On June 24, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas (Press release, Innate Pharma, JUN 24, 2020, View Source [SID1234561424]).

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The FDA decision is based on a quality assessment of a new Good Manufacturing Practice (GMP)-certified batch that has been successfully manufactured for the lacutamab clinical development program, including the TELLOMAK trial. The Company can now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies.

In light of the FDA feedback, the Company is taking the operational measures to re-activate the US clinical trial sites.

"We are pleased that the FDA has approved the new clinical batch for the TELLOMAK trial, and we can resume enrollment of patients with Sézary syndrome and mycosis fungoides given the importance of novel and effective treatment options needed for these patient populations," commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma. "We’re confident in our ability to supply lacutamab in this important trial moving forward, and look forward to reactivating the trial globally as quickly as possible."

As a reminder, the FDA placed the TELLOMAK trial on partial hold due to GMP deficiencies at the Company’s manufacturing subcontractor site that managed the fill and finish operations of the lacutamab clinical vials for TELLOMAK. In Europe, the national regulatory authorities in Spain, Italy and Germany temporarily halted the trial whereas the French and UK regulatory authorities agreed to resume trial recruitment in those respective countries earlier this year. The Company is consulting the regulatory authorities in Germany, Italy and Spain in order to resume the trial in these countries soon.

The Company expects to start sharing data from the TELLOMAK trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.

Analyst webcast and conference call will be held today at 4:00pm CEST (10:00am EST)

Innate Pharma will host a live webcast and conference call today to discuss its lacutamab clinical trial program, including the Company’s PTCL strategy.

The presentation and live webcast details are available on Innate Pharma’s web site at www.innate-pharma.com, and below:

Webcast: View Source

Conference call dial in details:

France: +33 (0)170 700 781 | US: + 1 877 870 9135 | International: +44 (0) 2071 928 338

Conference ID: 20679317

A replay will be available on Innate Pharma’s website after the conference call.

About the GMP Deficiency:
This situation is related to GMP deficiencies put forward by the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or "RFS" (now known as Impletio Wirkstoffabfüllung GmbH). RFS was granted a GMP certificate by the Austrian regulatory agency in August 2018, which was further confirmed in October 2019 after two on-site inspections. In November, RFS unilaterally withdrew the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS also filed for bankruptcy.

The Company’s utmost priority is to ensure patient safety. An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.

About Lacutamab:
Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 85% of them with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It has a restricted expression on normal tissues.

Lacutamab was granted orphan drug status in the European Union and in the United States for the treatment of CTCL. In January 2019, the US Food and Drug Administration (FDA) granted Innate Pharma Fast Track designation for lacutamab for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.

About the TELLOMAK Trial:
TELLOMAK is a global, open-label, multi-cohort Phase II clinical trial conducted in the United States and Europe. In this clinical trial, lacutamab is being evaluated in patients with advanced t-cell lymphomas (TCL). TELLOMAK is expected to recruit up to 150 patients, with lacutamab evaluated:

As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab
As a single agent in approximately 90 patients with mycosis fungoides (MF) who have received at least two systemic therapies
In patients with MF, the study is designed to evaluate the benefit of lacutamab according to KIR3DL2 expression. The study comprises two cohorts in MF, testing lacutamab in KIR3DL2 expressing and non-expressing patients. These cohorts follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.

The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.

Scenic Biotech BV ("Scenic"), a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, reported that it has been awarded a €3.1 million Innovation Credit from the Dutch Government (Press release, Scenic Biotech, JUN 23, 2020, View Source [SID1234611030]). The funds will be used to advance the Company’s lead CD47/QPCTL immuno-oncology program through preclinical development towards human clinical studies.

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The Innovation Credit is awarded by the Dutch government through its agency RVO of the Ministry of Economic Affairs and Climate Policy and is aimed at the development of promising and challenging innovations. It will support the preclinical development of novel QPCTL (Glutaminyl-peptide cyclotransferase-like) inhibitors, completing the two-year project with an IND filing.

Scenic’s CD47/QPCTL immuno-oncology program builds on seminal work by the Netherlands Cancer Institute (NKI) and Leiden University Medical Centre (LUMC). An enzyme present in cancer cells, QPTCL was first demonstrated as a promising target for immuno-oncology by using the Company’s proprietary high-resolution genetics platform called Cell-Seq. The results of this discovery were published in the journal Nature Medicine.

QPCTL was found to be a druggable modifier of the CD47 innate immune checkpoint, which is one of the major mechanisms by which cancer cells evade detection by the immune system. As a result of this activity, CD47 is also known as the ‘don’t eat me signal’. After being the first to discover and validate QPCTL as a promising target in immuno-oncology, NKI and LUMCs scientists also showed that small molecule inhibitors of QPCTL can prevent the expression of functional CD47 on cancer cells, thereby causing the cancer cells to be attacked by macrophages and destroyed.

Scenic has gone on to develop a series of chemical inhibitors with potent inhibition against QPCTL and has filed a patent application related to this chemical series.

Dr Sebastian Nijman, co-founder and CEO of Scenic Biotech said:
"We are delighted to be selected for this award from the Dutch Government, recognizing the potential of our program to develop a new cancer therapy. The funding will enable us to accelerate the optimization of our proprietary small molecule QPCTL inhibitors and then advance them towards filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). This is the first step in the drug review process before clinical trials can begin and will represent an exciting milestone for our Company."

An Innovation Credit can include the technical development of a new product or process or the clinical development of a medicine or device and requires matching funding from Scenic. After the IND approval phase, Scenic will seek a Partner to support human clinical trials.

On June 23, 2020 Sana Biotechnology, Inc. (Sana), focused on engineering cells as medicines for patients, reported the funding of all tranches of its initial financing, raising over $700 million (Press release, Sana Biotechnology, JUN 23, 2020, View Source [SID1234567820]).

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With this financing, Sana’s shareholders include ARCH Venture Partners, Flagship Pioneering, Canada Pension Plan Investment Board, Baillie Gifford, F-Prime Capital, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds, Altitude Life Science Ventures, and multiple unnamed institutional investors.

"Sana is dedicated to modulating genes in cells as well as replacing damaged cells in the body," said Steve Harr, Sana President and CEO. "The commitment from this group of long-term investors enables us to concentrate on making discoveries that overcome the most important challenges to making gene and cell therapies that improve the lives of a broad swath of patients. I am proud of our progress to date in turning our technologies into potential therapies for serious diseases such as cancer, central nervous system diseases, heart disease and various genetic disorders."

Proceeds from Sana’s financing will be used to advance discovery and development within the company’s core platforms, including gene delivery, immunology, stem cell biology, and gene modification and control. Some approaches include in vivo delivery of genetic payloads to specific cells, ex vivo genetic modifications that hide allogeneic cells from a patient’s immune system, and applying stem cell biology to make differentiated cells to replace missing or damaged tissue. Proceeds are expected to support IND-enabling and initial clinical studies for multiple therapeutic candidates, buildout of manufacturing capabilities, and expansion of the company’s portfolio of enabling technologies. They will also support the continued addition of top talent to Sana’s team.

On June 23, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that it has entered into a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) with the intent to initiate a randomized phase II trial to evaluate the combination of ONCOS-102, Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, and standard of care (SoC) chemotherapy in malignant pleural mesothelioma (Press release, Targovax, JUN 23, 2020, View Source [SID1234564004]).

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Recently, Targovax reported encouraging results from the ongoing phase I/II trial evaluating intra-tumoral ONCOS-102 treatment in addition to SoC (pemetrexed and cisplatin) in first and second line unresectable mesothelioma, see press release here. These data indicate a potential clinical benefit of ONCOS-102, particularly in first line patients. Importantly, clinical responses were associated with robust immune activation, T-cell infiltration and up-regulation of PD-L1, and, as such, suggest that patients may benefit from the addition of anti-PD-1 checkpoint blockade.

Following these efficacy and mechanistic findings, Targovax and MSD have agreed to initiate a collaboration trial evaluating the combination of ONCOS-102, KEYTRUDA and SoC in first line mesothelioma patients. The trial will be a randomized phase II of up to 100 patients comparing this investigational triple combination against Keytruda and SoC. There is strong interest to participate in the trial among key opinion leaders and investigators, and multiple centers in both the USA and EU will be participating. The aim is to start enrolling patients into the trial within twelve months.

Øystein Soug, CEO of Targovax, said: "We believe the clinical immune activation data we have seen so far provide a strong scientific rationale for adding anti-PD1 checkpoint blockade to the ONCOS-102 and chemotherapy combination in mesothelioma. Therefore, we are delighted that MSD has agreed to support us in exploring this hypothesis by providing KEYTRUDA supply for our next trial. KEYTRUDA is the market-leading checkpoint inhibitor and thus our preferred choice of partner. We are hopeful that the combination of ONCOS-102, pembrolizumab and chemotherapy will lead to improved outcomes for patients with this challenging disease who currently have few treatment alternatives".

On June 23, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported that the Company will not advance its non-covalent BTK inhibitor vecabrutinib into the planned Phase 2 portion of the Phase 1b/2 trial in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies (Press release, Sunesis, JUN 23, 2020, View Source [SID1234561678]). The decision was made after assessing the totality of the data including the 500 mg cohort, the highest dose studied in the trial.

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"Although vecabrutinib continues to exhibit an excellent safety profile, there is insufficient evidence of activity in BTK-inhibitor resistant B-cell malignancies to advance the drug into the planned Phase 2 portion of the trial. One partial remission was observed after 11 treatment cycles in a CLL patient treated in Cohort 5 (300 mg BID) and a number of patients treated across the dose range explored (25 mg to 500 mg BID) saw stable disease; however, no other remissions have been observed," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "We will complete the Phase 1b and evaluate the best path forward for vecabrutinib. We are grateful for the patients and their families who participated in this trial, as well as the investigators and research staff at our trial sites."

Mr. Misfeldt continued: "We are shifting our resources and development focus to our first-in-class PDK1 inhibitor SNS-510. SNS-510 inhibits PI3K-dependent and PIP3-independent pathways important in both solid and hematologic malignancies. We remain on track to file an IND by the end of 2020 and expect to present additional preclinical findings at a medical meeting in the second half of the year. We expect that our current cash resources are sufficient to fund the company into 2021."

Vecabrutinib Phase 1b/2 Clinical update. Currently, five patients enrolled in cohorts 5-7 remain on treatment and continue to be followed. Vecabrutinib is very well tolerated across the dose range investigated.

Cohort 7 (500mg BID): Three (2 CLL, 1 MCL) of six treated patients had stable disease at first response assessment (beginning of cycle 4). One of the CLL patients is in Cycle 7, the MCL patient is in cycle 6 and one CLL patient was determined to have progressive disease after 6 cycles. We did not see a reduction in tumor burden in any of the patients with stable disease.

Cohort 6 (400mg BID): Of 6 patients treated, 2 CLL patients remain on study in cycle 9, one with stable disease and the other who had progressive disease at first assessment but continues to derive clinical benefit. One CLL patient who had stable disease with a 48% reduction in tumor burden at first assessment progressed in cycle 7.

Cohort 5 (300mg BID): One CLL patient remains on treatment in cycle 12 with a partial response observed at third response assessment done at the start of cycle 12.
About SNS-510

SNS-510 is a PDK1 inhibitor licensed from Millennium Pharmaceuticals, Inc. ("Takeda Oncology"), a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited. SNS-510 interaction with PDK1 inhibits both PI3K signaling and PIP3-independent pathways integral to many malignancies, and PDK1 can also be overexpressed in breast, lung, prostate, hematologic and other cancers. Evaluation of SNS-510 in the Eurofins Oncopanel, a panel of >300 genomically profiled cancer cell lines from diverse tissue origins, indicated that CDKN2A-mutated tumors are particularly sensitive to SNS-510. CDKN2A alterations are common in human cancers and may prove to be useful biomarkers for broad investigation of SNS-510 as a monotherapy and in combination with other anticancer agents. Sunesis is conducting an Investigational New Drug ("IND")-enabling program for SNS-510 and plan to file an IND by the end of 2020.