On September 14, 2021 PharmaMar (MSE:PHM) reported that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca (lurbinectedin) by the Australian Therapeutic Goods Administration (TGA), for the treatment of patients with metastatic Small Cell Lung Cancer (SCLC), that have progressed on or after prior platinum-containing therapy (Press release, PharmaMar, SEP 14, 2021, View Source [SID1234596668]).

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This means patients who have progressed after other existing treatment options will now be able to access another line of therapy. Lurbinectedin is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.

Australian lung cancer oncologist Professor Paul Mitchell from the Olivia NewtonJohn Cancer and Wellness and Research Centre at the Austin Hospital in Melbourne, Australia, said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease. He said fewer than 5% of these
patients currently survived more than five years post diagnosis.

"The new availability of lurbinectedin will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease," Professor Mitchell said. "With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes."

The TGA approval of lurbinectedin has been granted under a provisional regulatory pathway. The US Food and Drug Administration (FDA) and Australia’s TGA collaborated via ‘Project Orbis’ to accelerate availability to Australian patients.

Lurbinectedin’s approval is based on clinical data from an open-label, multi-center, single-arm phase II study in 105 adult patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with Relapsed SCLC, Lurbinectedin provided an Overall Response Rate (ORR) of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2nd line SCLC including some Australian sites. This study is expected to be completed in 2025.

Lurbinectedin is being made available in Australia by the independent pharmaceutical Company, STA, under an exclusive license from international partner, PharmaMar.

José María Fernández, Ph.D., President of PharmaMar said the Company was delighted Australian patients would now be provided access to lurbinectedin. "We are pleased to bring a new treatment choice to relapsed SCLC patients. The accelerated approval of lurbinectedin underscores its potential to fill an unmet need in this oftenoverlooked SCLC community." And added: "We are very thankful that the TGA has been the first regulatory agency to authorize three compounds from PharmaMar."

STA Chief Executive Officer, Carlo Montagner said the approval of lurbinectedin would potentially make a difference for around 400 Australian patients annually who had run out of treatment options. "We are delighted to be able to provide a new therapy option for patients with this difficult to treat cancer," he said. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Our mission has always been to provide therapies in area where there is an unmet need and SCLC is certainly one of these areas. We look forward to making a difference for these
patients and their families."

Lurbinectedin is currently available in Australia via a Special Access Program. Commercial supplies of lurbinectedin in Australia will commence early 2022.

On September 14, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that George Farmer, Ph.D., Chief Financial Officer, will present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 21, 2021 at 4:35 PM EDT (Press release, PureTech Health, SEP 14, 2021, View Source [SID1234587667]). A webcast of the presentation will be available at View Source

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On September 14, 2021 Leaps by Bayer, the impact investment arm of Bayer AG, reported that it has co-led a USD 15 million Series A investment round in agriculture and biotechnology innovator, Andes, with Cavallo Ventures (Press release, Andes Biotechnologies, SEP 14, 2021, View Source [SID1234587684]). Other new investors Builders VC, Germin8, Accelr8 and Wilson Sonsini participated, alongside existing investors KdT Ventures and Endurance.

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Through its novel seed treatment technology, called ‘Microprime’, Andes is reducing the need for synthetic fertilizers. The California-based company has developed a process for seamlessly integrating seeds with a unique library of microbes that colonize the seed’s root structure. This kick-starts a process known as biological nitrogen fixation, enabling the crop to draw down nitrogen from the air instead of relying on synthetic nitrogen fertilizers.

By developing self-sustaining Microprime seeds, Andes reduces the need for synthetic fertilizers, which require huge amounts of energy to produce and account for 3%, or 1.5 gigatons, of global greenhouse emissions. In enabling microbes to ride along with the seeds as they get planted, Andes’ Microprime technology provides a highly scalable solution that saves growers time and money.

The first generation of Microprime treated corn seeds will provide the equivalent of 30 to 50 lbs/acre of nitrogen through biological nitrogen fixation. The company is creating second generation microbes that target doubling the amount of nitrogen provided by the Microprime seeds.

Andes is also developing microbial strains for nature-based permanent carbon capture solutions to sequester and store CO2 from the atmosphere into the soil. This initially focuses on capturing carbon via microbial-powered corn crops. If deployed successfully at scale, it could capture gigaton-levels of carbon from corn and other crops. With the world’s total annual greenhouse gas emissions estimated to be 50 gigatons, nature-based carbon capture could make a sizeable contribution to global decarbonisation.

Agriculture currently consumes 50% of habitable land and 70% of the earth’s fresh water. Andes and Leaps by Bayer are committed to better using these resources through more efficient and sustainable agricultural practices.

Dr. Jürgen Eckhardt, Head of Leaps by Bayer said: "We invest in paradigm-shifting advances that can radically reduce the environmental impact of agriculture. Andes is an exceptional example of that: using novel seed technology to reduce the use of synthetic fertilizers and developing the next generation of agricultural carbon capture solutions. It’s exciting that our funding will help the Andes team scale its current offering and explore the possibilities of truly world-changing technologies like carbon capture."

"We are well past the need for sustainable products and practices. We can only avoid an irreparable climate disaster through solutions that are highly scalable and reliable," Gonzalo Fuenzalida, Andes CEO, explained. "At Andes we are seamlessly integrating the power of microbes within seeds to dramatically cut the need for synthetic fertilizers. This investment will allow us to expand on this success, as well as expand our technology to utilize the millions of acres of agricultural land to capture and store carbon emissions."

Andes will use part of the funds to scale its self-sustaining, nitrogen-fixing seeds across the U.S. market and expand into South America. The balance of funding will be invested to advance further research and development into Andes’ complementary nature-based permanent carbon capture technology.

On September 14, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 from September 16 – 21, 2021 (Press release, Aprea, SEP 14, 2021, View Source [SID1234594085]).

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Details for the ESMO (Free ESMO Whitepaper) 2021 mini oral presentation are as follows:

Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies
Speaker: Haeseong Park, Washington University in St. Louis
Presentation #: 516MO
Session: Mini oral session – Developmental therapeutics
Date and Time: Monday, September 20, 2021; 17:35 – 17:40 CEST (11:35 – 11:40am EDT)

On September 14, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at this upcoming investor conference (Press release, Nkarta, SEP 14, 2021, View Source [SID1234587668]):

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Cantor Virtual Global Healthcare Conference
Tuesday, September 28, 2021
4:00 p.m. ET – fireside chat presentation

A simultaneous webcast of the presentation will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.