On September 14, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported Phase 1 data with brenetafusp in patients with platinum resistant ovarian cancer at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Immunocore, SEP 14, 2024, View Source [SID1234646571]). In a proffered session to be held on Monday, September 16, 2024, the Company will present translational Phase 1/2 data with KIMMTRAK (tebentafusp-tebn) and brenetafusp demonstrating that T cell fitness gene expression signature in blood is an important parameter associated with clinical activity for both therapies in metastatic uveal melanoma.

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"Brenetafusp monotherapy is active in heavily pre-treated, platinum resistant ovarian cancer patients and can be combined safely with chemotherapy. We see the hallmarks of ImmTAC clinical activity in this Phase 1 data, such as disease control, ctDNA molecular response, and association with T cell fitness, which increases our confidence in the potential for brenetafusp in ovarian cancer," said David Berman, Head of Research and Development. "While early, the promising efficacy data from chemotherapy plus brenetafusp led us to expand the combinations we are studying, including in earlier-line platinum sensitive disease."

Dr. Claire Friedman, Gynecologic Medical Oncologist & Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, said: "While many solid tumors have benefited from the advances in immunotherapy, the treatment of recurrent ovarian cancer has remained an ongoing challenge. These data offer proof of concept that patients with advanced, platinum-resistant ovarian cancer can benefit from brenetafusp, alone or in combination with chemotherapy, and support further development of the drug in this patient population."

Phase 1 monotherapy data in heavily pre-treated platinum resistant ovarian cancer patients

Thirty-seven patients with heavily pre-treated (median 5 prior lines) serous ovarian cancer were treated with brenetafusp monotherapy, including four patients previously presented in the efficacy data set at ESMO (Free ESMO Whitepaper) 2022. A majority of patients had received prior bevacizumab (81%) and PARP inhibitors (59%).

Brenetafusp was well tolerated with no treatment-related discontinuation or death observed. The most frequent treatment-related adverse event was reversible and manageable cytokine release syndrome, observed in 57% of patients, with the majority being Grade 1.

Thirty-one of the 37 monotherapy patients were evaluable for RECIST v1.1 tumor assessment, 58% of whom demonstrated disease control (partial response and stable disease), including two confirmed partial responses (6.5% RECIST response rate). Of patients who had tumor progression, 64% were treated beyond progression (median of 2 additional months). Across all 37 patients, the median progression-free survival (PFS) was 3.3 months, and the overall survival (OS), while still maturing, was 73% at 6 months.

Of the 29 monotherapy patients evaluable for circulating tumor DNA (ctDNA) response, 31% (9/29) had a molecular response (≥0.5 log reduction by week 9).

Twenty-eight monotherapy patients were evaluable for baseline blood T cell fitness (TCF) gene expression signature. There was greater activity in patients with a TCF signature above median versus those at or below the median, respectively, including: disease control (80% vs 38%), PFS (3.7 months vs 2.2 months) and six-month OS (93% vs 47%).

Phase 1 chemotherapy combination data in heavily pre-treated platinum resistant ovarian cancer patients

As presented today at ESMO (Free ESMO Whitepaper) in a pre-clinical study poster (1021P), the combination of chemotherapy with brenetafusp has the potential to enhance clinical activity by increasing expression of the antigen presentation machinery in cancer cells.

In the Phase 1 trial, 16 patients with platinum-resistant ovarian cancer were treated with brenetafusp and either gemcitabine, nab-paclitaxel or pegylated doxorubicin chemotherapy. These patients were heavily pre-treated (median of 4 prior treatment lines) including prior bevacizumab (75%) and PARP inhibitors (75%). The safety profile of brenetafusp in combination with chemotherapy was consistent with the expected profile of each individual agent.

Thirteen of the 16 combination patients were evaluable for RECIST v1.1 tumor assessment. All 13 patients received prior platinum and taxane therapy, and 6 received prior gemcitabine. Sixty nine percent (9/13) of patients achieved disease control, including three partial responses (23% RECIST response rate). Historical chemotherapy efficacy data in this heavily pre-treated patient population is sparse but indicate response rates are less than 10%, with disease control rates typically ~40-50%1.

Eleven of the 16 combination patients were evaluable for ctDNA response. The molecular response rate was 82% (9/11). As previously reported for brenetafusp in cutaneous melanoma (ASCO 2024), ctDNA molecular response in this trial was also associated with longer OS and PFS.

T cell fitness associated with clinical benefit across ImmTAC platform and in different tumor types

At an oral proffered session on Monday, September 16, 2024, the Company will present translational data from previously treated, metastatic uveal melanoma (mUM) patients, including 132 patients treated with KIMMTRAK in a Phase 1/2 trial, and 22 patients treated with brenetafusp in a Phase 1 trial.

In the KIMMTRAK cohort, patients with a TCF signature greater than or equal to the median had higher clinical activity compared to patients with a TCF signature below the median, respectively, including longer OS (28 months vs 11 months), PFS (5 months vs 2 months) and disease control (67% vs 36%). The association of TCF signature with longer OS was independent of known prognostic factors in uveal melanoma. In addition, the TCF signature was associated with greater tumor reduction and a higher rate of on-target, melanocyte-related adverse events; both are consistent with the mechanism of action, and suggest that the signature is not purely prognostic.

This TCF signature, discovered for KIMMTRAK in mUM, was subsequently confirmed as an important parameter of clinical activity for brenetafusp in mUM (ESMO 2024), ovarian cancer (ESMO 2024), and cutaneous melanoma (ASCO 2024). The accumulating data suggests that ImmTAC therapies may deliver greater clinical activity in earlier line patients, where TCF is expected to be higher, leading the Company to investigate brenetafusp in these populations.

About ImmTAC molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

About the IMC-F106C-101 Phase 1/2 trial

IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers including non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. The Company is enrolling patients into three expansion arms in ovarian, NSCLC, and endometrial cancers. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp.

About Ovarian Cancer

Most patients with ovarian cancer are diagnosed with advanced disease, giving it the highest mortality amongst gynecological malignancies in the US and Europe. The current standard of care is surgery followed by platinum-based chemotherapy, and although many patients initially respond, the disease often recurs and, over time, becomes resistant to further platinum therapy. There is significant unmet need for new therapies that improve clinical outcomes in both platinum-sensitive and platinum-resistant ovarian cancer patients.

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma affecting the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).

On September 14, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported the company presented a poster analyzing real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations (NCMs) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place September 13-17, in Barcelona, Spain (Press release, Black Diamond Therapeutics, SEP 14, 2024, View Source [SID1234646567]).

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Of 11,434 sequenced cases of newly diagnosed and treatment-naïve EGFRm NSCLC within the Guardant Health (GuardantINFORM) clinical-genomic database, first-line treatment information was available and evaluated for 3,276 patients. Results revealed the presence of a broad spectrum of NCMs, including P-loop and αC-helix compressing (PACC) mutations, and allowed correlation with real-world treatment practices and therapeutic outcomes. Findings further demonstrated that current treatment practices for patients with NCMs are heterogenous: 36% of patients received osimertinib or afatinib and 60% of patients received chemotherapy and/or immunotherapy.

"There is a growing unmet need for new treatments for newly diagnosed NSCLC patients with PACC and other non-classical EGFR mutations," said John Heymach, M.D., Ph.D., Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. "Real-world treatment outcomes show that current EGFR TKIs provide little benefit to these patients, and chemotherapy brings significant toxicity, administration burden, and limited efficacy."

Newly diagnosed patients expressing NCMs discontinued osimertinib therapy at a median of 6.0 months versus patients expressing classical mutations, who remained on therapy for 13.8 months. Patients receiving afatinib discontinued therapy at a median of 8.0 months, and the median time to treatment discontinuation for patients on chemotherapy was 4.2 months.

"BDTX-1535 was designed to address a broad spectrum of EGFR mutations, with emphasis on non-classical mutations that extend beyond PACC mutations," said Elizabeth Buck, Ph.D., Chief Scientific Officer and co-founder of Black Diamond Therapeutics. "BDTX-1535 is the most advanced fourth- generation EGFR TKI in clinical development to address this underserved patient population."

The new real-world results build upon findings presented at the 2024 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting around the evolving EGFR mutation landscape in NSCLC that revealed more than 100 NCMs, which can be present in 20-30% of newly diagnosed patients. Black Diamond plans to disclose initial Phase 2 data in Q1 2025 in the first-line NCM setting. The company also plans to release initial Phase 2 results in the second/third-line setting later this month.

On September 14, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported updated Phase 1/2 clinical results for Bicycle Toxin Conjugate (BTC) zelenectide pevedotin (formerly BT8009) in metastatic urothelial cancer (mUC); BTC molecule BT5528 in advanced solid tumors, such as mUC and ovarian; and Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) BT7480 in advanced solid tumors (Press release, Bicycle Therapeutics, SEP 14, 2024, View Source [SID1234646566]). The company also shared an analysis of peripheral neuropathy, a key adverse event of interest associated with monomethyl auristatin E (MMAE)-based drug conjugates, in patients treated with BTC molecules. These data will be presented during a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona today.

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"We are pleased that the data presented at ESMO (Free ESMO Whitepaper) continue to support the promising response and differentiated safety profiles of our Bicycle molecules. Importantly, our lead investigational therapy zelenectide pevedotin continues to demonstrate an overall response rate that is in line with other drug conjugates used to treat metastatic urothelial cancer, but with a marked improvement in tolerability. Overall, we believe the data continue to demonstrate the potential of our Bicycle technology platform to create differentiated medicines designed to help patients not only to live longer but also to live well," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. "These clinical data are just the first set of updates that we have guided to delivering this year. In the coming months, we look forward to sharing initial imaging data from our growing radiopharmaceutical pipeline and additional data for zelenectide pevedotin in bladder, breast and lung cancer."

ESMO 2024 Data Highlights

Zelenectide pevedotin is a BTC molecule targeting Nectin-4, a well-validated tumor antigen, designed to overcome the significant toxicity associated with other drug conjugate approaches. Updated results from the ongoing Phase 1/2 Duravelo-1 trial evaluating 5 mg/m2 weekly of zelenectide pevedotin monotherapy in 45 mUC patients who had not previously been treated with enfortumab vedotin showed:

Among 38 efficacy-evaluable patients, a 45% overall response rate (ORR), including 1 confirmed complete response and 16 partial responses (13 confirmed). Stable disease was maintained in 9 patients, and 12 patients experienced progressive disease.
A median duration of response of 11.1 months among the 14 patients with confirmed responses.
An emerging differentiated safety profile, particularly around adverse events of interest such as peripheral neuropathy, skin reactions and eye disorders. Notably, there were no Grade ≥3 treatment-related adverse events (TRAEs) of peripheral neuropathy (any kind), skin reactions or eye disorders, and patients with pre-existing peripheral neuropathy were unlikely to develop worsening peripheral neuropathy during treatment with zelenectide pevedotin.
The global Phase 2/3 Duravelo-2 registrational trial of zelenectide pevedotin in patients with mUC is currently enrolling. Additional data updates for zelenectide pevedotin in combination with pembrolizumab in first line mUC and monotherapy in late line triple-negative breast cancer and non-small cell lung cancer (NSCLC) are planned for later this year.

BT5528 is a BTC molecule targeting EphA2, a tumor antigen that is widely expressed in many cancers and has historically been difficult to target using other drug conjugate approaches. Updated results from the ongoing Phase 1/2 trial evaluating 6.5 mg/m2 every two weeks and 5 mg/m2 weekly of BT5528 monotherapy in patients with advanced solid tumors showed:

Among 113 efficacy-evaluable patients, a 12% ORR in patients with advanced solid tumors.
The highest anti-tumor activity in mUC, with a 34% ORR in all efficacy-evaluable patients enrolled in the dose escalation and expansion cohorts. Among patients receiving 6.5 mg/m2 every two weeks, a 31% ORR was observed in the dose escalation and expansion cohort and a 45% ORR was observed in the expansion cohort only. A lower but acceptable ORR of 27% was observed in patients receiving 5 mg/m2 weekly.
No objective responses in patients with ovarian cancer who received 5 mg/m2 weekly. However, 5 patients maintained stable disease.
A suggested correlation between EphA2 expression and response. Among 14 patients with mUC who had available immunohistochemistry and response data, a 43% ORR was observed in EphA2-positive patients compared to a 20% ORR in EphA2-negative patients.
A clearly differentiated emerging safety profile, with none of the hemorrhage events or hematological toxicities that have been associated with other EphA2-targeting drug conjugates.
The company has begun assessing BT5528 at 6.5 mg/m2 every two weeks in combination with nivolumab. Results from this cohort are expected in 2025.

Low rates of treatment-related peripheral neuropathy (TRPN) following monotherapy treatment with BTC molecules zelenectide pevedotin or BT5528. In 149 patients treated with zelenectide pevedotin and 74 patients treated with BT5528 from ongoing Phase 1/2 studies, results showed:

TRPN in 28% of patients treated with zelenectide pevedotin and 19% of patients treated with BT5528, nearly all of which were low grade (1-2). One Grade 3 event (neuralgia) was reported in a patient treated with zelenectide pevedotin following prior therapy with enfortumab vedotin. No Grade 3-4 events were observed for BT5528.
Among zelenectide pevedotin-treated patients with peripheral neuropathy at baseline, 80% did not develop TRPN during treatment.
TRPN resulted in few dose modifications across the overall patient populations for zelenectide pevedotin and BT5528, and no drug withdrawals were necessary for either BTC molecule.
TRPN had completely resolved in 14% (zelenectide pevedotin) and 21% (BT5528) of patients, and 26% and 21%, respectively, had some resolution or improvement at time of reporting, though post-treatment follow-up was limited. Median time to resolution or improvement of TRPN was 2.2 weeks for zelenectide pevedotin and 1.7 weeks for BT5528.
The data support the hypothesis that the antibody-drug construct may be a primary driver of peripheral neuropathy rather than MMAE toxicity as was previously believed.

BT7480 is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Initial data from the Phase 1/2 dose escalation trial evaluating BT7480 in patients with advanced solid tumors showed:

Among 39 patients assigned to receive one of 10 different doses (0.002-3.5 mg/kg weekly) of BT7480, an emerging differentiated safety and tolerability profile with a low number of severe adverse events. Low rates of Grade ≥3 TRAEs (5%) and of treatment-related severe adverse events (TRSAEs) (8%) were reported, with no such events among those receiving the highest dose of 3.5 mg/kg.
Best overall response of stable disease in 13 patients, 5 of whom had NSCLC. Stable disease was prolonged (>8 months) in 3 patients, 2 with NSCLC and 1 with anal cancer. There were 2 unconfirmed partial responses, both in patients with cervical cancer.
Preliminary biomarker analyses that support BT7480 dual targeting of CD137 and Nectin-4 as demonstrated by enhanced immune cell activation, aligned with the proposed mechanism of action of BT7480.
As the maximum tolerated dose for BT7480 has not yet been reached, the company is continuing dose exploration in combination studies, starting with nivolumab.

The posters are available in the Publications section of the Bicycle Therapeutics website.

On October 10, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported that it has entered into a multi-target antibody discovery collaboration with Umoja Biopharma, a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-T cell therapies in oncology and autoimmunity (Press release, Nona Biosciences, SEP 13, 2024, View Source [SID1234647140]). This collaboration leverages Nona’s proprietary fully human heavy chain only antibody (HCAb) technology to produce novel in vivo generated CAR-T cell therapy drug candidates.

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Fully human HCAbs have the potential to significantly reduce immunogenicity and offer versatility in CAR design due to their compact size, simplified structure, and precisely calibrated binding properties. This partnership aims to combine Nona’s HCAb Harbour Mice platform and direct CAR-function-based HCAb library screening platform (NonaCarFx) with Umoja’s VivoVec platform to develop novel in vivo CAR-T cell therapies and expand the potential reach of this innovative delivery technology.

Dr. Jingsong Wang, MD, PhD, Chairman of Nona Biosciences, commented, "We are excited to collaborate with Umoja Biopharma, a pioneer in cell and gene therapy. We believe that our HCAb Harbour Mice technology and NonaCarFxTM platform, alongside with our extensive experience in oncology and immunology, will empower Umoja to generate novel CAR-T cell therapies that benefit patients worldwide."

Byoung Ryu, PhD, Umoja’s Executive Vice President of Discovery Research and Vector Biology added, "Nona is a great partner for Umoja as we continue to move the CAR-T cell field towards directly administrated in vivo CAR therapeutics. Nona has demonstrated capabilities for generating highly functional CAR candidates, and we look forward to developing multiple in vivo drug candidates through this partnership and ultimately, helping change outcomes for these patients."

On September 13, 2024 Krystal Biotech, a commercial-stage biotechnology company, reported that the Company will participate in the 2024 Cantor Global Healthcare Conference on September 18, 2024, in New York. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 1:20 pm ET and host investor meetings throughout the day (Press release, Krystal Biotech, SEP 13, 2024, View Source [SID1234646621]).

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A webcast of the presentation will be available here beginning at 1:20 pm ET on Wednesday, September 18, 2024 and will be posted on the Investors section of the Company’s website.