in the United States with the SEC. The common shares that may be issued by the Company through the ATM Offering have been conditionally approved for listing on the Toronto Stock Exchange ("TSX") and the required notices related to the ATM Offering have been filed with the Nasdaq as well. In obtaining TSX listing approval, the Company has relied on the "Eligible Interlisted Issuer" exemption from TSX rules under section 602.1 of the TSX Company Manual.

Piper Sandler, at IMV’s discretion and instruction, will use its commercially reasonable efforts to sell the common shares at market prices from time to time. No offers or sales of common shares will be made in Canada or through the facilities of the TSX or any other trading market in Canada.

The Company plans to use the net proceeds from the ATM Offering for general corporate purposes, including but not limited to working capital expenditures, capital expenditures, research and development expenditures, and clinical trial expenditures.

Copies of the ATM Prospectus Supplement and the accompanying final base shelf prospectus relating to the offered common shares may be obtained for free from the offices of Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these common shares in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction.

On August 5, 2022 Dizal reported that positive clinical updates highlighting the therapeutic potential of sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 20 insertion (EGFR Exon20ins) mutation at 2022 World Conference on Lung Cancer (WCLC) (Press release, Dizal Pharma, AUG 5, 2022, View Source [SID1234617713]).

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Lung cancer is the second most common cancer and leading cause of cancer death globally.1 NSCLC accounts for approximately 85% of all lung cancers. NSCLC patients with EGFR Exon20ins mutation lack effective treatment options.

Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity. It is currently being evaluated in late-stage development of multiple global pivotal studies as ≥ 2nd line treatment after platinum-based chemotherapy and 1st line treatment for treatment-naïve patients.

Updated findings from the studies were presented at 2022 WCLC. As of April 30, 2022, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%. In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%. The safety profile of sunvozertinib was amenable to long-term treatment. The most common drug related TEAE (treatment emergent adverse event) were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.

"We are excited to share these updated findings to peer clinicians, researchers and scientists at WCLC." said Dr. Xiaolin Zhang, CEO of Dizal, "With its superior antitumor efficacy and favorable safety, we are confident that sunvozertinib has the potential to become a best-in-class treatment option for NSCLC patients harboring EGFR Exon20ins mutation with persisting unmet medical need."

On August 5, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported new preclinical data supporting the potential best-in-class profile of NVL-655 – an ALK-selective inhibitor, and a "Trial in Progress" poster for the Phase 1/2 ARROS-1 study of NVL-520 – a ROS1-selective inhibitor (Press release, Nuvalent, AUG 5, 2022, View Source [SID1234617668]). NVL-520 and NVL-655 are central nervous system (CNS)-penetrant kinase inhibitors designed to specifically solve for the dual challenges of kinase resistance and selectivity commonly observed with currently available inhibitors.

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The two posters will be presented at the IASLC 2022 World Conference on Lung Cancer (WCLC) Annual Meeting taking place August 6-9, 2022 in Vienna, Austria. The posters will also be available on the Nuvalent website.

"Our presentations at WCLC showcase the value that our collaborations with leading physician-scientists and translational investigators bring towards characterizing and developing our parallel lead programs for patients with non-small cell lung cancer (NSCLC)," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "We are grateful for our continued collaborations focused on advancing the understanding of resistance to kinase inhibitors, as well as the dedication and support of the Phase 1 clinical investigators participating in our ongoing studies for patients with advanced NSCLC and other solid tumors."

"We selected NVL-520 and NVL-655 based on the demonstrated strength of their preclinical profiles and their potential to drive deep, durable responses for patients with ROS1-positive and ALK-positive cancers, respectively. With both programs now under clinical investigation, we remain committed to continued, rigorous preclinical characterization to both deepen our understanding of our programs as well as to support the advancement of tools and models that may help accelerate the development of new therapies for genomically-driven cancers," said Henry Pelish, Ph.D., Vice President of Biology at Nuvalent. "We are pleased to share data further characterizing NVL-655 in a new patient-derived model of lorlatinib-resistant ALK-positive NSCLC with the treatment-emergent G1202R/T1151M compound resistance mutation, developed by our clinical and translational collaborators at Gustave Roussy."

The MR448re patient-derived model was established from cancer cells retrieved from a NSCLC patient previously treated with four prior ALK kinase inhibitors and most recently progressing following treatment with lorlatinib. Presence of an EML4-ALK fusion and the G1202R/T1151M compound mutation was confirmed by sequencing.

"The rapid development of the MR448re patient-derived model and subsequent evaluation of NVL-655 is a testament to the efficient cooperation between our clinical and translational investigators, and our collaborators at Nuvalent," said Luc Friboulet, Ph.D., investigator at Gustave Roussy. "NVL-655 showed strong antitumor activity in this heavily refractory model, while lorlatinib showed limited inhibitory activity consistent with treatment history. This further supports the differentiating and potentially best-in-class preclinical profile of NVL-655, which has previously demonstrated the ability to retain activity in the presence of a broad spectrum of single and compound ALK resistance mutations while maintaining a wide selectivity window over TRKB."

A "Trial in Progress" poster summarizing the preclinical profile of NVL-520 and clinical trial design of the Phase 1/2 ARROS-1 study (NCT05118789) for NVL-520 will also be presented. This multicenter, open-label, dose-escalation and expansion trial is designed to evaluate NVL-520 as an oral monotherapy for patients with advanced ROS1-positive NSCLC and other solid tumors. The ongoing Phase 1 dose-escalation portion of the study is currently enrolling ROS1-positive NSCLC patients who have previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors previously treated with any prior therapy. Nuvalent plans to share preliminary dose-escalation data from ARROS-1 in the second half of 2022.

WCLC Presentation Overview:

Title: Preclinical Activity of NVL-655 in a Patient-Derived NSCLC Model with Lorlatinib-Resistant ALK G1202R/T1151M Mutation
Authors: H. Mizuta1, L. Bigot1, A. Tangpeerachaikul2, H.E. Pelish2, L. Friboulet1
Abstract Number: EP08.02-020
Session Category: Metastatic Non-small Cell Lung Cancer
Session Title: Molecular Targeted Treatments
Session Date and Time: August 7, 2022, 9:45am – 6:00pm CEST

1Gustave-Roussy, Villejuif, France; 2Nuvalent, Inc., Cambridge, MA, USA

Summary of Presentation:

ALK G1202R single and compound mutations are recurrent mechanisms of resistance to previous-generation therapies, including alectinib and lorlatinib.
NVL-655 showed strong antitumor activity in preclinical models derived from ALK positive patients who have progressed on treatment with earlier-generation ALK inhibitors, including a G1202R/T1151M compound mutation model derived from a patient previously treated with crizotinib, alectinib, brigatinib, and lorlatinib.
Among all inhibitors tested, NVL-655 continues to show the broadest activity across ALK fusion partners and resistance mutations while maintaining a wide selectivity window over TRKB.
NVL-655 is currently being evaluated in the Phase 1/2 ALKOVE-1 study for patients with advanced ALK+ NSCLC and other solid tumors, including those with ALK resistance mutations and CNS metastases (NCT05384626).
Title: NVL-520, a Highly Selective ROS1 Inhibitor, in Patients with Advanced ROS1-Positive Solid Tumors: The Phase 1/2 ARROS-1 Study
Authors: A. Drilon1, S-H.I. Ou2, S. Gadgeel3, M. Johnson4, A. Spira5, G. Lopes6, B. Besse7, E. Felip8, A.J. van der Wekken9, A. Calles10, M.J. de Miguel11, D.R. Camidge12, Y. Elamin13, S. Liu14, J. Bauman15, D. Haggstrom16, G. Riley17, H.E. Pelish17, V.W. Zhu17, J.J. Lin18
Abstract Number: EP08.02-041
Session Category: Metastatic Non-small Cell Lung Cancer
Session Title: Molecular Targeted Treatments
Session Date and Time: August 7, 2022, 9:45am – 6:00pm CEST

1Memorial Sloan Kettering Cancer Center, New York/NY/USA ,2University Of California Irvine Medical Center, Orange/CA/USA ,3Henry Ford Cancer Institute, Detroit/MI/USA ,4Sarah Cannon Research Institute, Nashville/TN/USA,5NEXT Oncology – Virginia Cancer Specialists, Fairfax/VA/USA ,6Sylvester Comprehensive Cancer Center at the University of Miami and the Miller School of Medicine, Miami/FL/USA ,7Institut Gustave Roussy, Villejuif Cedex/FR,8Hospital Vall d’Hebron, Barcelona/ES ,9University of Groningen, University Medical Centre Groningen,Groningen/NL ,10Hospital Universitario Gregorio Marañón, Madrid/ES ,11START Madrid-HM CIOCC, Madrid/ES,12University of Colorado Cancer Center, Anschutz Medical Campus, Aurora/CO/USA ,13MD Anderson Cancer Center, Houston/TX/USA ,14Georgetown University, Washington/DC/USA ,15Fox Chase Cancer Center, Philadelphia/PA/USA,16Levine Cancer Institute, Atrium Health, Charlotte/NC/USA ,17Nuvalent, Inc., Cambridge/MA/USA ,18Massachusetts General Hospital, Boston/MA/USA

Summary of Presentation:

NVL-520 has demonstrated CNS activity and potent and selective inhibition of ROS1 & ROS1 G2032R over TRKB in preclinical models. These data indicate the potential to minimize TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients with ROS1+ tumors, including those with ROS1 resistance mutations and CNS metastases.
ARROS-1 is a Phase 1/2 study evaluating the safety and activity of NVL-520 in patients with advanced ROS1+ NSCLC and other solid tumors, including those with ROS1 resistance mutations and CNS metastases.
The Phase 1 portion of the study is open and actively enrolling in the USA, Spain, the Netherlands, and France, with further global expansion planned.
Phase 2 cohorts are designed to support potential registration in TKI-naive or previously treated ROS1+ NSCLC.
About NVL-655

NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

About NVL-520

NVL-520 is a novel brain-penetrant ROS1-selective inhibitor designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R resistance mutation and those with the S1986Y/F, L2026M, or D2033N resistance mutations. NVL-520 has been optimized for brain penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit wild-type ROS1 and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients. NVL-520 is currently being investigated in the ARROS-1 study (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.