On November 10, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in two fireside chats, the first at the Stifel Healthcare Conference 2021, November 15-17, and the second at the Jefferies London Healthcare Conference, November 16-19. Both conferences will be held virtually (Press release, Cue Biopharma, NOV 10, 2021, View Source [SID1234608268]).

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During the fireside chats, Cue Biopharma will provide an updated corporate overview and recent data highlighting its lead clinical program, CUE-101, representative of the IL-2 based CUE-100 series, as a monotherapy and in combination with KEYRUDA (pembrolizumab) for the treatment of patients with HPV+ recurrent/metastatic head and neck cancer. The discussion will also focus on the Company’s CUE-100 series pipeline progress with drug product candidates CUE-102, targeting Wilms’ Tumor 1 (WT1) and CUE-103, targeting KRAS G12V, as well as its most recent Neo-STAT platform developments.

Presentation Details:

Stifel Healthcare Conference
Date and Time: Monday, November 15, 2:40 p.m. – 3:10 p.m. EST
Webcast link: View Source

A live and archived webcast of the fireside chat will be available on the Events page in the Investor and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

Jefferies Virtual London Healthcare Conference
Date and Time: The pre-recorded fireside chat will be available to conference attendees on-demand between 8:00 a.m. GMT/3:00 a.m. EST on Thursday, November 18 through 5:00 p.m. GMT/12:00 p.m. on Friday, November 19.

A replay of the fireside chat will be hosted on the conference website and available to attendees for 30 days after the event. For more information, email [email protected].

Also, an archived webcast of the fireside chat will be available after the conference on the Events page in the Investor and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

On November 10, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809, NASDAQ: EVO) reported that the Company reached additional programme designations within its neuroscience collaboration with Bristol Myers Squibb (NYSE:BMY) triggering payments of in total US$ 40 m to Evotec (Press release, Evotec, NOV 10, 2021, View Source [SID1234594996]).

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These target-based programme designations further bolster the growing pipeline and are expected to follow EVT8683, which Bristol Myers Squibb opted to license after the successful filing of an IND application with the FDA.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: "Our collaboration with BMS continues to be highly productive. These achievements are a testimony of the great team spirit between Bristol Myers Squibb and Evotec colleagues that enabled us to advance highly challenging programmes to key value inflection points."

The collaboration was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms and there is a huge unmet medical need for therapeutic modalities that slow down or reverse disease progression. The collaboration leverages Evotec’s industrialised iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

On November 10, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the third quarter of 2021 (Press release, Hookipa Pharma, NOV 10, 2021, View Source [SID1234595047]).

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"Our team remains focused on optimizing the potential of our versatile arenaviral platform to redefine success in cancer immunotherapy by driving strong tumor-specific T cell responses. Third quarter highlights include our clinical collaboration with Merck & Co., Inc., Kenilworth, NJ, USA, on our HB-200 program in head and neck cancer and the publication of our pre-clinical data in melanoma in Nature Communications, both of which offered external validation of the promise of our technology," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Given our recent HB-200 data update, we’re even more energized about the start of our Phase 2 combination study of HB-201 with pembrolizumab as a 1st- or 2nd-line treatment in head and neck cancers, as well as progressing and expanding our oncology pipeline with candidates for prostate and KRAS-mutated cancers."

Quarter Highlights

In August, pre-clinical data on HOOKIPA’s arenaviral immunotherapeutic in melanoma was published in the peer-reviewed journal, Nature Communications. The data showed that HOOKIPA’s replicating Lymphocytic choriomeningitis (LCMV)-based vector, designed to target melanoma, modulated the tumor micro-environment and induced potent, antigen-specific T cell responses, resulting in tumor regression and tumor eradication in the pre-clinical setting. The data reinforce the potential of HOOKIPA’s arenaviral immunotherapeutic technology to activate and mobilize anti-tumor T cells for effective control and eradication of established tumors.

In September, HOOKIPA announced a clinical collaboration and supply agreement with Merck & Co, Inc., Kenilworth, NJ, USA (known as MSD outside of the United States and Canada) to evaluate the combination of HB-200, a novel arenaviral immunotherapeutic, and KEYTRUDA (pembrolizumab) as 1st-line treatment for patients with advanced head and neck cancer.
Business updates

On November 9, 2021 HOOKIPA provided a data update across its clinical development program. HOOKIPA announced it is advancing HB-201 to Phase 2, to be evaluated in combination with pembrolizumab as 1st- or 2nd-line treatment for Human Papillomavirus 16 Positive (HPV16+) squamous cell head and neck cancers (HNSCC). Interim Phase 1 data in heavily pre-treated patients continue to show HB-200 monotherapy (both HB-201 alone and HB-202/HB-201) is highly effective at expanding T cells, has a favorable tolerability profile and promising, early anti-tumor activity. As of November 1, 2021, among 28 patients dosed intravenously, HB-200 resulted in a 75 percent disease control rate and shrinkage of target lesions in 53 percent of patients. In these patients, HOOKIPA has observed three partial responses (including one confirmed and one unconfirmed in an ongoing patient) and one ongoing patient with a near partial response (29 percent tumor shrinkage). Based on the strength of the HB-200 data, HOOKIPA has prioritized its oncology portfolio, including HB-300 for prostate cancer and HB-700 for KRAS-mutated cancers, and plans further development of its infectious disease programs to be done in partnership with other companies.

Upcoming Milestones

Phase 1 HB-200 HPV16+ HNSCC additional data: mid-year 2022
Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 1st-line initial data: second half of 2022
Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 2nd-line initial data: second half of 2022
Randomized Phase 2 HB-200 + pembrolizumab HPV16+ HNSCC 1st-line trial initiation: first half of 2023
Investigational New Drug application for HB-300 in metastatic prostate cancer: third quarter 2022
Third Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2021 was $82.7 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $3.9 million for the three months ended September 30, 2021, and $4.0 million for the three months ended September 30, 2020. Revenues did not materially change compared to the three months ended September 30, 2020 though they included lower deferred revenues from upfront and milestone payments which were partially offset by higher cost reimbursements.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.7 million for the three months ended September 30, 2021, compared to $16.0 million for the three months ended September 30, 2020.

The primary drivers of the increase in direct research and development expenses were an increase in manufacturing and quality control expenses of $2.1 million, along with a general increase in other direct research and development expenses and laboratory expenses of $1.6 million, partially offset by a decrease in expenses for clinical studies of $0.6 million. The increase in manufacturing and quality control expenses as well as other direct research and development expenses was mainly due to the progress in HOOKIPA’s HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and manufacturing and quality control work in preparation of a further extension of the trial. Clinical study expenses decreased primarily due to the completion of patient enrollment of the Phase 2 study for our CMV vaccine candidate HB-101.

Internal research and development expenses increased by $1.6 million, mainly due to HOOKIPA’s increased research and development headcount.

General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2021 were $4.3 million, compared to $4.4 million for the three months ended September 30, 2020. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, partially offset by a growth in headcount along with increased salaries in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $20.0 million for the three months ended September 30, 2021, compared to a net loss of $13.6 million for the three months ended September 30, 2020. The increase was primarily due to an increase in HOOKIPA’s research and development activities.

On November 10, 2021 NuCana plc (NASDAQ: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies 2021 London Healthcare Conference (Press release, Nucana BioPharmaceuticals, NOV 10, 2021, View Source [SID1234595062]).

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Event: Jefferies 2021 London Healthcare Conference
Presentation Date: Wednesday, November 17, 2021
Presentation Time: 4:20 PM GMT

The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On November 10, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported at its virtual Spotlight Event being held today that, following recent discussions with the U.S. Food and Drug Administration ("FDA"), it plans to conduct a new, single-arm Phase 3 pivotal study of UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer ("NMIBC") (Press release, UroGen Pharma, NOV 10, 2021, View Source [SID1234595078]). This new study, which is expected to initiate in early 2022, is expected to enroll approximately 220 patients across 90 sites.

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"We have worked diligently with the FDA over the past several years to define the unmet need in low-grade NMIBC, with a particular focus on the intermediate risk population that typically experiences multiple recurrences," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are preparing to initiate a single-arm pivotal study of UGN-102 to form the basis for a New Drug Application for UGN-102 in the treatment of low-grade, intermediate-risk NMIBC. We believe this new study increases the probability of regulatory success for UGN-102 given its streamlined design in addition to the encouraging results observed from our Phase 2 OPTIMA II study."

UroGen is grateful to the investigators and patients who are participating in the ATLAS study and believes the data generated will represent an important component of the planned UGN-102 NDA submission, which remains on track for 2024. In light of the new planned Phase 3 trial, UroGen will stop enrollment in the ATLAS trial. Patients already enrolled in ATLAS will have the option to remain in the study until completion.

In addition to the updated clinical plan for UGN-102, the Spotlight Event features presentations on UroGen’s earlier-stage, locally administered immunotherapy candidates, UGN-301 and UGN-201, as well as two expert panel discussions on future directions in treating NMIBC, other types of bladder cancer and the potential benefits of UroGen’s immunotherapy pipeline products in non-urologic cancers.

Distinguished panelists discussing the current treatment landscape and potential future innovations in NMIBC include:

Dr. Sandip Prasad, a urologist in community practice with Atlantic Medical Group and the Morristown Medical Center;
Dr. Gary Steinberg, Professor of Urology and Director of the Bladder Cancer Program at NYU Langone Medical Center; and
Dr. William Huang, Professor of Urology and Radiology at NYU and Chief of Urology at Tisch Hospital.
The experts reviewing the unmet needs of patients with high-grade NMIBC and the potential for locally applied combination therapy include:

Dr. Karim Chamie, Associate Professor of Urology at UCLA Medical Center; and
Dr. Joshua Meeks, Associate Professor of Urology, Biochemistry and Molecular Genetics at Northwestern University Feinberg School of Medicine.
"Immunotherapy for the treatment of high-grade bladder cancer, with primary attention toward our TLR-7 agonist, UGN-201 and our anti-CTLA4 antibody, UGN-301, is a key area of focus of our earlier-stage pipeline," said Dr. Mark Schoenberg, Chief Medical Officer of UroGen. "We have pursued a series of pre-clinical studies to determine whether our RTGel platform might provide a method for delivering highly potent immunomodulators directly to the bladder surface, avoiding the toxicity associated with systemic administration. Our studies conducted to-date suggest bladder cancer treated with a combination of a TLR-7 agonist and an anti-CTLA4 antibody using our RTGel technology, produces improved survival relative to treatment with other checkpoint inhibitors in RTGel, either alone or in combination with UGN-201."

UroGen is currently conducting non-human primate toxicity studies to facilitate the initiation of a multi-arm Phase 1 study of UGN-301 in early 2022 to be followed by UGN-301 in combination with other agents. This approach leverages UroGen’s unique platform for drug delivery and provides an opportunity to evaluate intravesical delivery of its anti-CTLA4 monoclonal antibody in combination with other immuno-modulators, chemotherapies, gene therapy and innate immune stimulators, including UGN-201.