On November 14, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported third quarter 2023 financial results and provided an update on recent pipeline progress (Press release, Onconova, NOV 14, 2023, View Source [SID1234637635]). Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.

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"Onconova has made excellent progress in the third quarter of 2023. Starting with our lead program, narazaciclib, a differentiated inhibitor of multiple kinases including CDK4/6, we advanced the registrational trial preparations in the first indication, for patients with low grade endometrioid endometrial cancer (LGEEC). CDK4/6 inhibitors have substantially changed the face of cancer care for the better and become a multibillion-dollar drug class. We believe narazaciclib has the potential to be differentiated by potently targeting proteins putatively involved in the resistance pathways of cancer cells that the approved agents fail to significantly inhibit," said Steve Fruchtman, M.D., President and Chief Executive Officer.

Dr. Fruchtman continued, "We are seeing clinical and biological target engagement with narazaciclib and an acceptable safety profile at therapeutic dosing levels in the Phase 1/2 program. To date, we have not seen significant neutropenia and thus remain on target to deliver narazaciclib as a daily anti-cancer drug not requiring time off to permit marrow recovery, in contrast to the most commonly prescribed CDK4/6 inhibitor. In addition, to date, narazaciclib has not caused significant diarrhea, another limitation of other CDK4/6 inhibitors. Based on this profile, we have decided to dose escalate to at least one more cohort in each of the ongoing U.S. studies, to ensure that we achieve the optimal recommended Phase 2 dose. This may extend the Phase 1/2 program into the first quarter of 2024. We believe this is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and wide therapeutic index."

"From a corporate perspective, in the third quarter, we named Dr. Victor Moyo as Chief Medical Officer and Meena Arora as Vice-President, Global Medical Affairs & Research and Development, putting us on very solid footing to advance the clinical plan and regulatory strategy for narazaciclib and rigosertib. In addition, we continue to actively engage in a range of discussions related to partnering opportunities, to support the progression of our programs," continued Dr. Fruchtman. "Finally, we progressed the development of a registrational study plan for rigosertib, our cell pathway inhibitor, for the ultra-rare indication of recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-associated SCC). These developments were complemented by impressive medical meeting presentations on both programs by our collaborators."

Near Term Narazaciclib Milestones: Onconova intends to:

· present preclinical data at two December medical meetings: the San Antonio Breast Cancer Symposium (SABCS) and the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper);
· continue the dose escalation segment of the Phase 1/2 program which may bring us into the first quarter of 2024;
· provide a read-out on narazaciclib’s safety and pharmacology in the first half of 2024;
· provide an update on our registrational trial-readiness over the next few quarters, including the definition of our recommended Phase 2 dose, engagement with the FDA on the pivotal trial design, and continuing to work with external clinical experts including the Gynecologic Oncology Group (GOG), and the European Network for Gynecologic Oncology Trials (ENGOT).

Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications such as breast cancer, ovarian cancer, and mantle cell lymphoma.

Rigosertib milestones: Onconova confirms plans to provide an update on the next steps to obtain orphan designation for rigosertib in RDEB-associated SCC and for the registrational program in the first half of 2024.

Second Quarter Financial Results

Cash and cash equivalents as of September 30, 2023, were $25.2 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the third quarter of 2024.

Research and development expenses were $2.5 million for the third quarter of 2023, compared with $3.6 million for the second quarter of 2022.

General and administrative expenses were $2.7 million for the third quarter of 2023, compared with $2.1 million for the second quarter of 2022.

Net loss for the third quarter of 2023 was $4.7 million, or $0.23 per share on 21.0 million weighted average shares outstanding, compared with a net loss of $5.4 million, or $0.26 per share for the third quarter of 2022 on 20.9 million weighted average shares outstanding.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing:

· (800) 715-9871 for domestic and
· (646) 307-1963 for international callers and
· Using conference ID 3238751

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

On November 14, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and reported third quarter 2023 financial results (Press release, Nuvalent, NOV 14, 2023, View Source [SID1234637634]).

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"This has been another incredible year of execution for Nuvalent. With our recent presentation at ANE, we have now delivered preliminary proof-of-concept data for both of our novel parallel lead programs in ROS1 and ALK-positive cancers, and our third development candidate, NVL-330, is advancing toward clinical development," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This level of achievement in just over five years since first program inception is only made possible by the tireless dedication of our team to our goal of delivering potential new therapies to patients as quickly as possible."

Dr. Porter continued, "As we turn our focus towards execution on our global development plans to support potential NDA submission and continued portfolio expansion, we are committed to maintaining the high standard and sense of urgency we have established to date. We continue to grow our team in support of this next phase of development and are thrilled to welcome Dr. Perrin Wilson, who brings deep expertise in both business development and commercial strategy."

"We are encouraged by the positive reception to our progress and continued support from both new and longstanding stockholders, leading to a successful $300 million public offering," added Alexandra Balcom, Chief Financial Officer at Nuvalent. "With a strong portfolio, proven team, and meaningful cash runway extension expected into 2027, we believe we are well positioned to evaluate opportunities to further accelerate and expand the potential reach of our programs, and to deliver on our mid- and long-term goals."

Recent Pipeline Highlights and Key Anticipated Milestones

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Reported Preliminary Phase 1 Clinical Data from ALKOVE-1 Trial that Support Best-In-Class Potential of NVL-655 for Patients with ALK-Positive NSCLC: Nuvalent recently reported preliminary dose-escalation data from the Phase 1 portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) at the 35th AACR (Free AACR Whitepaper)-NCI-EORTC Symposium in Boston, Massachusetts. Preliminary activity was demonstrated in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who had likely exhausted all available therapies including lorlatinib, had a history of brain metastases, or had single or compound ALK resistance mutations. Additionally, NVL-655 demonstrated a favorable preliminary safety profile consistent with its ALK-selective, TRK sparing design.

The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial and is focused on further characterizing the safety, pharmacokinetics, and pharmacodynamic profiles, determining the recommended Phase 2 dose (RP2D), and if applicable, the maximum tolerated dose of NVL-655. Upon RP2D selection, the trial is designed to transition directly into the Phase 2 portion, which will evaluate the safety and activity of NVL-655 in several expansion cohorts of patients defined based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are intended to support potential registration in patients with ALK-positive NSCLC who are both lorlatinib-naïve and lorlatinib-treated.

In addition to the planned Phase 2 cohorts, Nuvalent intends to use these preliminary data in patients with heavily pre-treated ALK-positive NSCLC to guide discussions with physicians that will inform development strategies in TKI-naïve ALK-positive NSCLC.

•
Initiated the Phase 2 Portion of the ARROS-1 Trial of NVL-520 with Registrational Intent for Patients with Advanced ROS1-positive NSCLC:Nuvalent announced the initiation of the Phase 2 portion of ARROS-1 trial following alignment with the US Food and Drug Administration (FDA) on a RP2D of 100 mg daily. The Phase 2 portion of the trial includes potential registrational cohorts for patients with TKI-naïve and TKI-pretreated ROS1-positive NSCLC. The company expects to share updated data from the ARROS-1 trial at a medical meeting in 2024.
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Advancing NVL-330 through IND-enabling Studies: Nuvalent is continuing to advance NVL-330, its novel HER2-selective inhibitor in development for the treatment of HER2 exon 20 insertion-positive cancers, through IND-enabling studies.

Recent Leadership Appointments

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Strengthened Leadership Team with Appointment of Perrin Wilson, Ph.D., as Senior Vice President of Business Development & Strategy:Dr. Wilson brings over 15 years of experience across business development and commercial functions, including leading deals from research stage to company acquisitions and integrations, championing brand strategy and product launches. Before joining Nuvalent, Dr. Wilson held positions of increasing responsibility at Forma Therapeutics/Novo Nordisk, including Head of Forma Business Development and Integration Management Office, Vice President Business Development and Senior Director Global Marketing, Sickle Cell Disease Strategy. During her time at Forma, Dr. Wilson led the Novo Nordisk acquisition and the out-licensing of Forma’s oncology portfolio to three different partners, and was responsible for developing the global brand plan for Forma’s lead molecule and supporting ex-US and lifecycle management strategy. Prior to Forma, Dr. Wilson spent seven years at Takeda in various business development and commercial roles leading several transactions to strengthen Takeda’s oncology pipeline, including the acquisition of ARIAD, and leading the global strategy and pre-launch preparations for Takeda’s myelodysplastic syndromes program. Dr. Wilson received her B.Sc. degree in biology from Lafayette College and a Ph.D. in biomedical sciences from The Rockefeller University.

Financing Highlight

Completed Successful Public Offering of Common Stock Raising $300 Million in Gross Proceeds: On October 19, 2023, Nuvalent closed an underwritten public offering of 5,357,143 shares of Class A common stock at a price to the public of $56.00 per share. The gross proceeds from the offering were approximately $300 million, resulting in net proceeds of approximately $282 million after deducting underwriting discounts, commissions and other offering expenses.

Upcoming Events

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Stifel 2023 Healthcare Conference: Management will be participating in a fireside chat on Wednesday, November 15, 2023, at 12:00 pm ET in New York, NY.
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Piper Sandler 35th Annual Healthcare Conference: Management will be participating in a fireside chat on Wednesday, November 29, 2023, at 1:00 pm ET in New York, NY.

A live webcast of each fireside chat will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

Third Quarter 2023 Financial Results

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Cash Position & Operating Runway: Cash, cash equivalents and marketable securities were $413.3 million as of September 30, 2023. The company’s cash, cash equivalents and marketable securities as of September 30, 2023, in combination with the net proceeds from the public offering of approximately $282 million, are expected to extend the company’s operating runway into 2027.
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R&D Expenses: Research and development (R&D) expenses were $29.6 million for the third quarter of 2023.
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G&A Expenses: General and administrative (G&A) expenses were $9.2 million for the third quarter of 2023.
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Net Loss: Net loss for the third quarter of 2023 was $33.6 million, or $0.59 per share.

On November 14, 2023 NKGen Biotech Inc. (Nasdaq: NKGN) (NKGen or the Company), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer (NK) cell therapeutics, reported its financial results for the third quarter ended September 30, 2023, and provided business highlights (Press release, NKMax America, NOV 14, 2023, View Source [SID1234637633]).

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"We had a very exciting quarter as a newly Nasdaq-listed company," said Paul Y. Song, M.D., CEO of NKGen. "We recognize the volatility in the market, but we believe in our NK cell therapy approach to address some of society’s biggest healthcare challenges. Our approach continues to show promise, including by our recent IND approval and the continued progress observed in our autologous SNK01 program with the completion of, and positive data readouts from, our Phase I clinical study in Alzheimer’s disease."

"We are highly focused on raising additional capital to fund our trials and operations and advance our differentiated NK cell therapy programs," continued Dr. Song. "We remain on track with our near-term milestones, including commencing our Phase I/IIa clinical trial for Alzheimer’s Disease by year end, an IND filing for our SNK01 program for Parkinson’s Disease, and a preliminary data readout of our SNK02 allogeneic Phase I study in solid tumors, the first and only product candidate that does not require lymphodepletion, the latter two which are anticipated in the first quarter of 2024."

Third Quarter 2023 Key Business Highlights

The Company closed its previously announced business combination with Graf Acquisition Corp. IV (Graf), pursuant to which NKGen became a wholly-owned subsidiary of Graf, and changed its name to NKGen Operating Biotech, Inc.
Presented Phase I clinical trial data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference.
90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer’s disease composite score (ADCOMS) following 11 weeks.
SNK01 given intravenously (IV) appears to cross the blood-brain barrier to reduce Cerebrospinal Fluid (CSF) Aβ42/40 and pTau181 levels and neuroinflammation, as measured by Glial Fibrillary Acidic Protein (GFAP); this effect appears to be persistent at Week 22.
No treatment related adverse events were observed.
Poster can be viewed here: PowerPoint Presentation (www.nkgenbiotech.com).
FDA clearance of IND for SNK01 NK cell therapy to treat moderate Alzheimer’s Disease.
First patient dosed in Phase I clinical trial of SNK02, allogeneic NK cell therapy product candidate, for the treatment of solid tumors.
Presentations at the NKGen Investor Event on July 20, 2023 and the Cantor Fitzerald Healthcare Conference on September 27, 2023 presented topics on NKGen’s differentiated intellectual property and approach to NK cell therapy for Alzheimer’s and Parkinson’s diseases, NKGen’s Phase I clinical trial data of SNK01 to treat patients with Alzheimer’s disease, and preclinical compassionate use case studies.
Third Quarter 2023 Financial Results

Cash position: As of September 30, 2023, the Company had total cash of $8.8 million, after partial payment of transaction expenses.

Research and development (R&D) expenses: R&D expenses for the third quarter of 2023 were $3.9 million compared to $4.1 million in the same period in 2022. The decrease was primarily due to decreased clinical trial subject recruitment costs.

General and administrative (G&A) expenses: G&A expenses for the third quarter of 2023 were $3.0 million compared to $1.9 million in the same period in 2022. The increase was primarily due to stock option grants made during the first quarter of 2023.

Net loss: For the third quarter of 2023, the Company reported a net loss of $33.2 million, compared to a net loss of $6.7 million in the same period in 2022. The increase was primarily due to loss from issuance of the forward purchase agreements entered into in connection with the closing of the business combination as well as the recognition of transaction costs related to the business combination that were allocated to liability-classified instruments issued.

Debt: As of September 30, 2023, the Company had total debt liabilities of $20.2 million, comprised of $4.9 million in bank debt, $5.3 million in related party loans, and $10.0 million in form of a senior convertible note held by NKMAX Co., Ltd.

Business Combination: In connection with the business combination with Graf, the Company received approximately $21.9 million in gross proceeds, comprising approximately $1.7 million from the Graf trust account and approximately $20.2 million from the transactions in relation to the issuance of warrants and senior convertible notes. In addition, in accordance with the forward purchase agreements, $32.9 million in funds were deposited into escrow accounts, which were not received by the Company in connection with the closing of the business combination. The escrowed funds may be released to the Company, the investors, or a combination of both. In addition, the Company’s legacy convertible notes converted into shares of common stock of the Company. Furthermore, in connection with the business combination, approximately $14.3 million in transaction costs and deferred underwriting fees were settled at or prior to the closing of the business combination, and approximately $7.3 million remained unpaid as of September 30, 2023.

On November 14, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2023 (Press release, Innate Pharma, NOV 14, 2023, View Source [SID1234637630]).

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"With our strong cash position, we continue to execute against our strategy to develop innovative proprietary and partnered assets with key players. We look forward to this year’s ASH (Free ASH Whitepaper) Annual Meeting where we will present the final results of the lacutamab TELLOMAK Phase 2 study in patients with Sézary syndrome. We are also very pleased that at the same meeting, our partner Sanofi will share updated data from the Phase 1/2 study using SAR443579 / IPH6101 in patients with hematologic malignancies, a product using Innate’s innovative ANKET NK cell engager platform," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As monalizumab continues to progress in Phase 2 and 3 lung cancer trials with AstraZeneca, we look forward to sharing further updates on our proprietary portfolio as we progress our lead proprietary ANKET NK cell engager, IPH6501 and our Nectin-4 targeted ADC, IPH45 towards the clinic."

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

The live webcast will be available at the following link:

View Source

Webcast participants can use the chat tool to ask written questions during the conference.

Participants may also join via telephone to ask oral questions during the conference using the following registration link: View Source

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

TELLOMAK, the ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023 (n=170 patients). Final data in Sézary syndrome will be presented in an oral presentation at the ASH (Free ASH Whitepaper) (American Society of Hematology) Annual Meeting 2023. The Company plans to share the results with the regulatory authorities. The Company still expects final data from the mycosis fungoides (MF) cohort in H2 2023.
The Company announced that it will report positive final data from the Phase 2 TELLOMAK study in Sézary syndrome at the ASH (Free ASH Whitepaper) 2023 Annual Congress on 9 December. The ASH (Free ASH Whitepaper) abstract states that the data demonstrate that lacutamab showed promising clinical activity and an overall favorable safety profile. In the heavily pre-treated post-mogamulizumab patient population with an average of six prior lines of therapy, in the Intention to treat population (ITT), the global confirmed objective response rate (ORR) was 37.5% (21/56). Confirmed ORR in the skin was 46.4% (26/56) and confirmed ORR in the blood was 48.2% (27/56). Median progression-free survival was 8.0 months (95% CI 4.7-21.2). Additional data will be presented at the ASH (Free ASH Whitepaper) 2023 Annual Congress.
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) are ongoing. The Phase 1b trial is a Company-sponsored clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL. The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial is an investigator-sponsored, randomized trial by The Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
Initial data from the Phase 1b trial will be presented in a poster session at the ASH (Free ASH Whitepaper) Annual Meeting 2023. The ASH (Free ASH Whitepaper) 2023 abstract states that preliminary Phase 1b data in patients with R/R PTCL confirm the acceptable safety profile of lacutamab monotherapy.
The Phase 2 KILT study is ongoing.
In October 2023, the US Food and Drug Administration (FDA) placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented. The Company is currently undertaking efforts to address the US FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.
ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes four public drug candidates born from the ANKET platform: SAR443579/IPH6101 (CD123-targeted), SAR’514/IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored.

SAR443579/IPH6101, SAR’514/IPH6401 and IPH62 (partnered with Sanofi)

SAR443579/IPH6101

The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
At ASH (Free ASH Whitepaper) 2023, a presentation from the Sanofi oncology pipeline will report updated efficacy and safety results and show data across all dose levels tested, including observed clinical remissions. Abstract details include:
As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across 8 Dose Levels (DLs) at 10 – 6000 μg/kg/dose were included. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. In DLs with a highest dose of 1000 μg/kg QW, 5/15 AML (33.3%) patients achieved a CR (4 CR / 1 CRi) as of the cut-off date. Data from PK/PD and in vitro mechanistic analyses studying dose-response relations will also be presented. SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile.
Preliminary Pharmacokinetics (PK) and Pharmacodynamic (PD) Analysis of the CD123 NK Cell Engager SAR’579/IPH6101 in patients with relapsed or refractory AML, B-ALL or HR-MDS were presented during the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress 2023. As of the data cut-off on August 7, 2023, two responders remained in remission after 8.8 and 12.2 months of treatment.
SAR’514/IPH6401

The Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, led by Sanofi, in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA) is ongoing.
IPH62

As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET platform, and the company has the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, Innate received a €25m upfront payment and is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.
IPH6501 (proprietary)

Following approval of the IND-filing by the FDA in July 2023, IPH6501, Innate’s proprietary CD20 targeted tetra-specific ANKET continues toward a Phase 1 clinical trial in 2023.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 trial run by AstraZeneca. The trial is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track.
IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.
Antibody Drug Conjugates:

Fueling its R&D engine, the Company continues to develop different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET platform and continuing to explore Antibody Drug Conjugates (ADC) formats. Beyond its proprietary programs, the Company has an ongoing agreement with Takeda on ADCs.

IPH45 (Nectin-4 ADC):

IPH45 is Innate’s proprietary Nectin-4 targeting antibody drug conjugate including a Topoisomerase I inhibitor payload. IPH45 continues toward a Phase 1 clinical trial.
Corporate update

Dr. Sonia Quaratino, MD, PhD, has been appointed as Executive Vice President and Chief Medical Officer of Innate Pharma, effective October 2023. Dr. Quaratino brings over 25 years of experience in basic research, clinical development, and translational medicine, having worked in academia, global large pharmaceuticals, and biotechs. Recently, Dr. Quaratino was Chief Medical Officer at Georgiamune INC.(USA) and prior to that she was Chief Medical Officer at Kymab (UK), a clinical-stage biopharmaceutical company with a focus on immune-mediated diseases and immuno-oncology, acquired by Sanofi in 2021. Previously, she held roles at Novartis (Switzerland) and Merck Serono (Germany) and was Professor of Immunology in UK at the University of Southampton. Her research has been published in high impact scientific journals.
On April 26, 2023, Innate announced the establishment of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of September 30, 2023, the balance available under our April 2023 sales agreement remains at $75 million.
Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €121.9 million as of September 30, 2023. At the same date, financial liabilities amounted to €40.3 million.

Revenues for the first nine months of 2023 amounted to €36.5 million (€44.3 million for the same period in 2022). For the nine-month period, ended September 30, 2023, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca, Sanofi and Takeda.

On November 14, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the third quarter ended September 30, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2023, View Source [SID1234637629]).

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"We are very pleased with the progress of the last quarter," noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Our efforts to improve drug delivery for protein kinase inhibitors brought IkT-001Pro to pre-NDA stage just 15 months after opening of the IND. Our neurodegenerative disease programs with risvodetinib are expanding, with 20% of the Phase 2 201 Trial in untreated Parkinson’s disease enrolled coupled with our efforts to initiate a Phase 2 program in Multiple System Atrophy. Finally, our internal and external medicinal chemistry programs are yielding important insights into the design of next generation Abl kinase inhibitors that could lead to a pipeline of beneficial products for Abl kinase-related diseases. Collectively, this has been a very productive period for the Company."

Recent Developments and Upcoming Milestones:

Advancing Phase 2 ‘201’ Trial of Risvodetinib (IkT-148009) in untreated Parkinson’s disease: As of November 10, 2023, 28 sites are open and actively evaluating prospective trial participants. Twenty-four participants have been enrolled, 7 prospective participants are in screening and 15 potential participants are going through informed consents.

The 201 Trial patient portal (www.the201trial.com) has been visited by more than 20,000 unique people since launch in September, 2023. The pre-qualification process has led to 201 unique individuals to contact open clinical sites, the first step in the evaluation process that could lead to enrollment. Monthly site enrollments have increased month-over-month since this patient outreach program was initiated.
Unblinded functional analysis from the 201 Trial are encouraging: In August 2023, unblinded functional assessments of 11 patients with untreated Parkinson’s disease were presented at the Movement Disorder Congress in Copenhagen, Denmark. These participants were withdrawn from the trial following the FDA’s temporary clinical hold in November, 2022, which was lifted January, 2023. These assessments showed that patients receiving the 200 mg dose of risvodetinib (N=3) saw a greater than 10 point improvement over placebo in the sum of motor and non-motor scores after once daily treatment for up to 11 weeks; by contrast, a typical patient with Parkinson’s disease would worsen by 3 to 6 points in the sum of motor and non-motor score assessments over a 12 month period. While the number of treated participants is too small for the Company to conclude a clinical benefit, these early data are cautiously encouraging.
Received Orphan Drug Designation in Multiple System Atrophy (MSA): In October 2023, risvodetinib was granted Orphan Drug Designation by the FDA for the treatment of MSA. In animal model studies of MSA, risvodetinib was shown to be therapeutically active. The designation by the FDA underscores the need for innovative treatment options for patients afflicted with this rare and rapidly progressing Parkinson’s-related disorder. The Company is pursuing a comparable designation in the European Union, or E.U., as part of its efforts to initiate a Phase 2 clinical trial to evaluate risvodetinib in MSA. The Company is discussing conduct of the trial with private foundations, Federal and industry stakeholders in an effort to initiate this trial in the future.
Completed the ‘501’ bioequivalence studies with IkT-001Pro: In October 2023, Inhibikase completed its bioequivalence studies of IkT-001Pro, measuring the bioequivalent dose to both 400 mg and 600 mg imatinib mesylate. The study enrolled a total of 66 healthy volunteers in three parts. In single dose studies, bioequivalent IkT-001Pro induced fewer neurological, musculoskeletal and gastrointestinal adverse events relative to 400 mg imatinib mesylate. Gastrointestinal adverse events were more persistent for imatinib mesylate in the study evaluating bioequivalence to 600 mg imatinib mesylate. Measures of bioequivalence along with safety and tolerability data are being submitted as briefing materials for a pre-NDA meeting with the FDA to reach agreement on the requirements for approval of IkT-001Pro under the 505(b)(2) statute.
Initiated preclinical development of second-generation c-Abl inhibitors: In August 2023, Inhibikase initiated preclinical development of new molecules arising from internal medicinal chemistry and external collaborations identifying second generation molecules that could enhance suppression of neurodegeneration or address other diseases that could benefit from Abl kinase inhibition.
Third Quarter Financial Results

Net Loss: Net loss for the three months ended September 30, 2023 was $4.60 million, or $0.86 per share, compared to a net loss of $4.49 million, or $1.06 per share in the quarter ended September 30, 2022.

R&D Expenses: Research and development expenses were $3.23 million for the quarter ended September 30, 2023 compared to $2.98 million in the quarter ended September 30 2022. The increase was primarily due to the Company’s ongoing Phase 2 ‘201’ PD clinical trial costs.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2023 were $1.62 million compared to $1.54 million for the quarter ended September 30, 2022. The increase was driven by net increase in normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $16.83 million as of September 30, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Conference Call Information
The conference call can be accessed by dialing 1-833-816-1414 (United States) or 1-412-317-0506 (International) with the conference code 0866324. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.