On May 26, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) will be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7, 2022 (Press release, Leap Therapeutics, MAY 26, 2022, View Source [SID1234615146]).

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"As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study. "DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward."

Key Initial Findings from the Investigator-Sponsored Phase 1b/2a Clinical Trial:

Data that will be presented at ASCO (Free ASCO Whitepaper) is from the completed Phase 1 portion of the study. Thirteen patients were enrolled, with 7 patients in the DKN-01 monotherapy cohort and 6 patients in the DKN-01 plus docetaxel combination cohort. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity (DLT). The study also aims to study correlations between DKK1 expression and tumor genetics, histology and anti-tumor activity.

Highlights from the data include:

No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 5 evaluable patients had a PR as measured by RECIST (3 confirmed, 2 unconfirmed) and by PSA50
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer (AVPC)
Further accrual into the phase 2 part of this study is ongoing, alongside preclinical and correlative studies aimed at investigating the mechanism of action of DKN-01 in prostate cancer.

On May 26, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune, and infectious diseases reported it will deliver an oral presentation and two poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 3 – 7, 2022 (Press release, Immunocore, MAY 26, 2022, View Source [SID1234615163]).

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CLINICAL SCIENCE SYMPOSIUM

Title: Updated overall survival (OS) data from the phase 1b study of tebentafusp (tebe) as monotherapy or combination therapy with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma (mCM)

Presenter: Mark Middleton
Date and Time: June 5, 2022; 9:45 a.m. CDT
Session: Clinical Science Symposium: Bispecifics: Are two better than one?
Abstract ID: 104
POSTER PRESENTATIONS & ABSTRACTS

Title: Treatment with tebentafusp beyond radiographic progressive disease (PD) in metastatic uveal melanoma (mUM)

Presenter: Ryan Sullivan
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9585
Title: Analysis of the effect of systemic corticosteroids on survival from tebentafusp in a phase 3 trial of metastatic uveal melanoma

Presenter: Alexandra Ikeguchi
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9584
Title: Overall survival (OS) in metastatic uveal melanoma: A summary of recent prospective trials

Author: Josep M. Piulats
Publication only
Presentations and posters will be available for registered attendees on the ASCO (Free ASCO Whitepaper) website from June 3-7, 2022.

About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects 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 granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise 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 tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

On May 26, 2022 Alpha Tau Medical Ltd. (NASDAQ: DRTS) (NASDAQ: DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 26, 2022, View Source [SID1234615066]).

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"2022 is an important year for the Company, as we look to initiate a number of important clinical trials across large global markets, including our first U.S. pivotal trial as well as trials in internal organs such as the prostate," commented Alpha Tau CEO Uzi Sofer. "The first quarter of 2022 already saw us reach a number of meaningful milestones, including our first U.S. data read out and our debut as a public company traded on NASDAQ under symbol "DRTS." We are also working in parallel to expand our manufacturing capabilities and to strengthen our supply chain in the U.S., Israel, and Asia, as part of the expansion of our clinical trial activities and future commercialization."

First quarter 2022 Corporate Highlights:

Reported results in January 2022 from the first pilot multi-center study of Alpha DaRT in the United States, led by Memorial Sloan Kettering Cancer Center. In this trial of malignant skin and soft tissue cancer patients, a complete response, as measured by RECIST criteria, was observed in all ten out of ten tumors treated (100%), with no product-related serious adverse events reported. Alongside these data, a 98% overall response rate was observed in a pooled analysis of superficial tumors treated that reached their efficacy endpoint measurement by quarter end, across the Company’s various trials.
Completed patient recruitment in the Company’s Japanese pivotal trial in head and neck cancer, with data submission targeted for the second half of 2022.
Entered into a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center in January 2022 to evaluate the combination of Alpha DaRT with DNA-repair inhibitors and immune checkpoint inhibitors for the treatment of breast tumors.
Completed its business combination in March 2022 with Healthcare Capital Corp., a special purpose acquisition company, together with a concurrent Private Investment in Public Equity (PIPE) financing, raising a total of approximately $104 million in gross proceeds, and commenced trading of its shares and warrants on the Nasdaq Capital Market under the symbols "DRTS" and "DRTSW", respectively.
Appointed Ruth (Ruti) Alon to its Board of Directors in March 2022. Ms. Alon brings a wealth of healthcare experience and serves on the boards of multiple private and public companies in the sector.
Upcoming 2022 Milestone Targets Include:

First Israeli patient in the prostate cancer feasibility trial in the second quarter of 2022.
Initiation of multi-center pivotal U.S. trial in skin cancers in the middle of 2022.
Recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the second half of 2022.
Submission of Alpha DaRT pivotal trial in head and neck cancer to Japan’s PMDA in the second half of 2022 for marketing authorization.
Financial results for the first quarter ended March 31, 2022

R&D expenses for the quarter ended March 31, 2022 were $5.2 million, compared to $2.2 million for the same period in 2021, primarily due to increased R&D activity and increased share-based compensation costs.

Marketing expenses for the quarter ended March 31, 2022 were $0.2 million, compared to $0.2 million for the same period in 2021.

G&A expenses for the quarter ended March 31, 2022 were $3.3 million, compared to $0.4 million for the same period in 2021, primarily due to costs associated with the merger with Healthcare Capital Corp., increased professional fees and share-based compensation.

Financial expenses, net, for the quarter ended March 31, 2022 were $17.0 million, compared to $9.0 million for the same period in 2021, primarily due to an increase in the revaluation of warrants.

For the quarter ended March 31, 2022, the Company had a net loss of $25.7 million, or ($0.54) per share, compared to a loss of $11.7 million, or ($0.29) per share, in the same period in 2021.

Balance Sheet Highlights

As of March 31, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $107.0 million, compared to $31.9 million on December 31, 2021. In addition, incremental proceeds of approximately $13 million from the original PIPE were received after March 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years.

In addition, the Company’s Board of Directors approved a program for the buyback of the Company’s publicly traded warrants in an amount of up to $3 million. Repurchases may be started or suspended at any time without prior notice, depending on market conditions and other factors.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On May 26, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease (SCD), prostate cancer and other rare hematologic diseases and cancers, reported that it will hold a virtual R&D Day today to provide a comprehensive update on its pipeline and strategic vision (Press release, Forma Therapeutics, MAY 26, 2022, View Source [SID1234615083]).

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The R&D event is taking place today at 8:00 a.m. ET. A live webcast will be available in the "News & Investors" section of Forma’s website.

"We are pleased to share insights into Forma’s unique commitment to patients and expansion of etavopivat development into transfusion-dependent populations that have tremendous unmet need across sickle cell disease, thalassemia and MDS," said Frank Lee, president and chief executive officer of Forma.

"In our early stage research pipeline, we are excited to introduce a USP1 program that targets a novel DNA damage repair pathway relevant to a broad range of tumor types." said David Cook, chief scientific officer of Forma. "We are also capitalizing on our knowledge of the emerging science of red blood cell health by exploring areas beyond hematologic disease."

Etavopivat (oral PKR activator) Program in SCD, thalassemia and MDS:

In addition to ongoing enrollment in the Phase II/III Hibiscus Study in SCD, Forma will outline ongoing and anticipated future development plans:

A Phase II trial is enrolling patients in three cohorts: SCD with chronic transfusion, and both transfusion-dependent and non-transfusion-dependent thalassemia. Etavopivat has the potential to address RBC health, hemolytic anemia and/or ineffective erythropoiesis in these populations, leading to reduction of transfusion burden and associated iron overload and improvement of anemia.

A Phase II trial in lower risk MDS is planned to commence in the second half of 2022. Dr. Michael Savona of Vanderbilt University will review the significant unmet need in lower-risk MDS and the potential for etavopivat to provide a well-tolerated oral treatment that may be able to improve the ability of bone marrow to produce healthier RBCs.

Analyses from the completed Phase I trial in SCD show benefit in both pain events reported in the trial and vaso-occlusive crises (VOC’s) occurring on treatment.

Enrollment in the Phase II/III Hibiscus Study in SCD is on track for the first interim analysis (IA1) in late 2022.

FT-7051 (oral CBP/p300 inhibitor) in prostate cancer:

Forma’s Phase I trial continues to enroll men with metastatic castration-resistant prostate cancer (mCRPC).

As of May 12, 2022, 25 patients have enrolled in the Phase I dose escalation trial, assessing the predicted efficacious exposure range supported by target engagement.

The trial population is heavily pre-treated, with a high AR-v7 positivity rate and mutation burden.

Future trial enrollment to include less heavily pre-treated patients and alternative dosing schedule to address adverse events, with updated results expected in the first half of 2023.

Research Pipeline/RBC Health:

Forma’s ongoing research efforts are focused on novel mechanisms of action in oncology and expansion in red blood cell health and hematologic diseases:

Forma’s research pipeline is led by the USP1 program (FT-3171), targeting a novel DNA damage repair pathway with potential to address multiple tumor types in both poly ADP ribose polymerase inhibitor (PARPi)-sensitive and resistant settings.

FT-3171 IND filing is expected in the first half of 2023.

Ongoing pre-clinical research is targeting areas of expansion for RBC health, novel mechanisms that may be complementary to etavopivat in rare hematology, and targeted oncology.

On May 26, 2022 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported multiple presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3 to June 7, 2022 (Press release, Replimune, MAY 26, 2022, View Source [SID1234615099]).

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Details for the presentations are as follows:

Data presentation

Updated results from the skin cancer cohorts from an ongoing Phase 1/2 multi-cohort study of RP1, an enhanced potency oncolytic HSV, combined with nivolumab (IGNYTE)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 146
Abstract: 9553
Trial in progress presentations

A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 184a
Abstract: TPS9593
An open-label, multicenter, phase 1b/2 study of RP1, a first-in-class, enhanced potency oncolytic virus in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 187a
Abstract: TPS9597
A phase 1 trial of RP2, a first-in-class, enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody as a single agent and combined with nivolumab in patients with advanced solid tumors

Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 339b
Abstract: TPS2704
An open-label, multicenter, phase 1 study of RP3 as a single agent and in combination with nivolumab in patients (pts) with solid tumors

Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 340a
Abstract: TPS2705
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.

Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.