On January 17, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that management will be participating in the following investor conference (Press release, Gritstone Bio, JAN 17, 2024, View Source [SID1234639289]):

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B. Riley Securities’ 4th Annual Oncology Conference (Fireside Chat)
Date and Time: Thursday, January 18, 2024 at 1:30pm ET
Presenter: Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer

A live webcast of the fireside chat will be available via View Source An archived replay will be accessible for 30 days following each event.

On January 17, 2024 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), reported that the final patient has been enrolled in its Phase I clinical trial (Press release, Evogene, JAN 17, 2024, View Source [SID1234639287]).

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Initiated on July 11, 2022, the Phase I trial was specifically designed to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy. Bristol Myers Squibb’s Opdivo is the immune checkpoint inhibitor in the trial. The study takes place at The Davidoff Center and the Rambam Health Care Campus in Israel.
Biomica remains on track with preliminary results, and the first data point readout is expected in H1 2024.

Dr. Elran Haber, CEO of Biomica, stated: "We are pleased to complete the Phase 1 Proof of Concept study enrollment, marking a critical step forward in developing our groundbreaking BMC128. We are excited about the progress made thus far and confident about the potential of BMC128 to address the unmet needs in the treatment of ICI-refractory cancer patients."

About BMC128:
BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by MicroBoost AI tech engine.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

On January 17, 2024 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from January 25-27 in San Francisco, California, highlighting the company’s progress in making long-term survival outcomes a possibility for more patients with genitourinary cancers, as well as showcasing potential new options and therapeutic platforms that may transform treatment paradigms across tumor types (Press release, Bristol-Myers Squibb, JAN 17, 2024, View Source [SID1234639285]). Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.

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The first presentation of data from the CheckMate -67T study will highlight the potential of a subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) in advanced or metastatic clear cell renal cell carcinoma (RCC). Research to be shared will also add to the evidence supporting the use of Opdivo (nivolumab)-based combinations in patients with advanced RCC, including four-year follow-up data from the CheckMate -9ER trial and eight-year results from the CheckMate -214 trial. In addition, data will be presented on an investigational androgen receptor (AR) ligand-directed degrader (LDD; BMS-986365) in metastatic castration-resistant prostate cancer (mCRPC), providing validation for the targeted protein degradation platform in solid tumors and representing one of the company’s next waves of potential registrational assets.

"We are excited to present our research at ASCO (Free ASCO Whitepaper) GU 2024, which will demonstrate not only our long-standing leadership in oncology with our work in immunotherapy, but also our commitment to developing new assets and approaches to treating cancer from our differentiated research platforms such as targeted protein degradation in an effort to provide patients with better, long-term outcomes," said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb. "These results simultaneously showcase the ongoing success of Opdivo-based combinations in metastatic disease and our contributions to the future of cancer treatment and research. We are especially eager to share data for the first time showing the potential of our subcutaneous formulation of a proven agent, and a new mechanism of action in a difficult-to-treat tumor type – both of which could have a tremendous impact on existing standards of care and the patient experience."

Key data being presented by Bristol Myers Squibb at ASCO (Free ASCO Whitepaper) GU 2024 include:

First disclosure of pharmacokinetics, efficacy and safety results from the Phase 3 CheckMate -67T trial with subcutaneous nivolumab (nivolumab and hyaluronidase) being presented in a late-breaking oral session. This marks the first presentation of data evaluating subcutaneous nivolumab compared to its intravenous formulation.
Eight-year data from the Phase 3 CheckMate -214 study with Opdivo plus Yervoy (ipilimumab) showing ongoing survival and response benefits over sunitinib among intermediate- and poor-risk patients with advanced RCC, as well as among all randomized patients. These data represent the longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic RCC.
Four-year follow-up data from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with Exelixis’ CABOMETYX (cabozantinib). These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for previously untreated advanced RCC.
First presentation of clinical outcomes from the company’s targeted protein degradation platform in solid tumors with Phase 1 data from BMS-986365 (CC-94676), an oral drug selectively targeting AR. BMS-986365 induces effective and durable suppression of AR signaling, overcomes resistance to existing AR pathway inhibitors (ARPI) therapies and shows promising clinical activity in heavily pre-treated patients with mCRPC across wildtype, amplified and mutant AR status, highlighting this asset as the potential best-in-class AR-ligand directed degrader that may help overcome resistance to standard of care ARPIs in patients with mCRPC, a difficult-to-treat tumor type.
Summary of Presentations:

Abstract Title

Author

Presentation
Type/#

Session Title

Session
Date/Time (ET)

Prostate Cancer

First-in-human phase 1 study of CC-94676, a first-in-class androgen receptor (AR) ligand-directed degrader (LDD), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Dana Rathkopf

Poster

Abstract #134

Poster Bd. #F5

Poster Session A: Prostate Cancer

Thursday, January 25

2:30 PM – 4:00 PM

Renal Cell Carcinoma

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.

Saby George

Oral

Abstract #LBA360

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Results from 55-month follow-up of the CheckMate 9ER trial.

Maria Teresa Bourlon

Rapid Oral

Abstract #362

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): Long-term follow-up data from the phase 3 CheckMate 214 trial.

Nizar Tannir

Rapid Oral

Abstract #363

Rapid Oral Abstract Session C: Renal Cell, Adrenal, and Testicular Cancers

Saturday, January 27

4:00 PM – 5:15 PM

Adjuvant nivolumab monotherapy vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from Part B of the randomized, phase 3 CheckMate 914 trial.

Robert Motzer

Oral

Abstract #LBA358

Oral Abstract Session C: Renal Cell Cancer

Saturday, January 27

11:10 AM – 12:45 PM

Treatment patterns and costs among patients with metastatic renal cell carcinoma (mRCC) in the United States: A real-world study using integrated claims and clinical data.

Daniel Geynisman

Poster

Abstract #398

Poster Bd. #F22

Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers

Saturday, January 27

10:00 AM – 11:00 AM

Urothelial Carcinoma

Estimating the impact of adjuvant treatment with nivolumab on long-term survivorship rates compared with surveillance: Analyses of disease-free survival (DFS) from the phase 3 CheckMate-274 trial.

Daniel Geynisman

Oral

Abstract #528

Role of Immunotherapy in Advanced Urothelial Carcinoma: Sequencing, Pairing, Rechallenging

Friday, January 26

5:30 PM – 6:45 PM

Characteristics of patients (pts) with muscle-invasive urothelial carcinoma (MIUC) who received adjuvant nivolumab (NIVO) or adjuvant platinum-based chemotherapy (CHEMO) in the real-world (RW) setting.

Alex Chehrazi-Raffle

Poster

Abstract #565

Poster Bd. #E14

Poster Session B: Urothelial Carcinoma

Friday, January 26

2:30 PM – 4:00 PM

All abstracts except late-breaking abstracts will be available on ASCO (Free ASCO Whitepaper)’s digital program at 5:00 PM Eastern Time (ET) on January 22, 2024. All late-breaking abstracts will be available on ASCO (Free ASCO Whitepaper)’s digital program at 10:00 AM ET on their day of presentation at the meeting.

On January 17, 2024 Amplia Therapeutics reported that the first patient in the Phase IIa portion of the ACCENT trial has begun dosing (Press release, Amplia Therapeutics, JAN 17, 2024, View Source [SID1234639272]). The ACCENT trial is examining the combination of Amplia’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy in first-line patients with advanced pancreatic cancer.

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In November 2023, the Company announced completion of the Phase 1b stage of the ACCENT trial where ascending doses of narmafotinib, in combination with the standard-of-care chemotherapy regime of gemcitabine and Abraxane, were dosed to first-line patients with advanced pancreatic cancer. This dose-escalation stage identified a safe and well-tolerated dose of narmafotinib that provides sufficient circulating drug levels to significantly block the activity of the FAK enzyme.

Importantly, there were promising preliminary signs of efficacy from the collected Phase 1b data. The identified dose of narmafotinib is now being tested in patients, in combination with gemcitabine and Abraxane, in a Phase 2a trial.

The Phase 2a trial is being conducted at six trial sites open in Melbourne, Sydney and Brisbane and the five additional sites which have been opened in Korea. The trial will initially enrol 26 patients over the coming months and an interim analysis of efficacy will then be conducted in mid-2024. An efficacy assessmentshowing six or more partial or complete responses out of the 26 patients will be considered statistically significant to continue the trial. An additional 24 patients will then be enrolled to give a total of 50 patients for this trial.

Amplia CEO and MD Dr Chris Burns commented: "Initiation of the Phase 2a stage of the trial is a significant milestone for Amplia. We are excited to be moving ahead with the nextstage of the ACCENT trial with a safe and well-tolerated dose of narmafotinib. The trial in advanced pancreatic patients will determine whether narmafotinib, in combination with gemcitabine and Abraxane, provides improved efficacy forthe treatment of this devastating cancer. Patients and clinicians are desperate for improved treatment options given the current five-year survival for newly diagnosed patients is only 12%."

About the ACCENT Trial
The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’. The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b) determined an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

This second stage (Phase 2a), of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.

More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On January 17, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA) (Press release, Imugene, JAN 17, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/239ef0da-fe2d-1182-07cf-4453d3a72429/Phase_1_CF33_hNIS_Study_Update_Positive_Early_Signals.pdf [SID1234639271]).

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As of 12 January 2024, 38 patients have been dosed with VAXINIA during the continuing dose escalation phase, comprised of 19 patients dosed intratumourally and 19 patients dosed intravenously as either monotherapy or in combination with pembrolizumab.
31 patients were evaluable for efficacy (received at least their first scan at day 42). In the IT cohorts (14 patients), 7 of 15 (47%) injected lesions had a reduction in tumour burden, 3 lesions were completely eradicated. 3 patients (21%) had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma (a type of biliary tract cancer); and 2 partial responses in patients with melanoma (skin cancer) by RECIST. In IV cohorts (17 patients), 53% of patients achieved stable disease as their best response. • Patients who received prior checkpoint blockade therapy derived clinical benefit with and without pembrolizumab.
Trial expansion is planned for 10-20 patients with biliary tract cancers.
Early results presented this week at the annual ASCO (Free ASCO Whitepaper)-GI Symposium in San Francisco, California, show that 7 patients with gastrointestinal cancers who received CF33-hNIS alone including 3 colorectal, 2 biliary tract, 1 pancreatic and 1 liver cancer showed positive treatment effects, with a disease control rate (all CR, PR and SD) of 86%. Importantly, in these patients, changes in tumour burden correlated with systemic immunological changes known to promote anti-tumour immunity. The poster "Oncolytic Virus CF33-hNIS Monotherapy for the Treatment of Gastrointestinal Malignancies" will be presented on 18 January 2024 during Session A: Cancers of the Esophagus and Stomach and Other GI Cancers from 11:45 AM-1:15 PM.
Imugene MD & CEO Leslie Chong said: "This latest data reinforces the early positive responses we’ve seen in gastrointestinal cancers and in particular for cholangiocarcinoma (bile duct cancer). It provides an excellent platform to investigate the impact of VAXINIA at higher dose levels as we also expand the trial to additional patients with hard-to-treat biliary tract cancers. It is a proud moment for us to be able to present these results at ASCO (Free ASCO Whitepaper)-GI, and promote the potential of VAXINIA and CF33 more broadly."

Notably, 1 patient with biliary tract cancer, treated IT with mid-dose level displayed pseudoprogression (see below) with a 49% increase in tumour burden after 2 cycles of therapy. However, by the 4th cycle they achieved a Complete Response (iCR) with no known recurrence in over 430 days. A second patient with bile duct cancer, who previously progressed on prior drug therapies, achieved Stable Disease (SD) for > 4 months upon receiving IV-administered CF33-hNIS.

About Biliary Tract Cancers
Bile duct cancers are difficult to treat and typically respond modestly to immunotherapy drugs. Pseudoprogression is a phenomenon in which the cancer initially appears to be growing, largely due to the cancer cells being infected by the virus then followed by infiltration of cancer fighting immune cells. However, it is usually followed by a decrease in tumour burden when the therapy takes effect. This phenomenon can benefit patients receiving immunotherapy but often leads to premature discontinuation of treatment owing to the false impression the cancer is growing.

About the MAST Trial
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall, the study aims to recruit cancer patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumourally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.