On May 26, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that the European Commission (EC) has granted conditional marketing authorization of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel in December 2017 (Press release, Legend Biotech, MAY 26, 2022, View Source [SID1234615116]).

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CARVYKTI is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies.1 CAR-T therapy is specifically developed for each individual patient, and it is administered as a single infusion.1,2

"The approval of CARVYKTI by the European Commission marks Legend’s first approval in the region and is a significant milestone as we advance our commitment to bring innovative cell therapies to patients with the highest unmet need," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "The CARTITUDE-1 data showed that CARVYKTI provides the potential for long, treatment-free intervals for heavily pre-treated patients, and is a valuable treatment option for patients with multiple myeloma. We look forward to working with Janssen to bring this new option to patients across Europe."

This approval was supported by the pivotal CARTITUDE-1 study, including patients who had received a median of six prior treatment regimens (range, 3-18), and had previously received an IMiD, PI and anti-CD38 monoclonal antibody.3 Findings showed that at a median duration of 18 months follow-up (range, 1.5-30.5), a one-time treatment with cilta-cel resulted in deep and durable responses, with 98 percent (95 percent confidence interval [CI], 92.7-99.7) of patients with RRMM responding to therapy (98 percent overall response rate [ORR] (N=97)).3,4 Notably, 80 percent of the patients achieved stringent complete response (sCR), a measure in which a physician is unable to observe any signs or symptoms of disease via imaging or other tests after treatment.3

The safety of cilta-cel was evaluated in 179 adult patients across two open-label clinical trials (MMY2001 and MMY2003). The most common adverse reactions (≥20 percent) were neutropenia (91 percent), cytokine release syndrome (CRS) (88 percent), pyrexia (88 percent), thrombocytopenia (73 percent), anemia (72 percent), leukopenia (54 percent), lymphopenia (45 percent), musculoskeletal pain (43 percent), hypotension (41 percent), fatigue (40 percent), transaminase elevation (37 percent), upper respiratory tract infection (32 percent), diarrhea (28 percent), hypocalcemia (27 percent), hypophosphatemia (26 percent), nausea (26 percent), headache (25 percent), cough (25 percent), tachycardia (23 percent), chills (23 percent), encephalopathy (22 percent), decreased appetite (22 percent), oedema (22 percent), and hypokalemia (20 percent).4

"There continues to be an unmet need for patients with relapsed or refractory multiple myeloma who have exhausted existing treatment options. Data from the CARTITUDE-1 trial have shown that cilta-cel provides deep and durable responses for heavily pre-treated patients. Today’s approval by the European Commission reinforces the potential of this new treatment option for multiple myeloma patients in Europe," said Hermann Einsele, Full Professor of Internal Medicine and Director of the Medizinische Klinik und Poliklinik II of the Julius Maximilian University, Würzburg, Germany.*

As a highly personalized medicine, where a patient’s own T-cells are reprogrammed to target and kill cancer cells, administration of CAR-T therapy requires extensive training, preparation, and certification to ensure the highest quality product and experience for patients.2 Through a phased approach, Legend Biotech’s strategic partner, Janssen, will work diligently to activate a limited network of certified treatment centers and will aim to increase availability of cilta-cel across Europe, in an effort to provide oncologists and patients with treatment in a reliable manner.

This EC Marketing Authorization follows the approval of CARVYKTI by the U.S. Food and Drug Administration (FDA) on February 28, 2022.

*Hermann Einsele, M.D., FRCP has not been paid for contributing to this press release.

About CARVYKTI (ciltacabtagene autoleucel; cilta-cel)

CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.4 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.4 The CARVYKTI CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.4 Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.4

In December 2017, Legend Biotech Corporation entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.5

In April 2021, Legend announced the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of cilta-cel for the treatment of patients with relapsed or refractory multiple myeloma. In addition to U.S. Breakthrough Therapy Designation granted in December 2019, cilta-cel also received Breakthrough Therapy Designation in China in August 2020. In February 2019, cilta-cel received Orphan Drug Designation from the U.S. FDA from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In May 2022, the Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained, on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.6 Cilta-cel was approved the U.S. Food and Drug Administration (FDA) in February 2022.5

About CARTITUDE-1

CARTITUDE-1 (NCT03548207)7 is an ongoing Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.4

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.8 In Europe, it is estimated that more than 50,900 people were diagnosed with multiple myeloma in 2020, and approximately 32,500 patients died.9 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.10 Although treatment may result in remission, unfortunately, patients will most likely relapse.11 Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.12,13

On May 26, 2022 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies and immune repertoire-based patient stratification tools, reported that Young T. Kwon, PhD, Alchemab’s Chief Financial and Operating Officer, has succeeded Douglas A. Treco, PhD as Chief Executive Officer and member of the Board, who resigned for personal reasons (Press release, Alchemab Therapeutics, MAY 26, 2022, View Source [SID1234615115]).

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Houman Ashrafian, Chairman of the Board said, "Doug was instrumental to our successful Series A financing and has made significant contributions to Alchemab. He led us in advancing our novel platform and our lead programs in neurodegeneration and cancer, and has helped build out an extremely talented team and established a solid operational foundation, including new operations in the U.S. We are extremely fortunate that he has been a part of Alchemab during this period of rapid growth and scientific progress."

"We are delighted that Young will lead our Company and join our Board," Dr. Ashrafian continued. "He has established himself as an outstanding leader and we are thrilled that he will be driving the Company forward during this exciting phase of growth. In addition to building transformative biotech companies, Young’s track record working with and developing talented teams will build on and shape Alchemab’s diverse, ambitious and unique culture. As the Company continues to grow its footprint in the U.S. and the U.K., we look forward to working with Young to advance our novel programs to the clinic and build out our highly differentiated platform."

"I am excited by Alchemab’s potential," said Dr. Kwon, "Over the last six months I have seen how combining experienced drug discovery capabilities with the latest computational approaches pave a new era in therapeutics discovery. I am grateful to Doug for his support and guidance and I look forward to the challenge of building upon the outstanding foundations that he has established."

Dr. Kwon has served as Alchemab’s Chief Financial and Operating Officer since November 2021. Dr. Kwon previously served as Chief Financial and Business Officer of Momenta Pharmaceuticals until its acquisition by Johnson & Johnson in October 2020. Prior to Momenta, Dr. Kwon was a business development professional at Biogen and worked at the venture capital firm Advanced Technology Ventures, investing in early-stage biotech and medical device companies. Dr. Kwon received a B.S. in biology from Massachusetts Institute of Technology and a Ph.D. in Biological Chemistry and Molecular Pharmacology from Harvard University.

On May 26, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that 100 years of clinical evidence supporting the use of proenzymes as a new therapeutic approach to treat cancer can be considered ‘compelling’ (Press release, Propanc, MAY 26, 2022, View Source [SID1234615114]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, has researched the effects of proenzymes against cancer for over 15 years and first came across the technology in his search to extend the life of several late-stage patients suffering from malignant solid tumors in the mid 2000’s. It was Professor John Beard from Edinburgh University who first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. Since then, several scientists have endorsed Beard’s hypothesis with encouraging data from patient treatment.

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In 1902, in an article published in The Lancet, Professor Beard proposed that the answer to questions about the origin of cancer could be found in the field of embryology. Professor Beard tested his theory in a mouse model of cancer. After injections of commercially available pancreatic enzyme trypsin, the tumor in a treated mouse was much smaller than that in an untreated control. Over several years, a number of physicians in the UK and US injected enzyme preparations with some remarkable success stories. As a result, the physicians began writing letters to the editor summarizing their clinical cases, such as Medical Record in the early 1900’s.

For example, Dr Campbell wrote about a 56-year-old male with a malignant left tonsil the size of a hen’s egg, experiencing left facial paralysis and constant pain. After periodic injections for a month, the infiltrations in the tongue and tonsil were greatly decreased, pain free and felt well. A second example, Dr Oldfield, reported a 65-year-old male with an abdominal tumor with secondary metastases in the stomach, full of solid tumor and in great pain. After daily injections for 3 months, the patient was reported to eat and sleep well, returned to a normal weight. Dr Outfield concluded that "No-one…can doubt the immense improvement that has taken place." However, mixed results in the early stages of treatment were observed and attributed by Beard to the wide variation in the quality of enzymes of available enzymes at the time.

Over the years, there have been further clinical cases investigated into the use of enzymes as a way to treat cancer. Of particular note was the work undertaken by molecular biologist from Bucknell University, Dr Josef Novak and a retired Czech oncologist, Dr Frantisek Trnka. Drs Novak and Trnka undertook extensive laboratory work in the late ‘90s and 2000s, publishing their work in the journal Anticancer Research in the mid 2000s, where they first proposed that the enzyme extracts as recommended by Beard, must be used in the "proenzyme" form to ensure their selective activation at the tumor site. They also undertook clinical research, administering a proenzyme treatment via a suppository formulation to 20 late-stage cancer patients, with a range of malignancies, of which 10 survived, ranging from 8 months to 10 years, with minimal, or non-existent side effects normally seen with current standard therapies. The conclusion of Drs Novak and Trnka from this work was the discovery "that proenzyme therapy mandated first by John Beard nearly one hundred years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential."

As a result of the clinical evidence observed throughout the years, Dr Kenyon decided to undertake his own investigation motivated by the condition of a number of late-stage cancer patients he treated in his clinical practice at The Dove Clinic, in Hampshire, UK. Consequently, the clinical efficacy of a suppository formulation containing pancreatic proenzymes was evaluated in the context of a UK Pharmaceuticals Special Scheme and results published in a peer reviewed journal, Scientific Reports. Clinical effects were studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancer and melanoma) after treatment with a rectal formulation consisting of pancreatic proenzymes trypsinogen and chymotrypsinogen.

Dr Kenyon concluded that no severe or serious adverse events related to the rectal administration were observed. Patients did not experience any hematological side effects as typically seen with classical chemotherapy regimens. No allergic reactions after rectal administration of suppositories were also observed. In order to assess the therapeutic activity of rectal administration, overall survival of patients under treatment was compared to the life expectancy assigned to a patient prior to treatment start. Nineteen (19) from 46 patients (41.3%) with advanced malignant diseases, most of them suffering from metastases, had a survival time significantly longer than their expected, in fact, for the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months). Although the number of patients per cancer indication was naturally quite low, 3 out of 8 patients with prostate cancer and 5 out of 11 patients with gastrointestinal cancers appeared to particularly benefit from the treatment with the proenzyme suppositories.

"As a result of my research over the last 15 years, as well as the clinical evidence over the last 100 years, proenzyme therapy can have a meaningful and long-lasting clinical benefit on patients suffering from solid tumors, but without the side effects associated with standard therapies, which is simply compelling," said Dr Kenyon. "Since the pioneering work undertaken by Professor John Beard and his medical colleagues, in the early 1900’s, their approach was ahead of their time, but since then, our understanding of tumor cell biology means we have elucidated how the activated enzymes works against solid tumors and in particular, cancer stem cells, optimized the formulation and its clinical effects, and developed a product candidate to pharmaceutical standard which can be administered by I.V. injection to maximize the exposure at the tumor site. My scientific and clinical research team at Propanc Biopharma are preparing to take our lead product candidate, PRP, into a world first, Phase I, First-In-Human study in advanced cancer patients suffering from solid tumors. The 100-year history of enzyme therapy gives me confidence we are on the right pathway with an exciting approach for the treatment and prevention of metastatic cancer from solid tumors, which is the main cause of patient death for sufferers."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On May 26, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 9 at 1:30pm EDT (Press release, FibroGen, MAY 26, 2022, View Source [SID1234615113]).

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A live audio webcast of the event will be available on the "Events & Presentations" section of the FibroGen Investors webpage at www.fibrogen.com. A replay will be available for approximately 30 days.

On May 26, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the 2022 Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 1:00 p.m. Eastern Daylight Time / 19:00 Central European Time (Press release, Affimed, MAY 26, 2022, View Source [SID1234615112]).

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A live webcast of the presentation will be accessible on Affimed’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

For more information on the conference or to schedule a one-on-one meeting with Affimed’s management, please contact Jefferies or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.