On August 23, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration has approved a Phase II study of selinexor (XPOVIO) for the treatment of patients with myelofibrosis (MF) (Press release, Antengene, AUG 23, 2021, View Source [SID1234586822]).

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MF is a clonal bone narrow neoplasm which can emerge either as primary MF (PMF), polycythemia vera (PV) or essential thrombocythemia (ET). The disease is primarily characterized by fibrosis in the bone marrow, extramedullary hematopoiesis, anemia, splenomegaly, constitutional symptoms, and possible progression to leukemia that would shorten patients’ survival. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is currently the only curative treatment for MF. However, such treatment is commonly associated with a high rate of complications and treatment-related deaths. According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of MF, patients with intermediate-2 or high-risk MF ineligible for allo-HSCT and with a platelet count of ≥50×109/L should be treated with JAK inhibitors ruxolitinib or fedratinib (2020 NCCN Guidelines). Due to the poor prognosis of patients who have failed or developed resistance to these targeted therapies, MF still represents an urgent unmet medical need.

This randomized, open-label, global multicenter Phase II study will be conducted at 15 centers across China, including the primary trial center the First Affiliated Hospital Soochow University, and enroll approximately 20 patients in total. The study is designed to evaluate the safety and efficacy of selinexor versus physician’s choice (PC) in patients with MF who had received at least six months of treatment with a JAK1/2 inhibitor. Enrolled patients will be randomized in a 1:1 ratio into one of the two treatment arms, to receive either single agent selinexor or PC treatment. The primary endpoint of the study is the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35), as assessed by the independent radiographic review committee (IRC).

Prof. Depei Wu, Director of Hematology Department at the First Affiliated Hospital Soochow University, and the principal investigator of the study, noted: "MF is a relatively rare form of proliferative neoplasm in the bone narrow that has long lacked effective treatment options before the emergence of targeted therapies. Allo-HSCT is currently the only curative treatment for patients with MF, yet not all patients with MF are eligible to or tolerant of the treatment. Although ruxolitinib has already been approved in China for the treatment of MF, patients who have failed on or developed resistance to the therapy still have very limited treatment options. This randomized, open-label, global multicenter Phase II study is designed to assess the safety and efficacy of selinexor versus physician’s choice (PC) in patients with MF who had received at least six months of treatment with a JAK1/2 inhibitor. We are very hopeful that this study will provide additional evidence supporting the exploration of effective treatments for MF and ultimately provide a new treatment option to patients with MF in China."

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "The NMPA’s approval for this clinical trial of selinexor in patients with MF marks another major milestone in our effort in developing selinexor in a broad range of diseases, and a big step towards expanding potential indications for this candidate drug. We are confident that selinexor will demonstrate its clinical utility in the treatment of MF as we progress with this clinical development program. We look forward to advancing this study under the oversight of the NMPA, and aim to achieve a clinical breakthrough for patients with MF in China."

About Selinexor (XPOVIO)

Selinexor is a first-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), Selinexor is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, Korea, Australia, New Zealand and the ASEAN countries, and already obtained an NDA approval in South Korea through a priority review process.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (RR DLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or RR DLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting multiple clinical trials of selinexor for the treatment of MM, DLBCL, endometrial cancer, and peripheral T and NK/T-cell lymphoma, and five of these trials are at late-stages (Phase II/III).

On August 23, 2021 China Medical System Holdings Limited reported that 2021 Interim Results Announcement (Press release, China Medical System, AUG 23, 2021, View Source [SID1234586821])

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Performance Highlights

Maintained Good Business Growth: Turnover increased by 23.6% to RMB3,843.0 million; in the case that all medicines were directly sold by the Group, turnover increased by 28.7% to RMB4,269.3 million; profit for the period increased by 25.5% to RMB1,631.6 million.
Initiated the Industrial Investment in Chinese Biotech: Capitalized on strong capabilities on clinical execution, commercialization and capital strength to empower the clinical development and commercialization of domestic innovative products; made equity investment in Trinomab, would establish a joint venture, and added two natural fully human antibody drugs into the pipeline.
Upgraded the Innovative Pipeline: Deployed more than 20 innovative products, among which 9 products had been approved for marketing in the U.S./Europe, and 4 had completed or were under registration clinical trials in China. The harvest of innovation is coming.
The Professional Dermatology and Medical Aesthetic Business System Has Taken Shape: Acquired the dermatology and medical aesthetic specialty company Luqa to enrich the dermatological product portfolio and extend its reach to the medical aesthetic field; acquired Carnation, entered into collaboration with EC Healthcare and Shandong Chuangxin successively, to constantly expand the dermatology and medical aesthetic business layout.
Expanded and Optimized the Healthcare Business: Flagship stores have been launched on three mainstream cross-border e-commerce platforms, namely JD Worldwide, Youzan Mall and Tmall International. A total of 88 quality products from 14 well-known European and American brands have been put on the stores.
HONG KONG, Aug. 23, 2021 /PRNewswire/ — China Medical System Holdings Limited ("CMS", or the "Company", SEHK: 867), together with its subsidiaries (the "Group"), a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China, announced its unaudited results for the 6 months ended 30 June 2021 (the "Reporting Period").

In the first half of 2021, the Group had a turnover of RMB3,843.0 million (H1 2020: RMB3,108.1 million), an increase of 23.6% over the same period last year; in the case that all medicines were directly sold by the Group, turnover increased by 28.7% to RMB4,269.3 million (H1 2020: RMB3,316.6 million). Profit for the period recorded an increase of 25.5% to RMB1,631.6 million (H1 2020: RMB1,300.5 million). Declared interim dividend was RMB0.2641 per share.

Mr. Lam Kong, Chairman and Chief Executive of CMS, said "In the first half of 2021, CMS achieved sound business growth under the synergy of positive brand images of its products, the professional academic promotion, and the compliant, efficient and refined management. With the rich experience in international development and academic promotion network resources in multiple therapeutic fields, the Group achieved in-depth development in the pharmaceutical business, while constantly expanding its business boundaries and rapidly promoting the development of the dermatology and medical aesthetic business as well as the healthcare business. At the same time, the Group actively explored on innovation and change, and initiated a new model of industrial investment in Chinese Biotech, injecting new momentum for the sustainable development of the Group, building a more proactive and promising "New CMS"."

Initiating the Industrial Investment in Chinese Biotech
Since the second half of 2017, the Group has been investing and deploying overseas innovative products in relatively mature stages due to the fact that overseas biotechnologies have outpaced China’s for many years, so as to shorten the gap between the launching time of innovative medicines at home and abroad, and improve the accessibility of Chinese patients to innovative medicines with real clinical needs. However, in recent years, under the leadership of top scientists, Chinese Biotech have continuously made breakthroughs in innovative biotechnologies via leveraging their talent advantages, flexible R&D strategies, favorable policies and capital supports. Meanwhile, their innovative products that were once in early R&D stage have gradually moved into the commercialization stage. For focusing on their own strengths and improving the efficiency of pharmaceutical industry development, an international mainstream industry ecosystem will be formed in China’s pharmaceutical industry that biotech companies will be responsible for innovation, while big pharmaceutical companies responsible for commercialization. The trend for the Group to become an incubation platform of innovative product for Chinese Biotech has emerged. Following the trend, during the Reporting Period, the Group capitalized on its previous accumulated advantages, such as efficient clinical execution, commercialization capability and capital strength, to initiate the industrial investment in Chinese Biotech, in order to empower the rapid launching of the innovative products in China.

In April 2021, the Group announced that it would make equity investment in and establish a joint venture with Trinomab Biotech Co., Ltd ("Trinomab"). Trinomab will be responsible for drug discovery and preclinical studies, while the Group responsible for clinical development, registration, and commercialization, etc. This collaboration initiated a new model for the Group’s industrial investment in Chinese Biotech.

Innovative Pipeline
The Group will continue to empower the clinical development and commercialization of innovative medicines in China through industrial investment in Chinese Biotech, equity investment in Overseas Biotech, and strategic collaboration with Global Biopharma.

In the first half of 2021, the Group’s innovative pipeline continued to expand. The Group successively reached cooperation with Trinomab on the innovative products developed through its fourth-generation antibody technology platform HitmAb, the Fully Human Anti-SA Hlα Antibody (a natural fully human antibody drug with Hlα neutralizing activity) and Fully Human Anti-HCMV Antibody (a natural fully human antibody drug with HCMV neutralizing activity). Meanwhile, the clinical development of innovative products was accelerated in China. By now, the New Drug Application of 1 blockbuster product (Diazepam Nasal Spray) has been accepted, the bridging trial of 1 blockbuster product (Tildrakizumab Solution for Injection) has met the primary endpoint, and the bridging trials of 4 blockbuster products (Cyclosporine Eye Drops 0.09% and Desidustat Tablets, Methylthioninium Chloride Enteric-coated Sustained-release Tablets, and Methotrexate Injection, Pre-filled Syringe) have been actively moved forward.

Pipeline – Launched Overseas or Under Marketing Application Review

* In July 2021, the New Medicine Application of Diazepam Nasal Spray was accepted by NMPA in China.
** In August 2021, the clinical trial application of Methylthioninium Chloride Enteric-coated Sustained-release Tablets was approved by NMPA in China.
*** In August 2021, the clinical trial application of Methotrexate Injection, Pre-filled Syringe was approved by NMPA in China.

Pipeline – Under Clinical Stages

Dermatology and Medical Aesthetic Business
The Group has been deeply engaged in the dermatology field for many years, and established rich promotion network resources, including the dermatologists and the hospital and retail channel resources. In order to fully utilize the existing advantageous resources and improve the operation efficiency in the dermatology field, the Group split the dermatology line (including the products and teams) for independent operation, so as to achieve comprehensive diseases management in the dermatology field while further expanding its business boundary to the field of medical aesthetics.

During the Reporting Period, the Group acquired Luqa Ventures Co., Limited ("Luqa"), a dermatology and medical aesthetic specialty company, to enrich the dermatological product portfolio and enter the medical aesthetic field that is featured with consumption attributes. The Group acquired Shanghai Carnation Medical Technology Co., Ltd. ("Carnation"), a R&D and manufacturing platform company of medical aesthetic devices with focused ultrasound technology, and obtained FUBA5200 Focused Ultrasound Body Contouring System, which is a non-invasive body shaping and fat reduction device using focused ultrasound technology with independent intellectual property rights. As a R&D platform for energy-based medical aesthetic devices, Carnation will continually provide cutting-edge medical aesthetic devices with focused ultrasound technology for the Group. The Group entered into a strategic collaboration memorandum with EC Healthcare, the largest non-hospital medical service provider in Hong Kong, and both sides would explore to set up a medical aesthetic training and education platform for registered medical aesthetic practitioners in China. The Group entrusted Shandong Chuangxin Pharmaceutical Research and Development Co., LTD. ("Shandong Chuangxin") for development of dermatology and medical aesthetic products, so as to promote the in-depth deployment in the dermatology and medical aesthetic field. As at 30 June 2021, the dermatology and medical aesthetic business system of the Group has been gradually enhanced, and "CMS Aesthetics", a professional dermatology and medical aesthetic company, has taken shape.

Healthcare Business
The Group continued to stringently select functional and quality healthcare products with unique ingredients globally according to medical concept and high standards, via leveraging its strengths accumulated over years, including overseas channel resources, mature product evaluation system and efficient global supply chain system. While continuously launching new products, the Group also created a number trending products. As at 30 June 2021, the Group has collaborated with 14 well-known European and American brands on more than a hundred of products, 88 of which have been launched in "CMS Health Overseas Flagship Store" or "CMS Overseas Flagship Store" on the three mainstream cross-border e-commerce platforms, JD Worldwide, Youzan Mall and Tmall International. At the same time, the Group actively explored the new retailing business mode for the healthcare products, to capitalize on the professional client resources in its promotion channels to provide professional guidance and services to consumers, to help consumers understand and cope with sub-health, and to create better consumer experience, providing consumers with healthy lives.

Commercialization System
The Group has a comprehensive commercialization system and possesses of proven successful experience in sales and promotion, having created professional brand images and good sales records for a number of branded original medicines and exclusive medicines. As a number of the Group’s innovative products are about to enter the commercialization stage, the value of its commercialization platform will be further released.

During the Reporting Period, the Group continued to explore and refine the products’ academic differentiation advantages, and organized and participated in online and offline academic conferences, to deepen the brand building. The Group also actively expanded and optimized the academic promotion network. At the same time, the Group deepened the retail market deployment and increased investment in e-commerce channels to better prepare for the prescription outflow. For medical aesthetic products and dermatology grade skincare products with stronger consumption attributes, the Group actively utilized its mature dermatologist resources as well as academic platforms to analyze the academic value and efficacy of products, built brands influence via new media marketing, and directed customer traffic through online and offline channels to facilitate the rapid growth of sales volume. In addition, the Group also strengthened construction of the compliance system as well as the professional teams, and enhanced the refined team management to facilitate the efficient implementation of marketing strategies.

As at 30 June 2021, the Group’s commercialization network covered about 57,000 hospitals and medical institutions, and more than 200 thousand drugstores nationwide.

Marketed Products
The Group’s marketed products recorded good growth. The marketed products mainly involve products under the cardio-cerebrovascular line (mainly include Plendil, XinHuoSu and Deanxit), digestion line (mainly include Ursofalk, Salofalk, Bioflor and Combizym), ophthalmology line (mainly include Augentropfen Stulln Mono Eye Drops) and dermatology line (mainly include Hirudoid). During the Reporting Period, the products under cardio-cerebrovascular line recorded a revenue of RMB1,789.0 million, an increase of 23.2% compared with the same period last year. In the case that all medicines were directly sold by the Group, the revenue of products under cardio-cerebrovascular line would increase by 29.9% to RMB2,321.1 million compared with the same period last year; the revenue of products under digestion line increased by 25.7% to RMB1,455.2 million compared with the same period last year; the revenue of the product under ophthalmology line increased by 45.9% to RMB166.0 million; the revenue of the product under dermatology line increased by 54.4% to RMB131.6 million.

In addition to the above products, the Group’s major marketed products also included products from the dermatology and medical aesthetic business, such as the prescription medical aesthetic product Aethoxysklerol (the international brand for the treatment of sclerotherapy of varicose veins with years of clinical application); the medical aesthetic products Stratamark (clinically proven topical silicone gel with efficacy and safety to prevent and treat stretch mark), Strataderm (an effective silicone gel indicated for prevention of hyperplasia and improvement of new and old scars for a wide population), Mesoestetic-Mesohyal Series (matching therapies to provide customized medical aesthetic solutions), and Neauvia Hyaluronic Acid Series (based on the cross linker technology SMART and having excellent rheology, high biocompatibility and good integrity); the dermatology grade skincare products Atopic Piel Series (a combination of washing and moisturizing to repair the damaged skin barrier and effectively relieve itching of sensitive skin).

Mr. Lam Kong concluded, "In the future, the Group will continue to invest in quality products of all business segments, improve the commercialization capability and the refined management system, and fully synergize different business segments, to promote the synchronous development of three businesses segments, including the pharmaceutical business, the dermatology and medical aesthetic business, as well as the healthcare business, and to accelerate the enterprise value growth. Meanwhile, the Group will consolidate its strengths to further enhance the abilities in project planning, clinical execution, commercialization, and capital strength, etc., so as to build a professional and efficient incubation platform of innovative medicines for global biotech companies, facilitating more domestic innovative products to produce world-class impacts, and contributing to the Healthy China construction."

On August 23, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the closing of its previously announced registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) at an effective purchase price of $5.00 per share for gross proceeds of approximately $70 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, PharmaCyte Biotech, AUG 23, 2021, View Source [SID1234586820]). In a concurrent private placement, PharmaCyte also issued to the investors in the offering unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock.

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Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company will be 18,979,465 and the Company will have approximately $90 million in cash in its bank account.

H.C. Wainwright acted as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $5.00 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The Company intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to fully fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, (iii) to continue clinical development of the Company’s cancer program, (iv) to continue development of the Company’s diabetes program, (v) to continue development of the Company’s malignant ascites program and (iv) for general corporate purposes.

The shares of common stock (and common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021, and an additional registration statement on Form S-3 filed on August 19, 2021, pursuant to Rule 462(b), which became effective automatically upon filing. The offering of the shares of common stock (or common stock equivalents) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and the accompanying base prospectus relating to the shares of common stock (or common stock equivalents) being offered in the registered direct offering have been filed with the SEC and are available on the SEC’s website at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended ("Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On August 23, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported recent business progress and second quarter 2021 financial results (Press release, TransCode Therapeutics, AUG 23, 2021, View Source [SID1234586819]).

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"2021 has so far been foundational for TransCode, highlighted by our recent initial public offering and listing on Nasdaq. With resources from the IPO and additional support from the NIH, we are driving progress across our organization, including key staff additions who bring valued expertise to our team and advancement of our preclinical work," said Michael Dudley, co-founder, president and CEO of TransCode Therapeutics. "Looking forward, we are positioning to move our pipeline into clinical development, as we seek to demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology. We remain on track to submit an exploratory Investigational New Drug Application (eIND) in the first quarter of 2022 to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Second Quarter 2021 and Recent Highlights

Completed an initial public offering of 7,187,500 shares of common stock, including full exercise of the underwriters’ option to purchase additional shares, resulting in aggregate gross proceeds of $28.8 million, before deducting underwriting discounts and commissions and other offering expenses.
Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million expected over three years to support the clinical evaluation of TTX-MC138. The Company expects to use these funds for translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery and target engagement of TTX-MC138.
Strengthened the Company’s leadership team with several key appointments, including:
Judy Carmody, Ph.D., as SVP of Operations, Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D., as Principal Scientist; and
Dejan Juric, M.D., appointed to its Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and breast cancer specialist, is currently serving as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.
Advanced preclinical work for TTX-MC138, the Company’s lead program, targeting miR-10b for treatment of metastatic solid tumors. The Company has completed development of a diagnostic assay validating a method for measuring miR-10b expression in patient blood and tissue samples. This new assay should support future TTX-MC138 clinical trials including the initial Phase 0 study.
Initiated IND-enabling activities to support its planned eIND filing for TTX-MC138.
Planned Upcoming Milestones

TransCode continues to advance its portfolio and has set the following goals:

TTX-MC138
Submission to FDA of an eIND application in the first quarter of 2022.
Initiation of Phase 0 clinical study evaluating TTX-MC138 for treatment of metastatic solid tumors later in 2022.
Concurrent completion of IND-enabling studies to support second half of 2022 filing an IND application for a Phase I clinical trial of TTX-MC138.
Publication of preclinical results supporting its TTX delivery platform in the second half of 2021.
Second Quarter Financial Highlights

Cash and Cash Equivalents: As of June 30, 2021, cash and cash equivalents totaled approximately $80 thousand, excluding approximately $25.4 million in net proceeds from the Company’s July IPO.
R&D Expenses: Research and development expenses were approximately $212 thousand in the second quarter of 2021, compared to approximately $75 thousand in the second quarter of 2020. The increase was primarily due to purchases of materials, license fees, lab facility expenses, costs related to development of intellectual property, and share-based compensation expenses.
G&A Expenses: General and administrative expenses were approximately $144 thousand in the second quarter of 2021, compared to approximately $177 thousand in the second quarter of 2020. The increase was primarily due to increased legal, accounting, insurance, and investor relations costs associated with the Company’s IPO and to share-based compensation expenses.
Operating Income (Loss): Operating loss was approximately $356 thousand in the second quarter of 2021, compared to approximately $92 thousand in the second quarter of 2020. Net income was approximately $2.8 million, or $0.60 per basic share and $0.51 per diluted share, for the second quarter of 2021, compared to a net loss of approximately $127 thousand, or $0.03 per basic and diluted share, for the second quarter of 2020. The results in the second quarter of 2021 primarily reflect a change in fair value of derivative liabilities related to convertible promissory notes. The convertible promissory notes automatically converted into common stock upon completion of the IPO. In the foreseeable future, the Company expects that operating losses will increase substantially and does not expect net profits.
Financial Guidance

TransCode expects that its cash and cash equivalents as of June 30, 2021, together with net proceeds from its initial public offering and the SBIR award, are sufficient to fund planned operations through year-end 2022.

On August 23, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in Europe (Press release, Agilent, AUG 23, 2021, View Source [SID1234586818]). The assay is now CE-IVD marked for use as an aid in identifying esophageal cancer patients for treatment with KEYTRUDA using Combined Positive Score (CPS) ≥ 10.1 In Europe, KEYTRUDA is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2 negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10].2

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"Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence."

"PD-L1 has been established as an essential biomarker for anti-PD-1 therapies like KEYTRUDA," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence."

In Europe, almost 53,000 people were diagnosed with esophageal cancer in 2020, and this type of cancer caused more than 45,000 deaths the same year.3

KEYTRUDA is a humanized monoclonal antibody that enhances the ability of the immune system to detect and fight tumor cells. KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.2 KEYTRUDA and other targeted immunotherapies are changing cancer treatment, and their therapeutic value is being realized across a growing list of cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for KEYTRUDA in partnership with Merck (known as MSD outside the United States and Canada).