On September 9, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors (Press release, BioNTech, SEP 9, 2022, View Source [SID1234619318]). The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany.

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BNT211 is a novel therapeutic approach which comprises a synergistic combination of two of BioNTech’s proprietary platforms. The candidate combines an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate recently received Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the third- or later-line treatment of testicular germ cell tumors. The designation was granted based on the encouraging initial data particularly in patients with testicular cancer which is the most common type of germ cell tumors. BioNTech presented data from the ongoing Phase 1/2 trial (NCT04503278; 2019-004323-20) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022 and at the annual meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) in May 2022.

"This new dataset further supports the encouraging results we have seen for BNT211 to date. Together with the recently granted PRIME designation for BNT211 in testicular cancer it also reinforces our strategy to combine two of our key technology platforms in hard-to-treat tumor indications," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We are grateful for the continued support from both clinicians and regulators that enables us to rapidly advance the clinical evaluation of BNT211 as a novel treatment option for cancer patients with an otherwise very poor prognosis."

The updated data read-out presented at ESMO (Free ESMO Whitepaper) (data cut-offs: June 15, 2022 for safety and August 16, 2022 for efficacy) included data from 22 patients (21 evaluable for efficacy) who received CLDN6 CAR-T cells at dose levels 1 (1×107 CAR-T cells, n=7, including one patient with CAR-T dose below dose level 1) and 2 (1×108 CAR-T cells, n=15) alone or combined with CARVac. Tumor indications included testicular cancer (n=13), ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, gastric cancer (one patient each) and one patient with a tumor of unknown primary origin. Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 showed encouraging signs of clinical activity and was well tolerated. All 22 patients showed robust, dose-dependent CAR-T cell expansion after infusion with cell frequencies close to 109 total counts in dose level 2. At the cut-off date, available data demonstrated the long-term persistence of CAR-T cells observed in some patients for more than 100 days, and in one patient for 200 days. Two patients have been treated without lymphodepletion as preconditioning and a strongly reduced CAR-T expansion was observed. Adverse events, including cytokine release syndromes (CRS) and dose limiting toxicities were manageable. One transient occurrence of neurotoxicity grade 1 and one grade 3 CRS were observed that quickly resolved.

Efficacy assessment of the 21 evaluable patients showed a best overall response rate (ORR) of 33% and a disease control rate (DCR) of 67% with one complete response, six partial responses and seven patients with stable disease. In line with the earlier data set initially presented at AACR (Free AACR Whitepaper) this year, particularly encouraging clinical responses were seen in patients with testicular cancer treated with dose level 2 after lymphodepletion (n=7), where one complete response, three partial responses and two stable diseases were observed, representing an ORR of 57% and a DCR of 85%. As previously reported, antitumor activity tended to be higher at the higher dose of CAR-T cells and when combined with the mRNA vaccine. 5 of 10 patients in the CARVac combination group showed a partial response compared to 2 of 9 patients in the monotherapy cohort (CAR-T cell treatment only) excluding two patients that have been treated without lymphodepletion.

About BNT211
Aiming to harness the power of cell therapies for solid cancers and to overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech’s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. CARVac is based on BioNTech’s backbone-optimized uridine mRNA (uRNA)-lipoplex technology which through its inherent adjuvant function enables a potent T cell stimulation to improve persistence and functionality of the adoptively transferred CAR-T cells, thereby enabling the investigation of a therapeutic effect even at low CAR-T doses. BNT211 is an investigational CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered by BioNTech founders and expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

On September 9, 2022, AIM ImmunoTech Inc. (the "Company") Presented a company presentation (Presentation, AIM ImmunoTech, SEP 9, 2022, View Source [SID1234619317]).

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On September 9, 2022 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.41 per share (Press release, AbbVie, SEP 9, 2022, View Source [SID1234619316]).

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The cash dividend is payable November 15, 2022, to stockholders of record at the close of business on October 14, 2022.

Since the company’s inception in 2013, AbbVie has increased its dividend by more than 250 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On September 9, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that positive data from its signal-finding Phase 1 SURPASS trial (Press release, Adaptimmune, SEP 9, 2022, View Source [SID1234619313]). The data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2022 Congress by SURPASS investigator, David Hong, M.D., of The University of Texas MD Anderson Cancer Center . In conjunction with ESMO (Free ESMO Whitepaper) 2022, Adaptimmune will provide an update on the SURPASS Phase 1 data and outline future plans for its SURPASS family of trials, during a live virtual event to be held at 8 a.m. EDT today (details to join below).

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"Our SURPASS signal-finding trial continues to be a great success," said Adrian Rawcliffe, Chief Executive Officer, Adaptimmune. "We are seeing robust levels of clinical response in heavily pre-treated people with late-stage cancers expressing MAGE-4, independent of tumor type. Our product candidate has been well tolerated and it is abundantly clear that this next gen CD8 TCR T-cell can effectively target solid tumors and is markedly more potent than our first-gen product in tumors outside of sarcoma. With these results, we have the opportunity to convert signals of efficacy into products for multiple cancer indications, such as ovarian, gastroesophageal, urothelial, and head & neck cancers which are large populations with high unmet medical need. We are thankful to both the dedicated clinical trial participants and their caregivers, for their commitment to helping us develop and deliver innovative cancer therapies."

"I’m encouraged by the responses we’ve seen thus far in multiple solid tumor types during the SURPASS signal-finding trial, and I look forward to seeing data from future clinical studies," said David Hong, M.D., Professor and Deputy Chair of Investigational Cancer Therapeutics at MD Anderson. "This is an important and exciting time in oncology with TCR T-cell therapies, such as afami-cel and the next–gen CD8 therapy, and their potential to help clinicians manage aggressive and difficult-to-treat cancers."

Positive data in Phase 1 SURPASS trial support advanced clinical development

Data are consistent with and build upon the results reported at ESMO (Free ESMO Whitepaper) 2021, with an acceptable safety profile and continued positive antitumor activity. Data were reported from 44 people enrolled at sites in the US, Canada, and the EU who received a single dose of ADP-A2M4CD8 and 43 people were evaluable

for efficacy (August 01, 2022, data cut).1 People in this trial had advanced, late-stage metastatic cancers and were heavily pre-treated having received a median of 3 prior lines of therapy (range 1-8). Efficacy figures are provided in Appendix 1. Further information about standard of care and the high unmet medical need for these solid tumor cancers is provided in Appendix 2.

Overall antitumor activity and responses

The Phase I SURPASS trial is ongoing and the overall response rate2 for the 43 evaluable people is 33% (including confirmatory scans for two people with unconfirmed partial responses at the time of the data cut). Most people experienced meaningful antitumor activity with a disease control rate of 81%. The median duration of response was 12 weeks (range 7 to 65+ weeks).

For the subset of 25 people with ovarian, urothelial, and head & neck cancers, the response rate is 44%.

Acceptable safety profile of ADP-A2M4CD8 supports further clinical development

Adverse events reported are consistent with those experienced by people with late-stage metastatic cancers undergoing chemotherapy, immuno-oncology therapy and/or adoptive cell therapy. Among adverse events (AEs) of special interest: 32 people (73%) had cytokine release syndrome (CRS); most events were low grade and resolved (~86% ≤ Grade 2). Eleven people (25%) had cytopenia (Grade ≥3) at 4 weeks after treatment. Three people (7%) had Immune effector Cell -Associated Neurotoxicity Syndrome (ICANS) related to ADP-A2M4CD8.

There were 2 deaths reported as related to ADP-A2M4CD8 by investigators. A 60-year-old woman with ovarian cancer with a large tumor burden in her lungs died due to pneumonia and CRS. As reported at ESMO (Free ESMO Whitepaper) 2021, a 71-year-old man with adenocarcinoma of the esophagus and a history of chronic anemia died due to bone marrow failure.

Ovarian cancer and the Phase 2 SURPASS-3 trial planned to initiate this year

Results: Most people had reductions in target lesions and there was an 86% disease control rate (12 out of 14) and 5 (36%) had confirmed clinical responses including one complete response.

Unmet need: People with platinum-resistant disease have limited options, with overall response rates of less than 13% with currently approved therapies, median progression-free survival of less than 4 months and median overall survival of 13 months or less (Please refer to Appendix 2 for more information and references).

Strategy for ovarian cancers: The Company plans to pursue a Phase 2 trial, SURPASS-3, opening in late 2022/early 2023 in ovarian cancer in collaboration with The GOG Foundation, Inc. (GOG). The SURPASS-3 trial (GOG-3084) will evaluate ADP-A2M4CD8 in both monotherapy and in combination with nivolumab (a PD-1 checkpoint inhibitor) in a two-arm design in people with platinum resistant ovarian cancer.

Urothelial and head & neck cancers: data support clinical advancement

Results urothelial cancer: The majority (6 out of 7) of people with late-stage, metastatic urothelial cancer who received a single dose of ADP-A2M4CD8 had reductions in target lesions and 3 had confirmed responses. In addition, there was one additional unconfirmed response received after the data cut-off.

1 One person with melanoma treated in July 2022 was not evaluable for efficacy as of the data cut.

2 Antitumor activity was determined per RECIST v1.1 criteria by investigator review and these interim data will continue to evolve.

Unmet need urothelial cancer: Treatment options are suboptimal for people with advanced/metastatic disease. People receiving checkpoint inhibitors after progressing on platinum-based chemotherapy have an overall response rate of approximately 20%, and for certain checkpoint inhibitors, median progression-free survival of approximately 2 months and median overall survival of 10 months. (Please refer to for more information and references).

Results head & neck cancer: There were 3 confirmed responses out of 4 people with late-stage, metastatic head and neck cancer who received a single dose of ADP-A2M4CD8.

Unmet need head & neck cancer: People with recurrent or metastatic disease have overall response rates of approximately 19% for checkpoint inhibitor monotherapy and 36% for checkpoint inhibitors in combination with chemotherapy with median progression-free survival of 3-to-5 months and median overall survival of 13 to 15 months. Cetuximab as a monotherapy or in combination in the second-line or later settings provides a median progression-free survival of less than 4 months and median overall survival of less than 8 months (Please refer to Appendix 2 for more information and references).

Strategy for urothelial as well as head & neck cancers: The Company will continue to enroll people with urothelial as well as head & neck cancers in the monotherapy arm and combination arm with a PD-1 inhibitor (nivolumab) of the ongoing Phase 1 SURPASS trial. As the signals in these cancers mature with the accrual of additional monotherapy and combination data from the SURPASS Phase 1 trial, the Company will progress to further development activities including evaluation of combination strategies and/or later phase clinical development.

Gastroesophageal cancers: modifications to the ongoing Phase 2 SURPASS trial

Results: There were 13 people with late-stage, metastatic gastroesophageal cancers who received ADP-A2M4CD8 in the Phase 1 SURPASS trial. There was 1 confirmed and 1 unconfirmed response that subsequently confirmed after the data cut-off. There is clear antitumor activity in these cancers with an encouraging disease control rate (10 out of 13 people) in this heavily pre-treated advanced population.

Unmet need: People in the second-line treatment setting have few effective options with about 28% responding to standard of care, median progression-free survival of around 4 months and median overall survival of approximately 10 months. Less than 25% of chemotherapy-treated people make it to the third-line treatment where response rates are low with a median progression free survival of approximately 2-3 months. (Please refer to Appendix 2 for more information and references).

Strategy for gastroesophageal cancers: The Company initiated SURPASS-2 last year, which is a Phase 2 trial for people with advanced gastroesophageal cancers who received a maximum of 2 prior lines of systemic treatments for advanced disease. The Company plans to amend the SURPASS-2 trial to include an additional cohort in combination with a PD-1 inhibitor and is exploring options to combine in earlier line treatment.

Details for ESMO (Free ESMO Whitepaper) 2022 Oral Presentation

On Saturday, September 10, 2022, at 15:45 CET/09:45 EDT, David Hong, MD, Professor, Deputy Chairman in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, will present a data update from the Phase 1 signal-finding SURPASS trial at the ESMO (Free ESMO Whitepaper) 2022 Congress.

Adaptimmune Live Virtual Event Today: September 9, 2022, 8:00 a.m. EDT

You can join the event with this link: https://bit.ly/3QBacNt.

The Company will host a live virtual event today from 8 a.m. EDT (1:00 p.m. BST) to present a perspective on the ESMO (Free ESMO Whitepaper) data as well as Adaptimmune’s next steps for the SURPASS family of trials. Kathleen Moore, M.D., Professor, Division of Gynecologic Oncology, Stephenson Cancer Center at the University of Oklahoma, member of The GOG Foundation, Inc.’s Investigator Council, Associate Director of the GOG Partners, a GOG Foundation, Inc. program and an investigator in the SURPASS Phase 1 trial, will present her perspectives and be available for a Q&A.

On September 9, 2022 Tiziana Life Sciences Ltd.(Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, reported that it has been notified that Matthew Davis, its Chief Medical Officer, purchased 100,000 common shares at $0.76 per share (Press release, Tiziana Life Sciences, SEP 9, 2022, View Source [SID1234619312]).

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