On March 29, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported the appointment of Reshma Rangwala, MD, PhD, as the Company’s Chief Medical Officer (Press release, Karyopharm, MAR 29, 2022, View Source,-MBA-and-Michael-Kauffman,-MD,-PhD-and-appointment-of-Reshma-Rangwala,-MD,-PhD-as-Chief-Medical-Officer [SID1234611124]). Dr. Rangwala will join the Company in mid-April 2022 and will be responsible for leading the Company’s clinical development programs and strategy.

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"We are delighted to have Dr. Rangwala join our team at this transformative point in our Company’s evolution," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Her extensive experience developing and executing clinical strategies for novel oncology therapeutics, as well as engaging regulators and the medical community at all stages of development, will be of immeasurable value as we accelerate our four core programs in clinical development."

"I am thrilled to join the Karyopharm team at this exciting and pivotal time in the company’s growth," said Dr. Rangwala. "Given their unique mechanism of action, both XPOVIO (selinexor) and eltanexor have significant potential for patients battling an array of cancer types and I look forward to leading the future clinical development and advancing both assets through the clinic. I am impressed with both the team and the science of XPO1 inhibition and I am excited to realize the potential of these important therapies."

Dr. Rangwala brings to Karyopharm more than a decade of experience in oncology and drug development. She was most recently the Chief Medical Officer at Aravive where she led the clinical development of batiraxcept across multiple tumor types. Prior to Aravive, she served as Vice President, Medical, at Genmab where she led the clinical development program for a first-in-class antibody drug conjugate and managed clinical strategy, protocol development, data monitoring, data analysis, study report authoring, and biologic licensing application preparations. Prior to Genmab, she served as Executive Clinical Director at Merck & Co., where she was involved in the clinical development of KEYTRUDA in non-small cell lung cancer and gynecologic malignancies. She received her B.S. in Biology from Duke University and her M.D./Ph.D. from the University of Cincinnati College of Medicine. Dr. Rangwala completed her internal medicine residency at Barnes Jewish Hospital in St. Louis, MO and her medical oncology fellowship at the Hospital of the University of Pennsylvania.

Further Transition of Co-Founders

Karyopharm also announced today that co-founders Sharon Shacham, PhD, MBA, and Michael Kauffman, MD, PhD will step down from their respective roles as Chief Scientific Officer and Senior Clinical Advisor as of May 31, 2022. Dr. Kauffman has stepped down from his role as a member of the Board of Directors. Dr. Shacham will continue to serve on Karyopharm’s Scientific Advisory Board and will serve in an advisory capacity.

"Through their unwavering dedication and passion, Drs. Shacham and Kauffman built Karyopharm from the ground up, bringing hope to countless cancer patients and their families. It has been an honor to work alongside them, and I’m truly grateful for their partnership over the last year. This executive transition has allowed us to glean as much knowledge and insight from our founders as possible, while also bolstering our leadership team in clinical and program management. We believe that we are well positioned for future success, with a promising and focused pipeline of assets as well as a strong commercial strategy," concluded Mr. Paulson.

"I want to thank all of my colleagues at Karyopharm for their partnership over the years as we built the XPOVIO and eltanexor franchises and advanced our development programs targeting both hematologic and solid tumor malignancies," said Dr. Shacham. "I’m confident the team will continue to achieve its objectives and deliver value to investors, healthcare providers and most importantly, to patients."

"It has been a pleasure working alongside the management team at Karyopharm as we grew the hypothesis about nuclear export and its role in cancer from an idea into a robust commercial enterprise with several programs in development that have significant potential for patients," said Dr. Kauffman. "As the Company enters this next stage of its evolution and growth, I believe Karyopharm is well-positioned to deliver on its mission to bring differentiated medicines to patients battling cancer."

On March 29, 2022 Keen Eye, a leading AI company in digital pathology for clinical research and Ultivue, Inc. an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, reported a collaborative agreement to promote multiplexed immunofluorescence (mIF) assays and scalable AI applications to unlock spatial analysis in clinical research (Press release, Ultivue, MAR 29, 2022, View Source [SID1234611142]).

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Ultivue develops unique solutions for use in mIF applications, imaging and spatial phenomics. Its proprietary InSituPlex technology enabling improved signal to noise data is designed for fast and comprehensive exploration of biologically relevant targets, up to 12-plex, with same slide-H&E analysis in tissue samples. This technology combines the power of computational pathology & spatial biology to guide translational science in immuno-oncology.

Ultivue recognizes the need for dedicated and custom AI models to analyze the complexity of mIF data at scale and to provide improved turn-around times and consistent readouts across large cohorts "We are looking forward to accelerating data generation for biopharma customers from mIF kits by partnering with Keen Eye. We can jointly support more scalable workflows which will allow us to meet increasing demand in clinical trials." said Florian Leiss, Ph.D. Vice President Digital Health Strategies at Ultivue.

Keen Eye is an AI Platform company dedicated to deliver accurate, standardized, and undiscovered tissue insights in research and clinical development using Deep Learning histopathology digital image analysis. Its proprietary models dedicated for spatial exploration of tumor microenvironment give access to reliable tissue segmentation, biomarker quantification, cell population profiling, and morphological discovery.

Thanks to Ultivue’s pre-optimized assays, the high accuracy achieved for every biomarker will drastically reduce errors during quantification steps as phenotypes combine several biomarkers. As Dr. Sylvain Berlemont, Keen Eye’s founder and CEO says, "We are thrilled to expand our application portfolio combined with best-in-class Ultivue mIF assays to biopharma companies and CROs. This partnership will undeniably support our customers to fully extend reproducibility and scalability throughout their clinical research.".

On March 29, 2022 Biosion, Inc., a global R&D stage biotechnology company, reported that Biosion and Pyxis Oncology (NASDAQ: PYXS) have entered into an agreement under which Pyxis Oncology will be granted an exclusive license to develop and commercialize Biosion’s anti-Siglec-15 monoclonal antibody, BSI-060T (now referred to as PYX-106), world-wide, excluding Greater China (Press release, Biosion, MAR 29, 2022, View Source [SID1234611327]). Under the terms of the agreement, Biosion will receive a $10 million up-front license fee from Pyxis Oncology. In addition to the up-front payment, Biosion has the potential to receive significant milestone payments for PYX-106, totaling up to $222.5 million and single to low double-digit royalties on commercial sales. Pyxis Oncology plans on submitting the IND for PYX-106 to the FDA by the second half of 2022 and initiating a Phase 1 trial shortly thereafter. Under the agreement, Pyxis Oncology has the opportunity to license additional preclinical assets that target anti-Siglec-15 using other approaches to treatment.

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"The anti-Siglec 15 monoclonal antibody, PYX-106, is an exciting addition to the Pyxis Oncology pipeline," said Jay Feingold, MD, PhD, Chief Medical Officer of Pyxis Oncology. "I believe this potential best-in-class program will address high unmet medical need in a variety of solid tumors including non-small cell lung cancer and head and neck cancer. As an oncologist, my passion has been advancing potential breakthrough medicines to treat patients with difficult-to-treat cancers who have little hope in the advanced and progressive setting."

Biosion continues to deliver breakthrough therapies to address unmet medical needs of patients worldwide. To accelerate the global development of its innovative pipeline, Biosion is expanding worldwide partnerships with leading biotech companies. "The licensing of our anti-Siglec-15 mAb to Pyxis Oncology for global development demonstrates the strength of our discovery engine to generate antibody-based therapeutics with superior properties," said Mingjiu Chen, Ph.D., Chief Executive Officer and founder of Biosion. Dr. Chen continued "Data from anti-Siglec-15 preclinical studies show that BSI-060T has high affinity, high cell binding and activity, dose-proportional activity on reducing immunosuppression of Siglec-15 on T cells and long half-life that will allow BSI-060T to become a best-in-class mAb in the treatment of solid tumors."

On March 29, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Tempest Therapeutics, MAR 29, 2022, View Source [SID1234611109]).

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"We are excited by the numerous achievements the Tempest team made in 2021, including emerging as a public company from a competitive merger process and establishing the collaboration with Roche that moved TPST-1120 into a first-line global, randomized HCC study," said Stephen R. Brady, chief executive officer of Tempest. "This and the broader progress made in the pipeline positions Tempest for a potentially transformative 2022. Our first clinical data presentation planned for ASCO (Free ASCO Whitepaper) in June is the first in a series of planned data releases over the course of the next 12-18 months, including initial ORR data from both our ongoing randomized TPST-1120 study with our partner Roche and the first monotherapy and combination therapy data from TPST-1495, our dual EP2/EP4 antagonist. We are excited about this ongoing positive evolution of Tempest, and we will continue to work to develop what we believe to be is a robust and diversified pipeline of novel cancer programs with the potential to treat a wide range of patients."

1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed Phase 1 monotherapy arm and nearing completion of the anti-PD-1 checkpoint inhibitor, nivolumab, combination dose escalation arms, and selected recommended Phase 2 dose ("RP2D"); and (ii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating monotherapy dose and schedule optimization towards establishing an RP2D; and (ii) commenced enrollment of a study evaluating combination dose and schedule optimization study with the anti-PD-1 checkpoint inhibitor, pembrolizumab.
SITC Presentation: at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, presented new preclinical efficacy data demonstrating that dual inhibition pf the EP2 and EP4 receptors with TPST-1495 is an optimal approach for targeting the prostaglandin pathway in cancer.
Expansion of Patent Portfolio: the U.S. Patent and Trademark Office issued patents covering composition of matter for our therapeutic product candidate TPST-1495.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) if accepted to present, presentation of Phase 1 monotherapy and combination data at ASCO (Free ASCO Whitepaper) 2022; and (ii) reporting of objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; and (ii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): (i) presentation of the first data demonstrating therapeutic benefit in tumor-bearing mice treated with systemically-administered proprietary targeted molecules at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) planned selection of development candidate in the second half of 2022.
Financial Results

Year End 2021

Tempest ended the year 2021 with $51.8 million in cash and cash equivalents, compared to $18.8 million at December 31, 2020. The increase was primarily due to the merger and concurrent PIPE financing, which closed in June 2021.
Net cash used in operations for the year ended December 31, 2021 was $26.0 million.
Net loss and net loss per share for the year ended December 31, 2021 were $28.3 million and $7.47, respectively, compared to $19.2 million and $41.03, respectively, for the same period in 2020.
Research and development expenses for the year ended December 31, 2021 were $17.2 million compared to $14.4 million for the same period in 2020. The $2.8 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the year ended December 31, 2021, general and administrative expenses were $9.8 million compared to $4.9 million for the same period in 2020. The increase of $4.9 million was primarily due to increased fees for audit and tax services and compensation expenses.
Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second half of 2023.

On March 29, 2022 Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2021 and highlighted recent progress and upcoming milestones (Press release, Alphamab, MAR 29, 2022, View Source [SID1234611143]).

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Highlights

First product launch: In November 2021, KN035 (Envafolimab) has received marketing authorization from the Chinese National Medical Products Administration (NMPA), becoming the world’s first and currently only subcutaneously injected PD-L1 antibody approved for marketing.
First year of commercialization: We recorded total revenue of RMB146.0 million yuan for the year ended December 31, 2021, of which RMB11.62 million yuan of revenue from the shipment of Envafolimab, RMB134 million yuan of revenue from KN026.
Rapid advancement of pivotal clinical trials: Several pivotal clinical studies of KN046 are ongoing, including squamous non-small cell lung cancer, PD-(L)1 refractory NSCLC, pancreatic cancer, thymic carcinoma, etc. BLA is expected to be submitted in 2022.
Exploring cornerstone therapies in the post-PD-(L)1 era: 10 clinical data of KN046 presented, continuing to explore major indications, PD-(L)1 refractory and PD-(L)1 inadequate response tumors; KN046 in combination with KN026 is expected to offer a chemotherapy-free solution.
Build a core commercialization team: In 2021, the company established a core commercialization team to accelerate the commercialization of KN046 and subsequent blockbuster products.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "2021 is the first year of the company’s commercialization. Envafolimab is the first domestic PD-L1 antibody approved for marketing in China and the world’s only subcutaneously administered PD-L1 antibody. KN046 has demonstrated excellent efficacy and potential for benefit in treating PD-(L)1 refractory and PD-(L)1 inadequate response tumors, etc. The BLA of KN046 insquamous NSCLC will be submitted soon. The pivotal phase III trials of KN046 in pancreatic cancer and PD-(L)1 refractory NSCLC have been initiated. A pivotal clinical trial of KN026, an anti-HER2 bispecific antibody, combined with chemotherapy as second-line treatment for gastric cancer has been initiated, and trials in the 1st-line and perioperative setting are under way. Data from the phase II study of KN026 combined with KN046 pave the way for further exploring chemotherapy-free regimens for HER2-positive solid tumors.

In 2021, the company has also made significant progress in our innovative R&D platform and product pipeline. We expect the innovative mechanism and preclinical efficacy of KN052 and JSKN-003 to be validated in clinical studies in 2022. Unmet medical needs, differentiation and global edge are the principles we have always adhered to.

The MRCT pivotal trial of KN046 in thymic carcinoma demonstrated our ability and confidence to develop innovative drugs to meet global health needs. Through cooperation with Pfizer, CSPC and other partners, we hope to accelerate the research and development of our candidates, and to benefit oncology patients worldwide as soon as possible.

Through the launch of Envafolimab, the company’s GMP has been fully validated. We will further expand our production capacity, improve our system, and expand our commercialization capability to lay a solid foundation for the launch of KN046 and subsequent new drugs. With 2021 already behind, we look forward a more exciting and rewarding 2022. Alphamab Oncology will stick to its vision and mission and develop steadily. We are working for more effective cancer medicines and will generate great returns for our long term shareholders.

BUSINESS HIGHLIGHTS

Since April 20, 2021, being the latest practicable date of the Company’s 2020 annual report, we have been making significant progress with respect to our product pipeline and business operations.

Product Pipeline

Our highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Our differentiated tumor product pipeline includes one approved for marketing by the NMPA, three in late clinical stage, and two that have received IND approval or ready for IND submission.

KN046

KN046 has completed phase I clinical trials in Australia and has simultaneously been under a phase II clinical trial in the U.S. Currently, four pivotal clinical trials of KN046 in China have been launched, including two pivotal clinical trials in NSCLC, one pivotal phase III clinical trial in PDAC and one pivotal trial in thymic carcinoma. There are approximately 20 clinical trials around the world covering more than 10 types of tumors including NSCLC, triple-negative breast cancer, ESCC and thymic carcinoma. The results of these clinical trials have demonstrated a preliminary profile of good safety and promising efficacy of KN046.

Events during the Reporting Period

In April 2021, we entered into a clinical trial collaboration and supply agreement with Pfizer Inc. to evaluate the efficacy and safety of KN046 in combination with Inlyta (axitinib), for the first-line treatment of NSCLC.
We achieved positive results of KN046 with respect to its preliminary efficacy and safety in combination with nab-paclitaxel and gemcitabine as first-line treatment for unresectable locally advanced or metastatic PDAC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We achieved promising preliminary results in a phase II, open-label and multi-center study of KN046 in combination with chemotherapy in patients with advanced NSCLC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the efficacy and safety results of KN046 plus paclitaxel/ cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic ESCC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the preliminary efficacy and safety results of a prospective phase II trial of KN046 in combination with Lenvatinib in the first-line treatment for advanced unresectable or metastatic HCC. Such research progress was presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We obtained research results of a phase II, open-label and multi-center clinical trial of KN046 in combination with platinum doublet chemotherapy as first-line treatment for advanced NSCLC harboring resistant oncogenic driver alterations. Such research results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
In September 2021, we received an IND approval for KN046 from the NMPA for initiating a multi-center, open-label and randomized-controlled phase II/ III pivotal clinical study (ENREACH-LUNG-02/KN046-302) to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted PD-(L)1 treatment.
We achieved significant efficacy and safety results of KN046 in combination with nab-paclitaxel/gemcitabine in the first-line treatment of locally advanced unresectable or metastatic PDAC. Such results were presented at the 2021 CSCO Annual Meeting.
In September 2021, the Company entered into a partnership agreement with Hangzhou Raygene Pharmaceutical Co., Ltd. to jointly develop the combination therapy of KN046 and RG001, a proprietary anti-tumor small molecule drug, for the posterior line treatment for advanced HCC and liver metastasis colorectal cancer.
In October 2021, a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC, completed the enrollment of 482 patients.
In October 2021, the first patient was successfully dosed in a multi-center, open-label and randomized-controlled phase II/III pivotal clinical trial of KN046 in Mainland China, which aims to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted anti-PD-(L)1 treatment.
In November 2021, the first patient was successfully dosed in a clinical trial of KN046 in combination with ALK-1 (activin receptor-like kinase-1) antibody developed by Kintor Pharmaceutical Limited, for the treatment of advanced or refractory solid tumors.
In November 2021, the Company entered into a collaboration agreement with Guangzhou MaxiNovel Pharmaceuticals Co., Ltd., for joint clinical cooperation of MAX-40279, a multi-target tyrosine kinase inhibitor independently developed by MaxiNovel, in combination with KN046 for the treatment of gastric cancer and other indications as agreed by both parties.
In November 2021, the Company received an IND approval for KN046 from the NMPA for initiating a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/ gemcitabine in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In December 2021, the first patient was successfully dosed in the U.S. in an open-label and multi-center phase II pivotal clinical trial of KN046 to evaluate efficacy, safety and tolerability of KN046 in subjects with advanced thymic carcinoma.
Events after the Reporting Period and expected milestones for 2022

In February 2022, the first patient was successfully dosed in a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/gemcitabine versus placebo in combination with nab-paclitaxel/gemcitabine, in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase II clinical trial to evaluate the efficacy, safety, tolerability of KN046 in combination with Inlyta (axitinib) in the treatment of advanced NSCLC.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase I/II clinical trial of KN046 in combination with MAX-40279, for the treatment of advanced or metastatic solid tumors.
KN046+chemo,1L sq-NSCLC: Complete the interim analysis and arrange for the BLA application as planned by mid-2022.
KN046+chemo,1L pancreatic cancer: Enroll in the majority of subjects for Phase III clinical trials.
KN046+Lenvatinib,1L HCC: Plan to start pivotal trial in 2022H2.
KN026

Events during the Reporting Period

We made advancement in evaluating the preliminary efficacy of KN026 for the treatment of HER2 expression in patients with advanced GC or GEJ. Such results were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
In August 2021, the first patient was successfully dosed in a phase II clinical trial of KN026 for the neoadjuvant treatment of HER2 positive early or locally breast cancer.
In August 2021, the Company received a notice of approval from the NMPA for the supplementary application for a pharmaceutical change of KN026 for clinical use, which allows KN026 liquid formulation to be used in clinical research. This is the first HER2 bispecific antibody in liquid formulation approved for conducting clinical research in China.
In August 2021, Jiangsu Alphamab Biopharmaceuticals Co., Ltd., the principal operating subsidiary wholly owned by the Company, entered into a licensing agreement with Shanhai JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited ("CSPC"), to develop and commercialize KN026 for the treatment of breast cancer and GC in Mainland China.
We made advancement in evaluating the preliminary efficacy and safety results of KN026 in combination with KN046 in patients with HER2-positive GI tumors. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We made progress in obtaining the preliminary safety and efficacy results of a phase II clinical trial of KN026 in combination with KN046 in patients with metastatic HER2-positive breast cancer. Such research progress was presented at the SABCS 2021.
We made progress in a phase I clinical trial of KN026 for the treatment of patients with HER2-positive metastatic breast cancer. Such research progress was presented at the SABCS 2021.
Events after the Reporting Period and expected milestones for 2022

In January 2022, the Company received an IND approval from the NMPA for initiating a randomized and multi-center phase II/III clinical trial of KN026 to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive GC (including GEJ) who have failed first-line treatment.
In January 2022, the phase II clinical trial of KN026 combined with KN046 in the treatment of HER2-positive solid tumors, successfully completed patient enrollment. The interim analysis is expected to be conducted in the second quarter of 2022.
In February 2022, data from a phase I clinical study of the KN026 for the treatment of HER2-positive metastatic breast cancer were published in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In March 2022, the preliminary results of phase II clinical trial of KN026 in combination with KN046 for the treatment of locally advanced unresectable or metastatic HER2-positive solid cancer were accepted for e-poster presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting.
KN046+KN026, Chemo-free, HER2+1L GC: Start the pivotal trial in 2022Q2.
KN035 (Envafolimab)

Events during the Reporting Period

In June 2021, the study design of the ENVASARC pivotal trial conducted in the U.S. for KN035 was presented by TRACON in a poster session at the 2021 ASCO (Free ASCO Whitepaper) annual meeting.
In June 2021, the U.S. FDA has granted orphan drug designation (ODD) to KN035 for the treatment of patients with soft tissue sarcoma. This is the second ODD for KN035 after the first ODD in advanced biliary track cancer and the fourth ODD that we obtained from the FDA.
In September 2021, we obtained an IND approval from the NMPA for KN035 in combination of Lenvatinib for the treatment of patients who have failed or are intolerant of platinum containing chemotherapy and are not suitable for radical treatment with locally advanced metastatic or recurrent non-microsatellite instability-high phenotype/non-DNA deficient mismatch repair endometrial cancer.
In November 2021, we obtained formal conditional approval from the NMPA for marketing KN035 (Envafolimab). The approval is for the treatment of MSI-H or dMMR advanced solid tumors.
In December 2021, the Company, 3D Medicines and Simcere, jointly announced that the first batch of prescriptions for KN035 (Envafolimab), the world’s first subcutaneously injected PD-L1 antibody, has been implemented across China.
KN019

The phase II clinical trial of KN019 for the treatment of rheumatoid arthritis completed the patient enrollment. The final analysis of clinical results is expected to be completed in the first half of 2022.
In 2021, we initiated a clinical study on the bioavailability of KN019 in the switch from intravenous infusion to subcutaneous administration.
KN052

In February 2022, the Company received an IND approval for KN052 from the NMPA for initiating a phase Ia/Ib clinical trial to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and antineoplastic activity of KN052 in the treatment of advanced solid tumors.
JSKN-003

The Company completed the efficacy validation and process development for JSKN-003 in June 2021 and targets to submit IND application in the second quarter of 2022.
Manufacturing Facilities

The facility of Jiangsu Alphamab is designed to house over 40,000L production capacity in total. We obtained a drug production license for the phase I-(1) of our new manufacturing facilities from Jiangsu Drug Administration, on July 6, 2020. Phase I-(2), including product workshop, pilot plant and R&D center, is under construction and expected to be put into operation in the first half of 2022; Phase I-(3) of our new manufacturing facilities has started construction.

Other Highlights

In May 2021, Jiangsu Alphamab entered into a collaboration agreement with Suzhou Alphamab Co., Ltd. for two technology development projects, namely, JSKN003 and the preparation process development project for mGalt1, a key material of conjugation process, and KN062 COVID-19 neutralizing bispecific antibody development project.
In December 2021, the Company was listed as one of the 2021 Top 100 Chinese Pharmaceutical Innovative Enterprise. The Company has been acknowledged as such for the third consecutive year.
In January 2022, the Company was awarded "The Most Valuable Pharmaceutical and Medical Company" award at the Sixth Golden Hong Kong Stocks Awards ceremony.
Financial Summary

For the year ended December 31, 2021，we recorded total revenue of RMB146.0 million. The Group mainly generates revenue from (i) sales of pharmaceutical product; (ii) royalty income; (iii) license fee income; and (iv) goods or consumables for R&D projects.
For the year ended December 31, 2021, the Group’s other income decreased by RMB64.1 million to RMB47.0 million, as compared to RMB111.1 million for the year ended December 31, 2020.
For the year ended December 31, 2021, our R&D expenses increased by RMB150.2 million to RMB481.4 million, compared to RMB331.2 million for the year ended December 31, 2020, primarily due to (i) the increase in the number of ongoing clinical trials; (ii) the expansion of the scale of our clinical studies; (iii) the advancement of clinical trials of our drug candidates; and (iv) the increase in staff cost due to the increase in our R&D staff.