On September 30, 2020 TargetCancer Foundation, with support from Bayer and in partnership with Foundation Medicine, Inc. and investigators from leading academic institutions, reported the first patients enrolled in the TCF-001 TRACK (Target Rare Cancer Knowledge) Study (Press release, TargetCancer Foundation, SEP 30, 2020, View Source [SID1234567824]). TRACK aims to provide individualized treatment recommendations to patients with rare cancers, defined as cancers with an incidence of six per 100,000 people per year in the U.S., informed by genomic analysis and in consultation with field-leading rare cancer clinicians and researchers. An expert virtual molecular tumor board (VMTB) will share these recommendations with patients and their healthcare providers (HCPs), ensuring the widest range of options are considered. To learn more about TRACK and how to enroll, visit www.targetcancerfoundation.org/track.

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For people diagnosed with cancer, it is important that they discuss genomic testing with their HCPs. Genomic testing can identify DNA alterations, or changes, within cancer cells that determine how a tumor behaves or why it grows.1 The results of genomic testing may help HCPs match patients to approved or investigational therapies based on the specific alteration identified.

"It wasn’t until years after my initial diagnosis that I learned a genomic tumor test might help identify what was driving my cancer and which therapy would be appropriate for me," said Susan, thyroid cancer patient and advisor on the TRACK Patient and Caregiver Advisory Council. "Ultimately, the testing identified an NTRK gene fusion, a rare genomic driver of multiple tumor types. I’m hopeful TRACK will enable patients like me with rare cancers to gain access to testing and make better informed decisions throughout their treatment journey."

TRACK participants’ subsequent treatments and responses will be prospectively tracked for at least one year, observing participant outcomes based on molecularly-informed treatment decisions. Through a remote consenting process, participants can fully enroll in the study from home without travelling to a clinical trial site. Beyond potentially informing treatment options, the data produced through TRACK will also contribute to the field’s understanding of genomics in rare cancers, addressing a critical unmet need where such knowledge is otherwise lacking. Studies show rare cancers generally receive less scientific consideration and financial support than trials of more common tumors.2

As a company dedicated to new and innovative approaches to treat cancer and broader access to genomic testing, Bayer’s financial support of the TRACK Study is another key initiative it has undertaken along with various laboratory and patient advocacy groups to advance patient care.

"People with rare cancers deserve better informed, individualized and targeted treatment choices, and we look forward to having these patients enrolled in TRACK," said Jim Palma, Executive Director, TargetCancer Foundation. "We are making significant strides in shifting clinical practice norms by challenging traditional methods of clinical trial enrollment and introducing virtual care into the treatment continuum, and we are grateful for Bayer’s longstanding support of these efforts."

"Those with rare cancers are especially vulnerable to reductions in research and limited access to treatments, especially during these uncertain times," said Joseph Germino, M.D., Vice President of Medical Affairs, Oncology at Bayer. "Bayer’s recent initiatives, including the support of TRACK, encourage genomic testing and subsequent tailored treatment approaches for patients to ensure optimal care."

TRACK is sponsored and managed by TargetCancer Foundation, in partnership with Foundation Medicine. In addition, the research team for TRACK includes Principal Investigator Razelle Kurzrock, M.D. (University of California San Diego), as well as co-Principal Investigators Vivek Subbiah, M.D. (University of Texas MD Anderson Cancer Center), James Cleary, M.D., Ph.D. (Dana-Farber Cancer Institute), and Roman Groisberg, M.D. (Rutgers Cancer Institute of New Jersey).

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On September 30, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer (Press release, Lantheus Medical Imaging, SEP 30, 2020, View Source [SID1234567823]). The NDA includes a request for Priority Review, which if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance. The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.

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"The completion of our NDA submission marks a significant milestone for Lantheus and our PyL clinical development program," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Prostate cancer is the second leading cause of cancer death in men. Fortunately, men can live for a long time with their disease if managed appropriately. There are approximately 3.2 million men in the United States annually living with this disease.1 We believe that PyL, if approved, will play an ongoing role in the diagnosis and management of prostate cancer."

The NDA is supported by data from two pivotal studies (OSPREY and CONDOR), designed to establish the safety and diagnostic performance of PyL imaging across the disease continuum of prostate cancer. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer. OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent prostate cancer, hormone sensitive prostate cancer, non-metastatic castrate resistant prostate cancer, and metastatic castrate resistant prostate cancer. OSPREY Cohort B demonstrated a sensitivity in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings, demonstrated a high correct localization rate and high detection rate, including patients with low PSA values. In the CONDOR study, 63.9% of patients had a change in intended disease management plans due to the PyL imaging results. We believe the results from these two studies, taken as a whole, demonstrate the ability of PyL to reliably detect and localize disease and could enable more appropriate patient management.

PyL has been administered in approximately 3,500 subjects globally, including the two Company sponsored studies, multiple investigator sponsored studies, as well as clinical use reported in the literature. Across all of these studies PyL has shown an attractive safety profile.

"We are extremely grateful to the prostate cancer patients and investigators who participated in PyL’s clinical development program," said Istvan Molnar, MD, Chief Medical Officer of Lantheus. "We believe that the demonstrated strong diagnostic performance of PyL, will assist in treatment decisions and, ultimately, may improve patient outcomes. We look forward to working with the FDA during the regulatory process in pursuit of our goal of bringing PyL to patients."

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About OSPREY

The Phase 2/3 OSPREY trial assessed the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high risk locally advanced prostate cancer (Cohort A) and distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% although the trial did not meet one of its the primary endpoints. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

About CONDOR

The Phase 3 CONDOR trial evaluated the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy. 63.9% of subjects in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the U.S. currently count themselves among prostate cancer survivors.1

On September 30, 2020 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that congratulated Orphazyme A/S (ORPHA.CO) (NASDAQ:ORPH) ("Orphazyme") on the September 29, 2020 pricing of its global offering, consisting of an initial public offering of American Depositary Shares in the U.S. and a concurrent private placement of ordinary shares in Europe. According to Orphazyme, the aggregate gross proceeds from its global offering will amount to approximately DKK 534,534,637 ($83,777,606 using a DKK/USD exchange rate of 6.3804) (assuming no exercise of the option to purchase additional shares) and DKK 614,714,770 ($96,344,237 using a DKK/USD exchange rate of 6.3804) (assuming full exercise of the option to purchase additional shares). CytRx has an agreement with Orphazyme that can yield milestone payments and royalties based on potential future sales of arimoclomol.

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In connection with Orphazyme’s global offering, it disclosed receipt of a filing communication from the U.S. Food and Drug Administration ("FDA") relating to the agency’s ordinary course review of its new drug application ("NDA") for arimoclomol in the treatment of Niemann-Pick disease Type C ("NPC"). The filing communication follows acceptance on a Priority Review basis by the FDA of Orphazyme’s NDA for arimoclomol in NPC and the agency’s establishment of the Prescription Drug User Fee Act ("PDUFA") target action date of March 17, 2021. Orphazyme stated that its receipt of the filing communication does not impact the FDA’s acceptance of its NDA, the target PDUFA action date or the Priority Review determination. Orphazyme’s disclosure notes that the filing communication constitutes preliminary notice from the FDA of potential review issues as part of its ordinary course review of the NDA and is not necessarily indicative of deficiencies that may be identified during the review. Orphazyme has stated that it intends to discuss the filing communication with the FDA.

In accordance with applicable securities laws, Orphazyme amended the registration statement on Form F-1 on file with the U.S. Securities and Exchange Commission. For further information concerning the FDA filing communication, we refer you to the "Recent Developments" section on Page 6 of Orphazyme’s amended Form F-1 filed on September 28, 2020.

CytRx will continue to provide updates that are relevant to its agreement with Orphazyme.

On September 30, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its tender offer to purchase any and all issued and outstanding shares of common stock of Pfenex Inc. (NYSE American: PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, expired at midnight (New York City time), at the end of the day on Tuesday, September 29, 2020 (Press release, Ligand, SEP 30, 2020, View Source [SID1234567818]).

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The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 27,591,554 shares were validly tendered and not withdrawn in the tender offer (including shares delivered through notices of guaranteed delivery), representing approximately 80.3% of Pfenex’s outstanding shares. Ligand’s wholly-owned subsidiary will accept for payment all shares that were validly tendered and not withdrawn prior to expiration of the tender offer, and payment for such shares will be made promptly, in accordance with the terms of the tender offer.

Ligand expects the merger to close on October 1, 2020, with Pfenex becoming a wholly owned subsidiary of Ligand. As a consequence of the merger, each outstanding Pfenex share not tendered and purchased in the offer (other than those as to which holders properly exercise dissenters’ rights and those owned at the commencement of the tender offer by Ligand or its direct and indirect subsidiaries) will be converted into the right to receive the same $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, without interest and less any required withholding taxes, that was offered in the tender offer. Following completion of the merger, Pfenex’s common stock will cease to be traded on the New York Stock Exchange American.

On September 30, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that management will participate in a fireside chat at the Jefferies Cell Therapy Virtual Summit on Tuesday, October 6, 2020 and 2:30 p.m. E.T (Press release, Fate Therapeutics, SEP 30, 2020, View Source [SID1234567817]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com.