On November 16, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the third quarter ended September 30, 2021 and provides a business update (Press release, AIM ImmunoTech, NOV 16, 2021, View Source [SID1234595703]).

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Third Quarter 2021 Financial Highlights:

As of September 30, 2021, AIM had cash, cash equivalents and marketable securities of $53.7 million, compared to $54.4 million as of December 31, 2020.

Research and development expenses for the three months ended September 30, 2021 were $2.0 million, compared to $1.1 million for the three months ended September 30, 2020.

General and administrative expenses for the three months ended September 30, 2021 were $1.8 million, compared to $2.1 million for the three months ended September 30, 2020.

The net loss from operations for the three months ended September 30, 2021 was $3.8 million, or $0.08 per share, compared to $3.3 million, or $0.08 per share, for the three months ended September 30, 2020.

Please refer to the full 10-Q for complete details.

2021 Clinical and Business Highlights

AIM has established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases. AIM’s strategy is to advance trials and activities that have the shortest path to potential FDA and EMA drug approval, providing opportunities for expedited success. AIM anticipates that these planned trials primarily will be AIM-sponsored and AIM-funded.

Immuno-oncology

Following statistically significant positive survival data collected from the Early Access Program at Erasmus Medical Center (Erasmus MC) in the Netherlands, AIM and its Contract Research Organization, Amarex Clinical Research LLC, submitted an Investigational New Drug application and an accompanying application for Fast Track status to the U.S. Food and Drug Administration for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are expected to participate. Assuming this trial and subsequent planned clinical trials confirm the existing data, AIM expects to then submit a New Drug Application for use of Ampligen in pancreatic cancer patients.

Furthermore, AIM continues to advance multiple additional Ampligen clinical trials at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including with checkpoint inhibitors:

Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. View Source
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1/2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Eight patients were enrolled and treated. AIM awaits publication of data. View Source
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver; 15 patients were enrolled and treated. AIM awaits publication of data. View Source
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. View Source
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. This study is recruiting patients and is designed for up to 24 patients. View Source
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. View Source
Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Additionally, AIM is awaiting publication of the results of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian cancer. The Phase 1 portion was designed to establish intraperitoneal safety. View Source

COVID-19 and Antiviral Therapies

In January, AIM entered into a Sponsor Agreement with the Centre for Human Drug Research (CHDR), a foundation located in Leiden in the Netherlands, to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. The objective was to establish safety for intranasal Ampligen as a potential broad-spectrum prophylaxis for respiratory viruses, including SARS-CoV-2. All patients had completed treatment by June 2021 and the interim results reported no Severe Adverse Events at any dosage level. During the third quarter, AIM released detailed safety data from the Phase 1 study which is available on the AIM website.

Following the completion of the Phase 1 dosing, and based on its positive interim results, in July 2021 AIM signed a Reservation and Start-Up Agreement with hVIVO, reserving space in hVIVO’s quarantine facility to sponsor a Phase 2a Human Challenge Trial (HCT) to test Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (a common cold virus) and Influenza as challenge viruses. This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The objective is to establish Ampligen’s potential as a broad-spectrum prophylaxis for respiratory viruses, a category that includes SARS-CoV-2 and future emerging pathogens with pandemic potential.

AIM submitted its study protocol to the Oxford Research Ethics Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA) on September 10, 2021. The REC approved the protocol, but the MHRA provided a response outlining areas of the submission where it requires additional information. The Company intends to re-submit its proposed protocol as soon as possible.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

Earlier this year, AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) in the U.S. dosed its first "Long Hauler" patient with the drug Ampligen, marking a significant milestone in AIM’s efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. As of September 30, 2021, there are 14 patients enrolled in this open-label expanded access treatment protocol including three post-COVID-19 patients with cognitive dysfunction. Early data from the ongoing AMP-511 Expanded Access Program has indicated that patients with cognitive function deficiency have reported improvements in cognitive function after Ampligen treatment. AIM intends to provide updates as the trial progresses.

Patents / Intellectual Property

During the quarter, AIM filed two COVID-19 related provisional patent applications. In August, AIM filed an application for Ampligen as both an intranasal and an intravenous therapy for what the Company describes as Post-COVID-19 Cognitive Dysfunction ("PCCD"). The U.S. Centers for Disease Control and Prevention refers to Long COVID or Long Haulers as Post COVID Conditions. One of these conditions is difficulty thinking or concentrating, sometimes referred to as brain fog. The people suffering from PCCD, including some young adults, can be afflicted with severe difficulties in concentrating; serious memory problems; and the inability to live an active lifestyle, to work and even to perform everyday tasks. Early data has demonstrated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Expanded Access Program have reported improvements in cognitive function. Similarly, in ME/CFS, data from the AMP-502 study showed that Ampligen improved cognitive function.

In September, AIM filed a patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2.

AIM believes that these two provisional patent applications are important steps towards advancing proposed studies in these areas.

"We are proud of the progress made through the third quarter," commented, Thomas K. Equels, CEO of AIM ImmunoTech. "We continue to advance multiple clinical trials towards major inflection points that we believe will provide significant benefits for patients and drive shareholder value. Given the broad immunological effects of Ampligen, as illustrated by our growing pre-clinical and clinical data, we believe Ampligen has tremendous market potential across a wide range of indications. We have maintained a strong balance sheet, which provides us funding to execute our corporate strategy, as well as internally fund clinical trials, which should accelerate our therapeutic development. We remain very encouraged by the outlook for the business and look forward to reporting on key upcoming developments."

On November 16, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported its financial results for the quarter ended September 30, 2021, and provided a business update on its progress over the reporting period (Press release, Immatics, NOV 16, 2021, View Source [SID1234595702]).

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"The unprecedented objective response rate we have observed during early dose escalation in the ACTengine IMA203 trial, encourages us to double down on our development strategy of our programs targeting PRAME," said Harpreet Singh, Ph.D., CEO at Immatics. "Following determination of target dose, we will start a concerted effort in early 2022 with multiple levers to pull to deliver durability of response. This will include deploying ACTengine IMA203 (1) as monotherapy at target dose, (2) in combination with a checkpoint inhibitor, (3) as an efficacy-enhanced next-gen TCR-T approach IMA203CD8 and (4) also now being able to offer IMA203 to patients with fewer lines of pre-treatments or less disease burden. We look forward to providing updates on these clinical outcomes throughout 2022."

Third Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203 – On November 13, Dr. Martin Wermke, coordinating investigator of the Phase 1 trial with IMA203 targeting PRAME, presented updated clinical data as a late-breaking oral presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The dose escalation phase of the trial for IMA203 is ongoing with dose level 3 completed at doses below 1 billion transduced cells in a heavily pre-treated patient population. In 15 out of 16 evaluable patients (94%), treatment with IMA203 achieved disease control and tumor shrinkage was observed in 14 out of 16 patients (88%). Objective responses (partial responses according to RECIST 1.1) were observed in 8 out of 16 patients (50%) across multiple solid cancer indications. 8 out of 13 patients (62%) treated at dose levels 2 and 3 had objective partial responses. Adverse events remained transient and manageable with no high-grade cytokine release syndrome or neurological toxicities observed. No dose limiting toxicities (DLTs) were observed since the previous data release on March 17, 2021. The data also revealed high T cell engraftment and persistence along with clinical responses which were associated with tumor infiltration.

Patient recruitment to the 4th and highest dose level (up to approximately 2.5 billion total transduced cells) for the ACTengine IMA203 trial is ongoing. Immatics plans to expand the IMA203 study to three Phase 1b (dose expansion) study cohorts including IMA203 as a monotherapy, IMA203 in combination with an immune checkpoint inhibitor and IMA203 cells co-transduced with a CD8 co-receptor, called IMA203CD8.

ACTengine IMA203CD8 – Immatics entered into an exclusive license agreement with Baylor College of Medicine (BCM) in Houston, Texas, for the development of next-generation adoptive cell therapies (ACT). BCM conducted foundational research for the use of CD8 co-receptor expression in an ACT setting. Through this agreement with BCM, Immatics gains access to pioneering work in the field of CD8αβ co-receptor expression to develop its next-generation ACT approaches. The agreement underscores Immatics’ long-term strategy to access innovative science and technologies to enhance the tolerability, potency, and ease of use of its TCR-T product candidates.

Immatics presented preclinical proof-of-concept data on its next-generation ACTengine IMA203CD8 program in a poster presentation at the 2021 SITC (Free SITC Whitepaper) Annual Meeting on November 12. The data demonstrated that equipping IMA203-T cells with CD8αβ, a T cell co-receptor, enhances anti-tumor activity of the engineered T cells. Immatics’ IMA203CD8 candidate showed functional superiority among 20 tested CD8 constructs including CD8α. IND submission for IMA203CD8 as part of the Phase 1b study expansion cohort is expected in the first half of 2022.

ACTengine IMA201 and IMA202 – The dose escalation Phase 1a study of the clinical ACTengine programs, IMA201 and IMA202, continues to advance with IMA202 at target dose level 3 and IMA201 at dose level 2. 12 heavily pre-treated patients have been treated with product candidates IMA201 and IMA202. 8 out of 12 patients showed disease control, and tumor shrinkage was observed in 4 patients. All adverse events for IMA201 and IMA202 continue to be transient and manageable with no DLTs observed. The next step in the IMA201 and IMA202 trials is to complete dose escalation including target dose (DL3).

ACTengine IMA204 – The fourth program of the different ACTengine IMA200 TCR-T programs, IMA204, is directed at the novel tumor stroma target COL6A3 exon 6 expressed in a large variety of solid cancers. IMA204 is utilizing a next-generation CD8-independent T cell receptor. IND-enabling studies with IMA204 are being completed. Submission of the IND application for IMA204 is expected in 2022.

TCR Bispecifics Program

TCER IMA401 – IMA401 is an antibody-like, "off-the-shelf" biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a Clinical Trial Application (CTA) is planned in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022.

TCER IMA402 – Immatics presented preclinical proof-of-concept data from its TCER program, IMA402, directed against PRAME, at the PEGS Boston Protein Engineering and Cell Therapy Summit in May. In additional pre-clinical studies, TCER IMA402 designed with a low-affinity T cell recruiter demonstrated superior tumor control than analogous TCER molecules with higher-affinity T cell recruiter domains. Production of GMP material for a Phase 1 clinical study is planned in 2022.

Third Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €173.2 million ($200.6 million1) as of September 30, 2021, compared to €192.8 million ($223.2 million1) as of June 30, 2021.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €6.4 million ($7.4 million1) for the three months ended September 30, 2021, compared to €7.9 million ($9.1 million1) for the three months ended September 30, 2020.

Research and Development Expenses: R&D expenses were €21.2 million ($24.5 million1) for the three months ended September 30, 2021, compared to €17.5 million ($20.3 million1) for the three months ended September 30, 2020. The increase is mainly due to expanded clinical activities for the ACTengine IMA200 series, as well as GMP manufacturing for the TCER compound, IMA401.

General and Administrative Expenses: G&A expenses were €8.3 million ($9.6 million1) for the three months ended September 30, 2021, compared to €9.2 million ($10.7 million1) for the three months ended September 30, 2020. The decrease is mainly due to one-time expenses in connection with the listing of the Company in 2020.

Net Loss: Net loss was €27.2 million ($31.5 million1) for the three months ended September 30, 2021, compared to €164.0 million ($189.9 million1) for the three months ended September 30, 2020. The decrease is mainly due to a one-time share listing expense of €152.8 million ($176.9 million) in connection with the listing of the Company in 2020.

Upcoming Investor Conferences

Jefferies Global Healthcare Conference – November 16-18, 2021
Piper Sandler 33rd Annual Healthcare Conference – November 30 – December 2, 2021
11th Annual SVB Leerink Global Healthcare Conference – February 14 – 18, 2022

To see the full list of events and presentations, visit View Source
Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of September 30, 2021 (1 EUR = 1.1579 USD).

About Immatics’ PRAME Programs
Immatics’ PRAME programs are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers – such as uterine carcinoma, synovial sarcoma, melanoma, ovarian carcinoma, uveal melanoma, squamous NSCLC, breast carcinoma and HNSCC – thereby supporting the programs’ potential to address a broad cancer patient population. PRAME demonstrates a high target peptide density per tumor cell and is homogenously expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, the Company has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203, and its TCR Bispecifics pipeline, TCER IMA402. Both therapeutic modalities have distinct attributes and mechanisms of actions suitable for cancer patients at different disease stages and tumor types.

About ACTengine IMA200 programs
Each of the product candidates of the IMA200 programs is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and the associated programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.

On November 16, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that the results from a Phase 1 trial evaluating multiple ascending doses and the food effect of LYT-100 (deupirfenidone) were published in the journal Clinical Pharmacology in Drug Development (Press release, PureTech Health, NOV 16, 2021, View Source [SID1234595701]). Topline results from this Phase 1 study were previously announced in November 2020 and demonstrated that LYT-100 was well-tolerated in healthy volunteers under both fed and fasting conditions.

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LYT-100 is PureTech’s wholly-owned therapeutic candidate that is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. It is currently being evaluated in two Phase 2 trials in patients with Long COVID respiratory complications and breast cancer-related, upper limb secondary lymphedema. Enrollment in the Long COVID respiratory trial is expected to be completed by the end of 2021, with topline results anticipated in the first half of 2022. Topline results from the breast cancer-related, upper limb secondary lymphedema trial are anticipated in 2022.

"The data set from the completed Phase 1 MAD study, including a favorable safety and tolerability profile, reaffirms our belief that LYT-100 has the potential to be an attractive therapeutic option across a range of conditions. There are substantial shortcomings with the current standards of care for patients living with fibrotic lung disease, and we believe that the anti-fibrotic and anti-inflammatory properties along with the favorable tolerability profile demonstrated with LYT-100 to date could address this issue," said Michael Chen, Ph.D., Head of Innovation at PureTech Health. "We’re encouraged by these results and look forward to the upcoming clinical readouts as we advance LYT-100 in multiple indications."

LYT-100 is a selectively deuterated form of pirfenidone that retains the pharmacologic properties of the parent compound but is expected to be metabolized at an attenuated rate. GI-related tolerability issues have historically been associated with pirfenidone and have limited its usage in patients at the therapeutic dose approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF). Despite a noted dose-efficacy response in clinical trials in patients with IPF, higher doses of pirfenidone have not been adequately explored due to limitations in tolerability. PureTech is currently exploring the pharmacokinetic (PK) and tolerability profile of LYT-100 across a range of doses in order to determine whether LYT-100 can achieve higher levels of systemic exposure than the currently FDA-approved dose of pirfenidone.

Multiple ascending dose and food effect study results

The Phase 1 multiple ascending dose and food effect study was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK profile and food effect of LYT-100 in healthy volunteers in both fed and fasting states. Plasma concentrations of LYT-100 and its metabolites were measured to determine PK parameters.

Part 1 assessed multiple ascending doses of LYT-100 administered in doses of 100 mg, 250 mg, 500 mg, 750 mg and 1000 mg BID over five days without dose titration. Part 2 assessed the effect of fed versus fasting conditions on the PK profile of LYT-100 following a single 500 mg dose. No dose limiting toxicities were noted, and a maximum tolerated dose was not determined.

All adverse events (AEs) that were possibly or probably related to LYT-100 were mild. Of the 40 participants, 37 (92.5%) completed part 1 of the study and eight participants who completed part 1 also completed part 2. The most common AEs across part 1 of the multiple ascending dose cohorts were headache, abdominal distension and nausea. There were no tolerability issues after administration of a single dose of 500 mg given with or without food.

A dose-proportional PK profile was observed with LYT-100 throughout the range of doses studied. As with pirfenidone, LYT-100 exposure was affected by food, with fed conditions resulting in lower drug exposure compared to fasting conditions. The ratio of exposure during fed conditions was approximately 20% to 25% less than exposure during fasting. Fed conditions led to a 26% reduction in Cmax observed with LYT-100, while the Cmax reduction stated in the ESBRIET (pirfenidone) U.S. Prescribing Information is 49%.

The therapeutic dose of pirfenidone approved by the FDA for the treatment of IPF is 801 mg three times a day. LYT-100 is designed to potentially improve upon this regimen. In a previously conducted single-dose crossover study, an 801 mg dose of LYT-100 resulted in greater drug exposure than an 801 mg dose of pirfenidone. In part 1 of the multiple ascending dose study, LYT-100 was well-tolerated at a dose above 801 mg.

Additional Phase 1 studies and future development plans

Given that the maximum tolerated dose for LYT-100 was not determined in the original Phase 1 study, PureTech initiated a second multiple ascending dose study earlier this year to evaluate higher doses of the drug in healthy volunteers. PureTech also initiated additional Phase 1 studies to further evaluate the PK, dosing and tolerability of LYT-100 in healthy volunteers and healthy older adults to inform the clinical development of LYT-100 across multiple indications. Results from these studies are expected in the first quarter of 2022.

About LYT-100

LYT-100 is PureTech’s most advanced therapeutic candidate from within its Wholly Owned Pipeline. A deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis, including lung disease (e.g., IPF and potentially other PF-ILDs and Long COVID respiratory complications and related sequelae), and disorders of lymphatic flow, such as lymphedema. PureTech is also exploring the potential evaluation of LYT-100 in other inflammatory and fibrotic conditions such as myocardial, kidney and other organ system fibrosis based on clinical data around the use of pirfenidone in these indications.

PureTech completed a Phase 1 multiple ascending dose and food effect study evaluating LYT-100 in healthy volunteers and found it to be well-tolerated at all doses tested. In the fourth quarter of 2020, PureTech initiated a Phase 2 trial evaluating LYT-100 as a potential treatment for Long COVID respiratory complications and related sequalae and a Phase 2a proof-of-concept study evaluating LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema. PureTech has also initiated additional Phase 1 clinical trials to further explore the PK, dosing and tolerability of LYT-100 in healthy volunteers. Results from these trials are expected to provide additional supportive data to inform the clinical development of LYT-100 across multiple indications.

1 Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection, also known as post-acute COVID-19 syndrome (PACS).

On November 16, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2021 (Press release, Innate Pharma, NOV 16, 2021, View Source [SID1234595699]).

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"In the period, we continued to execute against our strategic priorities as we reported readouts from two of our partnered portfolio programs. This included randomized Phase 2 data for monalizumab in combination with durvalumab in unresectable, Stage III NSCLC as well as pre-clinical data from our lead ANKET molecule targeting CD123 in acute myeloid leukemia. These readouts continue to set the stage for delivering both near and long-term value, while also highlighting the strength and depth of our core R&D efforts," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Looking ahead, we will continue to advance our lacutamab development program and move our early-stage R&D activities towards the clinic with our next generation ANKET platform. We also look forward to seeing AstraZeneca’s upcoming plans for monalizumab’s registrational study in unresectable, Stage III NSCLC, which further reinforces our strategy of building a sustainable business with a robust R&D engine."

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 following the event.

Pipeline highlights:

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In September, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%).
Based on the data, AstraZeneca announced plans to initiate a Phase 3 trial for both combinations of monalizumab or oleclumab plus durvalumab in the unresectable, Stage III NSCLC setting for patients who had not progressed after concurrent chemoradiation therapy.
Separately, AstraZeneca also announced that it is starting a Phase 2 clinical trial, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC.
Innate will present data from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which was accepted as a mini oral presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) conference in December 2021.
Lacutamab (anti-KIR3DL2 antibody):

Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are initiating:
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) plans to initiate an 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.
ANKET (Antibody-based NK cell Engager Therapeutics):

IPH6101/SAR443579

In November Innate and Sanofi shared new data on IPH6101/SAR443579 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference. IPH6101/SAR443579 is the first NKp46/CD16-based NK cell engager using Innate’s proprietary ANKET multispecific antibody format that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells.

IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines and primary AML blasts, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor cytokine release and a favorable safety profile in comparison to T-cell engagers.
Tetra-specific ANKET

In September and November 2021, Innate also presented at the ESMO (Free ESMO Whitepaper) 2021 and SITC (Free SITC Whitepaper) conferences respectively. Innate shared data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen.

The tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.
IPH5201 (anti-CD39):

AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab. The data is expected to be presented in 2022.
IPH5301 (anti-CD73):

The Company is initiating an investigator-sponsored Phase 1 trial of IPH5301 in collaboration with the Institut Paoli-Calmettes.
Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €141.8 million as of September 30, 2021. At the same date, financial liabilities amounted to €16.1 million.

Revenues for the first nine months of 2021 amounted to €10.3 million (€33.6 million for the same period in 2020). For the nine-month period, ended September 30, 2021, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi.

On November 16, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has entered into a Memorandum of Understanding (MoU) with The National Nuclear Laboratory (NNL) to explore avenues to supply Pb-212 to researchers, and possibly clinicians, in the United Kingdom and Europe, using Viewpoint’s proprietary isotope generator, VMT- -GEN (Press release, Viewpoint Molecular Targeting, NOV 16, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-enters-agreement-with-uk-based-national-nuclear-laboratory-ltd-to-advance-development-of-targeted-alpha-therapy-for-cancer/ [SID1234595698]).

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VMT- -GEN is an elegantly-designed isotope generator that provides therapeutic doses of Pb-212 for the Company’s therapeutics – part of its ("Theranostic") programs for the treatment of cancers (including metastatic melanoma, neuroendocrine tumors, and other oncology indications in the company pipeline).

"This agreement is great news for the UK nuclear medicine research community and ultimately, cancer patients. Targeted radionuclide therapy with alpha-emitting radionuclides such as actinium-225 has shown some astonishing success in early small-scale trials for treating cancer patients recently, but availability of these radionuclides is a major roadblock to implementing it more widely, particularly in the UK. The availability of lead-212 made possible by this collaboration will go a long way to removing this roadblock, allowing the UK’s world-leading radiochemistry, radiobiology and clinical researchers to develop new treatments for cancer," added Phil Blower, DPhil, FRSC, Professor of Imaging Chemistry, KCL, Head of Dept of Imaging Chemistry and Biology.

The National Nuclear Laboratory is a UK government owned and operated nuclear services technology provider covering the whole of the nuclear fuel cycle. As part of the agreement, Viewpoint and NNL will explore opportunities for the provision of feedstock radionuclides at the appropriate specification for production of VMT-α-GEN generators; and the use of laboratory facilities required for the production of generators in the UK.

"This agreement with NNL is a momentous step forward as we work to deploy our proprietary VMT- -GEN generator and thereby expand the global availability of lead-212. We believe our VMT- -GEN holds a tremendous amount of potential and this collaboration enables us to supply lead-212 to support preclinical work and clinical trials utilizing VMT-α-GEN in the United Kingdom," commented Michael K. Schultz, PhD, Chief Science Officer of Viewpoint. "We are committed to bolstering our networks with researchers as well as distribution in the UK and Europe to optimize that potential. We are honored to be working with the NNL team and look forward to leveraging their knowledge and expertise."

Radionuclide generators such as VMT- -GEN are used commonly in radiopharmaceutical manufacturing operations and nuclear medicine facilities across the world. The devices share a common characteristic of enabling the production of a purified chemical form of the radionuclide needed that can be easily combined with ligands that seek out cancerous tumors. Because the shelf life of VMT- -GEN is based on longer-lived radionuclides, a single shipment of VMT- -GEN can be used to produce radiopharmaceutical doses daily, for up to a week or more. Given their small footprint, multiple generators can easily be operated within a single facility simultaneously. The device also simplifies radioactive waste management as the spent generator can be easily returned to the manufacturer in approved packaging to eliminate radioactive waste from the medical center or radiopharmacy.