On February 29, 2024 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported recent updates on the progress made within key areas of its proprietary End-to-End Platform, at the 7th CAR-TCR Summit Europe taking place in London from February 27-29, 2024 (Press release, MediGene, FEB 29, 2024, View Source [SID1234640683]).

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Data presented and discussed include

Barbara Lösch, Head of Technology & Innovation, spoke at a Seminar titled "Incorporating Modular Control into Cell Therapies through Receptors to Enhance Therapy Persistence & Safety". Options to boost specific efficacy at tumor site through modular control such as logic gating and switch receptors were discussed, including implementing a switch receptor to allow precise control of cells to minimize toxicity.
Dr. Dolores Schendel, Chief Scientific Officer of Medigene gave a presentation titled "Developing Effective Methods to Monitor, Track & Assess T-Cell Efficacy In Vivo & In Vitro". Prof. Schendel provided an overview of the Company´s proprietary End-to-End (E2E) Platform that has embedded a multitude of different technologies, providing solutions to overcome significant challenges in treating solid tumors and improving T cell receptor engineered T cell (TCR-T) therapies with respect to safety, efficacy and durability.
This presentation is available on Medigene’s website: View Source

Kirsty Crame, MD, VP Clinical Strategy & Development, participated in a panel discussion titled "Selecting the Right Indications to Ensure Successful Clinical Outcome", highlighting the importance of balancing multiple, potentially conflicting criteria, such as commercial viability and feasibility of patient recruitment in early phase trials, as critical to the potential success of an asset.
"The success of TCR-T therapies against solid tumors depends on three major areas of innovation, the generation of optimal safe, sensitive, and specific TCRs, tools to enhance engineered these T cells to overcome the suppressive tumor microenvironment, and finally strategies for TCR-T manufacturing that allow optimization of drug product composition and rapid delivery to the right patients", said Dolores Schendel, Chief Scientific Officer of Medigene. "With our E2E Platform, we provide solutions for all of these key areas, with innovation at multiple sequential steps of the discovery and development process. With our unique set of technologies, we are well positioned to provide new, best-in-class differentiated TCR-T therapies for treatment of patients with solid tumors."

On February 29, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, reported that the company’s lead clinical asset, CUE-101, will be featured in a presentation at the 2024 Multi-disciplinary Head and Neck Cancers Symposium given by Alexander Dimitrios Colevas, M.D., a principal investigator at Stanford University participating in the CUE-101 clinical trial (Press release, Cue Biopharma, FEB 29, 2024, View Source [SID1234640682]). The symposium is being held in Phoenix, Arizona and virtually from February 29 – March 2, 2024.

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Dr. Colevas will discuss previously presented data from the company’s ongoing Phase 1 trial evaluating CUE-101, as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of 47% in first line (1L) patients treated with CUE-101 and pembrolizumab, compared to the historical ORR of 19% reported in the KEYNOTE-48 trial. In second line (2L) and beyond patients treated with CUE-101 monotherapy, the reported median overall survival (mOS) was 20.8 months, compared to a mOS of approximately eight months reported in the KEYNOTE-40 trial.

"Preliminary data of CUE-101 in combination with immunotherapy has been really promising with a much higher response rate than we would expect from immunotherapy alone, and a very tolerable side effect profile", stated Dr. Colevas.

Presentation Details
Poster Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic (R/M) HPV16+ head and neck cancer patients.
Poster Number: 7
Poster Session: III
Presenter: Alexander Dimitrios Colevas, M.D., professor of medicine and medical oncologist, Stanford Cancer Center, Stanford University School of Medicine
Date and Time: Friday, March 1, 2024 at 2:35 p.m. MST

About CUE-101 and the Phase 1 Trial
CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or "cues" to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA).

On February 29, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), one of the leading Canadian biotechnology companies working in the field of immune-oncology, reported the publication of a peer-reviewed study on the anticancer properties of its dual Accum-E7 vaccine, one of Defence’s experimental product designed to treat established cervical cancer (Press release, Defence Therapeutics, FEB 29, 2024, View Source;utm_medium=rss&utm_campaign=defence-announces-peer-reviewed-publication-on-accum-e7-anti-cancer-vaccine-in-cancer-science-journal-and-financing-update [SID1234640678]). The study, which was published in the prestigious journal of Cancer Science, is entitled, "An engineered Accum-E7 protein-based vaccine with dual anti-cervical cancer activity", and can be directly accessed at the following address View Source

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The human papillomavirus (HPV) can cause genital warts subsequently leading to cervical, anal, or head and neck cancers. Prophylactic HPV vaccines were therefore developed to prevent these infections and their associated complications. The most widely used of all four commercially available HPV vaccines is Gardasil-9. However, this vaccine has challenges: it requires three doses and the vaccine manufacturing remains costly, which may be prohibitive to low-income countries. In addition, the vaccine cannot provide complete protection against all 14 high-risk HPV subtypes as it only targets 9 of them. Furthermore, the vaccine should be administered before HPV exposure implying that it cannot treat existing infections or established cervical cancer.

The peer-reviewed study on Defence’s Accum-E7 anti-cancer vaccine presents an engineered Accum-E7 protein-based vaccine capable of providing a durable memory response when used prophylactically. In addition, the selection of E7 as a target "non-self" antigen widened the vaccine scope of application as it can also control the growth of pre-established cervical tumors through the generation of potent cytotoxic T lymphocytes (CTLs). "Overall, this engineered Accum-E7 vaccine is safe, simple to engineer and manufacture making it an elixir candidate capable of providing both prophylactic and therapeutic activity against cervical cancer", says Dr. Rafei, the Chief Scientific Officer of Defence Therapeutics.

The key highlights of the Accum-E7 study are:

Prophylactic vaccination using the Accum-E7 vaccine confers complete protection despite multiple challenges.
Accum-E7 elicits antibodies capable of interfering with cancer cell proliferation in vitro.
Therapeutic vaccination using Accum-E7 synergises with multiple immune-checkpoint inhibitors.
The therapeutic effect of Accum-E7 relies on cross-presenting dendritic cells (DCs) and CD8 T cells.
Vaccination using Accum-E7 is safe and immunogenic as shown in the conducted GLP study.
"This prestigious peer-reviewed publication provides an additional example of how the Accum technology can be exploited in the development of vaccines. It also opens up a new line of investigations where Defence’s more potent Accum variants could be tested as bioconjugates to protein antigens," said Mr. Plouffe, Chief Executive Officer of Defence Therapeutics.

In summary, our study shows that Accum-E7: i) provides potent protection (prophylactic vaccination) and durable memory responses, ii) triggers antibodies exhibiting a non-negligible role in fighting cervical tumors, iii), controls established tumors when delivered in combination with several immune-checkpoint inhibitors (therapeutic vaccination), and iv) is relatively safe, well tolerated and immunogenic by animals even when used at higher doses (GLP study).

Financing Update

The Company also provides an update to its previously announced non-brokered private placement of up to 1,500,000 units of the Company (each a "Unit") at a price of $1.50 per Unit for gross proceeds of up to $2,250,000 (the "Offering"). Following the first tranche closing of 567,000 Units for aggregate proceeds of $850,500 on January 30th, 2024, the Company has received a 45-day extension from the Canadian Securities Exchange to complete the Offering.

On February 29, 2024 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, Cardiff Oncology, FEB 29, 2024, View Source [SID1234640677]).

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"2024 is a pivotal year for Cardiff Oncology and we are excited for our upcoming randomized data readout from our lead program in first-line mCRC later this year," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The mCRC data we shared in August 2023, and the ONSEMBLE data we are disclosing today, demonstrates onvansertib’s contribution to the standard of care of bevacizumab (bev) and chemotherapy in treating RAS-mutated mCRC. Given there have been no new therapies approved in this large cancer indication in the last 20 years, 2024 marks a critical step in realizing onvansertib’s potential to provide clinical benefit to the large number of newly-diagnosed RAS-mutated mCRC patients, and create value for the stakeholders in our company."

Upcoming expected milestones

•First-line RAS-mutated mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended December 31, 2023, and subsequent weeks include:
•Provided a clinical update on Phase 2 randomized second-line ONSEMBLE trial in mCRC. New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients. In the trial, patients who were bev naïve demonstrated an objective response rate (ORR) of 50% on onvansertib. No clinical responses were observed in patients who received standard of care with FOLFIRI/bev or patients who were previously exposed to bev. For additional information, please refer to the press release issued by the Company today which provided an update on the ONSEMBLE trial.
•Announced first patient dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer. The trial, whose clinical execution is being conducted by Pfizer Ignite, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard of care (SoC) vs. SoC alone. Interim topline results from CRDF-004 are expected in mid-2024. Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
•Announced the publication of data from Phase 1b study in second line KRAS-mutated mCRC in Clinical Cancer Research. The findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer disclosed by Cardiff Oncology

in August 2023 have been published in the peer-reviewed journal Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
Full Year 2023 Financial Results:
Liquidity, cash burn, and cash runway
As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the full year 2023 was approximately $30.9 million, a decrease of approximately $2.9 million from $33.8 million for the same period in 2022.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q3 2025.
Operating results
Total operating expenses were approximately $45.9 million for the full year ended December 31, 2023, an increase of $5.6 million from $40.3 million for the same period in 2022. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website following the completion of the call.

On February 29, 2024 Amgen (NASDAQ:AMGN) reported that it will present at the 44th Annual TD Cowen Health Care Conference at 9:10 a.m. ET on Tuesday, March 5, 2024 (Press release, Amgen, FEB 29, 2024, View Source [SID1234640676]). Peter Griffith, executive vice president and chief financial officer at Amgen, and Paul Burton, senior vice president and chief medical officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.