On December 4, 2019 MaxCyte, the global cell-based therapies and life sciences company, and KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to achieve higher probabilities of success in drug development, reported that the companies have entered into a new development and commercialization agreement (Press release, MaxCyte, DEC 4, 2019, View Source;adoptive-cell-therapy-programs-300968617.html [SID1234551943]). Under the agreement, KSQ gains rights to use MaxCyte’s Flow Electroporation technology and ExPERT instruments for the advancement of KSQ’s engineered tumor-infiltrating lymphocyte (eTIL) programs, which the company is developing for the treatment of PD-1 refractory solid tumors.

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Under the terms of the agreement, KSQ obtains non-exclusive clinical and commercial use rights to MaxCyte’s cell engineering platform to develop multiple adoptive cell therapies. In return, MaxCyte is eligible to receive certain milestone payments in addition to other licensing fees.

"Adoptive cell therapies hold significant potential to improve outcomes for patients that are otherwise unresponsive to current treatments," said David Meeker, M.D., Chief Executive Officer of KSQ. "MaxCyte’s technology will play an important role in enabling the further development of our eTIL programs as we work to bring best-in-class, cell-based medicines forward for difficult to treat solid tumors."

MaxCyte’s ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

"We are delighted to have signed this agreement with KSQ Therapeutics, a company that’s forging an exciting path in the field of adoptive cell therapies with the potential to deliver significant benefits to patients. This is the fifth commercial license we have signed this year, demonstrating that MaxCyte is the partner of choice for leading technology companies, like KSQ, that are at the cutting edge of cell therapy and gene editing," said Doug Doerfler, President & CEO of MaxCyte, Inc.

On December 4, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Bortezomib for Injection 3.5 mg/vial, approved by the U.S. Food and Drug Administration (USFDA) via a 505(b)(2) new drug application (NDA) pathway for intravenous use only (Press release, Dr Reddy’s, DEC 4, 2019, View Source [SID1234551927]).

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"We’re pleased to bring this product to market for the customers and patients who will benefit from this cost-efficient alternative in the marketplace," explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. "This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio of products in the Hospital segment."

Dr. Reddy’s Bortezomib for Injection 3.5 mg/vial is for intravenous use only and is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Important Safety Information:

What Important Information Should I Know About Bortezomib for Injection, 3.5 mg/Vial?

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy
For intravenous use only. Do not administer Bortezomib for injection by any other route
Bortezomib for injection retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with bortezomib and who have relapsed at least six months after completing prior bortezomib treatment. Treatment may be started at the last tolerated dose
Bortezomib can cause fetal harm when administered to a pregnant woman
Who Should Not Use Bortezomib for Injection, 3.5 mg/Vial?

Patients with hypersensitivity (not including local reactions) to bortezomib or boron. Reactions have included anaphylactic reactions
Bortezomib for injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib products
If you are or plan on being pregnant. Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection because of potential risk to the fetus and should use effective contraception during treatment with Bortezomib for injection and for seven months following the final dose
Males with female sexual partners of reproductive potential should not father a child and must use effective contraception during treatment with Bortezomib for injection and for four months following treatment
Females should not breastfeed during treatment with Bortezomib for injection and for two months after treatment
What should I tell my healthcare provider before taking Bortezomib for Injection, 3.5 mg/Vial?

Before taking Bortezomib for Injection, tell your doctor if you previously have had or currently do have:

Preexisting symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy
History of syncope, receiving medications known to be associated with hypotension, and are dehydrated which may increase risk of hypotension
Are at risk factors for, or have existing heart disease
Have high tumor burden, risk of tumor lysis syndrome
Are pregnant or plan to be pregnant
Are nursing
If you are receiving dialysis
Have moderate or severe hepatic impairment
Are taking medications for diabetes
Are using other prescription and non-prescription medications and/or dietary and herbal supplements
What are possible side effects of Bortezomib for Injection, 3.5 mg/Vial?

Call your doctor or get emergency help right away if you develop:

Peripheral Neuropathy
Hypotension
Cardiac Toxicity
Pulmonary Toxicity
Posterior Reversible Encephalopathy Syndrome (PRES)
Gastrointestinal Toxicity
Thrombocytopenia
Neutropenia
Tumor Lysis Syndrome
Hepatic Toxicity
Thrombotic Microangiopathy
Please refer to the Package Insert for a complete list of possible side effects associated with Bortezomib for Injection

What are the most common side effects of Bortezomib for Injection, 3.5 mg/Vial?

Nausea
Diarrhea
Thrombocytopenia
Neutropenia
Peripheral neuropathy
Fatigue
Neuralgia
Anemia
Leukopenia
Constipation
Vomiting
Lymphopenia
Rash
Pyrexia
Anorexia
Dizziness
Syncope
What should I avoid while taking Bortezomib for Injection, 3.5 mg/Vial?

Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection. Females of reproductive potential must use contraception during treatment with Bortezomib for injection and for seven months following treatment
Avoid breastfeeding while receiving Bortezomib for injection and for two months after last dose
Avoid coadministration with medications that are strong CYP3A4 inducers
Avoid dehydration due to risk of hypotension, gastrointestinal toxicity, tumor lysis syndrome – Patients should drink adequate fluids
Bortezomib may cause fatigue, dizziness, syncope, orthostatic/postural hypotension, therefore Patients should not drive or operate machinery if they experience any of these symptoms
For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to [email protected] or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at View Source

On December 4, 2019 Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish drug discovery company, reported that a lead compound meeting certain pre-defined criteria has been selected in their collaborative research programme aimed at developing first-in-class protein-protein interaction inhibitors for a target of therapeutic importance in cancer and other diseases (Press release, Dong-A, DEC 4, 2019, View Source [SID1234551944]).

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The milestone transition provides Dong-A ST with exclusive global rights for further development and commercialization of products based on, or derived from, the lead compound. In return, Beactica receives an undisclosed milestone payment and is eligible to further payments for certain preclinical, clinical and regulatory milestones as well as royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A ST. Full financial details remain undisclosed.

"The collaboration between Dong-A and Beactica was initiated to develop next generation anti-cancer therapeutics and we greatly appreciate the phenomenal contribution Beactica has made in identifying novel modulators for a highly sought-after target," said Dr Taeyoung Yoon, Senior Vice President and Head of Research of Dong-A ST. "We are committed to advance this innovative programme with the ultimate aim to make a clinical impact where it is urgently needed."

"We are delighted to achieve this milestone under our collaboration with Dong-A, further validating the strength of our approach and drug discovery platform, as well as our success in collaborating globally with leading pharmaceutical companies," said Dr Per Källblad, CEO of Beactica. "Dong-A’s commitment to advance this programme towards the clinic is encouraging."

The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018.

On December 4, 2019 ImCheck Therapeutics, a biotech company developing a first-in-class antibody to activate gamma delta (gd) T cells in a range of cancer indications and a portfolio of novel immunotherapies for the treatment of cancer and autoimmune diseases, reported the closing of a $53 million (€48 million) Series B financing round (Press release, ImCheck Therapeutics, DEC 4, 2019, View Source [SID1234551908]). The round was co-led by Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), and Bpifrance through its InnoBio 2* and Large Venture funds and joined by new investors Wellington Partners, Agent Capital and Alexandria Venture Investments. Life Sciences Partners (LSP), Gimv, Idinvest Partners, Kurma Partners and Boehringer Ingelheim Venture Fund that contributed to the 2017 €20 Million Series A round also participated for a significant portion of this raise. The proceeds of the Series B will be used to fund the initial clinical trial for ImCheck’s first-in-class monoclonal antibody ICT01, to further expand the company’s broad pipeline of immunomodulators targeting the butyrophilins super-family and to bring additional immuno-oncology antibody programs into the clinic.

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"ImCheck’s first clinical trial starting next year with ICT01 is based on comprehensive translational research supporting its potential to activate gd T cells to kill malignant cells. The Series B funding, bringing the total capital raised in 2.5 years to nearly $80 million, allows us to accelerate the development of our unique immuno-oncology pipeline, further investigate the potential of our antibodies in autoimmune disease, and establish clinical operations and corporate development activities in the US," said Pierre d’Epenoux, Chief Executive Officer at ImCheck Therapeutics.

ImCheck’s Board of Directors will transition to include Michael Baran from Pfizer Ventures, Thibaut Roulon from Bpifrance, Regina Hodits from Wellington, Rémi Droller from Kurma, Vincent Brichard from LSP, Bram Vanparys from Gimv, Debasish Roychowdhury as independent Chairman and Pierre d’Epenoux, CEO of ImCheck.

"We believe that furthering the understanding of gd T cell activation could provide the basis for an area of research that could have tremendous potential for treating patients with certain cancers and autoimmune diseases, and we are pleased to be co-leaders in this financing round," commented Michael Baran, PhD, MBA, Principal, Pfizer Ventures and Executive Director, External Science & Innovation, Pfizer.

"ImCheck has produced a pipeline of first-in-class immuno-modulatory antibodies targeting gd T cells and built a world-class drug development organization with a significant potential to expand the current immune-modulatory arsenal against cancer," added Thibaut Roulon, PhD, Investment Director at Bpifrance.

"We are very pleased to add these top tier institutional and strategic investors from both the US and EU in the closing of our Series B financing," commented Debasish Roychowdhury, MD, Chairman of ImCheck Board of Directors. "We believe this investment represents a strong validation of our pipeline and its potential both in cancer and autoimmune diseases."

Legal counsel for the Series B transaction provided by Dentons Europe and Dechert LLP. Investor relations support provided by Trophic Communications. French media and communications support provided by ATCG.

On December 4, 2019 Karus Therapeutics Ltd (‘Karus’), a clinical-stage biopharmaceutical company developing precision medicines for cancer, reported that new data will be presented from its KA2237 Phase I study at the ASH (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida, 9 December 2019 (Press release, Karus Therapeutics, DEC 4, 2019, View Source [SID1234551928]).

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The Phase I clinical trial, conducted at The University of Texas MD Anderson Cancer Center, has examined the safety, tolerability, pharmacokinetic properties and pharmacodynamic effects of KA2237 in patients with relapsed/refractory B-cell lymphoma.

KA2237 is a potent, orally-active and dual-selective PI3 Kinase (PI3K) p110β/δ inhibitor. The p110δ isoform is an attractive therapeutic target, with several known inhibitors demonstrating efficacy in B-cell lymphomas. Karus aims to overcome mechanisms of tumor escape by simultaneously targeting PI3K p110β.

Tim Edwards, Karus’ Executive Chairman, commented:

"As we continue in our mission to develop transformative precision medicines for cancer, ASH (Free ASH Whitepaper) provides the perfect opportunity to showcase the potential of KA2237 in the treatment of hematological and solid tumors. We are pleased to be presenting our new data and look forward to connecting with more of the hematology community."

Details of the poster presentation are as follows:

Title: 4099. Results of a First in Human, Dose Ascending, Phase I Study Examining the Safety and Tolerability of KA2237, an Oral p110β/δ Inhibitor in Patients with Relapsed/Refractory (R/R) B-Cell Lymphoma
Time and Date: 18:00–20:00, Monday 9 December
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Presenters: Dr Loretta Nastoupil, MD (on behalf of MD Anderson Cancer Center) and Dr Philip Beer, MD, PhD (on behalf of Karus).