On November 28, 2022 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel quantitative protein and phosphoprotein-based assay for breast cancer, reported the acceptance of two poster presentations evaluating the potential use and utility of its novel RPPA (Reverse Phase Protein Array) technology at the San Antonio Breast Cancer Symposium (SABCS) 2022 (Press release, Theralink Technologies, DEC 1, 2022, View Source [SID1234624733]).

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!

Mick Ruxin M.D., CEO of Theralink Technologies stated, "We are so pleased to have multiple poster presentations accepted at SABCS this year. During our presentations we will highlight the potential of our innovative RPPA-based technology for clinical molecular profiling of breast cancer patients. With the excitement around advancements in treatment options for patients with HER2 Low metastatic breast cancer, it is important as ever to have clarity on HER2 status. The Theralink Assay for Advanced Breast Cancer can provide additional levels of quantified clarity for patients who need it the most."

Additional details on the upcoming posters and corresponding abstracts are shown below. Full text of the abstracts are available on the SABCS website here.

Spotlight Poster Presentation:

Title: ‘Novel Quantitative HER2 Assay for Determining Dynamic HER2 Expression in the HER2 INC 0 "Ultra Low" Setting: Implications for Precision Therapy in HER2- Breast Cancer.’

Session Title: HER2 Low: A Sperate Entity? Special Session – Hall 3

Date: Wednesday, December 7, 2022

Time: 9:45 – 11:00 am CT

Poster Presentation:

Title: ‘Impact of the Theralink CLIA Protein/Phosphoprotein Assay on Treatment Selection in Routine Clinical Practice: a Prospective Observational Study in Advance Breast Cancer.’

Program Number: P4-07-51

Session Title: Poster Session #4 – Hall 1

Date: Thursday, December 8, 2022

Time: 7:00 – 8:15 am CT

The Theralink management team welcomes the opportunity to meet with you in-person in San Antonio at SABCS 2022. Please email [email protected] if you would like to arrange for a private meeting with Theralink representatives.

On December 1, 2022 Provectus (OTCQB: PVCT) reported that new data from the Company’s ongoing, multi-cohort, Phase 1b/2 study of the combination of small molecule cancer immunotherapy PV-10, an intratumoral formulation of Provectus’ rose bengal sodium (RBS) active pharmaceutical ingredient, and anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of immune checkpoint blockade (CB)-naïve Stage III cutaneous melanoma (NCT01223415) are being presented at Melanoma Bridge 2022 in Naples, Italy and online from December 1-3, 2022.

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!

Entitled "Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in stage III cutaneous melanoma," the video oral communication and poster presentation are available by clicking on the Company website links below:

The video communication narrated by Chief Technology Officer Eric Wachter, PhD, and
The conference poster.
Key Highlights of the Melanoma Bridge 2022 Presentation:

Efficacy (6 patients; investigator-assessed RECIST v1.1)
50% complete response (CR) (3/6) and 83% overall response rate (ORR) (5/6)
Rapid CRs – 2 within 15 weeks and 1 within 27 weeks
Durability

Median progression-free survival (PFS) not reached during 2-year treatment interval; 83% PFS rate
All CRs ongoing after 18 to 36 months of study follow-up
Survival

Median overall survival (OS) not reached
100% OS rate for CRs; ongoing after 18 to 36 months of study follow-up
Safety

Consistent with established patterns of PV-10 and Keytruda single-agent use
Consistent with prior PV-10 and Keytruda combination therapy cohorts of CB-naïve and CB-refractory advanced melanoma patients1,2
Mechanism of immune action

Precise, increased, PV-10-induced T-cell activity preceded CR
Similar immune upregulation observed in (a) monotherapy PV-10 treatment of Stage III melanoma patients3 and (b) PV-10 and Keytruda combination treatment of CB-refractory advanced melanoma patients2
Dominic Rodrigues, Vice Chair of Provectus’ Board of Directors said, "These data demonstrate the potential for rapid, durable, complete response in Stage III melanoma patients by combining individually active anticancer agents PV-10 and checkpoint blockade. Intratumoral PV-10 treatment and as-needed retreatment of baseline and any new melanoma lesions use checkpoint blockade to boost the precise, tumor-specific, systemic adaptive immune response generated from the response of PV-10-injected lesions to drive robust patient outcomes."

Planned Combination PV-10 and CB Treatment of 1st-Line Stage III Melanoma

Successfully combining PV-10 and CB in Stage III melanoma patients (50% CR and 83% ORR) is predicated on achieving rapid response of PV-10-injected lesions that may lead to rapid, durable CR of patients and ultimately to improved PFS and OS:

Single-agent PV-10 achieved 56% CR (and 63% ORR) of injected lesions in Stage III patients4, but only 23% CR (and 54% ORR) of non-injected lesions, and a median PFS of 8.9 to 9.8 months 5,
Single-agent CB may exhibit a similar response rate in Stage III (M0) patients (27% CR and 54% ORR) to PV-10’s response rate in non-injected lesions, with a median PFS of 11.7 months 6, and
The combination of PV-10 and CB in CB-naïve Stage IV patients has shown the potential for significant combinational interaction and durability, while also presenting a non-overlapping safety profile1,7.
Mr. Rodrigues added, "To prove the synergistic clinical benefit of combining PV-10 and checkpoint blockade for the first-line treatment of Stage III melanoma, we plan to initiate a Phase 2/3 randomized control trial of PV-10 and standard of care checkpoint blockade versus standard of care checkpoint blockade in 2023. This trial is essentially a head-to-head comparison of PV-10 combination therapy and monotherapy Keytruda."

On December 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the Biologics License Application ("BLA") for the investigational medicine 131I-omburtamab ("omburtamab") for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, DEC 1, 2022, View Source [SID1234624723]).

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 letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.

Y-mAbs is assessing the implications of the CRL and its plans for the omburtamab program.

"We are disappointed by the CRL but not surprised based on the outcome of the ODAC meeting on October 28. We want to express our gratitude to all the patients, their families, and investigators who have participated in our clinical trials and advocated for the advancement of omburtamab," said Thomas Gad, President, and Interim Chief Executive Officer. "While we evaluate the implications of the CRL for the future of omburtamab, we are excited about refining our focus primarily to drive growth from DANYELZA and validate our SADA platform in the clinic, with the goal of bringing innovative solutions to patients and value to our shareholders.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On December 1, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will host an investor event on December 10 during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA (Press release, Affimed, DEC 1, 2022, View Source [SID1234624722]).

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!

Investor event information
Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
Location: New Orleans, LA and virtual
Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies. The investor event will take place in-person and virtually and a webcast of the event will be available in the "Webcasts" section on the "Investors" page of Affimed’s website at View Source
To access the event via phone, please dial +1 (929) 205-6099 for U.S. callers, or +44 (203) 481-5240 for international callers, and reference meeting ID 847 4106 6227 approximately 15 minutes prior to the call.
To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected].
A replay of the webcast/call will be archived on Affimed’s website for 30 days after the call.

About AFM13
AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL). AFM13 has shown single agent efficacy in HL and TCL and is currently being evaluated as monotherapy in a single arm registration-directed trial in peripheral TCL (REDIRECT). In addition, AFM13 showed high response rates in combination with the anti-PD-1 antibody Keytruda (ORR: 88%, CR: 46%) and in combination with allogeneic cord blood-derived NK cells (ORR: 100%, CR: 71%). Affimed recently entered into a partnership with Artiva to develop AFM13 in combination with Artiva’s allogeneic, cryopreserved, NK cell product AB-101 in HL and TCL.

On December 1, 2022 Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, reported that it has assumed full commercial activities and is relaunching oral AKYNZEO (netupitant/palonosetron capsules) in Canada (Press release, Knight Therapeutics, DEC 1, 2022, View Source;in-Canada-12-1-2022 [SID1234624720]).

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!

Knight and Helsinn Healthcare SA ("Helsinn") entered into an exclusive license, distribution and supply agreement for oral/IV AKYNZEO in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI oral/IV (palonosetron) in Canada (the "Products") in May 2022.

AKYNZEO (netupitant/palonosetron capsules) for oral administration is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021.

"We are excited to take over Canadian commercialization of AKYNZEO, an innovative once-per-cycle fixed dose, dual combination antiemetic that offers a leading and guideline-recommended prophylactic treatment for chemotherapy induced nausea and vomiting," said Samira Sakhia, President and CEO of Knight. "AKYNZEO builds upon Knight’s growing Canadian oncology portfolio, increasing our presence in this important therapeutic area."

"Chemotherapy induced nausea and vomiting remain some of the most feared potential side effects of chemotherapy. While remarkable advances have been made in new chemotherapeutics, benefitting the lives of our patients, it is incumbent upon oncologists to try to make their journeys as safe and comfortable as possible. AKYNZEO, a combination of the pharmacologically and clinically distinct 5-HT3 receptor antagonist palonosetron and the selective NK1 receptor antagonist netupitant, has simplified antiemetic prophylaxis, providing an effective therapy with the lowest pill burden, and has been greatly appreciated by our cancer patients," said Dr. Sandeep Sehdev, medical oncologist at the Ottawa Hospital Cancer Centre & Scientific Advisor for the Canadian Breast Cancer Network.

About AKYNZEO
AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone prior to chemotherapy has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.