On May 15, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that four abstracts with Innate’s drug candidates have been accepted for the European Association of Hematology (EHA) (Free EHA Whitepaper) 2024 Congress, taking place June 13-16, 2024 in Madrid, Spain (Press release, Innate Pharma, MAY 15, 2024, View Source [SID1234643377]).

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Two abstracts are related to SAR443579 (IPH6101), an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi and currently being evaluated as a monotherapy in a Sanofi-sponsored Phase 1/2 clinical trial for the treatment of blood cancers with high unmet needs.
Two abstracts are related to IPH6501, Innate’s second generation ANKET for the treatment of relapsed or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma, currently in Phase 1/2 clinical trial.
"We’re pleased to see a continued momentum around our ANKET platform assets, SAR443579 and IPH6501," said Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "With their innovative format, we believe that NK Cell Engagers will benefit for patients who are in high unmet medical need, and we look forward to continue the studies with these assets."

EHA abstract details:

SAR443579 / IPH6101 (under development by Sanofi)

Abstract: S146
Abstract Title: Completed dose-escalation from the First-in-Human, Phase 1/2 Study of CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk-Myelodysplasia
Abstract type: Oral Presentation

Abstract: P475
Abstract Title: Exploring Dose-response Relationship of a Novel CD123 NK Cell Engager SAR443579 in Acute Myeloid Leukemia (AML) Models
Abstract type: Poster Presentation

IPH6501

Abstract: P1251
Abstract Title: Preclinical assessment of IPH6501, a first-in-class IL2V-armed tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL, in comparison with a CD20-targeting T Cell Engager
Abstract type: Poster Presentation
This abstract is embargoed until 23.05.2024 23:00 CEST, until publication by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. for their 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

The Abstract PB3041, "A Phase 1/2 trial investigating safety, tolerability, and preliminary antitumor activity of IPH6501, a first-in-class NK Cell Engager, in patients with R/R CD20-expressing NHL" will be available in the EHA (Free EHA Whitepaper) abstracts book.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not α subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023).

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales.

On May 15, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2024 and recent corporate progress (Press release, Abeona Therapeutics, MAY 15, 2024, View Source [SID1234643313]).

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"We are grateful to our existing as well as new investors who have demonstrated their support through the recent financing, which has extended our cash runway into 2026, well beyond anticipated regulatory milestones," said Vish Seshadri, Chief Executive Officer of Abeona. "We now remain focused on working with the FDA to address the CMC deficiencies noted in the CRL and making the BLA resubmission to bring pz-cel to RDEB patients as soon as possible."

First Quarter and Recent Progress

Corporate highlights

● On May 7, 2024, Abeona closed a $75 million underwritten securities offering with participation from both new and existing investors.
● In January 2024, Abeona entered into a $50 million credit facility and received the first tranche of $20 million.

Pz-cel for RDEB

● In April 2024, Abeona received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB), based on the need for additional Chemistry Manufacturing and Controls (CMC) information. In the CRL, the FDA noted that certain additional information needed to satisfy CMC requirements must be resolved before the application can be approved. The information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods. The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel. The Company anticipates completing the BLA resubmission in the second half of 2024.
● New pz-cel data will be presented at upcoming medical meetings. At the Society for Investigative Dermatology (SID) Annual Meeting, being held on May 15-18, 2024, new long-term safety data with up to 11 years of follow-up has been accepted as a late-breaking presentation.

U.S. commercial launch preparations for pz-cel

● Abeona continues to advance key commercial activities in preparation for a potential U.S. launch for pz-cel, including onboarding discussions with epidermolysis bullosa treatment sites, conducting medical and payer engagement, as well as building supply chain and enterprise capabilities to support the Company’s transition to a commercial stage company.

First Quarter Financial Results and Cash Runway Guidance

Cash, cash equivalents, restricted cash and short-term investments totaled $62.7 million as of March 31, 2024, compared to $52.6 million as of December 31, 2023. Net cash used in operating activities was $14.5 million for the three months ended March 31, 2024.

Abeona estimates that its current cash and cash equivalents, restricted cash and short-term investments, as well as the credit facility, combined with the net proceeds from the underwritten securities offering, are sufficient resources to fund operations into 2026, before accounting for any potential revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher or PRV, if awarded by the FDA.

Research and development expenses for the three months ended March 31, 2024 were $7.2 million, compared to $8.0 million for the same period of 2023. General and administrative expenses were $7.1 million for the three months ended March 31, 2024, compared to $4.0 million for the same period of 2023. Net loss was $31.6 million for the first quarter of 2024, or $1.16 loss per common share, including a change in the fair value of warrant liabilities due to remeasurement of the Company’s issued stock purchase warrants. Net loss in the first quarter of 2023 was $9.1 million, or $0.54 loss per common share.

Conference Call Details

The Company will host a conference call and webcast on Wednesday, May 15, 2024, at 8:30 a.m. ET, to discuss the first quarter results. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 496484 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

On May 15, 2024 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported interim results from an ongoing Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib for the treatment of ER+/HER2- metastatic breast cancer (Press release, Olema Oncology, MAY 15, 2024, View Source [SID1234643330]). These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).

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The poster, titled "A Phase 1b/2 Study of Palazestrant (OP-1250) in Combination with Ribociclib in Patients with Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Advanced and/or Metastatic Breast Cancer", highlighted that:

•
Across 50 treated patients, the combination of up to 120 mg of palazestrant with the full and approved dose of 600 mg of ribociclib daily was well tolerated, with no new safety signals or enhancement of toxicity and an overall safety profile consistent with the established safety profile of ribociclib plus an endocrine therapy.
•
Palazestrant did not affect ribociclib drug exposure and ribociclib had no clinically meaningful effect on palazestrant drug exposure.
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Promising preliminary efficacy was observed to date with a clinical benefit rate (CBR) of 85% across all CBR-eligible patients (11/13), 83% in ESR1-mutant patients (5/6), 86% in ESR1-wild-type patients (6/7), and 83% in prior CDK4/6 inhibitor patients (10/12).
•
Partial responses were observed in five patients through the data cut-off (2 confirmed, 3 unconfirmed) among 23 response-evaluable patients.
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Findings from this study support the continued clinical development of palazestrant in combination with ribociclib for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer.
"The data we are presenting at the ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin add further support to our thesis that palazestrant possesses key characteristics that make it a potential backbone endocrine therapy of preference for ER+/HER2- breast cancer, both as a monotherapy and in combination with other targeted agents," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are grateful to the approximately 300 women to date that have participated across our clinical trials. We are excited with the progress we are making, and we look forward to advancing toward our goal of transforming the endocrine therapy standard of care for breast cancer."

Phase 1b/2 Clinical Study Results

Enrollment

As of the data cut-off of March 13, 2024, 50 patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer with at least four weeks of follow-up were treated with palazestrant (3 patients each at 30 mg once daily and 60 mg once daily, 44 patients at the palazestrant recommended Phase 2 dose (RP2D) of 120 mg once daily) plus ribociclib 600 mg once daily (three weeks followed by one week off treatment). The majority of patients (37 or 74%) were 2nd/3rd line+, with 37 (74%) patients having received prior endocrine therapy for metastatic breast cancer, 35 (70%) patients having received prior CDK4/6 inhibitors (11 or 22% having received two prior lines of CDK4/6 inhibitors), and nine (18%) patients having received chemotherapy for metastatic breast cancer. Of 48 patients whose circulating tumor DNA (ctDNA) was assessed as of the data cut-off, 27% had activating mutations in ESR1 at baseline. The study is now fully enrolled with 60 patients.

Pharmacokinetics

Palazestrant demonstrated favorable pharmacokinetics characterized by high oral bioavailability, dose proportional exposure and a half-life of eight days as a single agent, with steady-state plasma levels showing minimal peak-to-trough variability enabling consistent inhibition of ER for the full dosing interval. Palazestrant did not affect ribociclib 600 mg drug exposure when compared with published exposure data for single-agent ribociclib. Steady-state trough values showed no clinically significant difference between the combination and single-agent palazestrant.

Safety and Tolerability

Treatment with palazestrant up to the RP2D of 120 mg was well tolerated with no dose-limiting toxicities, and the maximum tolerated dose (MTD) was not reached. The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2, and the severity and incidence of adverse events were consistent with the expected safety profile of ribociclib plus endocrine therapy. Ten patients had dose reduction of ribociclib only, due to QTcF prolongation (n=4), neutropenia (n=4) or fatigue (n=2). No patients discontinued palazestrant due to a treatment-related adverse event, and two patients discontinued ribociclib for neutropenia without discontinuation of palazestrant in the 120 mg cohort. Neutropenia was reversible in all patients and the timing was consistent with ribociclib-related neutropenia.

Efficacy

In a maturing dataset, palazestrant showed anti-tumor activity and prolonged disease stabilization in patients both with ESR1 wild-type and ESR1 activating mutations at baseline and in those previously treated with one or two lines of CDK4/6 inhibitors. Partial responses were observed in five patients (two confirmed, three unconfirmed as of data cut-off) out of 23 response-evaluable patients. Across patients who were CBR-eligible, the CBR was 85% (11/13) for all patients, 83% (5/6) for patients with ESR1-mutations, 86% (6/7) for patients that were ESR1 wild-type, and for CDK4/6i-pretreated patients the CBR was 83% (10/12). The longest duration on treatment is 44 weeks through the data cut-off, and 66% (33/50) of patients in this data set remain on treatment as of the data cut-off date.

A copy of the poster is available on Olema’s website under the Science section.

Company Investor Webcast and Conference Call

Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024 today, Wednesday, May 15, 2024, at 8:00 a.m. ET (2:00 p.m. CEST). Please register for the webcast by visiting the Investors & Media section of Olema’s website at olema.com.

About Palazestrant (OP-1250)

Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information, please visit www.opera01study.com.

On May 15, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported progress on its Phase 1b clinical study for their lead compound PH-762 (Press release, Phio Pharmaceuticals, MAY 15, 2024, https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-dosing-in-first-patient-cohort-in-ph-762-phase-1b-dose-escalation-study/ [SID1234643362]). Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.

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Phio’s Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study will assess the tumor response, and determine the recommended dose for further study of PH-762.

"This is exciting news for Phio and our lead compound PH-762 with the dosing of the 1st cohort completed, we look forward to advancing the study to bring an innovative treatment option to patients with skin carcinomas," said Robert Bitterman, CEO of Phio Pharmaceuticals.

On May 15, 2024 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, and Navigo Proteins GmbH (Halle, Germany), a biopharmaceutical company specializing in the discovery and development of Precision Medicine applications based on the Affilin technology platform, reported the signature of a strategic collaboration agreement for the discovery and development of new systemic radiotheranostic agents (Press release, Navigo Proteins, MAY 15, 2024, View Source [SID1234643378]).

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OPM operates three technological platforms dedicated to precision medicine. OncoSNIPER is a technology using AI to select and validate new therapeutic targets involved in resistant and metastatic cancers, in particular kinases and targets expressed specifically on the tumor cell surface. The aim is to discover and develop new kinase inhibitors based on the Nanocyclix technology platform and new radioligand therapy agents from its 3rd technology platform, Promethe.

The construction of radiotheranostics is based on the identification of a specific target on the cancer cells’ surface (surface antigen), and on small molecule, peptide, antibody or small protein (like Affilin) targeting molecules that are highly specific for the identified target, enabling radioactivity (emitters a, β+- or γ) to be delivered to the tumor cell and thus triggering its detection and destruction. This therapeutic approach has already been clinically proven in the treatment of metastatic prostate cancer (Pluvicto; Novartis) and inoperable or metastatic gastroenteropancreatic neuroendocrine tumors (Lutathera; Novartis).

OPM has chosen Affilins, a proprietary technology from Navigo Proteins GmbH, as biological targeting molecules to support its Promethe platform.

Affilins are small proteins derived from human ubiquitin, a protein naturally present in all cells. A huge number of ubiquitin variants are available in large libraries where each variant is modified in a slightly different way on its surface and has lost its natural biological functions but potentially binds to a given target structure. Phage display selection and screening is applied to identify Affilins that bind selectively and with high affinity to the targeted surface antigen, like antibodies. The molecular weight of Affilins is 1/15th of an antibody improving the pharmacokinetics, particularly the distribution and route of elimination which is predominantly through the kidney. Unlike antibodies, Affilins are resistant to proteases, acids and bases and are highly thermostable facilitating their radiolabeling. Because they are human derived, Affilins have a low immunogenicity risk (unwanted immune reaction after injection). The molecules have no post-translational modification like antibodies which allows their production in simple bacterial systems. Affilins are highly engineerable and can be combined with other functional elements, enabling a modular design of molecules, adapted to clinical needs. For all these reasons, Affilin molecules are ideal for use as radiotheranostic targeting molecules.

Navigo Proteins GmbH, a protein engineering company based in Halle, Germany, is headed by a strong and experienced team committed to leveraging Affilin technology in multiple areas. This collaboration will enable OPM and Navigo to build a first-class entity in the field of radioligand therapy based on the complementary strengths of the two companies. Navigo’s Board is composed of leading professors and scientists in the field of radioligand therapy, such as Oliver Buck (co-founder of ITM and member of the board of directors of Telix Pharmaceuticals).

Under the terms of the agreement, research will initially focus on two different targets in the field of oncology, particularly in resistant and metastatic digestive tract tumors, and molecules will be developed to the stage of drug candidates. Oncodesign Precision Medicine will fund this program over the next 3 years. This agreement is a first step towards a strong strategic alliance between OPM and Navigo Proteins GmbH with the vision to expand the partnership to additional targets.

Philippe GENNE, Co-founder, Chairman and CEO of Oncodesign Precision Medicine, said: " This strategic alliance will provide OPM with the opportunity to rapidly develop its portfolio of radiotheranostics and leverage its extensive knowledge and expertise in the discovery of next generation radioligand therapies. This is a promising therapeutic area that will revolutionize the treatment of inoperable and metastatic tumors. We are proud and delighted to benefit from the technology developed by Navigo, our partner in this collaboration, which in addition to its expertise in terms of Affilin engineering, is also a bio-industrial company with the ability to support innovative bioprocessing of Biologics, often a delicate stage in the development of such molecules. Our objective is to build a world-class player in the field of radioligand therapies in the near future."

Jan HOFLACK, Co-Founder and Chief Medical Officer of Oncodesign Precision Medicine added: " Our Promethe technology represents the 3rd key element in our fight against cancers without therapeutic solution. It is highly complementary to our other technologies, Oncosniper and Nanocyclix. These 3 approaches enable us to position ourselves on metastatic and resistant cancers, using immuno-oncology and radiotheranostics. These methods could be used in synergy in the future. Navigo’s Affilins give us access to a cutting-edge platform in terms of targeting vectors. The strengths and expertise of OPM and Navigo are highly complementary, which is the main reason for our alliance. Despite the logistical challenges associated with these radioligand therapy molecules, their potential to act both as imaging diagnostics at low doses and with an appropriate radioisotope, and as therapeutics at higher doses and with an isotope able to annihilate cancer cells, make them tremendous tools to fight cancers without a solution for the benefit of patients."

Henning Afflerbach, CEO of Navigo Proteins GmbH, concludes: "Our collaboration with Oncodesign Precision Medicine provides us with the ideal opportunity to advance our platform in radiotheranostics towards clinical application. Our proprietary Affilin technology offers unparalleled modularity combined with exceptional biodistribution properties making Affilins invaluable tools in our quest to revolutionize cancer treatment. By leveraging OPM’s expertise in preclinical development, targeted oncology and bio-industrial capabilities, we are keen to tackle together key challenges in targeted therapeutics development. Our alliance with OPM underscores the synergy between our strengths and expertise, aiming to deliver innovative solutions that benefit patients worldwide."

About radiotheranostics

This is a radiotherapy technique used in nuclear medicine in the field of oncology. Unlike external radiotherapy, irradiation is targeted by molecules able to bind to tumors. These are radiolabeled and administered intravenously, in the same way as chemotherapy or other targeted therapy. External radiotherapy is currently used in more than 50% of clinical protocols in oncology, but it is only feasible in the case of a single tumor or a limited number of tumors (oligometastases). Radioligand therapies, on the other hand, are well suited for the treatment of disseminated metastases.

Technologically, radioligand therapies are based on the administration of a targeting molecule containing a radioactive isotope (= radiopharmaceutical) aimed at specifically destroying tumors. Its effectiveness comes from the highly localized energy released in radioactive decay, which results in cell death preferentially of tumor cells, while not damaging adjacent healthy tissue. These particle-emitting radioisotopes are directed at targets over-expressed by tumor cells, using highly specific targeting molecules capable of recognizing and attaching to them. The specificity of the targeting molecule for a tumor marker enables healthy tissue to be spared and guarantees greater efficacy while limiting side effects, a strategy that is particularly well suited to disseminated diseases.

One of the advantages of radioligand therapies is the potential to create a theranostic agent, i.e. a radiopharmaceutical which, depending on the nature of the radiation from the chosen isotope, enables diagnostic imaging (prediction/therapeutic monitoring, β+ or γ emitters) or patient therapy (β-, α, auger emitters).