On March 5, 2025 Bioheng Therapeutics US LLC ("Bioheng"), a clinical-stage biotech company dedicated to developing innovative universal CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) (Press release, Bioheng Biotech, MAR 5, 2005, View Source [SID1234650921]). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development.

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"We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States," stated Jiangtao Ren, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng. "IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER platform’s ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies."

About CTD402
CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL/LBL. It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people, achieving an "off-the-shelf" capability for patients in need of CAR-T cell therapy.

About T-ALL/LBL
T-ALL/LBL are distinct clinical presentations of the same malignancy, originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1] While frontline therapy achieves high complete remission (CR) rates, the majority of patients ultimately experience relapse. Relapsed or refractory (R/R) disease is associated with poor outcomes, with a 5-year overall survival (OS) rate of less than 20%.[2]

On January 27, 2005 Danisco A/S (Copenhagen Stock Exchange) ("Danisco"), one of the world’s largest producers of food ingredients, and Genencor International, Inc. (Nasdaq: GCOR) ("Genencor"), a diversified biotechnology company that develops and delivers innovative products and services into the health care, agri-processing, industrial and consumer markets, jointly reported that they have signed a definitive agreement for Danisco to acquire all of the outstanding shares of common stock of Genencor, other than those held by Danisco, Eastman Chemical Company ("Eastman") or their respective subsidiaries, for $19.25 per share in cash (Filing, Genencor International, JAN 27, 2005, View Source [SID:SID1234515815]).

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In connection with the definitive agreement with Genencor, Danisco has entered into a definitive stock purchase agreement with Eastman under which Danisco will acquire all of the outstanding shares of common stock of Genencor held by Eastman for $15 per share in cash and all of the outstanding shares of preferred stock of Genencor held by Eastman for $44 million in cash. Danisco and Eastman currently each own approximately 42% of Genencor’s outstanding shares of common stock and 50% of Genencor’s outstanding shares of preferred stock.

"Being an advanced and recognised biotechnology company, Genencor will expand Danisco’s knowledge base significantly and broaden our access to an important new business area, industrial enzymes," said Alf Duch-Pedersen, Chief Executive Officer of Danisco.

"Our two companies know each other well and the synergy is obvious," said JJ Bienaimé, Chairman and Chief Executive Officer of Genencor. "Together, we will have the depth and the reach to achieve the vision we’ve had for our business."

The acquisition of the shares of Genencor’s common stock for $19.25 per share will be effected by means of a cash tender offer for all of the outstanding shares of common stock of Genencor, other than those held by Danisco and its subsidiaries, followed by a merger in which all Genencor stockholders, other than Danisco and its subsidiaries, who have not tendered their shares will receive the same per share price. The acquisition agreement is subject to certain conditions, including the tender of a majority of the outstanding shares of common stock of Genencor other than those held by Danisco, Eastman, the officers and directors of Genencor and its subsidiaries and the respective affiliates of each of the foregoing, receipt of regulatory approvals and other conditions. Subject to those conditions, Danisco and Genencor currently expect the acquisition to be completed by May 31, 2005.

A special committee comprised of independent directors of Genencor has reviewed the transaction on behalf of the Genencor stockholders unaffiliated with Danisco and Eastman. Upon the recommendation of the special committee, the board of directors of Genencor has approved the acquisition agreement and the transaction.

On January 10, 2005 Xenova Group plc (NASDAQ: XNVA; London Stock Exchange: XEN) reported that it has entered into a licensing agreement with Cancer Research Technology Limited (CRT) in respect of Xenova’s intellectual property relating to TA-CIN (Press release, Cancer Research Technology, JAN 10, 2005, View Source [SID1234523438]). TA-CIN is a vaccine developed by Xenova as a treatment for women with cervical dysplasia, and has proved safe and immunogenic in Phase I and Phase II clinical trials.

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CRT will facilitate a further Phase II clinical trial to be undertaken at St. Mary’s Hospital Manchester and associated laboratory studies at the Paterson Institute for Cancer Research in Manchester to evaluate TA-CIN in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia (VIN). This trial, expected to start shortly, will recruit between 20 and 30 women with known, pre-treated, or newly diagnosed VIN3. The primary end point is objective response of vulval intraepithelial lesions to treatment as well as evaluating safety, toxicity and tolerability of the combination treatment.

CRT will license TA-CIN patents, know-how and materials from Xenova and will undertake marketing of TA-CIN to potential commercial partners with a view to sub-licensing the development and commercialisation of the product. Net receipts from the sub-licensing of TA-CIN will be shared between Xenova and CRT after certain direct costs have been recouped.

Cervical dysplasia (also known as cervical intra-epithelial neoplasia, CIN) is one of a group of conditions, including VIN, known collectively as ano-genital intraepithelial neoplasia (AGIN), which are precursors to invasive cancers such as cervical cancer. Infection with certain high risk types of Human Papillomavirus such as HPV16, is closely associated with these dysplasias and cancers, which are difficult to treat and have a high recurrence rate.

David Oxlade , Chief Executive Officer of Xenova said: "We are delighted that the promising TA-CIN vaccine is now progressing into further Phase II studies through this relationship with CRT. This collaboration provides further evidence of the potential value of Xenova’s portfolio of novel cancer drugs."

Dr Keith Blundy, Chief Operating Officer of CRT stated: "We are pleased to in-license and develop this opportunity from Xenova, which clearly demonstrates CRT’s strategy for expanding our oncology portfolio and addressing our goal of cancer patient benefit".

On December 16, 2004 Allos Therapeutics, Inc. (Nasdaq: ALTH) reported that it has acquired an exclusive worldwide license from the University of Colorado Health Sciences Center, the University of Salford and Cancer Research Technology to develop and commercialize a new chemotherapeutic agent known as RH1 (Press release, Cancer Research Technology, DEC 16, 2004, View Source [SID1234523440]). The compound is currently being investigated in a Phase 1 clinical trial sponsored by Cancer Research UK, the largest volunteer-supported cancer research organization in the world.

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RH1 is a targeted cytotoxic prodrug that is bioactivated by the enzyme DT-diaphorase (DTD), which is over-expressed in many tumors relative to normal tissue, including lung, colon, breast and liver tumors. The drug exhibits a similar mechanism of action to the potent chemotherapeutic agent Mitomycin C, with greater potential activity against cells expressing high DTD and a potentially more favorable safety profile. RH1 was a nominated compound for advancement in the National Cancer Institute’s Developmental Therapeutics Program (DTP), which provides cancer drug discovery and development resources to the intramural, academic and industrial research communities.

"Pre-clinical work has shown RH1 to be a more efficient substrate for DTD than currently available agents," said Dr. David Ross, Professor of Toxicology and Chairman, Dept. of Pharmaceutical Sciences at the University of Colorado. "This drug may offer a means to selectively target tumors expressing high levels of DTD."

RH1 is currently being evaluated in patients with advanced solid tumors refractory to other chemotherapy regimens in an open label, Phase 1 dose escalation study chaired by Dr. Malcolm Ranson, Director Derek Crowther Unit, Christie Hospital, Manchester, UK. Up to 40 patients will be enrolled to test the safety, tolerability and pharmacokinetics (PK) of escalating doses of RH1. Patient DTD enzyme levels are being measured to correlate with drug efficacy. Recruitment began in September 2003 and is expected to complete in the second half of 2005.

"We’ve enrolled nearly a third of the desired number of patients for the study and are encouraged by results seen to date from both a safety and efficacy standpoint," said Dr. Ranson.

Under the terms of the agreement, Allos will make an up-front payment and a series of milestone payments based upon the achievement of specified development, regulatory and commercialization goals. Allos will also make royalty payments based on product sales, if any, resulting from the collaboration. Cancer Research UK will continue to support the ongoing Phase 1 dose escalation study, and Allos will have the right to obtain an exclusive license to the results of the study, for use in subsequent development and regulatory activities, upon payment of a one-time data option fee. Upon completion of the Phase 1 study, Allos will assume responsibility for all further development costs and activities. Financial terms of the transaction were not disclosed. However, Allos does not expect the in- licensing of RH1 to result in a material increase in its quarterly operating expenses for at least the next 18-24 months.

"We’re excited to add this novel compound to our growing oncology portfolio," said Michael E. Hart, President and Chief Executive Officer of Allos. "RH1 complements our current development programs and will allow us to capitalize on our in-house clinical, regulatory and manufacturing expertise."

On November 2, 2004 Cancer Research Technology Limited (CRT), the specialist oncology focussed technology transfer and development company, reported the completion of a Technology Transfer Agreement with Marie Curie Cancer Care, one of the largest cancer charities in the UK (Press release, Cancer Research Technology, NOV 2, 2004, View Source [SID1234523444]).

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Under the terms of this agreement CRT has been granted an exclusive option to assist in the development and commercialisation of any cancer related discoveries arising from the Marie Curie Research Institute (MCRI), the research institute which is part of Marie Curie Cancer Care.

Dr Peter O’Hare, Director of the MCRI, said of this agreement. "This new agreement enhances our ongoing relationship with CRT. With MCRI research expertise in key areas of cancer biology and the expertise of CRT in technology development and commercialisation, together we aim to maximise opportunity for research to bring benefit to cancer patients."

This agreement positively expands their existing relationship, in part by enabling the MCRI to work directly with CRT’s Development Laboratory.

CRT is distinctive amongst technology transfer organisations in having its own development laboratory, with core competences in molecular and cellular biology, drug discovery, medicinal chemistry and early pharmacology. The laboratory plays a key role within CRT in adding value to a scientist’s initial invention, enhancing its potential for commercialisation and therefore cancer patient benefit.

The Marie Curie Research Institute specialises in cutting-edge research. Scientists work right at the boundaries of our existing knowledge, seeking to find out more about the cellular mechanisms responsible for the development of cancer. Their work may identify novel anti-cancer targets, or completely new therapeutic strategies? but further development is needed to convert experimental results into therapies that can be used in the clinic.

Dr Keith Blundy, CRT’s Chief Operating Officer added: "The signing of this Technology Transfer Agreement marks a significant and exciting milestone in our relationship with Marie Curie Cancer Care. Both organisations are united in their mission of seeking cancer patient benefit and CRT looks forward to joining forces with scientists at the MCRI to achieve this."