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FN Media Group Presents USA News Group News Commentary VANCOUVER, British Columbia, June 8, 2023 /PRNewswire/ -- USA News Group - By utilizing newly developed novel mechanisms, biotech researchers and scientists are making strides in the battle against cancer. A study put out by researchers at the University of Texas MD Anderson Cancer Center recently detailed a previously unexplained type of cell death that could open the door for novel cancer therapies. How we arm ourselves in the battle against cancer is rapidly changing, thanks to novel mechanisms giving important results, such as those from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Gilead Sciences, Inc. (NASDAQ: GILD), iTeos Therapeutics, Inc. (NASDAQ: ITOS), GSK plc (NYSE: GSK), and Precigen, Inc. (NASDAQ: PGEN). O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) ended 2022 on a very strong note, receiving Fast Track Designation (FTD) for its flagship asset, pelareorep, a novel first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies. "Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication," stated Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study." At this year's Future of Oncology Virtual Symposium in early April, Oncolytics was selected to participate in a panel presentation called Novel Mechanisms with Important Readouts. Among the important results that Oncolytics has already announced was the release of interim clinical data in a cohort of the company's phase 1/2 GOBLET study for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) patients with the combination of pelareorep, the chemotherapies gemcitabine and nab-paclitaxel, and anti-PD-L1 checkpoint inhibitor, atezolizumab. The GOBLET study's pancreatic cohort delivered an impressive 69% objective response rate (ORR), including a complete response, which the National Cancer Institute defines as "the disappearance of all signs of cancer in response to treatment" (aka "remission"). For contextual reference, these ORR results were nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer. Pelareorep's impacts on cancer are also being researched, including through Oncolytics' first and longest-standing focus on its HR-positive HER2-negative metastatic breast cancer program. In 2022, ONCY completed enrollment in the program's second randomized Phase 2 trial, BRACELET-1, which is approaching a crucial data readout that the company anticipates sharing at a major medical meeting next quarter. "Just to provide some additional company history, our breast cancer program's prior positive results come from IND-213, a randomized Phase 2 trial that counts as one of the two pivotal studies required for regulatory approval of pela in breast cancer, per a special protocol assessment agreement with the FDA," said Dr. Coffey in the company's Q4 2022 earnings call. "IND-213 showed a statistically significant and clinically meaningful near doubling of overall survival in HR-positive HER2-negative breast cancer patients who received pela plus paclitaxel compared to those who received paclitaxel alone." Oncolytics currently boasts approximately CDN$32.1 million in cash, cash equivalents and marketable securities (as of December 31, 2022), providing projected runway through BRACELET-1's upcoming readout and into 2024. Back in May 2022, Gilead Sciences, Inc. (NASDAQ: GILD) and partner Dragonfly Therapeutics announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. As per the deal, Gilead secured an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001, and exclusive rights to develop and commercialize additional NK cell engager programs using Dragonfly's Tri-specific NK Engager (TriNKET™) platform. DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. "We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs," said Flavius Martin, MD, Executive Vice President, Research at Gilead. "We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases." iTeos Therapeutics, Inc. (NASDAQ: ITOS) in collaboration with GSK plc (NYSE: GSK) is evaluating its monoclonal antibody EOS-448 as a potential next-generation immuno-oncology agent in multiple combination studies. As per iTeos' Q4 and FY 2022 results, the companies are continuing the exploration of two novel triples in selected advanced solid tumors both in Phase 1b trials: EOS-448 with dostarlimab and GSK's investigational anti-CD96 antibody, and EOS-448 with dostarlimab and GSK's investigational anti-PVRIG antibody. iTeos is also engaged in a clinical development program targeting a novel mechanism in the adenosine pathway for its first-in-class small molecule program EOS-984. The company has already completed Investigational New Drug / Clinical Trials Application-enabling activities, including toxicity studies and anticipates initiating clinical studies for EOS-984 in mid-2023. In February 2023, GSK received regular approval from the FDA for Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. GSK intends for Jemperli to become the backbone of their ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly for patients who currently have limited treatment options. Working diligently to improve the field of CAR-T therapy, Precigen, Inc. (NASDAQ: PGEN) recently dosed its first patient in its ongoing Phase 1/1b Dose Escalation/Dose Expansion Study of its first-in-class investigational multigenic, autologous CAR-T cell therapy, PRGN-3007 UltraCAR-T platform in advanced ROR1-positive hematological and solid tumors. The target patient population for the study includes chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including breast adenocarcinomas encompassing triple-negative breast cancer (TNBC). There are estimated to be more than 100,000 patients diagnosed in both the hematological and TNBC target populations in the USA, EU and Japan in 2023. "Dosing the first patient with PRGN-3007, the next generation of UltraCAR-T incorporating PD-1 inhibition, is a significant milestone for the UltraCAR-T platform," said Helen Sabzevari, PhD, President and CEO of Precigen. "The PRGN-3007 study targets a broad range of hematological and solid tumor indications and this milestone helps us move closer to our vision for UltraCAR-T, which aims to deliver a library of personalized autologous UltraCAR-T therapies using overnight manufacturing at the patient's medical center." For more information please visit: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. 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Nov. 16, 2021 06:00 UTC Monalizumab in combination with durvalumab significantly delayed disease progression in AstraZeneca’s randomized Phase 2 COAST study in unresectable, Stage III NSCLC, advancing to Phase 3 Pre-clinical data presented at SITC with Sanofi from the lead next-generation NK cell engager platform, ANKET™ targeting CD123 in acute myeloid leukemia Cash position of €141.8million1 as of September 30, 2021 Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced its revenues and cash position for the first nine months of 2021. “In the period, we continued to execute against our strategic priorities as we reported readouts from two of our partnered portfolio programs. This included randomized Phase 2 data for monalizumab in combination with durvalumab in unresectable, Stage III NSCLC as well as pre-clinical data from our lead ANKET molecule targeting CD123 in acute myeloid leukemia. These readouts continue to set the stage for delivering both near and long-term value, while also highlighting the strength and depth of our core R&D efforts,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “Looking ahead, we will continue to advance our lacutamab development program and move our early-stage R&D activities towards the clinic with our next generation ANKET platform. We also look forward to seeing AstraZeneca’s upcoming plans for monalizumab’s registrational study in unresectable, Stage III NSCLC, which further reinforces our strategy of building a sustainable business with a robust R&D engine.” Webcast and conference call will be held today at 2:00 p.m. CET (8:00 a.m. ET) The live webcast will be available at the following link: Participants may also join via telephone using the following dial in numbers: France dial-in number: +33 8056 20 704 United States: +1 646 904 5544 All other locations: +1 929 526 1599 Access code: 043615 This information can also be found on the Investors section of the Innate Pharma website, . A replay of the webcast will be available on the Company website following the event. Pipeline highlights: Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca: In September, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%). Based on the data, AstraZeneca announced plans to initiate a Phase 3 trial for both combinations of monalizumab or oleclumab plus durvalumab in the unresectable, Stage III NSCLC setting for patients who had not progressed after concurrent chemoradiation therapy. Separately, AstraZeneca also announced that it is starting a Phase 2 clinical trial, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC. Innate will present data from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which was accepted as a mini oral presentation at the ESMO Immuno-Oncology (ESMO-IO) conference in December 2021. Lacutamab (anti-KIR3DL2 antibody): Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are initiating: Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL. Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) plans to initiate an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL. ANKET™ (Antibody-based NK cell Engager Therapeutics): IPH6101/SAR443579 In November Innate and Sanofi shared new data on IPH6101/SAR443579 at the Society for Immunotherapy of Cancer (SITC) conference. IPH6101/SAR443579 is the first NKp46/CD16-based NK cell engager using Innate’s proprietary ANKET™ multispecific antibody format that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells. IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines and primary AML blasts, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor cytokine release and a favorable safety pro comparison to T-cell engagers. Tetra-specific ANKET In September and November 2021, Innate also presented at the ESMO 2021 and SITC conferences respectively. Innate shared data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. The tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety pro non-human primates. IPH5201 (anti-CD39): AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab. The data is expected to be presented in 2022. IPH5301 (anti-CD73): The Company is initiating an investigator-sponsored Phase 1 trial of IPH5301 in collaboration with the Institut Paoli-Calmettes. Financial Results: Cash, cash equivalents and financial assets of the Company amounted to €141.8 million as of September 30, 2021. At the same date, financial liabilities amounted to €16.1 million. Revenues for the first nine months of 2021 amounted to €10.3 million (€33.6 million for the same period in 2020). For the nine-month period, ended September 30, 2021, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi. About Innate Pharma: Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need. Innate is a pioneer in the understanding of Natural Killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at . Information about Innate Pharma shares: ISIN code FR0010331421 Ticker code Euronext: IPH Nasdaq: IPHA LEI 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors: This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts, the Company’s continued ability to raise capital to fund its development and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2020, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. ___________________ 1 Including short term investments (€15.8 million) and non-current financial instruments (€39.9 million) View source version on businesswire.com: Contacts Investors Henry Wheeler +33 761 88 38 74 Henry.Wheeler@innate-pharma.fr Media Tracy Rossin (Global/US) +1 240 801 0076 Tracy.Rossin@innate-pharma.com ATCG Press Marie Puvieux (France) +33 (0)9 81 87 46 72 innate-pharma@atcg-partners.com Source: Innate Pharma S.A. View this news release online at: