On June 8, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported its acquisition of Frame Cancer Therapeutics, a private company focused on advanced genomics and bioinformatics to identify both unique and shared neoantigens across different cancer types (Press release, CureVac, JUN 8, 2022, View Source [SID1234615757]).

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 addition of Frame’s technology and talent to CureVac’s oncology research complements our ability to identify and validate promising neoantigens for our mRNA cancer vaccine programs," said Franz-Werner Haas, Chief Executive Officer of CureVac. "The bioinformatics platform developed by Frame’s researchers has the potential to identify a broad panel of neoantigens that go beyond conventional neoantigens and could strongly increase the likelihood of developing highly effective cancer vaccines. We are excited to join forces with the innovative Frame Cancer Therapeutics team and combine their bioinformatics capabilities with our own mRNA expertise to potentially deliver a new class of cancer vaccines."

Frame’s FramePro platform identifies structural changes within the cancer genome that give rise to new open reading frames. These new open reading frames result in novel proteins that are absent in healthy tissues and can thereby be recognized as foreign by the immune system. Although these genetic changes are highly specific to individuals, the resulting neoantigenic proteins may be shared among many patients, potentially enabling development of more broadly applicable cancer vaccines.

An additional application of Frame’s technology is the development of personalized cancer vaccines, thereby leveraging the full antigenic potential of a tumor. In December 2021, regulators in the Netherlands approved Frame’s clinical trial protocol to evaluate this approach based on a peptide vaccine in 15 patients with non-small cell lung cancer. CureVac will refocus development of personalized cancer vaccines on an mRNA modality.

"We are very enthusiastic about the great synergies between our content-driven approach in antigen discovery and validation and CureVac’s extensive experience with mRNA vaccine development," said Ronald Plasterk, Founder and CEO of Frame Cancer Therapeutics. "The resulting vaccines could greatly enhance our ability to activate the human immune system against cancer, both in a personalized and off-the-shelf manner."

The total consideration for the acquisition of Frame Therapeutics is valued at €32 million. It will be paid in CureVac shares. Following a 50 percent upfront payment, the residual amount will be split across two project milestone driven steps. CureVac will expand the antigen discovery and validation activities at the Amsterdam Science Park.

On June 8, 2022 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the second quarter of 2022 on Wednesday, July 27, 2022. Company executives will review financial results and address inquiries from investors and analysts during a conference call at 8:00 a.m. ET on the same date (Press release, Bristol-Myers Squibb, JUN 8, 2022, View Source [SID1234615756]).

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!

Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source To be directly connected to the conference call, enter your information here; the link will be active 15 minutes prior to the scheduled start time of the call, and does not require a dial-in number or operator assistance to be connected. Investors and the public can also access the live webcast by dialing in the U.S. toll free 888-300-0211 or international +1 786-460-7199, confirmation code: 6873379. Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. EDT on July 27 through 11:30 a.m. EDT on August 10, 2022, by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 6873379.

On June 8, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the first patient has been dosed in the expansion portion of the Phase I/II study of BT5528, Bicycle’s second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2 (Press release, Bicycle Therapeutics, JUN 8, 2022, View Source [SID1234615755]).

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 believe EphA2 is an attractive target for cytotoxin delivery and BT5528 has the potential to overcome the significant safety concerns seen with an antibody drug conjugate (ADC) approach to targeting EphA2," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased with the molecule’s emerging safety profile and early signs of anti-tumor activity and look forward to providing additional data from the completed Part A portion of the Phase I/II trial next quarter."

The Phase I/II multi-center, open-label trial comprises two parts: Part A, dose escalation and Part B, dose expansion. While Part A of the trial was designed to assess safety, pharmacokinetics and establish a Phase II dose, the dose expansion portion of the trial is primarily designed to assess the clinical activity of BT5528 at the recommended Phase II dose of 6.5mg/m2 every other week that was established in Part A. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on the results of the initial expansion cohorts. Dose expansion in urothelial and ovarian cancers will take place as the Company seeks to build on interim response data previously reported, as well as in a basket cohort of other solid tumors, including non-small cell lung cancer, triple-negative breast cancer, head and neck, and esophageal cancer.

On June 8, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Wednesday, June 15, 2022, at 2:00 p.m. PT (Press release, Alector, JUN 8, 2022, View Source [SID1234615754]).

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!

A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for at least 90 days following the event.

On June 8, 2022 Advaxis, Inc. (OTCQX: ADXSD), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported its financial results for the second quarter ended April 30, 2022 and provides a business update (Press release, Advaxis, JUN 8, 2022, View Source [SID1234615753]).

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!

Second Quarter Ended April 30, 2022 Financial Results and Recent Key Accomplishments:

Announced publication of The KEYNOTE-046 study in The Oncologist reporting that ADXS-PSA in combination with KEYTRUDA (pembrolizumab) is associated with prolonged overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC)
Announced updated clinical and immunogenicity data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL
In Part B, enrolling patients failing KEYTRUDA as last therapy and receiving ADXS-503 + KEYTRUDA, overall response rate (ORR) was 14% (2/14) and Disease Control Rate (DCR) was 36% (5/14)
Long-term follow up suggests that patients who achieve durable clinical benefit upon addition of ADXS-503 to pembrolizumab include those with PD-L1 expression ≥50% and secondary resistance to KEYTRUDA
ADXS-503 has pleiotropic effects that may reverse the resistance and/or enhance the activity of KEYTRUDA in patients with durable clinical benefit, including: the elevation of serum cytokines, the activation of Natural Killer (NK) cells, the proliferation and activation of exhausted CD8+ T-cells and the emergence of memory CD8+ T cells.
In Part C, enrolling patients receiving ADXS-503 + KEYTRUDA in the 1st-line metastatic setting, data continue to show a DCR of 67% (2/3)
Announced study design for investigator-initiated trial with the second off-the-shelf, multi-neoantigen immunotherapy developed at Advaxis (ADXS-504) for biochemically recurrent prostate cancer at Columbia University
Announced 1-for-80 Reverse Stock Split
The Company’s common stock will continue to trade on the OTCQX under the current symbol: "ADXS," with a "D" placed on the ticker symbol for 20 business days after the split
The new CUSIP number for the common stock following the Reverse Stock Split will be 007624406
Upcoming milestones
Present additional clinical and immune correlative data from Phase 1/2 clinical trial of ADXS-503
Present initial clinical and biomarker date from Phase 1 clinical trial of ADXS-504
Management Commentary

Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, "We presented encouraging clinical results at ASCO (Free ASCO Whitepaper) which demonstrate the benefits that select patients are experiencing in our on-going phase 1/2 study of ADXS-503 with pembrolizumab both in the setting of failing pembrolizumab as last therapy and in the 1st-line metastatic setting. We look forward to the continuing the enrollment of patients in part B of the study with the goal of achieving the target 20% ORR and to the continued enrollment and advancement of our clinical trial of ADXS-504 in collaboration with researchers at Columbia University. In addition, we have completed the execution of the 1-for-80 reverse stock split which allows the company to pursue a return to listing on the NASDAQ." Mr. Berlin added, "We continue to control our expenses and foresee our cash runway extending into the second fiscal quarter of 2024."

Second Quarter Ended April 30, 2022 Financial Results

Research and development expenses for the second quarter of fiscal year 2022 were $1.5 million, compared with $4.3 million for the second quarter of fiscal year 2021. The reduction of $2.8 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued. General and administrative expenses for the three months ended April 30, 2022 were approximately $1.8 million, compared to $3.4 million in the same three-month period in 2021. The decrease of $1.6 million primarily relates to decreases in rent and utilities, personnel costs and consulting costs.

As of April 30, 2022, the Company had approximately $32.1 million in cash and cash equivalents.