On April 28, 2022 IMV Inc. (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 the Company’s lead compound, maveropepimut-S (MVP-S), will be showcased in two presentations in breast and ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, IMV, APR 28, 2022, View Source [SID1234613129]). The meeting will be held in-person and virtually June 3-7, 2022, in Chicago, Illinois.

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Presentation Details

Neoadjuvant Survivin-targeted Immunotherapy Maveropepimut-S (MVP-S) to increase Th1 Immune Response in Ki67-high Hormone Receptor Positive (HR+) Early-stage Breast Cancer (ESBC)

Presenter: Sasha E. Stanton, M.D., Ph.D., Medical Oncologist and Assistant member, Cancer Immunoprevention Laboratory Earle A. Chiles Research Institute at the Providence Cancer Institute, Portland, OR
Poster Number: TPS1119
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Pembrolizumab, Maveropepimut-S and Low Dose Cyclophosphamide in Advanced Epithelial Ovarian Cancer –Results from Phase 1 and Expansion Cohort of PESCO Trial

Presenter: Ana Veneziani, M.D., Ph.D., Clinical Research Fellow at the Princess Margaret Cancer Centre, Toronto, ON
Poster Number: 5505
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

The presentations will be available on the IMV website under the Scientific Publications & Posters section following the meeting.

On April 28, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported two abstracts accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 3-7 at McCormick Place in Chicago and online (Press release, Sermonix Pharmaceuticals, APR 28, 2022, View Source [SID1234613128]).

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Details of the presentations are as follows:

Title: Open-label, Phase 2, Multicenter Study of Lasofoxifene (LAS) Combined with Abemaciclib (Abema) for Treating Pre- and Post-Menopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer and an ESR1 Mutation after Progression on Prior Therapies

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On April 28, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended April 2, 2022 (Press release, Thermo Fisher Scientific, APR 28, 2022, https://corporate.thermofisher.com/content/tfcorpsite/us/en/index/newsroom/press-releases/2022/Apr/28-Thermo-Fisher-Scientific-Reports-First-Quarter-2022-Results.html [SID1234613127]).

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First Quarter 2022 Highlights

First quarter revenue was $11.82 billion.
First quarter GAAP diluted earnings per share (EPS) was $5.61.
First quarter adjusted EPS was $7.25.
Delivered very strong financial results in the first quarter, with 16% Core organic growth and $1.68 billion of COVID-19 testing revenue.
Launched high-impact new products including the Applied Biosystems SeqStudio Flex Series genetic analyzer to improve clinical research and advance scientific discovery and the new Thermo Scientific TRACE 1600 Series Gas Chromatograph, one of four new instruments in our Gas Chromatography (GC) and GC-Mass Spectrometry (MS) Product Portfolio advancing analytical testing for food, environmental, industrial and pharmaceutical applications.
Strengthened our unique customer value proposition with the opening of a new biorepository in Vacaville, California, to advance our cell and gene therapy services. We also brought additional bioproduction capacity online for single-use containers and cell culture media.
Reflecting the customer value proposition for our pharma and biotech customers, and as an example of our trusted partner status, Moderna announced a 15-year strategic collaboration agreement with Thermo Fisher to enable large-scale U.S. manufacturing of future mRNA-based vaccines and therapies.
Building on our environmental, social and governance priorities and enabling broad adoption of sustainable solutions, we exceeded the milestone of shipping more than one million readily recyclable paper coolers to transport cold-chain products without the use of traditional polystyrene foam coolers.
Repurchased $2.0 billion of stock and increased our dividend by 15 percent.
"We are very pleased to deliver another quarter of excellent performance," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We started the year with great momentum, executing our proven growth strategy and continuing to be a trusted partner for our customers. Our PPD clinical research business is performing very well, the integration is going smoothly and we are even more excited about the opportunities we have to further enable the success of our pharma and biotech customers."

Casper added, "The strong execution by our team in the first quarter positions us to deliver another outstanding year."

First Quarter 2022

Revenue for the quarter grew 19% to $11.82 billion in 2022. Organic revenue growth was 3%, acquisitions increased revenue by 18% and currency translation decreased revenue by 2%. Core organic growth was 16%. COVID-19 testing revenue was $1.68 billion.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2022 was $5.61, versus $5.88 in the same quarter last year. GAAP operating income for the first quarter of 2022 was $2.82 billion, compared with $3.05 billion in the year-ago quarter. GAAP operating margin was 23.9%, compared with 30.8% in the first quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2022 was $7.25, versus $7.21 in the first quarter of 2021. Adjusted operating income for the first quarter of 2022 was $3.45 billion, compared with $3.51 billion in the first quarter of 2021. Adjusted operating margin was 29.2%, compared with 35.4% in the first quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Daylight Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 28, at 8:30 a.m. Eastern Daylight Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The access code is 310385. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News and Events" through Friday, May 13, 2022.

On April 28, 2022 I-Mab ("I-Mab" or the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported the appointments of Mr. Richard Yeh as Chief Operating Officer and Dr. John Hayslip as Chief Medical Officer (Press release, I-Mab Biopharma, APR 28, 2022, View Source [SID1234613126]). The two key appointments add greater depth and breadth of industry experience to the Company’s leading management team, further accelerating its global ambition in innovation and to become a specialty global biopharmaceutical company.

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"I-Mab has been on an exciting transformation journey. As we continue to push forward on multiple fronts to expand our capabilities and deliver on key milestones, the invaluable experience brought by these two leaders will facilitate the Company’s growth to the next phase," said Dr. Jingwu Zang, Founder, Chairman and Acting CEO of I-Mab. "Mr. Yeh will play an integral role in further enhancing our global investor network and strengthening our global business partnerships. While Dr. Hayslip will apply his nearly two decades of clinical research expertise in oncology to advancing our globally competitive pipeline of innovative assets."

Mr. Yeh will be based in Shanghai, China and report directly to Dr. Jingwu Zang. He will join I-Mab’s Board after the necessary process is completed. As the Company upgrades its worldwide operations and strengthens network with international investors, Mr. Yeh will be leading key aspects of I-Mab’s strategic investor interactions, global alliance management and major facilities across the world.

Mr. Yeh is an industry veteran with over 25 years of experience spanning senior leadership positions with biopharmaceutical companies and prominent Wall Street firms. Before joining I-Mab, Mr. Yeh was Chief Financial Officer and Head of Strategic Operations at Abbisko Therapeutics (HKEX: 2256), overseeing financial transactions, strategic planning, financial & accounting reports, risk management and fundraising. He also held a series of leadership positions including Chief Financial Officer of CStone Pharmaceuticals (HKEX: 2616), Managing Director and Business Unit Leader of Asia Pacific healthcare equity research at Goldman Sachs (Asia), and Head of China and regional healthcare research team at Citigroup Capital Markets Asia. Mr. Yeh also had robust experience in equity research covering the U.S. biotechnology sector at major firms including Citigroup and Bank of America Securities. Before his career on Wall Street, Mr. Yeh worked in the global strategic marketing group at Wyeth Pharmaceuticals and conducted drug discovery research at Amgen. Mr. Yeh earned his M.B.A. from the Samuel Curtis Johnson Graduate School of Management at Cornell University and Master of Science in Medical Biophysics from the University of Toronto and Ontario Cancer Institute.

"I am thrilled to join I-Mab," said Mr. Yeh. "I-Mab has been at the forefront of creating globally competitive innovation and developed an extensive network of strategic partnerships with major players around the world. I am excited to be part of I-Mab’s global ambition by working with such a high-caliber management team."

Dr. Hayslip will be based in the United States and report directly to Dr. Andrew Zhu, President of I-Mab. In his new role, Dr. Hayslip will lead the Company’s pipeline development, addressing the key challenges in clinical sciences to increase the probability of success and the speed of clinical development for I-Mab’s innovative assets.

Before joining I-Mab, Dr. Hayslip was Vice President of Clinical Development at Nektar Therapeutics (Nasdaq: NKTR). Dr. Hayslip also led development activities for multiple therapies while at AbbVie Oncology. He also comes with a depth of experience on lemzoparlimab (TJC4), having assembled and led the AbbVie cross-functional team to complete setup for patient enrollment for the global partnership between I-Mab and AbbVie on lemzoparlimab. Prior to joining AbbVie Oncology, Dr. Hayslip was an accomplished researcher and physician at the University of Kentucky’s Markey Cancer Center, where he led numerous cancer research studies with a primary focus in lymphoma and leukemia. He also served as the Chief for Hematology and Bone Marrow Transplant and as Director of Clinical Research and Data Management at the Markey Cancer Center. Dr. Hayslip received his medical degree from Northeast Ohio Medical University and a master’s degree in Clinical Research from the Medical University of South Carolina. Following his residency in internal medicine, Dr. Hayslip completed his fellowship in Hematology-Oncology at the Medical University of South Carolina leading to dual board certifications in both Hematology and Medical Oncology. Dr. Hayslip holds multiple U.S. and international patents and has published dozens of scientific papers and reviews in renowned journals including Lancet Haematology, Clinical Cancer Research, Leukemia Research, Blood, and Journal of Clinical Oncology.

"I-Mab’s focus on transformational therapies to address unmet medical needs through innovation has been an inspiration," said Dr. Hayslip. "I am excited to work with this talented global team and looking forward to bringing innovative cancer therapies to patients in areas of high unmet need."

On April 28, 2022 XBiotech (NASDAQ: XBIT) reported that the French National Agency for the Safety of Medicines and Health Products [L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)] approved the launch of a multicenter randomized clinical study for XBiotech’s candidate cancer treatment Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer (Press release, XBiotech, APR 28, 2022, View Source [SID1234613124]). The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.

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Investigators will combine Natrunix and trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer in subjects that have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. The study will randomize patients to receive the Natrunix plus chemotherapy or placebo plus chemotherapy and is designed to seamlessly proceed to a Phase III study based on achievement of certain early efficacy milestones.

Headed by Dr. François Ghiringhelli and Dr. Come Lepage, the clinical program will include over 20 participating clinical centers and enroll at least 160 subjects. Dr. François Ghiringhelli is Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Dr. Come Lepage, Prof. Department Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France. The study design was developed by the lead investigators in collaboration with XBiotech.

The first portion of the study will be an open label, dose escalation (3:3). The Phase II portion will be a multicenter, randomized, double blind, placebo-controlled, non-comparative trial that will enroll 160 subjects. The main objective of the phase II study is to evaluate the efficacy of Natrunix + trifluridine/tipiracil in comparison with placebo + trifluridine/tipiracil with respect to 6-month overall survival in patients with refractory metastatic colorectal cancer. Secondary efficacy measures in the phase 2 portion will include progression free survival, median overall survival, tolerance, quality of life, serum markers of inflammatory cytokines, and tumor markers by immunohistochemistry. With successful completion of the primary endpoint in the Phase II portion, the study will continue into a phase III trial with the number of additional patients enrolled based upon results from the Phase II.

Natrunix is a therapeutic monoclonal antibody discovered, manufactured and undergoing clinical development by XBiotech. The antibody blocks the activity of interleukin-1 alpha (IL-1α). Malignant tumors "trick" the body into producing IL-1α, which has multiple roles in supporting tumor growth and spread. IL-1α expression is also induced by cytotoxic chemotherapy. IL-1α is a potent activator of new blood vessel formation (upregulating VEGF and tumor neoangiogenesis); it mediates breakdown of connective tissue through stimulating matrix metalloproteinase production; facilitates metastasis (enhancing adhesion and migration across blood vessels); and mediates systemic illness (fatigue, anorexia, and anxiety) through activating the hypothalamic-pituitary-adrenal axis. Using Natrunix to block IL-1α in combination therapy could inhibit tumor growth and spread, reduce unwanted effects of chemotherapy, and improve outcomes.

Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths in the United States alone.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.