On December 29, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of teclistamab for the treatment of patients with relapsed or refractory (R/R) multiple myeloma (Press release, Johnson & Johnson, DEC 29, 2021, View Source [SID1234597842]). Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3.

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"Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high. Our relentless pursuit of treatments for this disease continues with the same sense of urgency that we have always had," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We look forward to working with the FDA in their review of our teclistamab submission."

The BLA submission for teclistamab is supported by data from MajesTEC-1 (NCT04557098, NCT03145181), an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with R/R multiple myeloma. In the study, investigators assessed efficacy outcomes, including overall response rate, very good partial response and complete response using International Myeloma Working Group (IMWG) criteria, as well as the safety profile of teclistamab. Updated MajesTEC-1 data were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.1

"The deep expertise, creativity and persistence of the entire Janssen R&D organization enabled the expeditious advancement of teclistamab for multiple myeloma," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "Today’s submission is another important step in our commitment to bring to patients truly transformational medicines that profoundly impact their health."

Multiple myeloma is an incurable blood cancer that affects white blood cells called plasma cells, which are found in the bone marrow and normally make antibodies which fight infection.2,3 When these plasma cells become malignant and develop into multiple myeloma, these myeloma cells proliferate and replace normal cells in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed and more than 12,000 will die from this disease in the U.S.4 While some patients with multiple myeloma initially have no symptoms, many patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.5

About Teclistamab
Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells.6,7,8,9,10 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.5

Teclistamab is currently being evaluated in several monotherapy and combination studies. In 2020, the European Commission and the U.S. FDA each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) and Breakthrough Therapy Designation (BTD) by the U.S. FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.11 The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.12

On December 29, 2021 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other life-threatening diseases, reported that the first patient has been dosed in the Phase Ib/II, open-label multi-center, REACH trial to evaluate ATG-016 (eltanexor) monotherapy in subjects with advanced solid tumors including those with genetic mutations (such as K-ras or p53) or a viral association (such as Epstein Barr Virus (EBV) and Human Papilloma Virus (HPV). Enrollment in the study is already underway (Press release, Antengene, DEC 29, 2021, View Source [SID1234597838]).

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"The opening of the REACH trial is a very important milestone for Antengene. As the second study of ATG-016 to be conducted in mainland China, it highlights our approach of running our own, complementary, additional studies in China on partnered products," said Jay Mei, M.D., Ph.D, Founder and CEO of Antengene. "Furthermore, this study underscores Antengene’s commitment to focusing our clinical development efforts on diseases that are particularly prevalent in China versus the US," continued Dr. Mei.

ATG-016/eltanexor and other SINE (Selective Inhibitor of Nuclear Export) compounds inhibit the nuclear chaperone protein called Exportin 1 (XPO1) that helps cancers grow by removing tumor suppressor proteins from the nucleus. ATG-016 is an orally-active, highly-specific next-generation XPO1 inhibitor with an improved pharmacological profile and reduced brain penetration versus the first novel SINE compound, ATG-010/selinexor. These attributes can potentially enable more frequent dosing and a better tolerated dosing regimen. ATG-016 demonstrated preliminary anti-tumor activity in a Phase I study in advanced solid tumors and hematologic malignancies. SINE compounds also inhibit replication of viruses that utilize XPO1 machinery. In preclinical studies, ATG-016 demonstrated an inhibitory effect on the growth of cancer induced by viruses such as EBV and HPV.

"The REACH study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-016/eltanexor monotherapy in patients with progressive or resistant disease, building on promising, published Phase I results. With 70% of cancer patients remaining as non-responders or progressing after initial response, Antengene has prioritized the development of treatments for advanced or resistant cancers," said Kevin Lynch, M.D., Antengene’s Chief Medical Officer. "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Antengene’s clinical studies," continued Dr. Lynch.

About the REACH Trial

The REACH trial is a multicenter, open-label Phase Ib/II exploratory trial comprising a dose-escalation portion and dose-expansion portion. The initial dose-escalation of ATG-016 will be conducted in patients with advanced solid tumors, to determine the maximum-tolerated dose (MTD), recommended Phase II dose (RP2D), and biologically effective dose of ATG-016. Then the study will proceed to the dose-expansion portion and initiate the Phase II study in patients with relapsed or metastatic penile squamous cell carcinoma or Stage IV nasopharyngeal carcinoma (endemic tumors in China and southeastern in China) to further assess the efficacy and safety of ATG-016 monotherapy. In the Phase II study, investigators will evaluate tumor responses every six weeks using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1).

About the SINE Compounds

SINE (Selective Inhibitor of Nuclear Export) compounds are inhibitors of the major nuclear export protein Exportin 1 (XPO1). Currently, there are three oral SINE compounds, ATG-010 (selinexor), ATG-016 (eltanexor), and ATG-527 (verdinexor), under clinical development. Antengene has an exclusive license from Karyopharm Therapeutics Inc. ("Karyopharm") to develop and commercialize these compounds in certain APAC markets.

About ATG-010/Selinexor/ XPOVIO

ATG-010/selinexor (XPOVIO) is the first-generation SINE compound. Karyopharm developed and secured approval by the US FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) and relapsed, refractory diffuse large B-cell lymphoma.

Antengene secured approval of ATG-010 in South Korea and China through a priority review process. Antengene is conducting 10 additional studies with ATG-010 in mainland China (3 in collaboration with Karyopharm).

About ATG-016/Eltanexor

Karyopharm is conducting a Phase I/II trial for eltanexor in subjects with Myelodysplastic syndrome (MDS).

Antengene is also evaluating ATG-016/eltanexor in the HATCH study, a Phase I/II monotherapy, registration-track study in high-risk MDS patients who have failed hypomethylating agents.

On December 29, 2021 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6026, an agonist monoclonal antibody targeting OX40 in cancer patient volunteers (Press release, BioThera Solutions, DEC 29, 2021, View Source [SID1234597833]). BAT6026 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform. The Antibody Dependent Cellular Cytotoxicity (ADCC) of BAT6026 has been enhanced through significant afucosylation of BAT6026.

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"OX40 is an important immune-oncology and autoimmune drug target. We are very excited about the preclinical profile of BAT6026, both as a single agent and in combination with other immune-oncology (IO) agents." said Dr. Jin-Chen Yu, SVP, Bio-Thera Solutions. "BAT6026 is one of multiple IO assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs) through enhanced ADCC effects. We plan to explore combinations of BAT6026 with BAT1308, our novel PD-1 antibody, to treat a broad range of cancers."

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT6026 is designed to assess the safety and tolerability of BAT6026 as a single agent. The study is expected to enroll subjects with advanced solid tumor. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.

About IDEAL Platform

Bio-Thera Solutions has developed a proprietary fully synthetic human antibody discovery platform called IDEAL, which stands for Intelligent Design and Engineered Antibody Libraries Platform. The CDR-H3 of our novel innovative antibodies is designed based on over 100,000 natural human antibody sequences. Our IDEAL library has an overall diversity of CDR-H3 over 3E+11. Fixed clinically proven frameworks are utilized to increase the odds of development. A universal affinity maturation library is used for all candidates. A fast high-throughput screening platform is employed.

On December 29, 2021 McKesson Corporation (NYSE: MCK) reported that it will release its third quarter fiscal 2022 financial results after market close on Wednesday, February 2, 2022 (Press release, McKesson, DEC 29, 2021, View Source [SID1234597830]). The company will host a live webcast of the earnings conference call for investors at 4:30 PM Eastern Time to review its financial results.

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Additionally, McKesson management will be participating in the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022.

The live webcast for each event, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.

On December 29, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the upcoming 40th Annual J.P. Morgan Healthcare Conference (Press release, Guardant Health, DEC 29, 2021, View Source [SID1234597829]).

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Guardant Health’s management is scheduled to present on Monday, January 10 at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.