On November 13, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2022 third quarter results and latest corporate development (Press release, InnoCare Pharma, NOV 13, 2022, View Source [SID1234623902]).

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, "We successfully got listed on the STAR Board of the Shanghai Stock Exchange, which makes InnoCare become the double-listed biotech company and will inject new momentum to the Company’s long-term development. We further uplifted our commercialization capabilities with continued revenue growth of orelabrutinib after its inclusion in China’s National Reimbursement Drug List (NRDL). We accelerated the pace of innovation and clinical development in the field of malignant tumors and autoimmune diseases with 13 drug candidates entering clinical trials in a bid to meet the unmet clinical needs. Our Guangzhou site was approved for commercial production of orelabrutinib…We have achieved high-quality development in various fields, and we are committed to becoming a world leading biopharma company with innovations as the key driving force."

Financial Highlights

The revenue reached about RMB442 million in the first three quarters of 2022, including about RMB400 million from drug sales, a year-on-year increase of 129%, mainly due to the continuous growth of orelabrutinib sales after its inclusion in the NRDL;
The research and development expenses reached RMB475 million in the first three quarters of 2022 due to more on-going projects, with an increase of 30% year-on-year excluding the impact of the upfront payment to Incyte last year;
The cash and cash equivalents1 rose to RMB9.23 billion, an increase of 37.5% year on year in the first three quarters of 2022, mainly due to the fund raised from the STAR Board listing;
The total assets expanded to RMB10.4 billion in the first three quarters of 2022, an increase of 40.7% compared with the end of 2021;
Excluding the impact of foreign exchange loss, the loss for the first three quarters of 2022 was RMB444 million, mainly due to the increase of research and development expenses. The foreign exchange loss was RMB399 million, which had no actual impact on the Company’s business operations.

STAR Board Listing

On September 21, 2022, InnoCare got listed on the STAR Board of the Shanghai Stock Exchange, raising a total of RMB2.92 billion. The listing on the STAR Board will further enhance InnoCare’s innovative advantages in blood tumors, solid tumors and autoimmune diseases, and contribute to achieving its strategic goal of benefiting global patients with its self-developed innovative drugs.

Pipeline Progress

InnoCare has built a robust pipeline. Orelabrutinib was in commercial stage with NRDL inclusion, tafasitamab was approved for use in the Boao Lecheng International Medical Tourism Pilot Zone, with 13 drug candidates in clinical trials and several others in IND enabling stage. In addition to monotherapy, InnoCare is also exploring the potential of the drug pipelines in combination with standard therapy or other therapies. The followings are the latest developments:

Blood Tumor

Orelabrutinib

Orelabrutinib is expected to be approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) soon;
The supplemental New Drug Application (sNDA) for orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (R/R WM) is under review by the NMPA. A phase II study of orelabrutinib for the treatment of R/R WM patients was published in eClinicalMedicine, a journal owned by The Lancet. At a median follow-up of 16.4 months, the MRR was 80.9%, the overall response rate was 89.4%, and the PFS rate was 89.4% at 12 months2;
The sNDA of orelabrutinib for the treatment of R/R Marginal Zone Lymphoma (MZL) has been accepted and granted priority review by the NMPA. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and orelabrutinib is expected to fill the gap in this therapeutic area;
Phase III registrational trial of orelabrutinib for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is expected to complete patient enrollment by mid-year of 2023;
Phase III registrational study of orelabrutinib for the first-line treatment of MCD subtype diffuse large B lymphoma (DLBCL) is conducted in China. InnoCare has developed a comprehensive toolkit to treat all stages of DLBCL patients with combination therapies;
Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) is conducted in the U.S.
ICP-B04 (Tafasitamab)

The first prescription of tafasitamab in combination with lenalidomide was filled at the Ruijin Hainan Hospital at Bo’ao, who achieved complete response (CR) after 2 cycles of treatment;
Phase II registrational trial of tafasitamab in combination with lenalidomide in China has enrolled about 20% of patients;
The biologics license application (BLA) for tafasitamab in combination with lenalidomide was accepted by the Department of Health, the Hong Kong Special Administrative Region, China. Once getting approval, it will benefit the DLBCL patients in greater bay area;
Tafasitamab has been included in the overseas Special Drug list of commercial insurance in more than 10 provinces and cities, which improves the access of DLBCL patients in these regions.
ICP-490

Novel targeted protein degrader ICP-490 has entered clinical trial in China for the treatment of R/R multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL).
ICP-248

BCL2 inhibitor ICP-248 has entered clinical trial, 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.
ICP-B02 (CM355)

ICP-B02, a CD20xCD3 bispecific antibody developed by InnoCare and Keymed, is in the clinical study for the treatment of CD20+ B-cell malignancies in China.
Solid Tumor

ICP-192 (Gunagratinib)

Initiate registrational trial in cholangiocarcinoma, and progress Phase II trial in urothelial cancer in China;
Progress basket trial, including gastric and head & neck cancer in China, Australia and U.S.
ICP-723

The first adolescent patient has been dosed in clinical trial with InnoCare’s second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients. InnoCare will also expand ICP-723 clinical study to treat pediatric patients (2 to 12 years old);
Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States.
ICP-B05 (CM369)

Monoclonal antibody ICP-B05 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences has entered into clinical stage, developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.
ICP-189

The clinical trials of Novel SHP2 allosteric inhibitor ICP-189 are conducted in China and the U.S., developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents.
Autoimmune Disease

Orelabrutinib

Phase II trial for systemic lupus erythematosus (SLE) delivered positive results, and further clinical development of orelabrutinib in SLE has been initiated;
Phase II trial for multiple sclerosis (MS) in collaboration with Biogen is progressing to the final stage of patient enrollment;
Phase II clinical trials of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) are undergoing in China.
ICP-488

Tyrosine kinase 2 (TYK2) JH2 allosteric inhibitor ICP-488 has completed single dose escalation study and started multi-dose escalation trial. ICP-488 is developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).
ICP-332

Phase II clinical trials of the novel TYK2 inhibitor ICP-332 for the treatment of atopic dermatitis (AD) of were initiated.
"In the challenging market environment, we still fulfilled the preset goals beyond expectations," said Dr. Cui. "Looking forward, we will continue to maintain our original aspiration, hold on the core value of ‘Science drives innovation for the benefit of patients’, strengthen the product pipelines, and accelerate the business development, in order to leverage our innovations achievements to generate greater values for the society."

To know more about the detailed financial data of InnoCare 2022 third quarter results, please log in View Source

Conference Call Information

InnoCare will host a conference call and webcast on Nov. 14, 2022 at 9:30 a.m. Beijing time.

On November 11, 2022 AimedBio reported that its candidate of ‘P018’ has been selected as a "novel therapeutics-based expansion research" project by the Korean Drug Development Project (KDDF) and will receive research funds to derive its lead over the next two years.

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!

P018 is an antibody targeting the tumor microenvironment (TME) which activates immune cells such as T cells and NK cells by removing tumor-associated macrophages (TAM).

AimedBio expects to solve unmet medical needs in solid cancers such as brain tumors and lung cancer through combination of P018 and immuno-oncology drugs.

(Press release, AimedBio, NOV 11, 2022, View Source;s_keyword=&s_where=&start=0 [SID1234656922])

On November 11, 2022 Oncopeptides, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that Pepaxti[] (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK (Press release, Oncopeptides, NOV 11, 2022, View Source [SID1234646787]).

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 approval of Pepaxti in UK is one additional important milestone for Oncopeptides that further validates our science and data," says Jakob Lindberg, CEO Oncopeptides AB. "Pepaxti provides clinical benefit to patients with triple class refractory disease. This is very good news for patients with multiple myeloma, whose treatment options ultimately become exhausted."

The marketing authorization in the UK is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study as a confirmatory study.

The clinical benefit of melflufen in multiple myeloma patients with a treatment history with no stem-cell transplant or a successful prior stem-cell transplant has recently gained additional support with data from the phase 3 LIGHTHOUSE study.

Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

On August 18, Pepaxti was granted marketing authorization by the European Commission in EU and in the EEA-countries Iceland, Lichtenstein, and Norway.

Multiple myeloma is an incurable disease that mainly affects people over 65 years of age. Data from Cancer Research UK (Cancer Research UK, 2010) and the Global Cancer Observatory (Globocan, 2020) states that the estimated prevalence of multiple myeloma is around 17.600 patients. There are around 6.000 new cases diagnosed every year.

Oncopeptides is currently assessing the market access opportunities for Pepaxti in the UK.

On November 11, 2022 BioInvent International AB (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies for cancer immunotherapy and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that a paper co-authored by researchers from BioInvent and Transgene is the recipient of this year’s Journal for ImmunoTherapy of Cancer (JITC) Best Oncolytic and Local Immunotherapy Paper Award (Press release, BioInvent, NOV 11, 2022, https://www.bioinvent.com/en/press/bioinvent-and-transgene-joint-paper-bt-001-wins-jitc-best-oncolytic-and-local-immunotherapy [SID1234624033]). The paper was highlighted at the annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference being held November 8-12, 2022, in Boston, MA, US.

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 annual award, judged by a prestigious review committee of SITC (Free SITC Whitepaper) leadership and the JITC Editorial Board, recognizes one paper in the Oncolytic and Local Immunotherapy category for presenting outstanding research on the role of therapeutic agents designed to target tumor cells or the tumor microenvironment.

The winning paper, Vectorized Treg-depleting αCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject ‘cold’ tumors, demonstrates in vivo proof of concept for Treg depleting immune checkpoint blocking vectorized αCTLA-4 as a highly effective and safe strategy to target CTLA-4.

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform that is armed with an anti-CTLA-4 antibody to illicit a strong and effective anti-tumor response. The drug is currently being evaluated in a Phase 1/2a clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) against solid tumors. Positive Phase 1 data announced in June 2022 confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumor activity.

The papers’ two co-first authors, Dr Monika Semmrich, Principal Scientist at BioInvent, and Dr Jean-Baptiste Marchand, Head of the Protein Science Lab at Transgene, will each receive a monetary prize. The award will be presented at the SITC (Free SITC Whitepaper) Meeting Awards Ceremony, taking place Friday, November 11 from 8:00 – 8:20 a.m. EST.

The full paper can be accessed here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 11, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer (Press release, NanOlogy, NOV 11, 2022, View Source;utm_medium=rss&utm_campaign=nanology-completes-enrollment-in-phase2a-trial [SID1234624007]).

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 single arm trial (NCT04314895) enrolled 18 subjects at four clinical sites with primary or recurrent nonoperable locally advanced stages II and III with nodal disease or stage IV advanced disease. Up to three monthly doses of IT LSAM-PTX were administered and subjects enrolled into the trial had prior or concurrent chemotherapy, radiotherapy, and/or immune checkpoint inhibitor (ICI) therapy as part of SOC.

The primary outcome measure for the trial is safety, as determined by treatment emergent adverse events. Secondary measures include plasma paclitaxel concentration, tumor response, survival, and immune response by flow cytometry analysis. A safety assessment was completed for each of the initial three subjects prior to open enrollment.

Preliminary data to date indicate IT LSAM-PTX is well tolerated with encouraging signs of tumor and immune response. Final data and clinical study report are expected by 3Q2023.

Lung cancer has the highest mortality of any cancer with 2.2 million new cases and 1.8 million deaths estimated globally in 2020 by GLOBOCAN. ICIs are rapidly becoming a SOC for the treatment of lung cancer often combined with other agents to increase response.

NanOlogy is in the planning stages of further clinical research in lung cancer to evaluate its LSAM investigational drugs combined with ICIs bolstered by a recently allowed US patent that covers use of locally delivered LSAM taxanes with systemic ICIs.

In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with signals of tumor and immune response and no confirmed drug-related serious adverse events.