On August 29, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has entered into a license agreement relating to its preclinical asset, Nepicastat, with Asieris Pharmaceuticals, a biotechnology company headquartered in China (Press release, Acorda Therapeutics, AUG 29, 2022, View Source [SID1234618729]). Under the terms of the agreement, Acorda will receive an upfront payment of $500,000, and up to an additional $7 million based on the achievement of regulatory milestones. Acorda will also receive a royalty on future net sales.

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Nepicastat is a small molecule drug and the license agreement provides for its development for all non-psychiatric indications and therapeutic uses. The asset has been held by Acorda’s U.S. subsidiary, Biotie Therapies, Inc.

On August 29, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical need, reported data from a poster presentation at the 19th International Myeloma Society Annual Meeting being held August 25-27, 2022, in Los Angeles, California (Press release, BeyondSpring Pharmaceuticals, AUG 29, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-presents-new-data-for-the-use-of-plinabulin-and-pegfilgrastim-to-decrease-neutropenia-burden-in-peri-transplant-multiple-myeloma-patients-at-the-19th-international-myeloma-society-annual [SID1234618728]). This is an open label, investigator-initiated study (NCT05130827) conducted at Memorial Sloan Kettering Cancer Center (MSK) that is evaluating the reduction in neutropenia burden with lead asset plinabulin in combination with pegfilgrastim in multiple myeloma (MM) patients who have undergone autologous hematopoietic stem cell transplantation (AHCT) and have received a high dose of melphalan, a type of chemotherapy. To date, plinabulin appears well tolerated, and preliminary data show that only one out of the 10 patients enrolled (10%) had non-engraftment related neutropenic fevers or febrile neutropenia (FN) with plinabulin and pegfilgrastim, compared to a historical number of 60% of FN with standard of care. Enrollment is ongoing, and full trial results will be presented at a later date.

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"The use of high dose melphalan with AHCT is a well-established therapeutic strategy for MM. However, it’s associated with a high frequency of FN, typically around 60% of patients, despite prophylactic use of pegfilgrastim and antibiotics. This can lead to significant clinical complications resulting in extended hospitalization, readmissions and increased financial cost," said Dr. Gunjan Shah, hematologist oncologist and principal investigator of the study at MSK. "With symptom burden during AHCT peaking at the time of white blood cell nadir (lowest point), it’s important to identify strategies that can help reduce the burden of neutropenia. The preliminary observation from this pilot trial is that adding plinabulin to prophylactic pegfilgrastim and antibiotics helped to prevent the occurrence of non-engraftment-related FN, which has the potential to be clinically meaningful and also beneficial from a health economics perspective."

In this pilot study, patients with MM are treated with a single dose of melphalan and undergo AHCT. Patients receive a plinabulin 40 mg fixed dose IV infusion, and on day +1, pegfilgrastim 6 mg is administered per standard of care. The objectives of this study were to evaluate neutropenia burden, safety, tolerability, neutrophil and platelet engraftment rate, disease response, progression free survival, overall survival and patient reported outcome (PRO) assessment of symptom burden.

Poster Presentation Details

Title: Plinabulin after Autologous Hematopoietic Cell Transplant to Decrease Duration of Neutropenia and Improve Quality of Life Peri-Transplant

Abstract #: P-194

Presenter: Dr. Gunjan Shah, hematologist oncologist and principal investigator of the study at MSK

10/15 patients have been enrolled and received plinabulin on Day 0 with a median age of 64 (range 58-74) and 40% of them were female. Patients received melphalan 140 mg/m2 (n=3) or 200 mg/m2 (n=7);
Efficacy summary:
Median white blood count (WBC) on Day 0, 1 and 2 was 7.6 (3.6 – 9.8), 5 (3.2 – 13.6) and 18.7 (5.1-59.1) x 10^9 cells/L, respectively;
Of the eight patients who have engrafted to date, median time to absolute neutrophil count (ANC) > 0.5 x 10^9 cells/L was 11 days (range 10-16). The median number of days of ANC <0.1 and <0.5 were two (range 1-3) and five days (range 4-9), respectively;
Six patients had fever at median of eight days post AHCT (range 9-12). Five patients with engraftment syndrome were treated with steroids, and there was one patient with non-engraftment-related neutropenic fever (representing 10% of the patients enrolled);
Safety Summary:
No patients have progressed or died;
Half of the patients had hypertension immediately after the plinabulin infusion, which is a known toxicity and resolved within a few hours;
PROMIS-29 PRO data were collected and will be analyzed.
Dr. Ramon Mohanlal, BeyondSpring’s executive vice president of R&D and chief medical officer, added, "Plinabulin has a fast onset mechanism of action that is different and complementary to that of G-CSF. We continue to evaluate new opportunities with plinabulin to unlock its tremendous potential. Preclinical data have shown that plinabulin induces apoptotic cell death in multiple cell lines and cells from MM patients. Therefore, the AHCT setting in MM is of particular interest because plinabulin has the potential to exert both neutropenia prevention and an anti-cancer benefit."

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent, which is a potent antigen presenting cell (APC) inducer that is being developed as an anticancer agent. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells and the second is a CIN prevention benefit. Plinabulin has single agent anti-cancer activity in a number of cancers including small cell lung cancer (SCLC) and multiple myeloma (MM). Plinabulin also exerts early-onset of action in the prevention of chemotherapy-induced neutropenia (CIN) by boosting the number of hematopoietic stem/progenitor cells (HSPCs).

On August 29, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published in Nature Medicine provide the first evidence that the pre-treatment tumor microenvironment (TME) can impact response to chimeric-antigen-receptor (CAR) T-cell therapy among patients with large B-cell lymphoma (LBCL) (Press release, Veracyte, AUG 29, 2022, View Source [SID1234618726]). The study findings demonstrated for the first time the prognostic and predictive capabilities of Veracyte’s proprietary biomarkers among LBCL patients treated with CAR T-cell therapy.

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"CAR T-cell therapies are changing the standard of care in cancer treatment, and their expanded use increases the need for tools to help identify the patients most likely to benefit from them. The prognostic and predictive roles of the TME have been described for solid tumors, but the importance of TME for CAR T-cell therapy outcomes, and particularly in LBCL, has not previously been established," said Jérôme Galon, Ph.D., research director at Inserm in France and senior vice president and scientific executive director at Veracyte, as well as lead author on the published paper. "This study is the first to demonstrate this important clinical connection, and also confirms Immunoscore CR and Immunosign as one of the first pre-treatment TME biomarkers to be associated with prolonged survival following CAR T-cell therapy."

This study aimed to identify biomarkers associated with CAR T-cell therapy outcomes in patients treated with Kite’s axicabtagene ciloleucel (axi-cel), a first-in-class anti-CD19 CAR T-cell therapy. Study investigators conducted a retrospective analysis using Veracyte’s Immunoscore Clinical Research (CR) and Immunosign 21 (IS21) assays, along with three custom panels (Immunoscore T-cell Exhaustion, TCE+ panels and Immunoscore Suppressive Cells panel) to compare pre-treatment TME patterns that were associated with improved response in Kite’s ZUMA-1 study, the pivotal Phase 2 trial in adult patients with relapsed or refractory LBCL.

Results published today suggest that the pre-treatment tumor immune contexture was associated with, and potentially a major determinant of, clinical outcomes in ZUMA-1 patients. Improved clinical outcomes were more associated with high resolution pre-treatment immune contexture characterized by Immunoscore CR and Immunosign 21 rather than with general T-cell gene profiles and densities.

"These findings advance the understanding of the TME and its association with clinical responses to anti-CD19 CAR T-cell therapy in DLBCL and could therefore enhance clinical benefit and outcomes for patients," said Francesco Marincola, M.D., global head of Cell Therapy Research, Kite. "The availability of validated immuno-oncology biomarkers could support further clinical studies of these therapies, particularly in earlier lines of treatment, and help advance our ability to provide precision medicine for patients with hematologic malignancies."

In the study, researchers noted rapid and broad changes across post-treatment TME immune programs associated with improved response, with marked decrease in B-cell lineage gene expression in responders’ TME.

Researchers also suggest that immune-based therapies with curative potential such as axi-cel should be considered in earlier lines of therapy where a larger percentage of patients have more favorable TME features and lower tumor burden, to potentially maximize clinical benefit.

"These findings suggest that our offerings can help provide key insights into the mechanism of action for immuno-therapies such as CAR T-cell treatment," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "We believe our extensive capabilities and expertise in immuno-oncology position us well to serve biopharma companies that are developing cutting-edge treatments such as CAR T-cell therapies, immune checkpoint inhibitors and others."

About Veracyte’s Immuno-Oncology Biopharma Offerings

Veracyte offers its biopharma partners unique, multi-omic capabilities, expertise and tools designed to optimize biomarkers, companion diagnostics and therapeutic clinical trials through robust analysis of patient oncology samples. These offerings include a comprehensive platform of immuno-oncology expertise and technologies focused on analyzing the tumor immune response. Assays currently available within this platform include Immunoscore, which measures patient immune response at the tumor site; Immunosign immune gene signature, which provides powerful pan-cancer immune gene signature analysis; and Brightplex multiplex spatial profiling, which provides quantitative immune phenotyping using digital pathology and image analysis software. For more information, please visit View Source

On August 29 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 29, 2022, View Source [SID1234618725]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

Since the announcement 22 August 2022, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 19,133,211 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12-month period beginning 2 February 2022. As of 26 August 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 17,422,432 B shares at an average share price of DKK 768.20 per B share equal to a transaction value of DKK 13,383,917,995

On August 29, 2022 Yumanity Therapeutics, Inc. ("Yumanity") (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, reported the filing of a registration statement on Form S-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Kineta, AUG 29, 2022, View Source;utm_medium=rss&utm_campaign=kineta-announces-the-filing-of-a-registration-statement-on-form-s-4-with-the-u-s-sec-related-to-the-reverse-merger-with-yumanity-therapeutics-ymtx [SID1234618724]).

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The Registration Statement contains a preliminary proxy statement and prospectus in connection with Yumanity’s previously announced proposed asset sale to Janssen Pharmaceutica NV ("Janssen") and merger with Kineta, Inc. ("Kineta"). Although the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Yumanity and the proposed transactions.

Both definitive transaction agreements were announced on June 6, 2022.

The two transactions are expected to close during the fourth fiscal quarter of 2022, subject to customary closing conditions, including approval of both transactions by the stockholders of Yumanity.