On February 4, 2021 I-Mab (the "Company") (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the first patient has been dosed in a phase 2 clinical trial (NCT04600817) of TJ107 (efineptakin alpha), a novel long-acting recombinant human interleukin-7 (rhIL-7), in patients with glioblastoma multiforme (GBM) in China (Press release, I-Mab Biopharma, FEB 4, 2021, View Source [SID1234574653]).

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The phase 2 trial is a randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of TJ107 in lymphopenic patients with newly diagnosed GBM who have been treated with standard concurrent chemoradiotherapy. The study’s goal is to determine the proportion of patients with an increase in the absolute lymphocyte counts and associated clinical response after the administration of the first TJ107 dose.

There is increasing evidence that lymphopenia induced by radiotherapy and chemotherapy is associated with poor survival in cancer patients. In case of GBM, standard treatments induce long-lasting lymphopenia in most patients, and currently there are no definitive therapies for it. A phase 1b study conducted by Genexine Inc. (KOSDAQ: 095700) demonstrated that TJ107 rapidly increased absolute lymphocyte counts and restored T cell counts especially in the naïve and memory subsets but not the regulatory T cells in terminally ill patients with solid tumors. TJ107 was well tolerated with no dose-limiting toxicity or cytokine release syndrome observed.

"Despite advances in standard therapy, GBM is associated with poor clinical outcomes and survival rates," said Professor Wenbin Li, Director of Department of Neuro-Oncology at Beijing Tiantan Hospital of Capital Medical University and the leading principal investigator of the clinical trial. "Based on its preclinical and clinical data, TJ107 promises to improve tolerance to the standard therapy, quality of life and prognosis in patients with GBM, and we look forward to making this drug accessible to our patients."

"TJ107 is the first and only long-acting rhIL-7 in the clinical stage globally and early studies have shown its potential to treat patients with GBM whose prognosis is still poor," said Dr. Joan Shen, Chief Executive Officer of I-Mab. "The initiation of the phase 2 trial brings us one step closer to delivering a highly innovative therapy to treat patients with one of the most life-threatening forms of cancer."

GBM is the most aggressive type of glial cancer which can arise in the brain de novo or evolve from existing tumors. GBM accounts for 17% of new brain and nervous system cancers in China, according to data from the World Health Organization in 2018.[1]

[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.

About TJ107/GX-I7

TJ107/GX-I7 (efineptakin alpha) is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize TJ107/GX-I7 in Greater China. TJ107/GX-I7 may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. TJ107/ GX-I7 has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On February 4, 2021 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that the underwriters of its previously announced global offering of ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)) have exercised their option to purchase 468,750 additional ADSs in full on the same terms and conditions as the global offering (Press release, argenx, FEB 4, 2021, View Source,ordinary%20shares%20(including%20ordinary%20shares [SID1234574619]). This option exercise brings the anticipated total gross proceeds from the global offering to approximately $1.15 billion (approximately €954.8 million) from the sale of an aggregate of 3,593,750 ordinary shares (including ordinary shares represented by ADSs).

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J.P. Morgan, Morgan Stanley, BofA Securities and Cowen acted as joint bookrunning managers for the offering.

The closing of the global offering, including with respect to the ADSs subject to the option, is expected to occur on February 5, 2021, subject to customary closing conditions.

The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on February 1, 2021. The final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On February 4, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that two abstracts featuring data from clinical studies evaluating Rubraca (rucaparib) in metastatic castration-resistant prostate cancer (mCRPC) and one abstract describing adverse events associated with mCRPC treatment based on real world evidence have been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium to be held virtually, February 11-13, 2021 (Press release, Clovis Oncology, FEB 4, 2021, View Source [SID1234574636]).

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"These data underscore our continued commitment to fully understanding the clinical role of Rubraca and to accelerating the delivery of transformative therapies to the advanced prostate cancer community," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The data that will be shared add to growing scientific knowledge about the science of mCRPC and broaden our understanding of Rubraca as a treatment option for patients diagnosed with mCRPC."

The following Clovis-sponsored abstracts will be available on February 8 at 5:00 pm ET and will also be available as posters for viewing starting February 11 at 8:00 am ET on ASCO (Free ASCO Whitepaper)’s Meeting Library. The posters can also be viewed at View Source starting February 11 at 8:00 am ET.

Abstract Number 80: Association of co-occurring gene alterations and clinical activity of rucaparib in patients with BRCA1 or BRCA2 mutated (BRCA+) metastatic castration-resistant prostate cancer (mCRPC)

Poster Session: Prostate Cancer – Advanced Disease
Date/Time: Thursday, February 11 at 8:00 am ET
Lead Author: Wassim Abida, MD, PhD, Memorial Sloan Kettering Cancer Center, New York, New York
Abstract Number 79: Rucaparib plus enzalutamide in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Pharmacokinetics (PK) and safety data from the phase 1b RAMP study

Poster Session: Prostate Cancer – Advanced Disease
Date/Time: Thursday, February 11 at 8:00 am ET
Lead Author: Arpit Rao, MBBS, University of Minnesota Medical School, Minneapolis, Minnesota
Abstract Number 61: Clinically significant events associated with metastatic castration-resistant prostate cancer (mCRPC) treatments

Poster Session: Prostate Cancer – Advanced Disease
Date/Time: Thursday, February 11 at 8:00 am ET
Lead Author: Kelvin A. Moses, MD, PhD, FACS, Vanderbilt University Medical Center, Nashville, Tennessee
About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

Rubraca U.S. FDA Approved mCRPC Indication

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

On February 4, 2021 Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that Eric Ostertag, M.D., Ph.D., Poseida Therapeutics’ Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day on February 12, 2021 at 10:30am ET (Press release, Poseida Therapeutics, FEB 4, 2021, View Source [SID1234574654]). In addition, management will be available for one-on-one meetings with investors .

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A live webcast of the fireside chat will be available on the Investors & Media Section of the Poseida website, www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On February 4, 2021 Shanghai Fosun Long March Medical Science Co., Ltd. (Fosun Long March) reported that it has executed a non-binding Letter of Intent (LOI) with bioAffinity Technologies, Inc. providing for Fosun to evaluate CyPath Lung, a non-invasive test for the early detection of lung cancer, with an expectation of negotiating and entering into binding agreements to commercialize the early lung cancer diagnostic in China (Press release, BioAffinity Technologies, FEB 4, 2021, View Source [SID1234574691]).

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Fosun Long March is a high-tech in-vitro diagnostics enterprise active in manufacturing, marketing, and research and development of diagnostic and laboratory instruments and reagents. Fosun Long March is a wholly owned company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 02196.HK; 600196.SH). Fosun Pharma is a leading healthcare company in China and is listed on the Shanghai Stock Exchange and on the Main Board of the Hong Kong Stock Exchange.

Dr. Yuejian Zhang, Chief Executive Officer of Fosun Long March, said, "We are impressed with the results of the CyPath Lung test validation trial that showed high accuracy in detecting lung cancer in people at high risk for the world’s most deadly cancer. CyPath Lung is patient-friendly and reasonably priced, making it a good fit in the China market. The test could make a very positive impact. Whilst China represents a little under 20% of the world’s population, it accounts for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2020, of which 18% are due to lung cancer. We look forward to proceeding with the collaboration with bioAffinity Technologies and working together to launch CyPath Lung in China."

Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies, said, "Fosun Long March is a driving force in healthcare, bringing medical breakthroughs to China and the world that improve the health and clinical outcomes of patients. We are very excited to be working with Fosun Long March in advancing CyPath Lung. China represents a $5 billion market for CyPath Lung. An estimated 780,000 people will be diagnosed with lung cancer annually in China, most often at late stage. CyPath Lung is proven to detect lung cancer at early stages, providing opportunities for more effective and less caustic treatments that can save lives."

Ms. Zannes continued, "CyPath Lung offers a simple, cost-effective and highly accurate test. Patients collect their sputum samples at home, a significant benefit during this time of COVID-19 that will last well after the pandemic subsides. Samples are processed at a central laboratory including use of a proprietary porphyrin that labels cancer. Single-cell analysis is performed at extraordinary speed by flow cytometry and data fed through our automated AI-designed platform to provide physicians with results in minutes. CyPath Lung showed 92% sensitivity and 87% specificity in detecting lung cancer in high-risk, heavy smokers who had lung nodules smaller than 2 cm or no nodules in the lung. The detection of small lung nodules in people who have early stage cancer can dramatically increase lung cancer survival."