On August 22, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 22, 2022, View Source [SID1234618529]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 15, 2022 to August 19, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 521,883 shares as treasury shares, corresponding to 0.79% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On August 22, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the diagnostic 64Cu SAR-Bombesin trial (BOP) for patients with prostate cancer is open for recruitment in Australia (Press release, Clarity Pharmaceuticals, AUG 22, 2022, View Source [SID1234618524]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BOP (Copper-64 SAR Bombesin in PSMA negative Prostate Cancer (BOP) is a Phase II investigator-initiated trial (IIT) in up to 30 patients led by Prof Louise Emmett at St Vincent’s Hospital Sydney. The BOP trial will be assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential for men with negative prostate specific membrane antigen (PSMA) positron emission tomography (PET) or low PSMA expression disease in patients with suspected biochemical recurrence (BCR) of their prostate cancer and patients with metastatic castrate resistant prostate cancer (mCRPC) who are not eligible for PSMA therapy. The trial will be imaging with 64Cu SAR-Bombesin on the day of administration as well as at later timepoints.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative1-4. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the Gastrin Releasing Peptide receptor (GRPr) found on up to 100% of prostate cancers5-9 as well as many other cancers. As such, the product could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

BOP builds on the data generated in PSMA-negative prostate cancer patients at St Vincent’s Hospital imaged under TGA SAS as well as from pilot diagnostic IIT of SAR-Bombesin in breast cancer patients, the C-BOBCAT trial, which was recently presented at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting.

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the BOP trial, commented, "The data we acquired to date for SAR-Bombesin through SAS, published as a case study10, has demonstrated diagnostic imaging potential in PSMA-negative prostate cancer and highlighted potential utility of the product as a theranostic agent. At St Vincent’s Hospital we imaged four men with 64Cu SAR-Bombesin under SAS. They had rising PSA levels but no detectable disease using currently available imaging techniques. SAR-Bombesin was able to detect disease in these patients which successfully led to changes in management of the patient and their disease.

"We are excited by the prospect of making SAR-Bombesin available to a larger pool of patients under clinical trial conditions so that we can carefully analyse the role of this product in the better management of patients. In addition, the central manufacture of these products enables more flexibility in administering the product and has the potential to improve scheduling due to a longer shelf-life in comparison to commonly used diagnostic isotopes such as 68Ga and 18F.

"I am very pleased to be working with Clarity on the Targeted Copper Theranostic (TCT) platform of products. The BOP trial investigating 64Cu SAR-Bombesin is our third trial using Clarity’s TCTs range of products," said Prof Emmett.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The early data we are generating on our SAR-Bombesin product is already changing the lives of patients with cancer. We are looking forward to progressing the development of this product in Australia and the US for diagnostic and therapeutic applications, hoping that it will provide new options for cancer patients who have few treatment options available to them at present. We believe that SAR-Bombesin has potential to provide large patient populations with accurate and precise detection and treatment of cancers that express the target and deliver clinical, environmental and logistical benefits enabled by the copper isotope pairing."

"BOP is yet another part of our collaboration with St Vincent’s Hospital and Prof Louise Emmett and we look forward to continuing our work on the development of TCTs with the mutual goal of improving treatment outcomes for children and adults with cancer" said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)5-9. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide11. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease12.

On August 21, 2022 BroadenBio reported the company received the official letter of acceptance (Study May Proceed Letter) from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial of Class I investigational new drug BB102 for advanced solid tumors (Press release, BroadenBio, AUG 21, 2022, View Source [SID1234640201]). The project has previously been approved for clinical study by the Center of Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2022, and a first-in-human Phase 1 clinical trial for patients with advanced solid tumors will soon be initiated in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BB102 is an innovative small molecule kinase inhibitor discovered and being developed by BroadenBio for the treatment of advanced solid tumors driven by abnormal oncogenic genes. Besides its novel mechanism of action, high selectivity, good safety, and over advantages, BB102 shows promising efficacy to mutation-driven tumors, and is expected to benefit more cancer patients.

On August 21, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2022 mid-year results which ended on June 30, 2022 (Press release, InnoCare Pharma, AUG 21, 2022, View Source [SID1234618526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "The announcement of 2022 mid-year results coincides with our seventh anniversary. In the challenging macro environment, we continue to make more achievements despite all the difficulties, and make breakthroughs in various fields in the first half of 2022: sharp revenue growth with orelabrutinib’s inclusion in China’s National Reimbursement Drug List (NRDL); the first prescription of tafasitamab in combination with lenalidomide in Boao Hope City and launch of registrational trial in mainland China; accelerating the pace of innovation and clinical development with 11 drug candidates entering clinical trials in a bid to meet the unmet clinical needs; advancing our international collaboration projects with Biogen and Incyte smoothly… "

Financial Highlights

The revenue increased by 142% year-on-year from 102 million1 for the six months ended 30 June 2021 to 246 million for the six months ended 30 June 2022, due to the increase of sales of orelabrutinib by 115% from 101 million to 217 million year-on-year after its inclusion in China’s NDRL.
The research and development expenses increased from 185 million for the six months ended 30 June 2021 to 274 million for the six months ended 30 June 2022, mainly due to more drug candidates entering clinical trials and more ongoing phase III trials.
The loss for the period excluding the impact of foreign exchange increased from 233 million for six months ended 30 June 2021 to 286 million for the six months ended 30 June 2022. The unrealized foreign exchange loss2 in the first half was 160 million.
The cash and cash equivalents3 slightly decreased from 6,550 million by the end of 2021 to 6,519 million for the six months ended 30 June 2022.
By now, InnoCare has built a robust pipeline, with orelabrutinib and tafasitamab at the commercial stage, 11 clinical stage assets and five other IND enabling stage candidates. Over 30 clinical trials are ongoing in China and globally.

________________________
1 Currency in the financial highlights refers to RMB
2 Unrealized exchange loss because of exchange rate changes, which has not actually incurred.
3 Cash and cash equivalents refer to cash, bank balance and investments measured at fair value investments

Blood Tumor

Orelabrutinib (BTK inhibitor)

There are multiple registrational and exploratory trials ongoing for blood tumor in China and the U.S.

Orelabrutinib’s supplemental New Drug Application (sNDA) was accepted by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL). So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.
The sNDA for R/R waldenstrom’s macroglobulinemia (WM) was accepted by the NMPA.
Phase III registrational trial for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is conducted in China. Patient enrollment is more than halfway.
In the U.S., a Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) is expected to complete patient enrollment in 2022.
Strengthen development in diffuse large B lymphoma (DLBCL)
A Phase III registrational study of orelabrutinib for the first-line treatment of MCD DLBCL was initiated.
The latest data of orelabrutinib in the treatment of DLBCL in a real-world analysis were released at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL.
A comprehensive tool-kit including orelabrutinib, tafasitamab, ICP-B02 and ICP-490 offers a unique position to treat all stages of DLBCL patients with combination therapies.
Latest clinical data of orelabrutinib in combination of anti-PD-1 antibody in the treatment of relapsed or refractory primary central nervous system lymphoma (PCNSL) was presented at the European Association of Hematology (EHA) (Free EHA Whitepaper). All patients were evaluable for response. The overall response rate (ORR) was 61.5%, with 38.5% complete remission (CR/CRu) and 23% partial remission. The combination is generally safe and well tolerated.
Phase III registrational trial for first-line treatment of MCL is conducted in China.
ICP-B04 (Tafasitamab)

The first prescription of tafasitamab in combination with lenalidomide was filled in China at the Ruijin Hainan Hospital for an eligible DLBCL patient.
The Company initiated the phase II registrational trial to support approval in mainland China.
The 2022 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines was released. Tafasitamab in combination with lenalidomide was listed as a Level II recommended treatment for adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation (ASCT).
The Biologics License Application (BLA) for tafasitamab was submitted in Hong Kong and will be submitted in Macao. Once approved in Hong Kong or Macao, this innovative drug can benefit patients in the Greater Bay Area.
The strategic collaboration with Incyte will not only offer a good opportunity to explore the potential clinical benefit to combine tafasitamab with orelabrutinib and InnoCare’s other assets for the treatment of B-cell malignancy, but also enhance InnoCare’s strength in the field of hematology and oncology.
ICP-B02 (CM355)

The first patient in China was dosed in clinical trial of CM355, a CD20xCD3 bispecific antibody developed by InnoCare and Keymed, for the treatment of CD20+ B-cell malignancies. CM355 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC) in the treatment of CD20+ B-cell malignancies.
ICP-490

The IND application of ICP-490 was accepted by the NMPA. ICP-490 was developed from InnoCare’s molecular glue platform. ICP-490 will be developed for the treatment of r/r multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL), including DLBCL.
ICP-248

The IND application of BCL2 inhibitor ICP-248 was accepted by the NMPA. ICP-248 is developed to treat malignant hematological tumors such as NHL and acute lymphoblastic leukemia (ALL) as single drug or in combination with other drugs such as BTK inhibitor.
Autoimmune Diseases

Orelabrutinib

Phase II trial for systemic lupus erythematosus (SLE) delivered positive results
In all evaluable patients, the SLE Response Index (SRI)-4 response rates at week 12 were 50.0%(7/14), 61.5%(8/13) and 64.3%(9/14) in patients treated with orelabrutinib at 50 mg, 80 mg and 100 mg respectively, compared with 35.7%(5/14) in patients treated with placebo, which indicated a trend of dose-dependent improvement.
Trends of reduction in proteinuria level and improvement of immunologic biomarkers were observed.
Further clinical development of orelabrutinib in SLE patient is under final discussion.
Phase II trial for multiple sclerosis (MS) in collaboration with Biogen is progressing to the final stage of patient enrollment.
Phase II clinical trial of Orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) will complete patient enrollment soon.
Phase II clinical trial of orelabrutinib for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in China was initiated.
ICP-332

Phase I clinical trial of the novel tyrosine kinas 2 (TYK2) inhibitor was completed, showing a positive safety profile. Phase II trials for the treatment of atopic dermatitis (AD) and psoriasis were initiated.
ICP-488

First cohort of phase I trial was completed. ICP-488 is a potent and selective TYK2 allosteric inhibitor, binding to the TYK2 JH2 domain, developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).
Solid Tumor

ICP-192 (Gunagratinib)

Completed dose escalation ranging from 2 mg to 26 mg with no dose-limiting toxicities (DLT) observed.
20 mg dose of gunagratinib showed good efficacy in cholangiocarcinoma patients. According to the data posted at ASCO (Free ASCO Whitepaper), among the patients who have completed at least one tumor assessment, the ORR was 62.5% and the disease control rate (DCR) was 100%.
Well positioned to enter potential registrational trial in cholangiocarcinoma.
Progressing Phase II trial in urothelial cancer in China.
Progressing basket trial, including gastric and head & neck cancer in China, Australia and U.S.
ICP-723

ICP-723 is a second generation TRK inhibitor, which overcomes acquired resistance to the first generation of TRK inhibitor.
Phase I dose escalation trials were treated with ICP-723 at doses of 1 mg to 16 mg once daily. ICP-723 was safe and well tolerated with no DLT observed.
100% ORR was observed in various types of solid tumors carrying NTRK gene fusion positive at dosages of 4 mg and above.
Well positioned to enter potential registration trial in China.
Study to expand potential use in adolescent and pediatric patients.
Clinical trial was initiated in the U.S.
ICP-189

The first patient was dosed in clinical trial of the novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 in China. ICP-189 is developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. ICP-189 has entered into clinical stage in China and the U.S.
ICP-033

The first patient was dosed in clinical trial of the novel RTK (Receptor Tyrosine Kinase) ICP-033 in China. ICP-033 is a multi-kinase inhibitor mainly targeting discoid in domain receptor 1 (DDR1) and vascular endothelial growth factor receptor (VEGFR) that inhibits angiogenesis and tumor cell invasion, normalizes abnormal blood vessels, and reverses the immunosuppressive state of the tumor microenvironment. ICP-033 will be potentially used as monotherapy and/or in combination with immunotherapy and other targeted drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.
ICP-B05 (CM369)

The NMPA accepted the IND application for monoclonal antibody CM369 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences. CM369 is an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody and a potential first-in-class drug. It will be developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.
Other Corporate Development

Financing
The China Securities Regulatory Commission approved the InnoCare’s application for the registration of the Proposed RMB Share Issue on Sci-tech Innovation Board of Shanghai Stock Exchange.
Manufacturing
Guangzhou: InnoCare Guangzhou site was approved for commercial production of orelabrutinib starting from June 30. The approval marked the embarking of InnoCare’s self-production, thereby providing patients with high-quality products and services.
Beijing: The ground-breaking ceremony of InnoCare Innovative Drug Site was launched. Integrating the headquarters, research and development center and large molecule production base, this site can meet the company’s growing business needs.
Authoritative Certificates
InnoCare was recognized as "technologically-advanced small giant" by Beijing Government Agency due to its innovation capability and market competitiveness in the pharma industry. The "technologically-advanced small giant" enterprises have become the key to improve the stability and competitiveness of the industrial ecosystem and supply chain.

Orelabrutinib was awarded with the "Beijing New Technology and New Product (Service) Certificate", recognized by five major government departments in Beijing including Science & Technology Commission, Commission of Development and Reform, Bureau of Economy and Information Technology, Commission of Household and Urban-Rural Development and Bureau of Market Supervision and Administration.
"Looking forward to the second half of 2022, we will continue our efforts to fulfill our mission of ‘Science drives innovation for the benefit of patients’, strengthen the development of our R&D platform, accelerate clinical trials globally, and actively explore international business opportunities to further unleash our potential for innovation and create greater value for the society," added Dr. Cui.

To know more about the detailed financial data and business update of InnoCare 2022 mid-year results, please log in View Source

Conference Call Information

InnoCare will host a conference call and webcast on Aug. 22, 2022 at 9:00 a.m. Beijing time. Participants must register in advance of the conference call. Details are as follows:

The call will be conducted in Mandarin.

On August 19, 2022 Huahui Health, a Beijing-based, clinical stage biotechnology company focused on discovering and developing virology, hepatology and oncology therapies, reported that its "First-in-Class" anti-tumor drug candidate HH-009 has completed the first patient dose in a Phase Ia clinical trial conducted in China (Press release, Huahui Health, AUG 19, 2022, View Source [SID1234642185]). It marked the first molecule amongst those investigational therapies of the same target in the world that entered clinical development stage. Currently, Huahui has brought 5 products with "First-in-Class" or "Best-in-Class" potential into clinical stage, including 3 anti-viral and 2 anti-tumor clinical assets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a potential "First-in-Class" anti-tumor therapy, HH-009 initiated a Phase Ia clinical study to evaluate its safety, tolerability and pharmacokinetic in solid tumors. Compared to other small-molecule inhibitors of the same target, HH-009 is a fully human monoclonal antibody with a novel mechanism of action, offering potential safety advantages over small-molecule drug candidates.

HH-009 has also planned to open an IND in the US by end of 2022.