On August 5, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the quarter ended June 30, 2020 (Press release, Zymeworks, AUG 5, 2020, View Source [SID1234562927]).

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"Among many notable accomplishments in the past quarter, I am particularly excited about the transition of our lead therapeutic program, zanidatamab, into late stage clinical development, providing a clear path for Zymeworks to seek its first potential approval in biliary tract cancer in 2022," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Looking ahead, with zanidatamab in five active Phase 2 programs and ZW49 advancing in its dose-escalation study, we anticipate a number of important data readouts over the next six to twelve months. We are proud of everything that we have accomplished and are well positioned to strategically execute on our mission of sending patients home to their loved ones, disease free."

Second Quarter 2020 Business Highlights and Recent Developments

•Zanidatamab (ZW25) Advances into Global Registration-Enabling Study
Zymeworks initiated a global Phase 2 registration-enabling study of single agent zanidatamab in patients with previously-treated HER2 gene amplified biliary tract cancer (BTC). This study is designed to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety and may enable filing of a Biologics License Application (BLA) as early as 2022.

•Zanidatamab Data Updates Support Advancement in First Line Gastric Cancer
In addition to BTC, updated data were also presented from single agent zanidatamab and zanidatamab in combination with chemotherapy in patients with refractory HER2-expressing gastroesophageal adenocarcinomas (GEA). Zanidatamab continues to demonstrate promising single agent anti-tumor activity with response rates and durability that further improved when zanidatamab was combined with either paclitaxel or capecitabine. Zymeworks plans to initiate its second registration-enabling study for zanidatamab as first line treatment for advanced HER2+ GEA.
•ZW49 Continues Dose Escalation
Zymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial. In the first half of the year, Zymeworks initiated recruitment at five additional clinical sites bringing the total to 11 across North America.

Merck Signs New Partnership to Develop Additional Azymetric Multispecific Antibodies
Long-term partner Merck signed a new licensing agreement to develop and commercialize up to three new multispecific antibodies toward Merck’s therapeutic targets in human health. Zymeworks is eligible to receive up to $411.0 million in option exercise fees and clinical development and regulatory approval milestone payments and up to $480.0 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

•Bristol-Myers Squibb Expands Partnership and Adds EFECT Platform
BMS (formerly Celgene) expanded its Azymetric collaboration with Zymeworks, gaining access to the EFECT platform and extending its research term, resulting in a $12.0 million upfront payment to Zymeworks. Milestones remain at up to $1.7 billion plus tiered royalties on global sales.

•Strengthens Clinical Drug Development Expertise
Pamela Farmer, MD, joins Zymeworks as Vice President, Pharmacovigilance to provide medical oversight and ensure comprehensive and timely risk-benefit assessments of Zymeworks safety data. Dr. Farmer has held various leadership roles in drug safety and pharmacovigilance at major pharmaceutical companies including Prothena, Amgen, Genentech, and BioMarin, working on multiple regulatory submissions including Rituxan, Actemra and Vimizim.

Financial Results for the Quarter Ended June 30, 2020

Revenue for the three months ended June 30, 2020 was $12.4 million as compared to $7.9 million in the same period of 2019. Revenue for the three months ended June 30, 2020 included recognition of a $12.0 million expansion fee resulting from the BMS collaboration agreement expansion, as well as $0.4 million in research support and other payments from our partners. Revenue for the same period in 2019 included a $3.5 million commercial license option exercise fee from Daiichi Sankyo, $3.0 million in development milestone payments from our partners, as well as $1.4 million in research support and other payments from our partners.

For the three months ended June 30, 2020, research and development expenses were $39.2 million as compared to $23.8 million in the same period of 2019. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing costs for zanidatamab, an increase in development activity for ZW49, an increase in licensing fee expenses as well as an increase in salaries and benefits expense from additional research and development headcount in 2020 as compared to the same period in 2019. Research and development expenses also included non-cash stock-based compensation expense of $3.2 million comprised of $3.3 million from equity classified equity awards and a $0.1 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.
For the three months ended June 30, 2020, general and administrative expenses were $13.5 million as compared to $12.8 million in the same period in 2019. The change was primarily due to an increase in salaries and benefits expense resulting from an increase in headcount to support our expanding research and development activities and higher insurance expenses offset by lower non-cash stock-based compensation expense in 2020, compared to 2019. General and administrative expenses included non-cash stock-based compensation expense of $3.7 million comprised of $4.0 million from equity classified equity awards and a $0.3 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

Net loss for the three months ended June 30, 2020 was $39.0 million as compared to $29.1 million in the same period of 2019. This was primarily due to the increases in research and development expenses and general and administrative expenses referred to above, partially offset by an increase in revenue.
Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.
As of June 30, 2020, Zymeworks had $512.0 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On August 5, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported second quarter 2020 financial results and recent business highlights (Press release, Sangamo Therapeutics, AUG 5, 2020, View Source [SID1234562926]).

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"We are very excited about our global collaboration agreement announced with Novartis last week. This is our second impactful partnership announced this year, and we believe it affirms the value our industry sees in our zinc finger technology," said Sandy Macrae, CEO of Sangamo. "By advancing our robust partnership strategy, we proactively expand our genomic medicines pipeline into potential additional new indications, create substantial value for shareholders, and advance our mission to bring our medicines to patients."

Recent Highlights

•Announced global collaboration agreement with Novartis to develop and commercialize gene regulation therapies to treat three neurodevelopmental targets, including genes linked to autism spectrum disorder and intellectual disability. Under the collaboration agreement, Sangamo expects to receive a $75 million upfront licensing fee from Novartis in the third quarter of 2020 and is eligible to earn up to $720 million in potential milestones, in addition to tiered high single-digit to sub-teen double-digit royalties on potential net commercial sales.
•In partnership with Pfizer, presented updated results from the Phase 1/2 Alta study evaluating giroctocogene fitelparvovec, or SB-525, gene therapy in patients with severe hemophilia A at the virtual World Federation of Hemophilia 2020 Congress. The results demonstrated sustained Factor VIII activity levels and no bleeding events or factor usage in the five patients who received the 3e13 vg/kg dose for up to 61 weeks, the extent of follow-up for the longest-treated patient in the cohort.
•Highlighted Sangamo’s zinc finger protein in vivo genome regulation programs and capabilities and research detailing Sangamo’s engineered adeno-associated virus (AAV) directed evolution platform in six abstracts presented at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper).
•Announced organizational changes in R&D designed to increase the speed and efficiency of clinical translation of Sangamo science, including separating the research and development organizations. Jason Fontenot, Senior Vice President and Head of Cell Therapy, was appointed Interim Head of Research, and a search for Head of Development is currently underway.

Second Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities were $664.9 million as of June 30, 2020, compared to $384.3 million as of December 31, 2019. The balance at the end of the second quarter reflects amounts received from our previously announced collaboration with Biogen for an upfront license fee and issuance of Sangamo common stock.

Consolidated net loss attributable to Sangamo for the second quarter ended June 30, 2020 was $35.9 million, or $0.26 per share, compared to a net loss of $30.3 million, or $0.26 per share, for the same period in 2019. Revenues for the second quarter ended June 30, 2020 were $21.6 million, compared to $17.5 million for the same period in 2019.

Total operating expenses were $59.4 million for the second quarter ended June 30, 2020, compared to $51.1 million for the same period in 2019. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $52.7 million for the second quarter ended June 30, 2020, compared to $46.2 million for the same period in 2019. The increase in operating expenses reflects our headcount growth and facilities expansion to support the advancement of our therapeutic pipeline and manufacturing capabilities. These increases were partially offset by a decrease in clinical and manufacturing supply expenses.

Financial Guidance for 2020

•On a GAAP basis, we are revising our operating expense guidance. We expect operating expenses to be in the range of $235 million to $250 million (previously expected to be in the range of $270 million to $285 million). This includes estimated stock-based compensation expense of approximately $25 million.
•We expect non-GAAP operating expenses, which excludes stock-based compensation expense, to be in the range of $210 million to $225 million (previously expected to be in the range of $245 million to $260 million).
•The reduction in our operating expense guidance is primarily driven by the evolving COVID-19 pandemic and its anticipated impact on our clinical program timelines.

Conference Call

Sangamo will host a conference call today, August 5, 2020, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5667347. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5667347.

On August 5, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported it will be featured as a presenting company at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 (Press release, Sesen Bio, AUG 5, 2020, View Source [SID1234562925]). The Company will provide an update on the regulatory process in the US and Europe, and the BD process outside the US.

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Event: Canaccord Genuity 40th Annual Growth Conference
Date: August 13, 2020
Time: 11:00-11:25 AM ET

A live webcast of the Company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.

On August 5, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 5, 2020, View Source [SID1234562924]).

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"Our TriTAC T cell engager pipeline continues to advance and we were pleased with the encouraging interim Phase 1 data for our lead program, HPN424, that we presented at the ASCO (Free ASCO Whitepaper)20 Virtual meeting," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We also announced early data from our second program, HPN536, which has continued to advance in a dose escalation trial for mesothelin malignancies. In addition, we advanced our third clinical program, HPN217, into the clinic which triggered a $50 million milestone payment from AbbVie, and submitted an IND for HPN328, our fourth TriTAC pipeline program. Looking ahead to the second half of 2020, we are preparing to advance HPN328 into the clinic for the treatment of DLL3-expressing tumors including small cell lung cancer."

Second Quarter 2020 Business Highlights and Other Recent Developments

In April, Harpoon announced the first patient was dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a global development and option agreement with AbbVie Inc. (NYSE: ABBV) and dosing of the first patient in the clinical trial triggered a $50 million milestone payment, which was received in June. HPN217 targets B-cell maturation antigen (BCMA), a well-validated target expressed on multiple myeloma cells. HPN217 is Harpoon’s third product candidate to enter the clinic.

In April, Harpoon appointed Andrew R. Robbins and Joseph S. Bailes, M.D., to its Board of Directors as independent board members. Among his many achievements, Mr. Robbins is credited with leading the highly successful U.S. launch of BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) in BRAF-mutant metastatic melanoma. Dr. Bailes is a medical oncologist with substantial experience in clinical practice, legislation, public policy and advocacy. For nearly two decades, he served in various executive leadership capacities with ASCO (Free ASCO Whitepaper), including as President.

In May, Harpoon presented interim data from the ongoing dose-escalation portion of a Phase 1 trial for HPN424 in patients with metastatic castration-resistant prostate cancer (mCRPC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. At the time of the data cutoff, 44 patients with progressive mCRPC had been treated in 11 cohorts. Initial safety data showed that HPN424 is generally well tolerated, and cytokine-related adverse events were transient and manageable. Early signals of clinical activity were suggested by multiple patients remaining on study for more than 24 weeks, and several patients with serum PSA declines. Additionally, pharmacokinetic data confirmed half-life extension, which supports the weekly dosing schedule, and pharmacodynamic data supports T cell activation and target engagement, which are consistent with the expected mechanism of action. Patient enrollment continues in the dose escalation phase of the trial in the U.S. and Europe, with a goal to identify a dose for an expansion phase planned for the second half of 2020.

In May, Harpoon provided a corporate pipeline update. In addition to reiterating and expanding upon HPN424 data presented at ASCO (Free ASCO Whitepaper)20, Harpoon provided an update on HPN536, its TriTAC currently being studied for the treatment of mesothelin-expressing tumors. Harpoon highlighted that the dose escalation portion of the study was progressing and, as of May 2020, included 15 ovarian and 10 pancreatic cancer patients. Adverse events were shown to be transient and manageable, and early pharmacokinetic data showed half-life extension supporting once-weekly dosing. In addition, Harpoon also presented advancements in the company’s second platform, ProTriTAC, which builds upon the core elements of the TriTAC platform by utilizing a prodrug approach, designed to allow T cell engagers to address cancer targets that would be limited by on-target toxicities.

In July, Harpoon appointed Joanne Viney, Ph.D., to its board of directors as an independent board member. Dr. Viney is an entrepreneurial scientist and experienced biotech executive with deep autoimmune and inflammatory disease expertise and currently serves as President, CSO and Co-founder of Pandion Therapeutics.

Second Quarter 2020 Financial Results

Harpoon ended the second quarter of 2020 with $175.4 million in cash, cash equivalents, and marketable securities compared to $155.1 million as of December 31, 2019. The increase was due to a $50.0 million milestone payment received from AbbVie, partially offset by cash used in operations.

Revenue for the second quarter ended June 30, 2020 was $2.8 million compared to $1.1 million for the second quarter ended June 30, 2019. For the six months ended June 30, 2020, revenue was $6.1 million compared to $2.1 million for the six months ended June 30, 2019. During both the three and six month periods, the increase in revenue was primarily due to revenue recognized from the upfront payment under the development and option agreement with AbbVie, signed in November 2019.

Research and development (R&D) expense for the second quarter ended June 30, 2020 was $11.9 million compared to $10.0 million for the second quarter ended June 30, 2019. For the six months ended June 30, 2020, R&D expense was $24.4 million, compared to $19.4 million for the six months ended June 30, 2019. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN424, HPN536, HPN217 and HPN328. These higher expenses were offset by a decrease in manufacturing costs due to a scale up of manufacturing activities in 2019 compared to 2020 to support our four TriTAC product candidates in various stages of development.

General and administrative (G&A) expenses for the quarter ended June 30, 2020 was $3.9 million compared to $3.7 million for the quarter ended June 30, 2019. G&A expense for the six months ended June 30, 2020 was $7.9 million compared to $9.6 million for the six months ended June 30, 2019. For the quarter ended June 30, 2020, the increase was primarily attributable to an increase in

personnel expenses due to an increase in headcount, offset by a decrease in legal fees associated with the Maverick Litigation incurred in 2019. For the six months ended June 30, 2020, the decrease was due to higher expenses incurred in 2019 primarily related to legal fees associated with Maverick litigation and consulting and accounting services, partially offset by an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company.

Net loss for the quarter ended June 30, 2020 was $12.7 million compared to $11.8 million for the quarter ended June 30, 2019. The net loss for the six months ended June 30, 2020 was $25.2 million compared to $25.4 million in the first six months of the prior year.

COVID-19 Update

In response to the ongoing COVID19 pandemic, Harpoon’s executive offices remain closed in compliance with county and state shelter-in-place orders, substantially all of the company’s employees continue to telecommute, with only a limited the number of staff working in the company’s laboratory. Harpoon is currently continuing its clinical trials it has underway at sites in the United States, and has not yet experienced any material delays or impacts as a result of the pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels and the company does not currently anticipate material interruptions. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.

On August 5, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the second quarter ended June 30, 2020 (Press release, Tracon Pharmaceuticals, AUG 5, 2020, View Source [SID1234562923]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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Recent Corporate Highlights

In July, TRACON filed the ENVASARC pivotal trial protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application. Following the 30 day FDA review period, TRACON expects to enroll the first patient in the ENVASARC trial evaluating the PD-L1 single domain antibody envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the fourth quarter of 2020. Key elements of the ENVASARC pivotal tri
Multi-center, open-label, randomized, non-comparative, parallel cohort study.

Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and will have received one or two prior lines of cancer therapy, and no prior immune checkpoint inhibitor therapy.

Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.

Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint. Nine of 80 objective responses (11.25% ORR) are required to demonstrate an ORR that is statistically higher than the 4% ORR reported for Votrient, the only approved therapy for refractory UPS/MFS, in its package insert.

Open-label format with blinded independent central review of efficacy endpoint data.

In May, TRACON announced positive results for envafolimab at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program from the Company’s corporate partners, 3D Medicines and Alphamab Oncology, that showed single agent envafolimab demonstrated a 30.0% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) or those with advanced gastric cancer who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments. The confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

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URL: www.traconpharma.com

In May, TRACON highlighted data at the 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program from the Alliance for Clinical Trials in Oncology that showed a 29% confirmed ORR in patients (n=14) with highly refractory UPS who received dual checkpoint inhibition with Opdivo in combination with Yervoy. For reference, cohort B of the ENVASARC pivotal trial will enroll UPS/MFS patients who will receive dual checkpoint inhibition with envafolimab with Yervoy.

In May, positive data were presented from multiple TRC102 clinical trials at the 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program. In a Phase 2 trial, two of 14 mesothelioma patients who progressed previously on Alimta had objective responses following treatment with Alimta and TRC102. In a Phase 1 trial, TRC102 in combination with chemo-radiation resulted in an objective response in all 15 patients with locally advanced non-squamous non-small cell lung cancer, including three patients who demonstrated a complete response to treatment. The 100% ORR indicates a significant improvement as compared to historical data of chemoradiation without TRC102 in advanced lung cancer.

"We were excited by the ASCO (Free ASCO Whitepaper) data presented by our corporate partners showing that envafolimab activity was comparable to the activity of the approved products Opdivo and Keytruda in separate trials of MSI-H/dMMR CRC. Moreover, we were encouraged by additional data presented at ASCO (Free ASCO Whitepaper) from the Alliance group which showed an impressive response rate for dual checkpoint inhibition with Opdivo and Yervoy in UPS. Importantly, these data provide the rationale for testing dual checkpoint inhibition using envafolimab and Yervoy in the ENVASARC trial," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Achieving a 29% response rate in ENVASARC would represent a marked improvement in the treatment of patients with refractory UPS/MFS, where the only approved therapy demonstrated a 4% response rate. We look forward to enrolling the first patient in ENVASARC later this year and plan to provide interim data in 2021, final data in 2022, and assuming positive clinical data and regulatory approval, potentially commercialize envafolimab in 2023."

Expected Upcoming Milestones

Completion of the 30 day FDA review period for the ENVASARC protocol, a pivotal trial in the sarcoma subtypes of UPS and MFS, that was submitted to the FDA on July 16, 2020.

Enroll the first patient in ENVASARC during the fourth quarter of 2020.

Submission of the envafolimab BLA with the National Medical Products Association in China (NMPA) by our partners, 3D Medicines and Alphamab Oncology.

Report top-line data from the Phase 1 dose escalation study of TJ4309, a CD73 antibody, as a single agent and in combination with Tecentriq (a PD-L1 antibody being supplied by Roche), in the second half of 2020.

Second Quarter 2020 Financial Results

Cash and cash equivalents were $14.5 million at June 30, 2020, compared to $16.4 million at December 31, 2019. We expect our current cash and cash equivalents to fund operations into the second quarter of 2021. If the remaining $11.7 million available under the Aspire Capital agreement as of June 30, 2020 were fully utilized, cash runway would extend late into the third quarter of 2021.

Research and development expenses for the second quarter of 2020 were $2.2 million, compared to $4.3 million for the second quarter of 2019. The decrease was primarily attributable to lower manufacturing expenses and clinical trial expenses due to the discontinuation of the Phase 3 TRC105 program.

General and administrative expenses for the second quarter of 2020 were $2.1 million, compared to $1.9 million for the second quarter of 2019.

Net loss for the second quarter of 2020 was $4.5 million, compared to $6.3 million for the second quarter of 2019.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partners for this program, plan to submit a BLA to the NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center.

About TRC253

TRC253 is a Phase 3 ready novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 recently completed a Phase 1/2 clinical trial in prostate cancer conducted by TRACON. TRACON believes TRC253 can be developed and commercialized successfully in China and is actively seeking a strategic collaboration.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.