On May 16, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to proceed with a clinical trial of Phio’s lead product candidate, PH-762 (Press release, Phio Pharmaceuticals, MAY 16, 2023, View Source [SID1234631779]). PH-762 is an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. Phio plans to initiate its Phase 1b clinical trial of intratumoral PH-762 in patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell in the second half of 2023.

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"The clearance of our IND application for PH-762 represents a significant milestone in Phio’s continued evolution from drug discovery to clinical development," said Phio’s President and CEO, Robert Bitterman. Dr. Mary Spellman, Acting Chief Medical Officer, added, "Cutaneous malignancies may be both locally destructive and systemically devastating. We look forward to investigating this new immuno-oncology approach to treat these carcinomas."

The initial multi-center, dose-escalating, Phase 1b clinical trial under Phio’s cleared IND is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762.

Phio will focus its efforts on the U.S. clinical trial and intends to wind down its first-in-human clinical trial for PH-762 in France, which was limited to the treatment of patients with metastatic melanoma.

PH-762 has also received clearance to proceed under an IND sponsored by AgonOx, Inc. in a clinical trial evaluating PH-762 treated "double positive" (DP) CD8 tumor infiltrating lymphocytes (TIL) in patients with melanoma and other advanced solid tumors.

On May 16, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the Company or OncoSec), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported a Type C meeting held with the US Food and Drug Administration (FDA) on May 15, 2023 (Press release, OncoSec Medical, MAY 16, 2023, View Source [SID1234631777]). The purpose of the meeting was to discuss the trial design for a planned randomized, open-label Phase 2 clinical trial in patients with high-risk, resectable melanoma to evaluate the neoadjuvant treatment combination of the Company’s tavokinogene telseplasmid, a plasmid encoding human interleukin 12 (IL-12), administered intratumorally by electroporation (TAVO-EP) with intravenous KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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The meeting with the FDA represents an important next step on the Company’s path to pursue clinical development of TAVO-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.

The Company discussed with the FDA the proposed design of a global randomized Phase 2 trial, which includes a primary endpoint of pathological complete response (pCR) rate and secondary endpoints including event-free survival (EFS) and pathological major response (pMR) rate. As discussed with the FDA, a single arm run-in stage is planned to confirm the appropriate neoadjuvant dosing schedule and allow the collection of mechanistic biomarker data to further evaluate the mechanism of action of TAVO-EP as a trigger for anti-tumor immune effector functions. In the randomized stage, neoadjuvant treatment with TAVO-EP in combination with pembrolizumab will be compared to pembrolizumab alone.

The rationale for the proposed trial is an evolving standard of care in neoadjuvant melanoma treatment. Recently published results from neoadjuvant trials have demonstrated the potential for neoadjuvant immunotherapy to improve long-term clinical benefits to patients, including a randomized Phase 2 trial (SWOG S1801) in 312 patients that demonstrated statistically significant improved EFS for neoadjuvant versus adjuvant pembrolizumab. The Company’s discussion with the FDA follows the release of interim data from an ongoing investigator-sponsored trial (IST) led by Dr. Ahmad Tarhini at the H. Lee Moffit Cancer Center & Research Institute evaluating TAVO-EP in combination with intravenous nivolumab, which showed encouraging clinical and pathological response rates (see press release on November 15, 2022). Preliminary data from this IST have also shown that several patients, predicted by biomarker analysis to be non-responders to immune checkpoint inhibitors, experienced clinical and pathological responses to TAVO-EP in combination with nivolumab. Generating additional data in the randomized Phase 2 trial is intended to further delineate the mechanism of action of intratumoral IL-12 in combination with intravenous anti-PD-1 antibodies in a larger sample size.

The Company appreciates the productive meeting with the FDA and the agency’s feedback on the trial design and potential strategies for future registrational paths. To allow data driven decisions in an evolving therapeutic landscape in neoadjuvant melanoma, the Company expects to engage in continued communication with the FDA and other applicable global regulatory agencies for feedback regarding an efficient development path to registration of TAVO-EP in combination with pembrolizumab in neoadjuvant melanoma.

"Melanoma patients require more effective treatment approaches early in the disease to avoid disease progression to late-stage disease. By providing a stimulus of immune effector functions, TAVO-EP in combination with immune checkpoint inhibitors is expected to offer a differentiated therapeutic approach compared to immune checkpoint inhibitors alone as discussed in our recent corporate update in April 2023. The unmet clinical need in advanced melanoma together with previously reported interim results from Dr. Tarhini’s IST in the neoadjuvant melanoma setting provide sound rationale for further development of TAVO-EP in combination with anti-PD-1 therapy prior to surgery. We are encouraged by our discussions with the FDA and the agency’s constructive feedback after the review of our draft protocol for TAVO-EP in combination with pembrolizumab for a randomized Phase 2 trial in the neoadjuvant setting and are looking forward to potentially initiating the trial before the end of 2023," said Robert Arch, Ph.D., Chief Executive Officer of OncoSec. "The single-arm run-in stage of the trial is intended to generate additional data in a cost-effective manner to inform a ‘GO/NO-GO’ decision and validate the appropriate dosing schedule for the randomized phase in the first year of the planned trial. I want to thank all patients who have participated in our clinical trials and my colleagues at OncoSec who seek to develop this novel therapeutic treatment approach designed to awaken the immune system to fight cancer."

On May 16, 2023 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported financial information for the first quarter of 2023, including its cash, cash equivalents and revenues, and provided a corporate update (Press release, Inventiva Pharma, MAY 16, 2023, View Source [SID1234631776]).

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Financial Results

Cash Position

As of March 31, 2023, the Company’s cash and cash equivalents amounted to €56.3 million, short-term deposits to 0.7 million2, and long term deposit to €9.3 million3, compared to €86.7 million, €1.0 million and €0.7 million as of December 31, 2022, respectively.

Net cash used in operating activities amounted to (€20.4) million in the first quarter of 2023, compared to (€15.0) million for the same period in 2022. R&D expenses for the first quarter were up 38% compared to the first quarter of 2022. This increase is in line with the clinical development activities planned in 2023 and mostly driven by costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D").

Net cash used in investing activities for the first quarter of 2023 amounted to (€8.4) million, compared to (€0.1) million in the first quarter of 2022. The change is mostly due to the change in deposits between both periods.

Net cash used in financing activities for the first quarter of 2023 amounted to (€1.2) million, compared to (€0.1) million in the first quarter of 2022.

Over the first quarter of 2023, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.5) million, compared to a positive effect of €0.2 million for the first quarter of 2022, due to the evolution of EUR/USD exchange rate.

Considering its current R&D and clinical development programs, the Company estimates that its existing cash, cash equivalents and deposits should allow the Company to fund its operations until the end of the fourth quarter of 20234. This cash runway estimate does not include the conditional second tranche of €25.0 million of the EIB loan agreement5.

Revenues

The Company did not recognize revenues for the first quarter of 2023, in line with the first quarter of 2022.

Main areas of progress in the R&D portfolio

Implementation of the new design of the Phase III NATiV3 clinical trial evaluating lanifibranor in NASH announced in January 2023 is continuing. The new design has been cleared by regulatory authorities in key countries, including the United States. A total of 376 trial sites are activated in 23 countries and 218 trial sites are already operating under the new design of NATiV3.
Receipt of a positive recommendation, on May 3, 2023, following the second meeting of the Data Monitoring Committee of the Phase III NATIV3 clinical trial to continue the study without modification of the protocol, confirming the good safety profile of lanifibranor.
Positive conclusion of the Renal Impairment study required for regulatory submission, demonstrating that lanifibranor pharmacokinetics is not affected in patients with renal impairment.
Enrollment for the NATiV3 trial is on track and the first visit of the last patient is targeted for the second half of 2023.
Two lanifibranor abstracts have been accepted for presentation at the European Association for the Study of the Liver (« EASL ») International Liver CongressTM
– "Early aminotransferase improvement in the phase 2b NATIVE study is predictive of response pattern of liver histology as well as hepatic and cardiometabolic health markers at the end of treatment in patients with non-cirrhotic NASH" – Prof. Quentin Anstee – Poster

– "Correlation between severity of hepatic steatosis and markers of cardiometabolic health, and effect of lanifibranor therapy in patients with non-cirrhotic NASH" – Michael Cooreman, MD – Poster

After having finalized patient recruitment in September 2022, the data analysis of the investigator-initiated study with lanifibranor in patients with nonalcoholic fatty liver disease ("NAFLD") and T2D is ongoing. The topline results are expected to be published in the middle of the second quarter of 2023.
Anticipated potential key milestones

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D – anticipated in the middle of the second quarter of 2023
Publication of the topline results of the LEGEND Phase IIa combination trial of lanifibranor in combination with empagliflozin in patients with NASH and T2D – anticipated in the second half of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – anticipated in the second half of 2023
Upcoming investor conference participation

Jefferies Global Healthcare Conference – June 7-9 – New York City
KBC Life Sciences Metabolics Day – June 20 – Brussels
Upcoming scientific conferences

The EASL International Liver CongressTM – June 21-24 – Vienna, Austria
The American Diabetes Association 83rd Scientific Sessions – June 23-26 – San Diego
Next financial results publication

Financial results, cash position and revenues, for the first half of 2023: Thursday, July 27, 2023 (after U.S. market close)

On May 16, 2023 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported a business update and provided financial results for the quarter ended March 31, 2023 (Press release, Immatics, MAY 16, 2023, View Source [SID1234631775]).

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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "We commenced 2023 with significant advances in our ACTengine IMA203 clinical trial, announcing encouraging data demonstrating that IMA203 is able to drive deep and durable responses independent of tumor type, with some responses ongoing beyond 9 months after treatment. As we continue to leverage the multi-cancer PRAME opportunity, we are pleased to have filed a CTA for IMA402, moving our second TCR Bispecifics candidate toward clinical evaluation. We look forward to providing a next update on our IMA203 TCR-T therapy candidates as well as announcing a potential fast-to-market pathway by the end of the year."

First Quarter 2023 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203 TCR-T monotherapy (Phase 1b Cohort A):

On May 2nd, Immatics provided an interim update covering data from 11 heavily pre-treated patients in Phase 1b dose expansion Cohort A (monotherapy). Patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67×109 TCR-T cells (range 1.30-8.84×109 TCR-T cells).
Treatment with IMA203 in Cohort A (monotherapy) continues to show manageable tolerability at doses of up to approximately 9 billion CD8+ TCR-T cells; no high-grade cytokine release syndrome (CRS) and no immune effector cell associated neurotoxicity syndrome (ICANS) observed in the 11 patients treated in Cohort A; no dose-dependent increase of CRS observed.
All 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS.
Objective responses were observed in last-line solid cancer patients including cutaneous melanoma, ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma.
Initial objective response rate (ORR) of 64% (7/11) was observed at ~week 6 (partial responses (PR) according to RECIST 1.1).
Confirmed ORR of 67% (6/9) was observed at ~month 3; initial responses at week 6 were confirmed for all 6 responders with an available subsequent 3-month scan.
Median duration of response2 was not reached (min 1.3+ months, max 8.8+ months) at a median follow-up3 of 8.5 months; two confirmed partial responses (cPR) ongoing at more than 9 months after treatment as well as three additional ongoing responses at 6+ months, ~3 months and 6+ weeks.
Objective responses were observed independent of solid tumor type at low, medium and high PRAME expression levels above Immatics’ MS-guided RNA threshold.
In addition to Cohort A (IMA203 monotherapy), ACTengine IMA203 TCR-T is currently being evaluated in two additional ongoing Phase 1b dose expansion cohorts:

Cohort B: IMA203 in combination with an immune checkpoint inhibitor. Cohort B is focused on generating safety data for potential further investigation of a combination approach as a front-line therapy.
Cohort C: IMA203CD8 TCR-T monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8×109 TCR-T cells/m2 BSA).
Immatics has prioritized patient treatment with IMA203 and IMA203CD8 TCR-T monotherapy in the last-line therapy setting.
Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned for 4Q 2023. Immatics’ IMA203 development strategy to realize the multi-cancer opportunity PRAME is based on two pillars aimed:
initially at a (1) fast-to-market approach in 1-2 last-line solid cancer types with high PRAME prevalence and where clinical proof-of-concept has been demonstrated, such as cutaneous melanoma (potentially bundled with uveal melanoma) and/or ovarian cancer and
later at a (2) planned broad development with expansion to other cancer types, such as uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach.
Immatics is currently building a state-of-the-art facility designed to manufacture ACTengine IMA203 TCR-T products, as well as other cell therapy candidates, for registration-directed trials and initial commercial supply. The facility is expected to be operational in 2024.

Autologous TCR-T pipeline

Bristol Myers Squibb exercised its first option and entered into a global license agreement with Immatics for the most advanced TCR-T product candidate from the 2019 multi-target strategic collaboration to develop four TCR-based adoptive cell therapies targeting solid tumors.
Immatics received an option payment of $15 million and is eligible for up to $490 million in milestone payments in addition to tiered royalties on net sales of the product.
TCR Bispecifics Programs

Immatics’ T cell engaging receptor (TCER) candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through Immatics’ proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.

TCER IMA401 (MAGEA4/8) – Phase 1 trial to evaluate safety, tolerability and initial anti-tumor activity of TCER IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 is being developed in collaboration with Bristol Myers Squibb.

TCER IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute (PEI) on April 14, 2023, to initiate the Phase 1/2 trial investigating IMA402 in patients with recurrent and/or refractory solid tumors. The trial is expected to commence in 2H 2023 with a first clinical data interim report planned in 2024.

Corporate Update

Nancy Valente, M.D., resigned from her position on Immatics’ Board of Directors effective May 12, 2023. Nancy has been appointed as Chief Development Officer at Xencor Inc.. Immatics would like to thank Nancy Valente for her valuable contributions during her time on Immatics’ Board of Directors.

First Quarter 2023 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €329.8 million ($358.7 million1) as of March 31, 2023, compared to €362.2 million ($393.9 million1) as of December 31, 2022. The decrease is mainly due to our ongoing research and development activities. The Company continues to project a cash runway into 2025.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €9.8 million ($10.7 million1) for the three months ended March 31, 2023, compared to €102.9 million ($111.9 million1) for the three months ended March 31, 2022. The decrease is mainly related to the recognition of revenue for the license portion of the collaboration agreement with Bristol Myers Squibb on IMA401 during the three months ended March 31, 2022.

Research and Development Expenses: R&D expenses were €27.6 million ($30.0 million1) for the three months ended March 31, 2023, compared to €25.1 million ($27.3 million1) for the three months ended March 31, 2022. The increase mainly resulted from higher costs associated with the advancement of the clinical and pre-IND pipeline of ACTengine and TCER candidates.
General and Administrative Expenses: G&A expenses were €9.6 million ($10.4 million1) for the three months ended March 31, 2023, compared to €9.3 million ($10.1 million1) for the three months ended March 31, 2022.

Net Profit and Loss: Net loss was €19.7 million ($21.4 million1) for the three months ended March 31, 2023, compared to a net profit of €85.7 million ($93.2 million1) for the three months ended March 31, 2022. The decrease resulted mainly from the one-time license fee income in connection with the IMA401 collaboration with Bristol Myers Squibb during the three months ended March 31, 2022.

Upcoming Investor Conferences

Jefferies Global Healthcare Conference, New York, NY – June 7-9, 2023
Jefferies London Healthcare Conference, London, U.K. – November 14-16, 2023
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On May 16, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has amended its clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support evaluation of darovasertib and crizotinib combination therapy in the company’s planned Phase 2/3 registrational clinical trial in MUM and to continue support of the company’s ongoing Phase 2 clinical trial in MUM (Press release, Ideaya Biosciences, MAY 16, 2023, View Source [SID1234631774]).

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"We are grateful to have Pfizer’s continued support – including their clinical expertise as a collaboration partner and with respect to drug supply, as we target initiation of our Phase 2/3 registrational trial in Q2 2023 for the darovasertib and crizotinib combination in first-line HLA-A2 negative MUM, with PFS as primary endpoint for potential accelerated approval. The efficacy we observed in our Phase 2 clinical trial for first-line metastatic uveal melanoma patients suggests compelling clinical efficacy and a potential paradigm shift for treating MUM patients," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDEAYA is currently evaluating the combination of darovasertib, an investigational PKC inhibitor, and crizotinib, an investigational cMET inhibitor, in patients with metastatic uveal melanoma (MUM) in an ongoing Phase 2 clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer (Pfizer Agreement). IDEAYA reported updated clinical data from the ongoing Phase 2 expansion cohort which demonstrated robust clinical efficacy in first-line and any-line MUM patients with a manageable safety profile.

IDEAYA plans to initiate a potential registration-enabling Phase 2/3 clinical trial in the second quarter of 2023 to evaluate the darovasertib and crizotinib combination in first-line MUM patients under a second clinical trial collaboration and supply agreement with Pfizer (Second Pfizer Agreement). The protocol for the registrational trial includes an integrated Phase 2/3 open-label study-in-study design in first-line MUM patients with an HLA-A*02:01 (HLA-A2) negative serotype. The clinical trial design includes a Phase 2 portion (~n=200) with progression free survival (PFS) as a primary endpoint for potential accelerated approval (AA). Patients enrolled in Phase 2 will continue on treatment within the same clinical trial and will be considered together with additional enrolled patients (n=~120) to evaluate OS in support of a potential Phase 3 confirmational approval.

IDEAYA and Pfizer amended the Second Pfizer Agreement relating to the supply of crizotinib in support of IDEAYA’s planned potential registration-enabling Phase 2/3 clinical trial. Pursuant to the as-amended Second Pfizer Agreement, Pfizer will provide IDEAYA with a first defined quantity of crizotinib at no cost to the Company, as well as an additional second defined quantity of crizotinib at a lump-sum cost to IDEAYA. The Company anticipates that the supply of crizotinib under the Second Pfizer Agreement, as amended, will be sufficient to support the planned Phase 2 and Phase 3 portions of the Phase 2/3 registrational clinical trial.

Separately, IDEAYA and Pfizer also amended the Pfizer Agreement relating to the supply of crizotinib in support of IDEAYA’s ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in MUM patients. Pursuant to this amendment, Pfizer will continue to provide IDEAYA with an additional defined quantity of crizotinib at no cost to the Company.

Under each of the Pfizer Agreement and the Second Pfizer Agreement, IDEAYA is the sponsor of the ongoing darovasertib and crizotinib Phase 2 clinical trial and the planned Phase 2/3 registrational trial, respectively. IDEAYA and Pfizer will jointly own clinical data from the combination studies and will also jointly own inventions, if any, relating to the combined use of darovasertib and crizotinib. IDEAYA and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the agreement.

IDEAYA owns or controls all commercial rights in its darovasertib program, including in MUM and in primary UM, subject to certain economic obligations pursuant to its exclusive, worldwide license to darovasertib with Novartis.