Black Diamond Therapeutics Plunges On Safety Signals In Solid Tumor Study

 

• Black Diamond Therapeutics Inc BDTX 34.55% reported initial data from the Phase 1 dose-escalation portion of the Phase 1/2 MasterKey-01 trial evaluating BDTX-189 in patients with advanced solid tumors.
• The data will be presented at the American Society of Clinical Oncology Annual Meeting.
• Till the cut-off date of April 2, 55 patients from twice-daily regimen were dosed. In a heavily pre-treated patient population, evidence of anti-cancer activity was observed.
• One confirmed partial response was observed in a lung cancer patient with EGFR Exon 20 mutation, who had previously responded and then progressed on poziotinib (at the data cut-off, 53% tumor regression observed).
• All three patients with NSCLC HER2 Exon 20 demonstrated stable disease.
• In the HER2-amplification cohort (n=6), one confirmed partial response (PR), with 90% tumor reduction, one unconfirmed PR (NSCLC), two patients with stable disease (ovarian and pancreatic), and two patients with progressive disease were observed.
• On the safety front, gastrointestinal events were the most common drug-related adverse events, low grade and manageable after medical intervention.
• 50% of the patients reported diarrhea & nausea, followed by vomiting in 30%. 13% also reported skin disorders.
• The company remains on track to initiate the potentially pivotal Phase 2 portion of the MasterKey-01 trial in the second half of 2021.
• Price Action: BDTX shares are down 29.2% at $15.74 during the premarket session on the last check Thursday.

https://www.benzinga.com/general/biotech/21/05/21212349/black-diamond-therapeutics-stock-plunges-on-safety-signals-in-solid-tumor-study-of-bdtx-189

Sensei Biotherapeutics has new Phase 1/2 head/neck carcinoma data at ASCO

 Data continue to show that SNS-301 in combination with pembrolizumab is well tolerated –

– One deep (71% tumor reduction) and durable (11 months) partial response and two longstanding (8 and 10 months) stable diseases observed in patients with no response to prior PD-1 blockade –

– Data show potential of company’s proprietary ImmunoPhage™ platform to expand and improve current oncology treatments −

Data from Phase 1/2 Trial of SNS-301 SSCCHN As of April 14, 2021

Data highlighted today are part of a poster (#6029), titled: “Update on Safety and Efficacy of a Phase 1/2 Trial of SNS-301 and Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck.” The abstract and related poster can be downloaded from the ASCO Meeting Library.

https://finance.yahoo.com/news/sensei-biotherapeutics-announces-clinical-data-210300950.html

Innoviva in strategic buyback of Glaxo's stake

 

• Innoviva to repurchase GSK’s current 32% stake in the company for $392 million

Innoviva, Inc. (NASDAQ: INVA) ("Innoviva" and "the Company") today announced the execution of definitive agreement to purchase of GSK’s equity stake in Innoviva, constituting approximately 32 million shares, or 32% of the outstanding common stock, at $12.25 per share, representing a 3% discount to the 5-day volume weighted average price of the Company’s common stock, for a total purchase price of $392 million.

Pavel Raifeld, Chief Executive Officer of Innoviva, stated: "We view the buyback as a compelling and highly accretive transaction demonstrating our ability to act strategically and opportunistically at the same time. We believe that it materially accelerates the delivery of our strategy, while also meaningfully improving our shares’ long-term trading dynamics with an aligned shareholder base. We remain focused on, and strongly positioned for, continued significant value creation for the benefit of all shareholders."

"GSK was our largest shareholder for many years and remains a key commercial partner. We are confident in the collaboration products’ excellent commercial prospects, especially given strong recent performance in the face of a challenging environment, and look forward to continued work with GSK to address significant unmet medical needs for patients suffering from respiratory diseases," concluded Mr. Raifeld.

Moelis & Company acted as a financial advisor and Willkie Farr Gallagher acted as a legal advisor to Innoviva.

https://finance.yahoo.com/news/innoviva-announces-strategic-repurchase-gsk-134000983.html

I-Mab showcases early cancer data at ASCO

 

• I-Mab (NASDAQ: IMAB) unveiled early results from Phase 1 study evaluating uliledlimab in combination with Roche Holdings AG’s (OTC: RHHBY) Tecentriq (atezolizumab) in patients with advanced cancer.

• An abstract detailing data from the trial will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place next month.

• I-Mab touted a 23% objective response rate and disease control rate of 46% in the study among 13 evaluable patients with several different types of advanced cancers.

• A patient with ovarian cancer achieved a complete response; two others saw a partial response, while three had stable disease.

• In particular, investigators reported no “hook effect” in the Phase I trial, meaning the antibody potency seemed to increase proportionately with the dose rather than losing inhibition at a higher dose, an issue observed with certain other drugs in the class.

• The clinical activity was observed in both PD-(L)1 treatment naïve and refractory cancer patients, including one partial response patient who previously failed Bristol-Myers Squibb Co’s (NYSE: BMY) Opdivo (nivolumab).

• The combination was safe and well-tolerated with no dose-limiting toxicity. All treatment-related adverse events were either mild or moderate.

https://finance.yahoo.com/news/mab-showcases-early-data-uliledlimab-101729443.html

MacroGenics falls on early stage cancer data: ASCO

 

• Dose escalation: anti-tumor activity observed in melanoma (including one confirmed partial response) and in mCRPC patients

• Cohort expansion in mCRPC: 11/22 (50%) patients have ≥ 50% PSA reduction; anti-tumor activity observed in four of seven patients evaluated (including one unconfirmed partial response)

• Conference call and webcast with external guest presenters on Friday, June 4, 2021 at 4:30 P.M. ET

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the Company’s ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset will be presented in a poster titled “Phase 1 Dose Escalation Study of MGC018, an anti-B7-H3 Antibody-Drug Conjugate (ADC), In Patients with Advanced Solid Tumors” (Abstract #2631) at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4-8, 2021.

Dose Escalation Results Update

The ASCO abstract included data as of January 21, 2021; updated data as of a May 3, 2021 cut-off are included below and will be presented at ASCO.

A total of 29 patients with advanced solid tumors were enrolled in five dose escalation cohorts with MGC018 at 0.5 to 4.0 mg/kg, administered intravenously every three weeks. This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO poster presentation. A recommended Phase 2 dose (RP2D) was defined as 3.0 mg/kg every three weeks.

mCRPC. Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in prostate-specific antigen (PSA) levels of ≥ 50% were observed in five of nine mCRPC patients treated in dose escalation, including one with substantial regression of bone disease. Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease. Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient. The nine mCRPC patients treated in dose escalation received a median of four therapies prior to MGC018, including taxane chemotherapy (eight patients) and next generation hormonal agents (all patients had previously received abiraterone, enzalutamide or both). All nine mCRPC patients in dose escalation are off therapy. Of the five patients who had ≥ 50% PSA reduction, one withdrew consent (without disease progression) at 4 months, one had new bone lesions at 6 months, one initiated subsequent therapy at 6 months, and two had no progression at 7 months.

Safety. Adverse events for the dose escalation cohorts of 0.5 mg/kg to 4.0 mg/kg as of the May 3, 2021 data cut-off were generally consistent with those previously reported at ASCO 2020. MGC018-related toxicities included hematologic and skin toxicities that have been clinically manageable. In dose escalation overall, at least one treatment-related adverse event was experienced by 27 of 29 patients (93%). At 4.0 mg/kg, one patient developed a dose-limiting toxicity manifested by Grade 3 fatigue that lasted for more than 72 hours and as previously reported, a Grade 4 neutropenia occurred in a patient in the 2.0 mg/kg cohort.

Conference Call

MacroGenics’ management will host a conference call and webcast with external guest presenters to discuss the preliminary MGC018 results on Friday, June 4, 2021 at 4:30 P.M. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 1583522. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days.

ASCO Presentation

The abstract for MacroGenics’ MGC018 poster presentation was submitted to ASCO in February 2021 and is available on the ASCO website at https://conferences.asco.org/am/abstracts. The poster will be available for on-demand viewing on the ASCO website and on the Events & Presentations page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm on or around June 4, 2021.

https://finance.yahoo.com/news/macrogenics-announces-preliminary-clinical-results-210500809.html

PDS Bio Phase 2 responses to be reported at ASCO

 Objective responses (tumor reduction) observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve patients and 63% (5 of 8) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy

PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced publication of abstract #2501 by the American Society of Clinical Oncology (ASCO). The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO Annual Meeting taking place June 4-8. The presentation, scheduled for June 7, is expected to include results from a larger sample than the 14 patients included in the abstract.

https://finance.yahoo.com/news/pds-biotech-announces-release-abstract-120000501.html

Adaptimmune Phase 2 gets positive responses in sarcoma; reporting at ASCO

 Data will support BLA filing for afamitresgene autoleucel next year -

- Responses observed across a broad range of antigen expression -

- Initial safety and durability are encouraging -

Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will report initial data from its Phase 2 SPEARHEAD-1 trial, with afamitresgene autoleucel (afami-cel, formerly ADP-A2M4), at the American Society of Clinical Oncology (ASCO) congress. Full abstracts were released online today. Data will be presented in an oral presentation by Dr. Sandra D’Angelo of the Memorial Sloan Kettering Cancer Center (Abstract #11504) on June 4th.

https://finance.yahoo.com/news/two-complete-responses-response-rate-210000957.html