On January 27, 2022 EORTC reported The MINDACT (EORTC 10041/BIG3-04) study, a multicentre, randomised phase 3 clinical trial, aims to identify those women with early-stage breast cancer who can be spared chemotherapy after surgery through the use of a genomic and clinical risk assessment. Between 2007 and 2011, 6693 patients aged 18 to 70 whose cancer had either not spread to the lymph nodes under the arm, or to no more than three nodes, were enrolled to the trial, which was carried out in 112 institutions in nine European countries (Press release, EORTC, JAN 27, 2022, View Source [SID1234607424]).

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The latest sub-group analysis, published recently in the Journal of Clinical Oncology* looked at the 15% of patients who had an ultra-low genomic risk of recurrence based on the 70-gene signature MammaPrint. After a median follow-up of 8.7 years, 99% of these patients had not died from their disease, and their risk of cancer spreading to other parts of the body (distant metastasis) was significantly less than for patients with low-risk tumours. Patients with ultra-low risk tumours had an excellent prognosis regardless of the result of their clinical risk assessment.

Of the ultralow-risk patients, 67% were aged 50 years or more, and 99% were estrogen receptor (ER)-positive. Systemic therapy was received by 84% of patients (69% endocrine therapy (ET), 14% endocrine therapy plus chemotherapy, 1% other) and 16% received no adjuvant systemic treatment.

"Although trials have shown that gene signatures can be used to identify subgroups of patients who can safely be spared chemotherapy, current guidelines still include the use of ET in all hormone receptor positive patients, even those at very low risk" said Dr Josephine Lopes Cardozo, from the Netherlands Cancer Institute and EORTC. "ET side effects are often underestimated, and, as a result, adherence to the treatment is poor, with only half of all patients finishing a five-year course. Our analysis of ultra-low risk patients shows that these patients might be candidates for further reduction of treatments such as ET."

The investigators hope that the ultra-low risk gene signature will be used in future trials investigating the de-escalation of ET in order to achieve a better balance between benefit and harm. Findings from earlier studies have suggested that the introduction of population-based screening programmes has led to an increase of tumours with low-risk and ultra-low risk molecular profiles, and that these are over-represented within screen-detected cancers. "Being able to identify these patients who may have a limited benefit from ET could help to personalize treatment by reducing treatment durations or completely omitting ET and ultimately preventing overtreatment," says Dr Lopes Cardozo. "This would have benefits not only for patients, but also save money for healthcare systems."

On January 27, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and neurodegenerative disease, reported that the company entered into a stock purchase agreement before the market close on January 27, 2022 with a syndicate of new and existing investors for a private placement of 5,945,943 shares of common stock at a purchase price of $1.11 per share for aggregate gross proceeds of approximately $6.6 million (Press release, Vaccinex, JAN 27, 2022, View Source [SID1234607441]). The private placement is expected to close on January 31, 2022, subject to customary closing conditions. No warrants, derivatives, or financial covenants are associated with the purchase agreement.

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Participants in the private placement include entities controlled by Dr. Maurice Zauderer, President and CEO of Vaccinex , and Albert D. Friedberg, Chairman of Vaccinex’s board of directors, each of which purchased $2 million worth of shares, as well as an entity controlled by Jacob Frieberg, another member of Vaccinex’s board of directors, and additional new and existing shareholders that are unaffiliated with Vaccinex, that together purchased the remaining $2.6 million worth of shares.

Vaccinex intends to use the net proceeds from the private placement to fund the ongoing development of its lead drug candidate, pepinemab, in cancer and neurodegenerative disease and for working capital and general corporate purposes.

Vaccinex also announced that during the month of January, prior to entering into the stock purchase agreement, Vaccinex sold approximately $3.5 million of shares of its common stock in January 2022 for a weighted average sales price of $1.16 per share under its existing open market sales agreement with Jefferies, LLC. This brings the total of new equity financing to date in 2022 to $10.1 million.

In connection with the private placement, Vaccinex will also enter into a registration rights agreement with certain of the private placement investors. Pursuant to the registration rights agreement, Vaccinex will agree to, among other things, use its reasonable best efforts to file with the Securities and Exchange Commission (the SEC) a registration statement covering the resale of the shares.

A description of the stock purchase agreement and registration rights agreement will be included in a Form 8-K to be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale are unlawful. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On January 27, 2022 HaemaLogiX Ltd (HaemaLogiX), the clinical-stage biotechnology company developing novel monoclonal antibody therapies for multiple myeloma, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that they have entered into an agreement to manufacture the next clinical batch (cGMP) of HaemaLogiX’s lead multiple myeloma drug candidate, KappaMab (Press release, HaemaLogiX, JAN 27, 2022, View Source [SID1234607458]).

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KappaMab is a monoclonal antibody which binds to a cell surface target called kappa myeloma antigen (KMA) that is only found on myeloma cancer cells and not on normal plasma cells. Specific binding of KappaMab to the myeloma cell enables the patient’s immune system to recognize the cell as abnormal, triggering the natural response to attack and kill the myeloma cell. As a result, only the cancer cells are depleted and normal healthy plasma cells are spared from the patient’s immune system attack.

To date, KappaMab has been tested in three clinical trials where it showed a good safety profile with no dose-limiting toxicities following single and multiple doses[1],[2],[3]. In a recent phase 2b clinical trial, KappaMab synergized with the immune modulator drug (IMiD) lenalidomide in combination with dexamethasone to produce more disease responses and improved quality of response versus case-matched lenalidomide plus dexamethasone alone in patients with relapsed, refractory multiple myeloma[2].

Bryce Carmine, Chairman and CEO, HaemaLogiX, commented: "Multiple myeloma is the second most common haematological cancer worldwide, with an estimated 32,000 new cases and over 12,500 deaths annually in the US alone (2019), and a European incidence roughly equivalent. The incurable nature of multiple myeloma makes it necessary to expand treatment options available to patients. We look forward to taking KappaMab back into the clinic alongside standard of care, and this Lonza agreement is an important step toward providing the drug product for our upcoming trial."

According to the terms of the agreement, Lonza will manufacture drug substance of KappaMab for clinical supply at Lonza’s new state-of-the-art cGMP mammalian manufacturing facility in Guangzhou (CN), which houses two 1,000-liter and two 2,000-liter single-use bioreactors. HaemaLogiX will leverage Lonza’s regulatory expertise, global manufacturing footprint, and extensive experience in manufacturing monoclonal antibodies.

Jeetendra Vaghjiani, Executive Director, Clinical Development & Strategic Marketing, Lonza, commented: "We are looking forward to building a collaboration with HaemaLogiX to help advance their multiple myeloma candidate towards commercial launch. We will leverage our unique flexible offering and state-of-the-art expertise in manufacturing monoclonal antibodies at our site in Guangzhou (CN)."

The target completion date for the drug product is Q4 2022. The drug product will then be used in Australian-based clinical trials, currently scheduled to begin in late 2022.

On January 27, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has been issued a patent from the Unites States Patent and Trademark Office covering certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), including Chimeric’s clinical-stage CAR T asset CHM 1101 and preclinical-stage CAR NK asset CHM 1301 (Press release, Chimeric Therapeutics, JAN 27, 2022, https://chimerictherapeutics.com/wp-content/uploads/2022/01/CHM-Receives-US-Patent-covering-CLTX-CAT-Technology.pdf [SID1234607406]).

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The patent has been granted under patent number US 11,230,577 B2 and entitled ‘Chimeric antigen receptors containing a chlorotoxin domain’.

Chimeric Therapeutics holds the exclusive worldwide licence to develop and commercialise US 11,230,577 B2 and related patent applications filed in other global territories.

Continued IP portfolio momentum
Chimeric Therapeutics CEO and managing director Jennifer Chow said: "We are delighted to have patent protection granted for CLTX CAR therapies in the United States, the single largest global market for biopharmaceutical products.

"The granting of this key US patent continues the momentum for the intellectual property portfolio underpinning our CLTX CAR pipeline assets, following the recent patent grant in Europe in September."

CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy developed by scientists at the City of Hope Medical Centre in California for the treatment of patients with solid tumours.It is currently being studied in a phase 1 clinical trial in recurrent/ progressive glioblastoma.

A second CLTX CAR T phase 1 clinical trial is planned to begin in 2022 in additional solid tumours.

CHM 2101 (CDH17 CAR T) is a novel, third-generation CDH17 CAR T invented at the University of Pennsylvania. CHM 2101 is in preclinical development with a planned phase 1 clinical trial in 2022 in Neuroendocrine Tumours, Colorectal, Pancreatic and Gastric Cancer.

On January 27, 2022 OncoArendi Therapeutics S.A. ("OncoArendi"; WSE: OAT), a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, reported the appointment of Samson Fung, M.D. as Chief Medical Officer (Press release, OncoArendi Therapeutics, JAN 27, 2022, View Source;utm_medium=rss&utm_campaign=oncoarendi-therapeutics-appoints-samson-fung-m-d-as-chief-medical-officer [SID1234607426]). Dr. Fung will be responsible for the company’s global clinical development, translational science and regulatory strategies and will lead the advancement of OATD-02, its novel dual arginase inhibitor into Phase 1.

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"Samson’s extensive experience in drug development and translational medicine together with his background in oncology and deep knowledge gained working at blue-chip biopharmaceutical companies, makes him a crucial addition to our team," said Marcin Szumowski, CEO and President of the Management Board. We are delighted to welcome Samson at this exciting time as we prepare to progress our pipeline of first in class cancer and fibrosis therapies, including our lead wholly owned candidate OATD-02, a highly potent dual arginase inhibitor, which is on track to start Phase 1 in the second half of 2022. "

Dr Fung added, "I am thrilled to be joining OncoArendi at such an important stage of its development. I am looking forward to working with the company’s talented team to build a robust pipeline of small molecule drugs that has the potential to transform the care of cancer and fibrosis patients around the world. "

Dr Fung brings more than two decades of global industry and senior leadership experience across the life science sector.

He has significant biotech experience with senior leadership roles (Head of Clinical Development, interim CMO) at several of Europe’s most successful biotech companies including argenx, Micromet, later acquired by AMGEN, and Morphosys.

Dr. Fung has also held senior roles in clinical development, medical affairs, business development and strategic marketing at leading global pharmaceutical companies including Roche, Novartis, Pharmacia/Pfizer, Novo Nordisk and AstraZeneca.

Dr. Fung graduated from the University of Freiburg, Germany and obtained his board certification in internal medicine with sub-specialization in oncology and hematology.