On June 16, 2023, Iovance Biotherapeutics, Inc. (the "Company") reported to have entered into a new Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") with respect to an at the market offering program, under which the Company may, from time to time in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $450.0 million of shares of the Company’s common stock, par value $0.000041666 per share (the "Common Shares") (Press release, Iovance Biotherapeutics, JUN 16, 2023, View Source [SID1234632745]). The Prior Sales Agreement (as defined below) was terminated, and the Sales Agreement replaces the Prior Sales Agreement.

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The issuance and sale, if any, of the Common Shares by the Company under the Sales Agreement will be made pursuant to a prospectus supplement, dated June 16, 2023, to the Company’s registration statement on Form S-3ASR, originally filed with the Securities and Exchange Commission on June 16, 2023, which became effective immediately upon filing.

Pursuant to the Sales Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"). Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose).

The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreement.

The Company is not obligated to make any sales of Common Shares under the Sales Agreement. The offering of Common Shares pursuant to the Sales Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreement and (ii) termination of the Sales Agreement in accordance with its terms.

The Sales Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Jefferies against certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of DLA Piper LLP (US) as to the legality of the Common Shares is being filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On June 16, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody (Press release, Innate Pharma, JUN 16, 2023, View Source [SID1234632744]). The data were presented at the 17th International Conference on Malignant Lymphoma, in Lugano, Switzerland.

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As of March 4, 2022, data cutoff, patients in the KIR3DL2-expressing MF cochort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months. In the KIR3DL2 non-expressing cohort (cohort 3, n=18), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months.

Lymph Node assessment is an important component of staging and response assessment in CTCL (cutaneous T cell lymphomas). In a recent update to the Olsen 2011 guidelines, it was clarified that the pathological assessment of lymph nodes be limited to those that satisfy nodal lymphoma i.e. N3 designation (Olsen 20221).

Based on these criteria, results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc]. In Cohort 3, comprising 18 patients with KIR3DL2 < 1% MF, findings remain unchanged.

"We are pleased to see the improved ORR of lacutamab in KIR3DL2 expressing mycosis fungoides patients, confirming the previously observed clinical activity in this heavily treated population," said Dr. Joyson Karakunnel, Chief Medical Officer of Innate Pharma. "We look forward to final data from the TELLOMAK Phase 2 trial in both Sézary syndrome and mycosis fungoides in 2023 and progressing the two additional trials that are ongoing with lacutamab in Peripheral T cell lymphoma."

Dr. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, added: "The higher global ORR according to updated lymph node evaluation highlights the importance of the adoption of latest guidelines, and is welcomed by the CTCL community. Treatment options are limited for patients with CTCL and the updated assessment of the TELLOMAK trial adds to growing evidence supporting the ongoing development of lacutamab in T cell lymphomas. We thank the investigators, clinical research coordinators, patients and caregivers involved in the ongoing TELLOMAK program."

Summary of Preliminary Efficacy Results in Cohort 2 (KIR3DL2 ≥ 1%):

Best

Response

in Skin

N=21

Best

Response

in Blood

N=8

Best Global

Response

N=21

Olsen 2011

(N1, N2, N3, Nx involved)

Olsen 2022

(N3 lymphoma involved )

Best Response (N)

CR

PR

SD

PD

NE

2 (9.5%)

10 (47.6%)

7 (33.3%)

2 (9.5%)

–

5 (62.5%)

0 (0%)

3 (37.5%)

0 (0%)

–

2 (9.5%)

4 (19%)

13 (61.9%)

2 (9.5%)

–

2 (9.5%)

7 (33.3%)

10 (47.6%)

2 (9.5%)

–

ORR%

[95%CI]

57.1%

[36.5-75.5]

62.5%

[30.6-86.3]

28.6%

[13.8-50.0]

42.9%

[24.5-63.5]

About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe 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 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.

About TELLOMAK:

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.
Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design.
All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic.
Overall, MF cohorts (cohort 2, cohort 3 and all comers) will enroll approximately 100 patients.

The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.

On June 16, 2023 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data (Press release, GlaxoSmithKline, JUN 16, 2023, View Source [SID1234632742]). The extended action date is 16 September 2023.

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GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.

Momelotinib is not currently approved in any market.

About momelotinib
Momelotinib has a novel mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). 1,2,3,4 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.1,2,4 Additionally, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.1,2,3,4

About myelofibrosis
Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anaemia. Myelofibrosis affects approximately 25,000 patients in the US.

On June 16, 2023 Ferring Pharmaceuticals reported the successful increase of its second Swiss Franc Bond offering by CHF 80 million (Press release, Ferring, JUN 16, 2023, View Source [SID1234632741]). This senior unsecured bond transaction is issued by Ferring Holding SA with 8-year maturity to 21st April 2031 at a fixed coupon rate of 3.25% per annum. The bonds will be listed on the SIX Swiss Exchange.

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In a good market environment, the offering again attracted much interest from high-quality institutional investors and banks, demonstrating recognition of the company’s successful track record and the uplift in the credit rating. The company is rated by Credit Suisse as BBB with positive outlook and now similarly by Fedafin as Baa with stable outlook. This increase takes the second bond offering to CHF 240 million with 8-year maturity to 21st April 2031 at a fixed coupon rate of 3.25% per annum, plus CHF 250 million with 4-year maturity to 21st April 2027 at a fixed coupon rate of 2.70% per annum.

Dominic Moorhead, Chief Financial Officer of Ferring Pharmaceuticals, said: "Following the successful outcome of our second bond offering in March 2023 in a volatile market, we are pleased to be able to increase the amount by CHF 80 million in the longer tranche, in order to now total CHF 490 million balanced between 4-year and 8-year maturity. The uplift in our credit rating to dual mid-BBB is also good recognition of our progress in recent years. Following the approval of two ground-breaking products by the US Food and Drug Administration (FDA) in late 2022, we continue investing in the launch and manufacturing scale-up of these exciting growth opportunities."

The net proceeds from the transaction will be used for general corporate purposes. The lead managers for the issue were Credit Suisse AG and Basler Kantonalbank.

On June 16, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies reported that it reached the final stages of its AccuTOXTM Chemistry, Manufacturing and Controls ("CMC") in preparation to IND filling for its Phase I clinical trial to treat melanoma patients at City of Hope, CA, USA (Press release, Defence Therapeutics, JUN 16, 2023, View Source;utm_medium=rss&utm_campaign=defence-manufacturing-of-accutox-cgmp-final-drug-product-optimization-for-its-phase-i-clinical-trial-at-city-of-hope [SID1234632740]).

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Every experimental drug must undergo rigorous manufacturing and quality control testing prior to IND submission. Biopeptek Pharmaceuticals, LLC, a renowned US based CDMO dedicated to the production of high-quality peptides for clinical applications, using cutting-edge science and technology, was mandated by Defence Therapeutics to complete these final crucial steps. With its state-of-the-art facilities and experienced scientific team, Biopeptek has optimized formulation and is currently manufacturing and packaging the AccuTOXTM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements.

"This is an important milestone for Defence’s AccuTOXTM program. With manufacturing and release assays being completed, Defence is now at the last step to summit its IND filing for Phase I clinical trial using AccuTOXTM as an injectable to treat melanoma," says Mr. Plouffe, CEO and president of Defence.

Biopeptek has already successfully completed a 12-month stability study testing AccuTOXTM active pharmaceutical ingredient ("API"). Testing included temperature fluctuations, humidity as well as strong light treatments. The conclusion is that AccuTOXTM is stable at temperatures ranging from 5 to -20C which is standard for a peptide API approved by Regulatory Agency. AccuTOXTM API meets all manufacturing/stability criteria as a standard peptide API used for clinical trial.