On May 10, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the quarter ending March 31, 2022 (Press release, Innate Pharma, MAY 10, 2022, View Source [SID1234614130]).

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"Again this quarter we made significant progress in our pipeline in particular with the presentation of positive data and clinical progress with our anti-NKG2A, monalizumab. We also saw a $50 million milestone from AstraZeneca triggered due to the first patient dosed in April in the Phase 3 lung cancer trial. This means our cash position is considerably strengthened to fund our pipeline ambitions into 2024," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We look forward to additional clinical milestones this year from our broad antibody pipeline, specifically readouts for lacutamab in the second half and further progress on ANKETTM, as we leverage scientific expertise and strong partnerships to deliver innovative treatments for people with cancer."

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

The live webcast will be available at the following link:
View Source

Participants may also join via telephone using the dial-in details below:
France: 0805 620 704
United States: 1 844 200 6205 / 1 646 904 5544
United Kingdom: 44 208 0682 558
All other locations: +1 929 526 1599
Access code: 051477

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 (IPH4102, anti-KIR3DL2 antibody):

The Phase 2 TELLOMAK study in Sézary syndrome and mycosis fungoides (MF) continues to progress and the Company expects to report preliminary data from both cohorts in the second half of 2022. In March 2022, Innate announced the opening of a new MF all-comers cohort in the TELLOMAK study. The all-comers cohort will be recruiting both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a potential companion diagnostic.
Two clinical trials are underway evaluating lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL):
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKETTM (Antibody-based NK cell Engager Therapeutics):

Recruitment continues in the Phase 1/2 clinical trial by Sanofi evaluating IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager, 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).
IPH64, the second ANKETTM drug candidate of the research collaboration with Sanofi, is progressing and the Company looks forward to updates on this asset.
Innate will provide updates on IPH65, the tetra-specific ANKETTM, throughout the year as progress is made toward an IND-enabling study in 2023.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

On April 29, 2022, Innate announced a $50 million milestone payment from AstraZeneca was triggered for dosing the first patient in the Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT). This is a post-period event.
Detailed results from the randomized AstraZeneca-sponsored Phase 2 COAST clinical trial, including monalizumab data in combination with durvalumab, were published in the Journal of Clinical Oncology on April 22, 2022. The results were initially presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021. The results of the interim analysis showed monalizumab in combination with durvalumab improved progression-free survival (PFS) and objective response rate (ORR) compared to durvalumab alone in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed after concurrent chemoradiation therapy (CRT). The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.
An oral presentation on April 11, 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the AstraZeneca-sponsored Phase 2 NeoCOAST randomized trial in resectable, early-stage NSCLC highlighted improved disease responses with durvalumab in combination withmonalizumab, oleclumab or danvatirsen, when compared to durvalumab alone. The follow-up randomized clinical trial, NeoCOAST-2, is enrolling patients with resectable, stage IIA-IIIA NSCLC to receive neoadjuvant durvalumab combined with chemotherapy and either oleclumab or monalizumab, followed by surgery and adjuvant durvalumab plus oleclumab or monalizumab.
The AstraZeneca-sponsored Phase 3 INTERLINK-1 trial of monalizumab plus cetuximab in immuno-oncology-pretreated head and neck cancer is ongoing with final data expected in 2024.
IPH5201 (anti-CD39), partnered with AstraZeneca:

Data for the Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (PD-L1) are expected to be presented in 2023.
IPH5301 (anti-CD73):

In March 2022, The Institut Paoli-Calmettes announced that the first patient had been dosed in the investigator-sponsored Phase 1 trial of IPH5301 (CHANCES). The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients.
ATM program:

On May 05, 2022, Innate announced the commencement 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.
Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €131.7 million as of March 31, 2022. At the same date, financial liabilities amounted to €43.8 million. Cash, cash equivalents and financial assets as of March 31, 2022 do not include the $50.0 million payment to be received from AstraZeneca.

Revenues for the first three months of 2022 amounted to €2.6 million (€4.5 million for the same period in 2021). For the three-month period, ended March 31, 2022, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca.

On May 10, 2022 Domain Therapeutics, a biopharmaceutical company specializing in the research and development of innovative drugs targeting G Protein-Coupled Receptors (GPCRs) in immuno-oncology, reported the closing of a US $42m (€39m) series A financing round co-led by Panacea Venture, CTI Life Sciences and 3B Future Health Fund, and joined by adMare BioInnovations, Schroders Capital, Omnes, Turenne Capital, Theodorus, Viva BioInnovator and existing investor Seventure Partners (Press release, Domain Therapeutics, MAY 10, 2022, View Source [SID1234614129]).

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This investment is a significant step forward for the French-Canadian company as it seeks to bring novel therapeutic solutions to cancer patients, aimed at bypassing immunosuppression mediated by GPCRs. Domain Therapeutics will use the proceeds of this financing to i) conduct the clinical development of its EP4R antagonist, DT-9081, ii) advance two additional GPCR programs, including an anti-CCR8 antibody, to the Investigational New Drug application stage, and iii) progress its discovery-stage pipeline of a number of first-in-class assets targeting GPCRs, identified through its proprietary platforms.

"We are pleased to welcome our new shareholders and I thank them all for their commitment at this decisive stage of our company’s growth," comments Pascal Neuville, CEO of Domain Therapeutics. "After having delivered a first GPCR drug candidate for immuno-oncology together with Merck KGaA, Domain is now committed to advance its own treatments reviving the immune system to defeat cancer."

With the expansion of immune checkpoint inhibitor treatments and the understanding of how tumors highjack and escape the immune system, even under immunostimulating treatments, GPCRs have recently emerged as strategic targets responsible of immunosuppression and treatment-resistance mechanisms. Domain Therapeutics is leveraging its insights into GPCR science and technology to develop a robust immuno-oncology pipeline designed to harness the power of immunity and to broaden the impact of immunotherapies. In addition, Domain Therapeutics scientists are hunting for biomarkers, tissue microarray data, genetic mutations and protein expression to select patients who will benefit most from its immunotherapy treatments.

"Panacea Venture foresees in Domain Therapeutics an outstanding potential in terms of value creation in the near future by leveraging the promise of GPCRs to deliver innovative immunotherapies," adds James Huang, Founding Managing Partner of Panacea. "We look forward to contributing to the success and the development of the company."

"We are very proud to co-lead this strategic financial round to support Domain Therapeutics capabilities to innovate and transform the company into a clinical-stage biotech." mentions Laurence Rulleau, Managing Partner at CTI Life Sciences. "The presence of Canadian investors in this Series A reinforces the footprint of Domain in Montreal and will increase the visibility of the company in North America for future financing and clinical development."

"Domain Therapeutics has a unique positioning in GPCR-mediated immunoresistance. The combination of two decades of expertise in GPCR drug discovery and the development of the oncology franchise over the last years holds great promise to deliver innovative immunotherapies to patients and to address high unmet medical needs," remarks Roberto de Ponti, Managing Director and General Partner of 3B Future Health Fund. "We are delighted to support Domain Therapeutics high-performing management team in transforming a comprehensive portfolio of programs into cancer treatments."

The Board of Directors of Domain Therapeutics is now composed of : James Huang (Director, Panacea Venture), Laurence Rulleau (Director, CTI Life Sciences), Roberto de Ponti (Director, 3B Future Health Fund), Emmanuel Fiessinger (Director, Seventure Partners), Youssef Bennani (Chairman of the Board of Directors), Sylvie Ryckebusch (Independent Director), Pascal Neuville (Director and CEO), Katherine Cohen (Observer, Panacea venture), Frédéric Lemaître Auger (Observer, adMare BioInnovations), Erwin Boos (Observer, Schroders Capital) et Guillaume Blavier (Observer, Omnes).

Advisors involved in this operation

Lawyers

Advisors of the company:

Bird & Bird (Paris, France) : Emmanuelle Porte (Partner) and Claire Tanguy (Associate).
Advisors of investors:

BCF (Montreal, Canada): Gino Martel, Julien Lefebvre (Partners), Luka Pavlovic (Associate);
Jones Day (Paris, France): Geoffroy Pineau-Valencienne (Partner) and Jeanne Plé (Associate) ;
Chammas & Marcheteau (Paris, France): Jerôme Chapron (Partner), Pauline Vigneron (Associate) ;
Taylor Wessing (Paris, France): Nicolas De Witt (Partner) ;
McDermott Will & Emery (Paris, France): Emmanuelle Trombe (Partner), Laetitia de Dinechin (Associate).
Intellectual Property

Advisors of the company:

Vossius & Partner (Munich, Allemagne) : Oswin Ridderbusch (European Patent Attorney);
Lavery Avocats (Montreal, Canada): Alain Dumont (Partner).
Advisors of investors:

Goodwin Procter LLP (Boston, United States): Theresa C. Kavanaugh (Partner).
Financial advisors

Advisors of the company:

Agile Capital Markets (Paris, France) : Eric Cohen (Managing Director), Michael Khayat (Associate) ;
CenPonts Healthcare (Paris, France) : Xianding Ma (Partner), Jinlong Yue (Executive Director).

On May 10, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has reported that the first patient has been dosed in the ‘STARLITE 2’ Phase II study of Telix Pharmaceuticals Limited (Telix) investigational renal cancer therapy product, TLX250 (177Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, Eczacıbaşı-Monrol Nuclear Products, MAY 10, 2022, View Source [SID1234614128]). Monrol supplied Lutetium (Lu-177 n.c.a) to Telix Pharmaceuticals to manufacture clinical doses of TLX250 for STARLITE 2 Phase II study. This collaboration may offer significant opportunities for clear cell renal cell carcinoma (ccRCC) patients in the future.

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The STARLITE 2 Phase II study (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with the anti-PD-11 immunotherapy Opdivo2 (nivolumab) for ccRCC, the most common and aggressive form of kidney cancer. The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. TLX250 targets carbonic anhydrase IX (CA9),3 a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.4 The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy. Telix’s investigational companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression.

Clinical doses of Telix’s investigational renal cancer companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is also produced by Eczacıbası Monrol in its Istanbul facility for the Phase III ZIRCON clinical trial.

ZIRCON Phase III study ("Zirconium Imaging in Renal Cancer Oncology") is an international multi-centre study at 34 sites in Europe, Australia, Turkey, Canada, and the United States. The study enrolled 30 patients in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.

Monrol is a company developing, manufacturing, and distributing world-class radiopharmaceutical products, radioisotopes to improve quality of life of cancer patients globally and one of the few producers of Lutetium-177 n.c.a, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability.

"Lu-177 n.c.a contributes to our mission to improve quality of life of cancer patients globally. Our new GMP certified facility exclusively designed for theranostic R&D and production with cutting edge technology will enable us to maximize supply of high-quality Lutetium worldwide. We are committed to working closely with Telix to potentially bring new therapeutic radiopharmaceutical agents into market soon to improve patients’ lives having life threatening diseases" said Monrol General Manager Aydin Kucuk".

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study STARLITE 2".

Disclosure: MSK has institutional financial interests related to Telix.

About Lutetium-177 n.c.a

Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today. Unique properties of Lutetium-177 n.c.a makes it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET), Prostate cancer and many other clinical development programs are ongoing for other cancers like ccRCC.

In line with the company mission to create hope for a better life for cancer patients, Monrol is establishing strategic partnerships with multinational pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards which will have an annual production capacity of 60 thousand doses. With its location close to Istanbul, a major transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether "indeterminate renal masses", typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer. Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is the subject of a global Phase III trial recruiting (ZIRCON trial, NCT03849118).

On May 10, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the first quarter of 2022 (Press release, AbCellera, MAY 10, 2022, View Source [SID1234614127]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We entered 2022 with strong momentum that we leveraged to start new drug discovery programs and demonstrate the power of our platform by discovering a panel of CD3 antibodies for use in precision cancer treatments," said Carl Hansen, Ph.D., CEO and President of AbCellera. "With our strong cash position and book of business, we also continued pursuing deal structures that allow us to capture more downstream value and expanded an existing partnership to include the option to co-develop therapeutic programs."

Q1 2022 Business Summary

Earned $317 million in total revenue.
Generated net earnings of $169 million, compared to $117 million in Q1 2021.
Added two programs under contract with an existing partner, resulting in a cumulative total of 158 programs under contract with 36 different partners.
Started discovery on six programs, bringing the cumulative number of program starts to 84.
Confirmed one new molecule advanced into the clinic, bringing the cumulative total to six.
Key Business Metrics

AbCellera added two discovery programs in Q1 to reach a cumulative total of 158 discovery programs as of March 31, 2022 (up from 119 on March 31, 2021), that are either completed, in progress, or under contract with 36 different partners (up from 29 on March 31, 2021). AbCellera started discovery on an additional six programs in Q1 to reach a cumulative total of 84 program starts (up from 54 on March 31, 2021). AbCellera’s partners advanced one additional molecule into the clinic in Q1 2022, bringing the cumulative total to six.

Discussion of Q1 2022 Financial Results

Revenue – Total revenue was $316.6 million, compared to $202.7 million in Q1 2021. Royalties associated with bamlanivimab and bebtelovimab were $307.0 million. The partnership business produced research fees of $9.3 million, compared to $4.0 million in Q1 2021. Licensing revenue was $0.2 million.
Research & Development (R&D) Expenses – R&D expenses were $26.4 million, compared to $12.4 million in Q1 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $2.4 million, compared to $2.6 million in Q1 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.3 million, compared to $6.4 million in Q1 2021, with the increase driven by investments to support the growth of the company and non-cash stock-based compensation.
Net Earnings – Net earnings were $168.6 million, or $0.59 per share on a basic and $0.54 on a diluted basis compared to $117.2 million, or $0.43 per share on a basic and $0.37 on a diluted basis in Q1 2021.
Liquidity – $786.1 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On May 10, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, will present at the upcoming H.C. Wainwright Global Investment Conference (Press release, ImmunoGen, MAY 10, 2022, View Source [SID1234614126]). The presentation will be available on May 24, 2022 at 7:00am ET.

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A webcast of the presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the webcast, a replay will be available at the same location.