On October 28, 2021 GenesisCare — one of the leading oncology providers in the United States, Australia, Spain, and the United Kingdom — reported it will be expanding access to the novel fluorinated prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging capabilities in its Florida, South Carolina, and Texas centers (Press release, GenesisCare, OCT 28, 2021, View Source [SID1234592156]). They plan to rapidly accelerate PSMA PET access at all U.S. GenesisCare sites by Q2 2022.

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A PSMA PET scan uses a small amount of a radioactive tracer such as PYLARIFY (piflufolastat F 18), the first and only commercially available FDA-approved PSMA PET imaging agent for prostate cancer. PYLARIFY targets and binds to the PSMA protein, which is found on nearly all prostate cancer cells, and lights up on a scan to pinpoint where cancer is located.

Prostate cancer is the second leading cause of cancer-related death for men in the United States. Finding novel approaches and standards to treat prostate cancer is critical. PSMA PET scanning is instrumental in advancing novel approaches, precision medicine, and standard of care for prostate cancer treatment. This revolutionary approach makes smaller lesions visible with greater accuracy than traditional CT or Tc bone scans, enabling oncologists to determine disease progression and adjust treatment more easily.

GenesisCare patients, like retired attorney Leonard Bitterman of Boca Raton, who received the first injection of PYLARIFY in the U.S. on June 3, 2021, have experienced improved outcomes and quality of life. "This new process has taken the guesswork out of my prostate cancer journey," said Bitterman. "My wife and I now have greater peace of mind with this new treatment and feel comfortable living life to its fullest."

"PSMA PET is a revolutionary diagnostic tool we’re now offering nationwide that allows doctors to see metastatic or recurrent prostate cancer earlier – anywhere in the body. This is a game-changer that will have a tremendous impact for patients across the U.S.," said Dan Collins, Founder and CEO, GenesisCare. "Through continued collaborations with medical imaging and theranostics leaders like Lantheus, GE, Telix and Clarity, and our leading team of global theranostics experts, we are able to bring the latest breakthroughs in cancer diagnostics and treatment to more patients, much faster."

"Innovative diagnostic tools like PSMA PET provide more accurate and earlier detection of disease than conventional imaging so our clinicians, along with their patients and families, can make more informed treatment decisions that lead to improved outcomes," stated Neal D. Shore, M.D. FACS, GenesisCare Chief Medical Officer of Urology and Surgery and National Urology Research Director. "We are very excited to offer PSMA PET imaging with the first FDA-approved and commercially available PSMA PET prostate cancer imaging agent, PYLARIFY, to all of our patients throughout the U.S."

On October 28, 2021 Stand Up To Cancer (SU2C) reported the Stand Up To Cancer–Fanconi Anemia Research Fund–Farrah Fawcett Foundation Head and Neck Cancer Research Team (Press release, SU2C, OCT 28, 2021, View Source [SID1234592155]). The team will concentrate on new approaches to address head and neck squamous cell carcinoma, with an emphasis on cancers related to the human papillomavirus (HPV) and Fanconi anemia.

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The team has been awarded $3.25 million over three years to advance therapies, support new approaches and improve patient outcomes for head and neck cancers. The team will receive $1.5 million each from the Fanconi Anemia Research Fund and the Farrah Fawcett Foundation. The American Head and Neck Society and the Head and Neck Cancer Alliance have each provided $125,000 to support the team. This is the first time these four organizations have come together in an unprecedented collaboration to take on some of the toughest challenges in head and neck cancers. This is also the first time SU2C has worked with a nonprofit foundation that is not directly focused on cancer research – the Fanconi Anemia Research Fund.

"There is tremendous work that needs to be done to make progress in treating head and neck cancers, which approximately 66,000 Americans will be diagnosed with this year," said Sung Poblete, PhD, RN, CEO of Stand Up To Cancer. "It is truly groundbreaking for these four donors to come together in this unique collaboration to support this team and make this critical research possible. I’m grateful for their vision and focus on our shared goal: to make more people impacted by head and neck cancers long-term survivors."

Agata Smogorzewska, MD, PhD, associate professor at The Rockefeller University will lead the research team and Barbara Burtness, MD, professor of medicine, interim associate director for diversity, equity and inclusion and co-leader, Developmental Therapeutics Program at Yale Cancer Center and Smilow Cancer Hospital, will serve as co-leader of the team.

The team will bring together experts working on different aspects of head and neck cancers with a focus on collaboration that speeds the discovery of new treatments. Using a variety of state-of-the-art tools to better understand how head and neck cancers develop, the team will improve treatments by identifying new combinations of current and emerging therapies that may be effective for these types of cancers.

"By improving our understanding of HPV-related and Fanconi anemia-associated cancers, we will be able to identify and develop new treatment and preventive strategies for individuals with these cancer types," said Smogorzewska. "Our ultimate goal is to achieve better survival without compromising quality of life that is currently limited by treatment toxicity. The challenges of treating patients with Fanconi anemia who develop cancer are profound due to the inability to use standard chemotherapy. Similarly, for patients with HPV-related cancer, development of treatment resistance leads to poor outcomes."

Head and neck cancers can appear in the nasal cavity, sinuses, lips, mouth, salivary glands, thyroid gland, throat or larynx. Fanconi anemia is a rare inherited disease characterized by the inability to repair DNA leading to bone marrow failure and cancer; the incidence of head and neck squamous cell carcinoma in people with Fanconi anemia is 500- to 700-fold higher than in the general population and treatment options are limited. Fanconi anemia, although rare, affects people of all ethnicities. HPV is a very common virus that can cause cancer, including cancer of the throat; approximately 45,300 people with HPV will get a cancer diagnosis every year in the U.S.

"The incidence of HPV-related head and neck cancer is increasing in all populations," said Burtness. "Existing treatments for HPV-related head and neck cancer are often toxic. New treatments offer the promise of reducing toxicity and are an option for patients who do not respond to standard treatment. Our team’s approach to identifying new effective combinations of current and emerging treatments that could allow for safer and more effective therapies is critical in order to save more lives."

In all races and ethnicities, men have higher rates of HPV-associated cancers of the oropharynx (back of the throat, including the base of the tongue and tonsils) than women. These diagnostics rates have surpassed cervical cancer in women bringing new urgency for this crucial research. Black and Hispanic men and women have lower rates of HPV-associated oropharyngeal cancers than white and non-Hispanic men and women. In addition to oropharyngeal cancers, HPV can also cause anal, cervical, penile, vaginal and vulvar cancers.

On October 28, 2021 HanAll Biopharma (KRX: 009420.KS) reported that the company had achieved sales of 25.5 billion won, an operating profit of 2.2 billion won, and a net profit of 2.1 billion won in the third quarter of 2021 (Press release, HanAll Biopharma, OCT 28, 2021, View Source [SID1234592154]).

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In the first nine months of the year, net sales were 76.7 billion won, a 15% increase compared to the same period last year, and the operating profit increased by 67% to 9.2 billion won. Increased sales were largely due to strong revenues with double digit growth from major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product.

As of the end of the third quarter, HanAll Biopharma maintained a stable financial status with net cash of 87.6 billion won and reported assets of 203.0 billion won, an equity of 163.9 billion won, and liabilities of 39.1 billion won.

[R&D Pipeline]

– HL161 (a novel, fully human, subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)
HL161 (INN: batoclimab), an antibody drug for autoimmune diseases caused by pathogenic antibodies, is currently undergoing clinical trials in the US and China through HanAll’s partners, Immunovant and Harbor BioMed.

The licensed partner in the US and Europe, Immunovant, is preparing to resume clinical trials, which were put on hold in February of this year due to an issue related to increased cholesterol. Program-wide data review suggests that HL161 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albumin. Immunovant announced its plan

1) to return to the clinic and initiate a pivotal Phase 3 myasthenia gravis (MG) trial and Phase 2 in warm autoimmune hemolytic anemia (WAIHA) in the first half of 2022 following meetings with regulators including the FDA,
2) to communicate with the FDA and other authorities to discuss future plans for Phase 2 trials for thyroid eye disease or other thyroid related disease and
3) to initiate new studies in two additional indications in 2022.

The licensed partner in greater China, Harbour BioMed, is currently conducting clinical trials in myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica (NMO), and thyroid eye disease (TED) in China. In September, Harbour BioMed released that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 2 trial of batoclimab in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Harbor BioMed reported the first dosing of the first patient in registrational Phase 3 trial of batoclimab in myasthenia gravis in China in September and expects BLA submission for the disease next year.

In Japan, HanAll Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) in collaboration with Immunovant. The study is expected to start in 2022.

– HL036 (a novel, topical anti-TNF biologic therapy for dry eye disease)
HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in ocular inflammation. The first Phase 3 clinical trial (VELOS-2) for dry eye disease was completed last year.

HanAll submitted the IND for the second Phase 3 clinical trial (study name: VELOS-3) to the US FDA on July 22, and is expected to begin clinical trials in the fourth quarter this year and have topline results next year. Due to the recent COVID related delays of global transportation, there was a delay in the investigational drug transportation. Accordingly clinical study initiation was rescheduled from the third quarter to the fourth quarter.

The VELOS-3 study is a Phase 3, multicenter, randomized, double-blind, and placebo-controlled study evaluating the efficacy and safety of tanfanercept ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease.

Harbor BioMed, the license holder for the Chinese market, started a pivotal Phase 3 trial in dry eye disease in the first half of the year, and plans to file a biologics license application (BLA) with NMPA in 2022 after the study ends.

– HL189 (tanfanercept)
HanAll Biopharma is exploring the options to expand the indications of tanfanercept to new inflammatory eye disorders including uveitis. Preclinical studies on uveitis have been conducted. The company will decide on new indications development plan in 2022.

– HL186/HL187 (novel immune-oncology therapies)
HL186 and HL187 projects are novel immuno-oncology antibodies that target TIM-3 and TIGIT, respectively, developed in collaboration with Daewoong Pharmaceutical. Both programs are at preclinical stage. The companies aim to develop differentiated immune checkpoint inhibitors with better efficacy and higher response rates for patients with cancer.

On October 28, 2021 Valens (NYSE: VLN), a premier provider of high-speed connectivity solutions for the audio-video and automotive markets, reported that it will release its third quarter 2021 financial results before the market opens on Thursday, November 11, 2021 (Press release, Valens Therapeutics, OCT 28, 2021, View Source [SID1234592153]).

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In conjunction with this announcement, Valens will host a conference call on Thursday, November 11, 2021 at 8:30 a.m. Eastern Time (ET) to discuss its third quarter 2021 financial results and business outlook. To access this call, dial +1 (855) 979-6654 (U.S.), 072 258 7959 (Israel) or +44 20 3936 2999 (all other locations). The conference call access code is 365140.

A live webcast of the conference call will be available via the investor relations section of Valens’ website at View Source The live webcast can also be accessed by clicking here. A replay of the conference call will be available on Valens’ website shortly after the call concludes.

On October 28, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported it will host a conference call to discuss financial results for the quarter ended September 30, 2021 and provide a corporate business update on Wednesday, November 10, 2021, at 4:30 pm EDT/ 2:30 pm MT (Press release, Ampio, OCT 28, 2021, View Source [SID1234592152]).

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In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode.

The conference call and webcast can also be accessed from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.