On November 3, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported presentations at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference being held November 9-12, 2021 virtually and in Boston, and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting held November 12-14, 2021 virtually and in Washington, D.C (Press release, Alector, NOV 3, 2021, View Source [SID1234594244]).

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

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

                  Schedule Your 30 min Free Demo!

Among the data being presented at CTAD are twelve-month biomarker and clinical data from the open-label Phase 2 INFRONT-2 study evaluating AL001 in individuals with frontotemporal dementia due to progranulin gene mutation (FTD-GRN). Alector will also present data from its Phase 1 study of AL003 in healthy volunteers and participants with Alzheimer’s disease. AL003 is being developed in collaboration with its partner, AbbVie.

At SITC (Free SITC Whitepaper), Alector will provide an update on AL009, a first-in-class multi-Siglec inhibitor that enhances innate and adaptive immunity to cancer by blocking a critical glycan checkpoint pathway.

Alector plans to host a conference call to review these data and the progress across its pipeline on November 12, 2021, at 4:00 p.m. ET.

Presentations at CTAD

Oral Presentation:

Presentation Title: Update on the Phase 2 Study of AL001 in Frontotemporal Dementia Patients Carrying a Granulin Mutation (OC32)
Presenter: Sam Jackson, M.D., MBA, Alector’s interim Chief Medical Officer
Session Date and Time: November 12, 2021 at 1:50 p.m. ET

Poster Presentations:
Poster presentations will be available for on-demand viewing starting November 9, 2021.

Poster Title: A Phase 1 Study of AL003 in Healthy Volunteers and Participants with Alzheimer’s Disease (P45)
Theme: Clinical trials: results
Presenting Author: Michael Ward, Ph.D., Senior Director, Clinical Science, Alector

Poster Title: A First-in-human Study of the Anti-Sortilin Antibody AL101 (P46)
Theme: Clinical trials: results
Presenting Author: Michael Ward, Ph.D., Senior Director, Clinical Science, Alector

Poster Title: Design of INFRONT-3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 IN FTD-GRN (P71)
Theme: New therapies and clinical trials
Presenting Author: Sam Jackson, M.D., MBA, interim Chief Medical Officer, Alector

Poster Presentation at SITC (Free SITC Whitepaper)

Alector’s poster will be presented on Friday, November 12, 2021, in the Poster Hall at the Walter E. Washing Convention Center in Washington D.C.

Poster Title: AL009, a Fusion Protein and Multi-Siglec Inhibitor, Repolarizes Suppressive Myeloid Cells and Potentiates Anti-Cancer Effects (#875)
Category: Novel Single-Agent Immunotherapies
Presenting Author: Sam Nalle, Ph.D., Associate Director, Alector

Conference Call Information

Alector management will host a conference call at 4:00 p.m. ET on November 12, 2021. Analysts and investors are invited to participate in the conference call by dialing (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 2065957. The live webcast can be accessed on the investor page of Alector’s website at investors.alector.com. A replay of the webcast will be available on Alector’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

On November 3, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, Chief Executive Officer, will participate in a fireside chat at the Jefferies London Healthcare Conference at 3:40 PM GMT / 10:40 AM EST on Tuesday, November 16, 2021 (Press release, Nanobiotix, NOV 3, 2021, View Source [SID1234594243]).

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

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

                  Schedule Your 30 min Free Demo!

The fireside chat will be webcast live from the Events section of the company’s website at www.nanobiotix.com. A replay of the webcast will be archived and available for one month following the event.

On November 3, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the third quarter ended September 30, 2021 (Press release, Zymeworks, NOV 3, 2021, View Source [SID1234594242]).

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

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

                  Schedule Your 30 min Free Demo!

"This year, we delivered upon our goal of presenting data showcasing the potential of zanidatamab to be the new foundational HER2-targeted therapy in first-line gastroesophageal adenocarcinoma (GEA)," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "These data support the launch of our second pivotal study, HERIZON-GEA-01, and we look forward to continuing our recent clinical success with upcoming catalysts for zanidatamab in early- and late-line metastatic breast cancer as well as in combination with Ibrance, Tukysa, tislelizumab, and agents targeting the CD47 pathway."

Third Quarter 2021 Business Highlights and Recent Developments

Clinical Data Supports Zanidatamab as Potential New Standard of Care in 1L HER2+ GEA
In September, we presented Phase 2 clinical data for zanidatamab in combination with chemotherapy in first-line metastatic HER2-positive GEA at the European Society for Medical Oncology Annual Congress. The data support zanidatamab as a potential new standard of care in 1L HER2-positive GEA and the initiation of a global, randomized Phase 3 trial scheduled to launch in the fourth quarter of 2021. Further information relating to the pivotal trial design and commercial strategy in gastrointestinal cancers will be provided on a webcast on Tuesday, November 9, 2021 at 4:15 p.m. ET (1:15 p.m. PT). Interested parties can access a live webcast via Zymeworks’ website.
Zanidatamab Plus Chemotherapy in Late-Line Breast Cancer to be Presented at San Antonio Breast Cancer Symposium
The presentation will feature new clinical data for zanidatamab, in combination with chemotherapy, as a late-line treatment for patients with HER2-positive breast cancer. The presentation will be available on Wednesday, December 8, 2021.
First Patient Dosed in Clinical Trial of Zanidatamab and Anti-CD47 Evorpacept (ALX148)
The Phase 1b/2 clinical trial is designed to evaluate the safety and efficacy of zanidatamab in combination with ALX148 (anti-CD47) in patients with advanced HER2-positive breast cancer, HER2-low breast cancer, and additional non-breast HER2-expressing solid tumors.
Study Commences in Investigator-Initiated Trial of Zanidatamab as Neoadjuvant Treatment in HER2-Positive Breast Cancer
A Phase 2 open-label trial to evaluate zanidatamab monotherapy as neoadjuvant treatment in patients with newly diagnosed HER2-positive early breast cancer is being co-lead by Dr. Vincent Valero and Dr. Funda Meric-Bernstam at the University of Texas MD Anderson Cancer Center. The primary endpoint of this study is to assess efficacy by pathologic complete response.
ZW49 Program Update
The ZW49 program continues to advance in the weekly and once every three week dosing schedules. Expansion cohorts evaluating 2.5 mg/kg every three weeks have enrolled 29 patients and are expected to complete enrollment (30 patients) prior to year end. In parallel, the weekly dose regimen has enrolled 14 patients and continues to dose escalate as the maximum tolerable dose has not been reached. No dose-limiting toxicities have been observed to date. The results of these studies will inform the recommended Phase 2 dose and schedule with safety and efficacy data expected to be presented at a medical conference in 2022.
Financial Results for the Quarter Ended September 30, 2021

Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as payments for research and development support. Revenue for the three months ended September 30, 2021 was $4.4 million compared to $2.6 million for the same period of 2020. Revenue for the third quarter of 2021 included a development milestone and research and development support under cost sharing arrangements. Revenue for the same period in 2020 included research and development support under cost sharing arrangements.

For the three months ended September 30, 2021, research and development expenses were $49.9 million compared to $54.4 million for the same period of 2020. The decrease was primarily due to lower third-party manufacturing expenses for zanidatamab which were partially offset by higher salary and benefit expenses from additional headcount as well as higher preclinical and other research and development program expenses. For the three months ended September 30, 2021, research and development expenses included non-cash stock-based compensation expense of $5.6 million from equity-classified equity awards and a $1.0 million recovery from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation, research and development expenses decreased by $3.3 million for the three months ended September 30, 2021 compared to the same period in 2020.

For the three months ended September 30, 2021, general and administrative expenses were $15.5 million compared to $21.9 million for the same period in 2020. For the three months ended September 30, 2021, general and administrative expenses included non-cash stock-based compensation expense of $4.8 million from equity-classified equity awards and a $3.6 million recovery from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation, general and administrative expenses increased by $4.9 million for the three months ended September 30, 2021 compared to the same period in 2020 primarily due to higher salary and benefit expenses from additional headcount, and professional fees.

Net loss for the three months ended September 30, 2021 was $60.6 million compared to $72.6 million for the same period of 2020. This was primarily due to the decrease in research and development and general and administrative expenses and the increase in revenue referred to above, which was partially offset by a decrease in interest income.

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 September 30, 2021, Zymeworks had $307.8 million in cash resources consisting of cash, cash equivalents and short-term investments. Based on our current operating plan, we believe that our current cash resources, combined with the collaboration payments we anticipate receiving, will enable us to fund our planned operations into late 2022 and potentially beyond.

On November 3, 2021 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 third quarter ended September 30, 2021 (Press release, Tracon Pharmaceuticals, NOV 3, 2021, View Source [SID1234594241]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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

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

                  Schedule Your 30 min Free Demo!

"We have once again utilized our CRO-independent Product Development Platform to augment our pipeline. The license of the potential best-in-class CTLA-4 antibody YH001 complements our prior license of the subcutaneously administered PD-L1 antibody envafolimab and satisfies our goal of owning complementary checkpoint inhibitors. We expect to initiate a trial combining these two drug candidates in sarcoma in the coming months," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "In the meantime, ENVASARC continues to enroll well at 26 sites, and we look forward to releasing interim efficacy data before the end of the year."

Recent Corporate Highlights

In October, TRACON licensed the CTLA-4 antibody YH001 from Eucure Biopharma. The Company expects to file an IND and initiate a Phase 1/2 trial of YH001 combined with envafolimab in soft tissue sarcoma subtypes in early 2022, and initiate trials of YH001 in other indications in combination with approved standard of care agents in late 2022.

In September, the book Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem, authored by TRACON senior management and profiling TRACON’s approach to efficient drug development, was published by ForbesBooks and is available on Amazon and other retailers.
Expected Key Upcoming Milestones

Interim ENVASARC efficacy data by end of 2021.

Request FDA breakthrough therapy designation or fast track designation for envafolimab by end of 2021, assuming positive interim efficacy data.

Decision on the envafolimab New Drug Application submitted by our partners 3D Medicines and Alphamab Oncology, in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration.
Third Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $29.9 million at September 30, 2021, compared to $36.1 million at December 31, 2020.

Research and development expenses for the third quarter of 2021 were $2.7 million, compared to $1.8 million for the third quarter of 2020.

General and administrative expenses for the third quarter of 2021 were $4.2 million, compared to $2.1 million for the third quarter of 2020. The increase was primarily attributable to legal expenses incurred due to the ongoing arbitration with I-Mab related to the TJ4309 and bispecific antibody agreements.

Net loss for the third quarter of 2021 was $7.0 million, compared to $4.0 million for the third quarter of 2020.
Conference Call Details

Wednesday, November 3, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 4846079
A live webcast of the conference call will be available online from the Investor/Events and Presentations page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

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 pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar 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 33% 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 ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled into cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

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 through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

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 an ongoing 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.

On November 3, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following conferences in November and December 2021 (Press release, MacroGenics, NOV 3, 2021, View Source [SID1234594240]):

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

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

                  Schedule Your 30 min Free Demo!

Credit Suisse 30th Annual Healthcare Conference. MacroGenics’ management will participate in one-on-one meetings and provide a corporate overview on Tuesday, November 9, 2021 at 8:00 am ET.
Stifel 2021 Virtual Healthcare Conference. MacroGenics’ management is scheduled to participate in a fireside chat on Tuesday, November 16, 2021 at 8:00 am ET, and will also participate in one-on-one meetings.
Evercore ISI 4th Annual HealthCONx Virtual Conference. MacroGenics’ management is scheduled to participate in a fireside chat on Thursday, December 2, 2021 at 8:25 am ET, and will also participate in one-on-one meetings.
JMP Securities Hematology and Oncology Summit. MacroGenics’ management is scheduled to participate in a fireside chat on Monday, December 6, 2021 at 1:00 pm ET, and will also participate in one-on-one meetings.
Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.