On June 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 20, 2024, View Source [SID1234644452]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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The third and fourth patients showed stable disease at their four- and two-month follow-up visits, respectively. Both patients are doing well, and neither showed any dose-limiting toxicities. Patients three and four are being treated at the Beverly Hills Cancer Center (BHCC).

The second patient, also being treated at the BHCC, previously had stable disease and showed a complete response in their brain metastasis. At the four-month follow-up visit, while stable disease of previously treated sites and a clean brain MRI were confirmed, a new site of disease, a sub-cutaneous metastasis, was detected by CT and PET scans. This patient is in generally good condition and tolerated their initial treatment well. As such, the Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA) approved a single-use, single-patient protocol, and on June 19, the patient started a new course of treatment with low-dose radiation and gamma-delta T cells under a single patient IND.

"We are optimistic the latest targeted treatment with Deltacel will control the second patient’s new lesion, which is suspected to have originated from a micro-metastasis not detected and therefore not targeted with radiation during the first course of treatment. This new protocol might be applied to all patients who received or will receive the Deltacel treatment and could be instrumental in controlling any new tumor lesions or progressing lesions," said Pietro Bersani, CEO of Kiromic BioPharma.

Kiromic BioPharma also reports submitting a request for Fast Track designation for Deltacel to the FDA. Fast Track designation facilitates and expedites the development and review of drugs that treat serious conditions and address unmet medical needs. For further information on Fast Track designation, please visit the FDA’s website.

"We continue to be encouraged by the favorable results of the Deltacel-01 trial, which reinforce our confidence in the potential of Deltacel to provide meaningful clinical benefits to patients in need. This confidence underscores the recent open-market purchases of common stock by several Kiromic directors and executive officers, as reported on Form 4 filings," noted Mr. Bersani.

"Proceeding with a single-use, single-patient protocol of Deltacel supports our commitment to advancing innovative therapies that address unmet clinical needs in unique ways, which include the possibility for retreatment," he added. "We are also excited about the potential of expediting Deltacel clinical development through Fast Track designation."

The fifth patient in the trial completed their 30-day safety visit at the BHCC with no toxicities reported, and the sixth patient is expected to be enrolled in July.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On June 20, 2024 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that the company has entered into a delisting agreement with Novartis BidCo AG and Novartis AG following the successful closing of the acquisition of MorphoSys by Novartis in May 2024 (Press release, MorphoSys, JUN 20, 2024, View Source [SID1234644468]). Novartis BidCo Germany AG (together with Novartis BidCo AG and Novartis AG hereinafter collectively referred to as "Novartis") also informed MorphoSys of their intention to merge MorphoSys into Novartis by initiating a squeeze-out of MorphoSys’ minority shareholders.

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In April 2024, Novartis submitted a voluntary public takeover offer for all outstanding MorphoSys no-par value bearer shares, offering MorphoSys shareholders € 68.00 per share in cash (the "Takeover Offer"). The acceptance period of the Takeover Offer and the statutory two-week additional acceptance period ended on May 13, 2024, and May 30, 2024, respectively. As of June 20, 2024, Novartis holds approximately 91.04% of the total MorphoSys share capital, including purchases by Novartis outside of the Takeover Offer. As a result, Novartis is the majority shareholder of MorphoSys, making MorphoSys a Novartis company.

MorphoSys and Novartis Sign Delisting Agreement

Following the settlement of the Takeover Offer, MorphoSys and Novartis today signed an agreement confirming that Novartis intends to launch a public delisting purchase offer (the "Delisting Offer") for all outstanding MorphoSys no-par value bearer shares that are not presently held by Novartis. Novartis will offer MorphoSys shareholders € 68.00 per share in cash, corresponding to its preceding Takeover Offer.

The Delisting Offer document is expected to be published by Novartis in early July 2024 after the German Federal Financial Supervisory Authority ("BaFin") has approved its publication, in accordance with the provisions of the German Securities Acquisition and Takeover Act. Once the Delisting Offer document is published by Novartis, a four-week (but not less than 20 U.S. business days) offer period for MorphoSys shareholders to tender their shares will commence.

Following publication of the Delisting Offer document, the MorphoSys Management Board and Supervisory Board will issue a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act. Additionally, in accordance with U.S. securities laws, Novartis will file the Delisting Offer document and a Tender Offer Statement on Schedule TO, and MorphoSys will file the joint reasoned statement and a Solicitation/Recommendation Statement on Schedule 14D-9 with the U.S. Securities and Exchange Commission (the "SEC").

Following BaFin approval, the Delisting Offer document and additional information relating to the Delisting Offer will be published by Novartis on this website: View Source The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 will be made available on the SEC’s website at www.sec.gov and under the "SEC Filings" section of the MorphoSys website at www.morphosys.com/en/investors.

Following the publication of the Delisting Offer document by Novartis, MorphoSys will apply for revocation of the admission to trading of MorphoSys shares on the regulated market of the Frankfurt Stock Exchange. MorphoSys also intends to delist from NASDAQ. After the delisting becomes effective, MorphoSys shares will no longer be traded on the regulated market of the Frankfurt Stock Exchange or on NASDAQ, and follow-up obligations from such a public listing no longer apply. Additionally, following deregistration with the SEC, MorphoSys will no longer be required to file reports with the SEC. Both the delisting from the Frankfurt Stock Exchange and the delisting from NASDAQ are expected to take place in the third quarter of 2024.

MorphoSys and Novartis Intend to Implement a Merger Squeeze-out of MorphoSys’ Minority Shareholders

Novartis also informed MorphoSys of their intention to merge MorphoSys into Novartis. In this context, Novartis has proposed entering negotiations with the MorphoSys Management Board regarding a merger agreement.

Given Novartis holds approximately 91.04% of the total MorphoSys share capital, Novartis is able to facilitate a squeeze-out of MorphoSys’ minority shareholders in connection with such a merger. Novartis will therefore seek the transfer of MorphoSys’ minority shareholders’ shares to Novartis against an adequate cash compensation (merger squeeze-out). The amount of the cash compensation has not yet been determined.

It is planned that the necessary shareholders’ resolution on the merger squeeze-out will be adopted at the MorphoSys Annual General Meeting expected to take place in August 2024.

On June 20, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients (Press release, Oncolytics Biotech, JUN 20, 2024, View Source [SID1234644453]). The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It is supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients. It will be conducted in collaboration with AIO-Studien-gGmbH (AIO), a clinical trial group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.

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"Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN’s important support for this program with gratitude. The US$5M Therapeutic Accelerator Award has made it possible for us to broaden our evaluation of potential therapies that have the potential to improve outcomes for pancreatic cancer patients."

Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, "Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, "I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies."

"Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal."

About GOBLET cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On June 20, 2024 Yellowstone Biosciences ("Yellowstone" or "the Company"), a pioneer of soluble bispecific T-cell receptor (TCR)-based therapies for human leukocyte antigen (HLA) Class II (HLA-II) targets in oncology, reported to unlock a new class of therapeutically targetable, frequently expressed antigens with potential to significantly transform patient lives (Press release, Yellowstone Bioscience, JUN 20, 2024, View Source [SID1234644469]). Syncona Limited ("Syncona") committed £16.5 million to fund the Company in progressing its operational build, lead programme in acute myeloid leukaemia (AML), and exploration into expanding its pipeline.

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Spun out of the University of Oxford with the support of Oxford University Innovation (OUI), Yellowstone is built around the pioneering research of Professor Paresh Vyas, a world-renowned scientific academic, key opinion leader and practising clinician with a specialist focus on AML. Over 20 years, Prof. Vyas’ laboratory has collected a proprietary biobank of over 10,000 samples from over 3,000 AML patients, including a rare cohort of patients cured by allogeneic blood cell transplantation. From this cohort a novel set of frequently expressed peptide antigens presented by HLA Class II were identified, which could unlock a new class of highly selective cancer therapeutics.

With privileged access to this biobank, Yellowstone has been formed to develop soluble bispecific TCR-based therapeutics targeting HLA Class II presented peptides on the surface of cancer cells in a number of cancers with high unmet need. By targeting peptides presented by HLA-II molecules, the Company’s bispecific T-cell engagers have the potential to selectively kill target tumour cells, whilst sparing healthy cells. The Company will focus initially on its lead programme in AML, which accounts for 62% of all leukaemia deaths1 and where there is no universally agreed standard of care for the majority of patients. Beyond AML, Yellowstone’s technology also has the potential to extend life and change the treatment landscape in other common solid tumours that express HLA-II, including ovarian cancer, non-small cell lung cancer (NSCLC), colorectal cancer, prostate cancer, breast cancer, renal cancer and melanoma.

Yellowstone will be led by a world-class management team, including Prof. Vyas, as Co-founder and Chief Scientific Officer, and Julian Hirst, who joins as Co-founder and Chief Financial Officer, bringing with him 20 years’ experience in biotechnology and investment banking, including senior finance roles at Immunocore and MiroBio. Neil Johnston also joins as Executive Chair, having spent 17 years at Novartis, most recently as Global Head of Business Development and Licensing. The Company will be guided by Syncona, a leading FTSE 250 life sciences investor, who has supported company launch and will continue to shape Yellowstone’s operational build. Chris Hollowood, CEO of Syncona, and Gonzalo Garcia, Investment Partner at Syncona, will hold Board positions at Yellowstone as part of the lead investor’s ongoing involvement.

Professor Paresh Vyas, Co-founder and Chief Scientific Officer of Yellowstone, said: "Frequently expressed antigens that can be targeted therapeutically are notoriously difficult to find but, through two decades of research, we have identified a new class of targets that have potential to treat cancer and extend patient’s lives. We believe that our technology has the potential to selectively kill tumour cells, whilst sparing healthy cells, in a range of cancers. The strategy that we have built, alongside Syncona, will initially focus on developing highly selective TCR-based therapies for AML, where we have formidable experience and data. Beyond that, we are committed to broadening our pipeline to other cancer settings to maximise Yellowstone’s potential."

Gonzalo Garcia, Investment Partner at Syncona and Non-executive Director at Yellowstone, commented: "Yellowstone is the latest company formed from Syncona’s model of creating and building businesses based on exceptional science and world-class founders. The work Prof. Vyas has undertaken in this field is truly remarkable. Although difficult to identify, tumour-selective, frequently expressed antigens are particularly strong cancer targets as they allow development and manufacturing of therapies that can treat large numbers of patients. We believe that Syncona can build a globally leading UK company around this novel discovery that has significant patient and commercial potential."

Yellowstone’s academic founders received support during the spin out from OUI’s Dr. Susan Campbell and Dr. Benedicte Menn. As part of their ongoing involvement, OUI will hold a board observer position at the company.

Dr Benedicte Menn, Senior Investment Manager, Oxford University Innovation, said: "With ambition to become a world class UK company, Yellowstone is our latest spinout from the University of Oxford. The company has potential to treat and extend the life of patients with different forms of cancer, starting with acute myeloid leukaemia. We’re delighted that Yellowstone and Syncona are partnering on this launch and look forward to tracking the progress of the pipeline."

On June 20, 2024 4 Redx Pharma (JPJ:REDX), the clinical-stage, small molecule biotechnology company,
reported that Phase 2 data from zamaporvint (RXC004), a Porcupine inhibitor targeting Wnt-ligand dependent GI cancers, will be presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI), 26-29th June, Munich, Germany (Press release, Redx Pharma, JUN 20, 2024, View Source [SID1234644454]).

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Zamaporvint is a potent, selective, orally-active Porcupine inhibitor in development for hard-to-treat GI cancers. The principal efficacy hypothesis for zamaporvint is for use in combination, which has been investigated in Phase 2 signal searching patient cohorts with anti-PD-1 therapy. Monotherapy for single agent activity has also been investigated. The PORCUPINE study was in genetically-selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) as monotherapy and immuno-oncology combination (clinicaltrials.gov NCT04907539). The PORUPINE2 study was in all-comers biliary tract cancer as monotherapy and immuno-oncology combination, and in genetically selected pancreatic cancer as monotherapy (clinicaltrials.gov NCT04907851).

The data will be presented in two posters, one on the PORCUPINE study and one on the PORCUPINE2 study. Notably, these data demonstrate that zamaporvint, in combination with an anti-PD-1 agent in genetically-selected patient populations has the potential to improve upon efficacy outcomes achieved with standard of care alone.
Details of the poster presentations are as follows:

1)
Abstract Title: Phase 2 results of the Porcupine (PORCN) inhibitor zamaporvint
(RXC004) in genetically selected microsatellite stable colorectal
cancer patients
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 37P

2)
Abstract Title: Phase 2 results of the porcupine (PORCN) inhibitor zamaporvint
(RXC004) in patients with pancreatic and biliary tract cancer
Session Title: Poster Session
Date/Time: Thursday 27 June 3:35 – 4:30pm CEST
Poster Number: 391P
A copy of the posters will be made available on Company’s website following the presentation at:
View Source